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Captopril questioned for diabetes patients in COVID-19 setting
Captopril appears to be associated with a higher rate of pulmonary adverse reactions in patients with diabetes than that of other ACE inhibitors or angiotensin receptor blockers (ARBs) and therefore may not be the best choice for patients with diabetes and COVID-19, a new study suggests.
The study was published online in the Journal of the American Pharmacists Association.
The authors, led by Emma G. Stafford, PharmD, University of Missouri-Kansas City School of Pharmacy, note that diabetes seems to confer a higher risk of adverse outcomes in COVID-19 infection and there is conflicting data on the contribution of ACE inhibitors and ARBs, commonly used medications in diabetes, on the mortality and morbidity of COVID-19.
“In light of the recent COVID-19 outbreak, more research is needed to understand the effects that diabetes (and its medications) may have on the respiratory system and how that could affect the management of diseases such as COVID-19,” they say.
“Although ACE inhibitors and ARBs are generally considered to have similar adverse event profiles, evaluation of postmarketing adverse events may shed light on minute differences that could have important clinical impacts,” they add.
For the current study, the researchers analyzed data from multiple publicly available data sources on adverse drug reactions in patients with diabetes taking ACE inhibitors or ARBs. The data included all adverse drug events (ADEs) reported nationally to the US Food and Drug Administration and internationally to the Medical Dictionary for Regulatory Activities (MedDRA).
Results showed that captopril, the first ACE inhibitor approved back in 1981, has a higher incidence of pulmonary ADEs in patients with diabetes as compared with other ACE-inhibitor drugs (P = .005) as well as a statistically significant difference in pulmonary events compared with ARBs (P = .012).
“These analyses suggest that pharmacists and clinicians will need to consider the specific medication’s adverse event profile, particularly captopril, on how it may affect infections and other acute disease states that alter pulmonary function, such as COVID-19,” the authors conclude.
They say that the high incidence of pulmonary adverse drug effects with captopril “highlights the fact that the drugs belonging in one class are not identical and that its pharmacokinetics and pharmacodynamics can affect the patients’ health especially during acute processes like COVID-19.”
“This is especially important as current observational studies of COVID-19 patients tend to group drugs within a class and are not analyzing the potential differences within each class,” they add.
They note that ACE inhibitors can be broadly classified into 3 structural classes: sulfhydryl-, dicarboxyl-, and phosphorous- containing molecules. Notably, captopril is the only currently available ACE inhibitor belonging to the sulfhydryl-containing class and may explain the higher incidence of adverse drug effects observed, they comment.
“Health care providers have been left with many questions when treating patients with COVID-19, including how ACE inhibitors or ARBs may affect their clinical course. Results from this study may be helpful when prescribing or continuing ACE inhibitors or ARBs for patients with diabetes and infections or illnesses that may affect pulmonary function, such as COVID-19,” they conclude.
Questioning safety in COVID-19 an “overreach”
Commenting for Medscape Medical News, Michael A. Weber, MD, professor of medicine at State University of New York, said he thought the current article appears to overreach in questioning captopril’s safety in the COVID-19 setting.
“Captopril was the first ACE inhibitor available for clinical use. In early prescribing its dosage was not well understood and it might have been administered in excessive amounts,” Weber notes.
“There were some renal and other adverse effects reported that at first were attributed to the fact that captopril, unlike any other popular ACE inhibitors, contained a sulfhydryl (SH) group in its molecule,” he said. “It is not clear whether this feature could be responsible for the increased pulmonary side effects and potential danger to COVID-19 patients now reported with captopril in this new pharmacy article.”
But he adds: “The article contains no evidence that the effect of captopril or any other ACE inhibitor on the pulmonary ACE-2 enzyme has a deleterious effect on outcomes of COVID-19 disease. In any case, captopril — which should be prescribed in a twice-daily dose — is not frequently prescribed these days since newer ACE inhibitors are effective with just once-daily dosing.”
This article first appeared on Medscape.com.
Captopril appears to be associated with a higher rate of pulmonary adverse reactions in patients with diabetes than that of other ACE inhibitors or angiotensin receptor blockers (ARBs) and therefore may not be the best choice for patients with diabetes and COVID-19, a new study suggests.
The study was published online in the Journal of the American Pharmacists Association.
The authors, led by Emma G. Stafford, PharmD, University of Missouri-Kansas City School of Pharmacy, note that diabetes seems to confer a higher risk of adverse outcomes in COVID-19 infection and there is conflicting data on the contribution of ACE inhibitors and ARBs, commonly used medications in diabetes, on the mortality and morbidity of COVID-19.
“In light of the recent COVID-19 outbreak, more research is needed to understand the effects that diabetes (and its medications) may have on the respiratory system and how that could affect the management of diseases such as COVID-19,” they say.
“Although ACE inhibitors and ARBs are generally considered to have similar adverse event profiles, evaluation of postmarketing adverse events may shed light on minute differences that could have important clinical impacts,” they add.
For the current study, the researchers analyzed data from multiple publicly available data sources on adverse drug reactions in patients with diabetes taking ACE inhibitors or ARBs. The data included all adverse drug events (ADEs) reported nationally to the US Food and Drug Administration and internationally to the Medical Dictionary for Regulatory Activities (MedDRA).
Results showed that captopril, the first ACE inhibitor approved back in 1981, has a higher incidence of pulmonary ADEs in patients with diabetes as compared with other ACE-inhibitor drugs (P = .005) as well as a statistically significant difference in pulmonary events compared with ARBs (P = .012).
“These analyses suggest that pharmacists and clinicians will need to consider the specific medication’s adverse event profile, particularly captopril, on how it may affect infections and other acute disease states that alter pulmonary function, such as COVID-19,” the authors conclude.
They say that the high incidence of pulmonary adverse drug effects with captopril “highlights the fact that the drugs belonging in one class are not identical and that its pharmacokinetics and pharmacodynamics can affect the patients’ health especially during acute processes like COVID-19.”
“This is especially important as current observational studies of COVID-19 patients tend to group drugs within a class and are not analyzing the potential differences within each class,” they add.
They note that ACE inhibitors can be broadly classified into 3 structural classes: sulfhydryl-, dicarboxyl-, and phosphorous- containing molecules. Notably, captopril is the only currently available ACE inhibitor belonging to the sulfhydryl-containing class and may explain the higher incidence of adverse drug effects observed, they comment.
“Health care providers have been left with many questions when treating patients with COVID-19, including how ACE inhibitors or ARBs may affect their clinical course. Results from this study may be helpful when prescribing or continuing ACE inhibitors or ARBs for patients with diabetes and infections or illnesses that may affect pulmonary function, such as COVID-19,” they conclude.
Questioning safety in COVID-19 an “overreach”
Commenting for Medscape Medical News, Michael A. Weber, MD, professor of medicine at State University of New York, said he thought the current article appears to overreach in questioning captopril’s safety in the COVID-19 setting.
“Captopril was the first ACE inhibitor available for clinical use. In early prescribing its dosage was not well understood and it might have been administered in excessive amounts,” Weber notes.
“There were some renal and other adverse effects reported that at first were attributed to the fact that captopril, unlike any other popular ACE inhibitors, contained a sulfhydryl (SH) group in its molecule,” he said. “It is not clear whether this feature could be responsible for the increased pulmonary side effects and potential danger to COVID-19 patients now reported with captopril in this new pharmacy article.”
But he adds: “The article contains no evidence that the effect of captopril or any other ACE inhibitor on the pulmonary ACE-2 enzyme has a deleterious effect on outcomes of COVID-19 disease. In any case, captopril — which should be prescribed in a twice-daily dose — is not frequently prescribed these days since newer ACE inhibitors are effective with just once-daily dosing.”
This article first appeared on Medscape.com.
Captopril appears to be associated with a higher rate of pulmonary adverse reactions in patients with diabetes than that of other ACE inhibitors or angiotensin receptor blockers (ARBs) and therefore may not be the best choice for patients with diabetes and COVID-19, a new study suggests.
The study was published online in the Journal of the American Pharmacists Association.
The authors, led by Emma G. Stafford, PharmD, University of Missouri-Kansas City School of Pharmacy, note that diabetes seems to confer a higher risk of adverse outcomes in COVID-19 infection and there is conflicting data on the contribution of ACE inhibitors and ARBs, commonly used medications in diabetes, on the mortality and morbidity of COVID-19.
“In light of the recent COVID-19 outbreak, more research is needed to understand the effects that diabetes (and its medications) may have on the respiratory system and how that could affect the management of diseases such as COVID-19,” they say.
“Although ACE inhibitors and ARBs are generally considered to have similar adverse event profiles, evaluation of postmarketing adverse events may shed light on minute differences that could have important clinical impacts,” they add.
For the current study, the researchers analyzed data from multiple publicly available data sources on adverse drug reactions in patients with diabetes taking ACE inhibitors or ARBs. The data included all adverse drug events (ADEs) reported nationally to the US Food and Drug Administration and internationally to the Medical Dictionary for Regulatory Activities (MedDRA).
Results showed that captopril, the first ACE inhibitor approved back in 1981, has a higher incidence of pulmonary ADEs in patients with diabetes as compared with other ACE-inhibitor drugs (P = .005) as well as a statistically significant difference in pulmonary events compared with ARBs (P = .012).
“These analyses suggest that pharmacists and clinicians will need to consider the specific medication’s adverse event profile, particularly captopril, on how it may affect infections and other acute disease states that alter pulmonary function, such as COVID-19,” the authors conclude.
They say that the high incidence of pulmonary adverse drug effects with captopril “highlights the fact that the drugs belonging in one class are not identical and that its pharmacokinetics and pharmacodynamics can affect the patients’ health especially during acute processes like COVID-19.”
“This is especially important as current observational studies of COVID-19 patients tend to group drugs within a class and are not analyzing the potential differences within each class,” they add.
They note that ACE inhibitors can be broadly classified into 3 structural classes: sulfhydryl-, dicarboxyl-, and phosphorous- containing molecules. Notably, captopril is the only currently available ACE inhibitor belonging to the sulfhydryl-containing class and may explain the higher incidence of adverse drug effects observed, they comment.
“Health care providers have been left with many questions when treating patients with COVID-19, including how ACE inhibitors or ARBs may affect their clinical course. Results from this study may be helpful when prescribing or continuing ACE inhibitors or ARBs for patients with diabetes and infections or illnesses that may affect pulmonary function, such as COVID-19,” they conclude.
Questioning safety in COVID-19 an “overreach”
Commenting for Medscape Medical News, Michael A. Weber, MD, professor of medicine at State University of New York, said he thought the current article appears to overreach in questioning captopril’s safety in the COVID-19 setting.
“Captopril was the first ACE inhibitor available for clinical use. In early prescribing its dosage was not well understood and it might have been administered in excessive amounts,” Weber notes.
“There were some renal and other adverse effects reported that at first were attributed to the fact that captopril, unlike any other popular ACE inhibitors, contained a sulfhydryl (SH) group in its molecule,” he said. “It is not clear whether this feature could be responsible for the increased pulmonary side effects and potential danger to COVID-19 patients now reported with captopril in this new pharmacy article.”
But he adds: “The article contains no evidence that the effect of captopril or any other ACE inhibitor on the pulmonary ACE-2 enzyme has a deleterious effect on outcomes of COVID-19 disease. In any case, captopril — which should be prescribed in a twice-daily dose — is not frequently prescribed these days since newer ACE inhibitors are effective with just once-daily dosing.”
This article first appeared on Medscape.com.
Part 2: Controlling BP in Diabetes Patients
Previously, I introduced the topic of self-care for patients with diabetes to prevent complications. Now let’s explore how to help reduce risk for cardiovascular conditions in these patients, starting with blood pressure control.
CASE CONTINUED
Mr. W’s vitals include a heart rate of 82; BP, 150/86 mm Hg; and O2 saturation, 98%. He is afebrile. You consider how to best manage glucose control and reduce the risk for cardiovascular conditions.
Reducing the Risk for Cardiovascular Conditions
The ADA recommends at least annual systematic assessment of cardiovascular risk factors, including weight, hypertension, dyslipidemia, chronic kidney disease (CKD), and presence of albuminuria.2 Managing these conditions to the standards supported by currently available evidence should reduce the risk for ASCVD in patients such as Mr. W. Two newer medication classes—glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors—offer potential benefit in reducing cardiovascular risk.15,16 Consider these medications for patients with diabetes or known ASCVD or for those who are at high risk for ASCVD and/or CKD.2,7
Furthermore, the ADA recommends using a risk calculator, such as the ASCVD Risk Estimator Plus created by the American College of Cardiology/American Heart Association (see http://tools.acc.org/ASCVD-Risk-Estimator-Plus), to stratify the 10-year risk for a first ASCVD event.2 This calculator can produce results that can help guide an individualized risk-reduction treatment plan for each patient. Also, consider low-dose aspirin for primary prevention in those at high risk for ASCVD (10-year risk > 10%) and for secondary prevention of ASCVD in those who have already had a cardiovascular event.2,7
Setting and Meeting BP Goals
Hypertension is common in patients with diabetes, with a recent study suggesting that ≥ 67% of these patients have elevated BP.17 Significant evidence demonstrates that BP control reduces morbidity and mortality in diabetes.18 Although the importance of BP control in this setting is widely known, recent studies have demonstrated that only 30% to 42% of affected patients meet their BP goals.19,20
How to make a BP goal. Guideline recommendations for setting specific BP goals have varied slightly over the past several years and are influenced by known comorbidities such as ASCVD and CKD. Patients should be part of the decision-making process to individualize goals based on their circumstances and safety. A BP goal of < 130/80 mm Hg is generally acceptable for patients who are known to have ASCVD or who are at high risk (≥ 15% risk) for ASCVD in the next 10 years.7 A goal of < 140/90 mm Hg is considered appropriate in those with a lower risk for ASCVD.7,8,21,22
Medications. Selecting an appropriate antihypertensive medication relies on multiple factors. Evidence supports the use of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers for diabetes, and both the AACE and ADA recommend these medications as an initial treatment option.2,7 They help reduce the progression of kidney disease in patients with albuminuria and may improve cardiovascular outcomes.23-27 When additional agents are needed to meet BP goals, the ADA recommends thiazide-like diuretics (chlorthalidone and indapamide) or calcium channel blockers (dihydropyridine).2 Although some hyperglycemic adverse effects have been observed with use of thiazide-like diuretics, these might be outweighed by the benefit of BP control.24
Continue to: Monitor the patient's BP
Monitor the patient’s BP at every visit, and advise the patient to regularly measure his or her BP at home with a BP cuff. Patients who may need assistance with at-home monitoring can be directed to an online guide on how to accurately measure their BP (see www.heart.org/en/health-topics/high-blood-pressure/understanding-blood-pressure-readings/monitoring-your-blood-pressure-at-home). For those who report consistently above-goal measurements at home, advise them to check their BP cuff, because an ill-fitting cuff is a well-known cause of inaccurate measurement. Patients also should be assessed for medication nonadherence, white coat hypertension, and secondary hypertension.7,8 If a patient’s BP is truly above goal, a step-up in therapy may be appropriate because without adequate BP control, the benefit in mortality and morbidity may not be fully realized.28
In Part 3, we’ll check in with Mr. W and discuss which patients require assessment for dyslipidemia. We’ll also explore the treatments, such as statin therapy, for this condition.
1. Centers for Disease Control and Prevention. Diabetes incidence and prevalence. Diabetes Report Card 2017. www.cdc.gov/diabetes/library/reports/reportcard/incidence-2017.html. Published 2018. Accessed June 18, 2020.
2. Standards of Medical Care in Diabetes—2020 Abridged for Primary Care Providers. American Diabetes Association Clinical Diabetes. 2020;38(1):10-38.
3. Chen Y, Sloan FA, Yashkin AP. Adherence to diabetes guidelines for screening, physical activity and medication and onset of complications and death. J Diabetes Complications. 2015;29(8):1228-1233.
4. Mehta S, Mocarski M, Wisniewski T, et al. Primary care physicians’ utilization of type 2 diabetes screening guidelines and referrals to behavioral interventions: a survey-linked retrospective study. BMJ Open Diabetes Res Care. 2017;5(1):e000406.
5. Center for Disease Control and Prevention. Preventive care practices. Diabetes Report Card 2017. www.cdc.gov/diabetes/library/reports/reportcard/preventive-care.html. Published 2018. Accessed June 18, 2020.
6. Arnold SV, de Lemos JA, Rosenson RS, et al; GOULD Investigators. Use of guideline-recommended risk reduction strategies among patients with diabetes and atherosclerotic cardiovascular disease. Circulation. 2019;140(7):618-620.
7. Garber AJ, Handelsman Y, Grunberger G, et al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm—2020 executive summary. Endocr Pract Endocr Pract. 2020;26(1):107-139.
8. American Diabetes Association. Comprehensive medical evaluation and assessment of comorbidities: standards of medical care in diabetes—2020. Diabetes Care. 2020;43(suppl 1):S37-S47.
9. Beck J, Greenwood DA, Blanton L, et al; 2017 Standards Revision Task Force. 2017 National Standards for diabetes self-management education and support. Diabetes Educ. 2017;43(5): 449-464.
10. Chrvala CA, Sherr D, Lipman RD. Diabetes self-management education for adults with type 2 diabetes mellitus: a systematic review of the effect on glycemic control. Patient Educ Couns. 2016;99(6):926-943.
11. Association of Diabetes Care & Education Specialists. Find a diabetes education program in your area. www.diabeteseducator.org/living-with-diabetes/find-an-education-program. Accessed June 15, 2020.
12. Estruch R, Ros E, Salas-Salvadó J, et al; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet supplemented with extra-virgin olive oil or nuts. NEJM. 2018;378(25):e34.
13. Centers for Disease Control and Prevention. Tips for better sleep. Sleep and sleep disorders. www.cdc.gov/sleep/about_sleep/sleep_hygiene.html. Reviewed July 15, 2016. Accessed June 18, 2020.
14. Doumit J, Prasad B. Sleep Apnea in Type 2 Diabetes. Diabetes Spectrum. 2016; 29(1): 14-19.
15. Marso SP, Daniels GH, Brown-Frandsen K, et al; LEADER Steering Committee on behalf of the LEADER Trial Investigators. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375:311-322.
16. Perkovic V, Jardine MJ, Neal B, et al; CREDENCE Trial Investigators. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med. 2019;380(24):2295-2306.
17. Trends in Blood pressure control and treatment among type 2 diabetes with comorbid hypertension in the United States: 1988-2004. J Hypertens. 2009;27(9):1908-1916.
18. Emdin CA, Rahimi K, Neal B, et al. Blood pressure lowering in type 2 diabetes: a systematic review and meta-analysis. JAMA. 2015;313(6):603-615.
19. Vouri SM, Shaw RF, Waterbury NV, et al. Prevalence of achievement of A1c, blood pressure, and cholesterol (ABC) goal in veterans with diabetes. J Manag Care Pharm. 2011;17(4):304-312.
20. Kudo N, Yokokawa H, Fukuda H, et al. Achievement of target blood pressure levels among Japanese workers with hypertension and healthy lifestyle characteristics associated with therapeutic failure. Plos One. 2015;10(7):e0133641.
21. Carey RM, Whelton PK; 2017 ACC/AHA Hypertension Guideline Writing Committee. Prevention, detection, evaluation, and management of high blood pressure in adults: synopsis of the 2017 American College of Cardiology/American Heart Association Hypertension guideline. Ann Intern Med. 2018;168(5):351-358.
22. Deedwania PC. Blood pressure control in diabetes mellitus. Circulation. 2011;123:2776–2778.
23. Catalá-López F, Saint-Gerons DM, González-Bermejo D, et al. Cardiovascular and renal outcomes of renin-angiotensin system blockade in adult patients with diabetes mellitus: a systematic review with network meta-analyses. PLoS Med. 2016;13(3):e1001971.
24. Furberg CD, Wright JT Jr, Davis BR, et al; ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002;288(23):2981-2997.
25. Sleight P. The HOPE Study (Heart Outcomes Prevention Evaluation). J Renin-Angiotensin-Aldosterone Syst. 2000;1(1):18-20.
26. Tatti P, Pahor M, Byington RP, et al. Outcome results of the Fosinopril Versus Amlodipine Cardiovascular Events Randomized Trial (FACET) in patients with hypertension and NIDDM. Diabetes Care. 1998;21(4):597-603.
27. Schrier RW, Estacio RO, Jeffers B. Appropriate Blood Pressure Control in NIDDM (ABCD) Trial. Diabetologia. 1996;39(12):1646-1654.
28. Hansson L, Zanchetti A, Carruthers SG, et al; HOT Study Group. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) Randomised Trial. Lancet. 1998;351(9118):1755-1762.
29. Baigent C, Blackwell L, Emberson J, et al; Cholesterol Treatment Trialists’ (CTT) Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010;376(9753):1670-1681.
30. Fu AZ, Zhang Q, Davies MJ, et al. Underutilization of statins in patients with type 2 diabetes in US clinical practice: a retrospective cohort study. Curr Med Res Opin. 2011;27(5):1035-1040.
31. Cannon CP, Blazing MA, Giugliano RP, et al; IMPROVE-IT Investigators. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med. 2015; 372:2387-2397
32. Sabatine MS, Giugliano RP, Keech AC, et al; the FOURIER Steering Committee and Investigators. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713-1722.
33. Schwartz GG, Steg PG, Szarek M, et al; ODYSSEY OUTCOMES Committees and Investigators. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome | NEJM. N Engl J Med. 2018;379:2097-2107.
34. Icosapent ethyl [package insert]. Bridgewater, NJ: Amarin Pharma, Inc.; 2019.
35. Bhatt DL, Steg PG, Miller M, et al; REDUCE-IT Investigators. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. 2019;380:11-22
36. Bolton WK. Renal Physicians Association Clinical practice guideline: appropriate patient preparation for renal replacement therapy: guideline number 3. J Am Soc Nephrol. 2003;14(5):1406-1410.
37. American Diabetes Association. Pharmacologic Approaches to glycemic treatment: standards of medical care in diabetes—2020. Diabetes Care. 2020;43(suppl 1):S98-S110.
38. Qaseem A, Barry MJ, Humphrey LL, Forciea MA; Clinical Guidelines Committee of the American College of Physicians. Oral pharmacologic treatment of type 2 diabetes mellitus: a clinical practice guideline update from the American College of Physicians. Ann Intern Med. 2017;166(4):279-290.
39. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease–mineral and bone disorder (CKD-MBD). Kidney Int Suppl (2011). 2017;7(1):1-59.
40. Pop-Busui R, Boulton AJM, Feldman EL, et al. Diabetic neuropathy: a position statement by the American Diabetes Association. Diabetes Care. 2017;40(1):136-154.
41. Gupta V, Bansal R, Gupta A, Bhansali A. The sensitivity and specificity of nonmydriatic digital stereoscopic retinal imaging in detecting diabetic retinopathy. Indian J Ophthalmol. 2014;62(8):851-856.
42. Pérez MA, Bruce BB, Newman NJ, Biousse V. The use of retinal photography in non-ophthalmic settings and its potential for neurology. The Neurologist. 2012;18(6):350-355.
Clinician Reviews in partnership with
Courtney Bennett Wilke is an Assistant Professor at Florida State University College of Medicine, School of Physician Assistant Practice, Tallahassee.
Clinician Reviews in partnership with
Courtney Bennett Wilke is an Assistant Professor at Florida State University College of Medicine, School of Physician Assistant Practice, Tallahassee.
Clinician Reviews in partnership with
Courtney Bennett Wilke is an Assistant Professor at Florida State University College of Medicine, School of Physician Assistant Practice, Tallahassee.
Previously, I introduced the topic of self-care for patients with diabetes to prevent complications. Now let’s explore how to help reduce risk for cardiovascular conditions in these patients, starting with blood pressure control.
CASE CONTINUED
Mr. W’s vitals include a heart rate of 82; BP, 150/86 mm Hg; and O2 saturation, 98%. He is afebrile. You consider how to best manage glucose control and reduce the risk for cardiovascular conditions.
Reducing the Risk for Cardiovascular Conditions
The ADA recommends at least annual systematic assessment of cardiovascular risk factors, including weight, hypertension, dyslipidemia, chronic kidney disease (CKD), and presence of albuminuria.2 Managing these conditions to the standards supported by currently available evidence should reduce the risk for ASCVD in patients such as Mr. W. Two newer medication classes—glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors—offer potential benefit in reducing cardiovascular risk.15,16 Consider these medications for patients with diabetes or known ASCVD or for those who are at high risk for ASCVD and/or CKD.2,7
Furthermore, the ADA recommends using a risk calculator, such as the ASCVD Risk Estimator Plus created by the American College of Cardiology/American Heart Association (see http://tools.acc.org/ASCVD-Risk-Estimator-Plus), to stratify the 10-year risk for a first ASCVD event.2 This calculator can produce results that can help guide an individualized risk-reduction treatment plan for each patient. Also, consider low-dose aspirin for primary prevention in those at high risk for ASCVD (10-year risk > 10%) and for secondary prevention of ASCVD in those who have already had a cardiovascular event.2,7
Setting and Meeting BP Goals
Hypertension is common in patients with diabetes, with a recent study suggesting that ≥ 67% of these patients have elevated BP.17 Significant evidence demonstrates that BP control reduces morbidity and mortality in diabetes.18 Although the importance of BP control in this setting is widely known, recent studies have demonstrated that only 30% to 42% of affected patients meet their BP goals.19,20
How to make a BP goal. Guideline recommendations for setting specific BP goals have varied slightly over the past several years and are influenced by known comorbidities such as ASCVD and CKD. Patients should be part of the decision-making process to individualize goals based on their circumstances and safety. A BP goal of < 130/80 mm Hg is generally acceptable for patients who are known to have ASCVD or who are at high risk (≥ 15% risk) for ASCVD in the next 10 years.7 A goal of < 140/90 mm Hg is considered appropriate in those with a lower risk for ASCVD.7,8,21,22
Medications. Selecting an appropriate antihypertensive medication relies on multiple factors. Evidence supports the use of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers for diabetes, and both the AACE and ADA recommend these medications as an initial treatment option.2,7 They help reduce the progression of kidney disease in patients with albuminuria and may improve cardiovascular outcomes.23-27 When additional agents are needed to meet BP goals, the ADA recommends thiazide-like diuretics (chlorthalidone and indapamide) or calcium channel blockers (dihydropyridine).2 Although some hyperglycemic adverse effects have been observed with use of thiazide-like diuretics, these might be outweighed by the benefit of BP control.24
Continue to: Monitor the patient's BP
Monitor the patient’s BP at every visit, and advise the patient to regularly measure his or her BP at home with a BP cuff. Patients who may need assistance with at-home monitoring can be directed to an online guide on how to accurately measure their BP (see www.heart.org/en/health-topics/high-blood-pressure/understanding-blood-pressure-readings/monitoring-your-blood-pressure-at-home). For those who report consistently above-goal measurements at home, advise them to check their BP cuff, because an ill-fitting cuff is a well-known cause of inaccurate measurement. Patients also should be assessed for medication nonadherence, white coat hypertension, and secondary hypertension.7,8 If a patient’s BP is truly above goal, a step-up in therapy may be appropriate because without adequate BP control, the benefit in mortality and morbidity may not be fully realized.28
In Part 3, we’ll check in with Mr. W and discuss which patients require assessment for dyslipidemia. We’ll also explore the treatments, such as statin therapy, for this condition.
Previously, I introduced the topic of self-care for patients with diabetes to prevent complications. Now let’s explore how to help reduce risk for cardiovascular conditions in these patients, starting with blood pressure control.
CASE CONTINUED
Mr. W’s vitals include a heart rate of 82; BP, 150/86 mm Hg; and O2 saturation, 98%. He is afebrile. You consider how to best manage glucose control and reduce the risk for cardiovascular conditions.
Reducing the Risk for Cardiovascular Conditions
The ADA recommends at least annual systematic assessment of cardiovascular risk factors, including weight, hypertension, dyslipidemia, chronic kidney disease (CKD), and presence of albuminuria.2 Managing these conditions to the standards supported by currently available evidence should reduce the risk for ASCVD in patients such as Mr. W. Two newer medication classes—glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors—offer potential benefit in reducing cardiovascular risk.15,16 Consider these medications for patients with diabetes or known ASCVD or for those who are at high risk for ASCVD and/or CKD.2,7
Furthermore, the ADA recommends using a risk calculator, such as the ASCVD Risk Estimator Plus created by the American College of Cardiology/American Heart Association (see http://tools.acc.org/ASCVD-Risk-Estimator-Plus), to stratify the 10-year risk for a first ASCVD event.2 This calculator can produce results that can help guide an individualized risk-reduction treatment plan for each patient. Also, consider low-dose aspirin for primary prevention in those at high risk for ASCVD (10-year risk > 10%) and for secondary prevention of ASCVD in those who have already had a cardiovascular event.2,7
Setting and Meeting BP Goals
Hypertension is common in patients with diabetes, with a recent study suggesting that ≥ 67% of these patients have elevated BP.17 Significant evidence demonstrates that BP control reduces morbidity and mortality in diabetes.18 Although the importance of BP control in this setting is widely known, recent studies have demonstrated that only 30% to 42% of affected patients meet their BP goals.19,20
How to make a BP goal. Guideline recommendations for setting specific BP goals have varied slightly over the past several years and are influenced by known comorbidities such as ASCVD and CKD. Patients should be part of the decision-making process to individualize goals based on their circumstances and safety. A BP goal of < 130/80 mm Hg is generally acceptable for patients who are known to have ASCVD or who are at high risk (≥ 15% risk) for ASCVD in the next 10 years.7 A goal of < 140/90 mm Hg is considered appropriate in those with a lower risk for ASCVD.7,8,21,22
Medications. Selecting an appropriate antihypertensive medication relies on multiple factors. Evidence supports the use of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers for diabetes, and both the AACE and ADA recommend these medications as an initial treatment option.2,7 They help reduce the progression of kidney disease in patients with albuminuria and may improve cardiovascular outcomes.23-27 When additional agents are needed to meet BP goals, the ADA recommends thiazide-like diuretics (chlorthalidone and indapamide) or calcium channel blockers (dihydropyridine).2 Although some hyperglycemic adverse effects have been observed with use of thiazide-like diuretics, these might be outweighed by the benefit of BP control.24
Continue to: Monitor the patient's BP
Monitor the patient’s BP at every visit, and advise the patient to regularly measure his or her BP at home with a BP cuff. Patients who may need assistance with at-home monitoring can be directed to an online guide on how to accurately measure their BP (see www.heart.org/en/health-topics/high-blood-pressure/understanding-blood-pressure-readings/monitoring-your-blood-pressure-at-home). For those who report consistently above-goal measurements at home, advise them to check their BP cuff, because an ill-fitting cuff is a well-known cause of inaccurate measurement. Patients also should be assessed for medication nonadherence, white coat hypertension, and secondary hypertension.7,8 If a patient’s BP is truly above goal, a step-up in therapy may be appropriate because without adequate BP control, the benefit in mortality and morbidity may not be fully realized.28
In Part 3, we’ll check in with Mr. W and discuss which patients require assessment for dyslipidemia. We’ll also explore the treatments, such as statin therapy, for this condition.
1. Centers for Disease Control and Prevention. Diabetes incidence and prevalence. Diabetes Report Card 2017. www.cdc.gov/diabetes/library/reports/reportcard/incidence-2017.html. Published 2018. Accessed June 18, 2020.
2. Standards of Medical Care in Diabetes—2020 Abridged for Primary Care Providers. American Diabetes Association Clinical Diabetes. 2020;38(1):10-38.
3. Chen Y, Sloan FA, Yashkin AP. Adherence to diabetes guidelines for screening, physical activity and medication and onset of complications and death. J Diabetes Complications. 2015;29(8):1228-1233.
4. Mehta S, Mocarski M, Wisniewski T, et al. Primary care physicians’ utilization of type 2 diabetes screening guidelines and referrals to behavioral interventions: a survey-linked retrospective study. BMJ Open Diabetes Res Care. 2017;5(1):e000406.
5. Center for Disease Control and Prevention. Preventive care practices. Diabetes Report Card 2017. www.cdc.gov/diabetes/library/reports/reportcard/preventive-care.html. Published 2018. Accessed June 18, 2020.
6. Arnold SV, de Lemos JA, Rosenson RS, et al; GOULD Investigators. Use of guideline-recommended risk reduction strategies among patients with diabetes and atherosclerotic cardiovascular disease. Circulation. 2019;140(7):618-620.
7. Garber AJ, Handelsman Y, Grunberger G, et al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm—2020 executive summary. Endocr Pract Endocr Pract. 2020;26(1):107-139.
8. American Diabetes Association. Comprehensive medical evaluation and assessment of comorbidities: standards of medical care in diabetes—2020. Diabetes Care. 2020;43(suppl 1):S37-S47.
9. Beck J, Greenwood DA, Blanton L, et al; 2017 Standards Revision Task Force. 2017 National Standards for diabetes self-management education and support. Diabetes Educ. 2017;43(5): 449-464.
10. Chrvala CA, Sherr D, Lipman RD. Diabetes self-management education for adults with type 2 diabetes mellitus: a systematic review of the effect on glycemic control. Patient Educ Couns. 2016;99(6):926-943.
11. Association of Diabetes Care & Education Specialists. Find a diabetes education program in your area. www.diabeteseducator.org/living-with-diabetes/find-an-education-program. Accessed June 15, 2020.
12. Estruch R, Ros E, Salas-Salvadó J, et al; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet supplemented with extra-virgin olive oil or nuts. NEJM. 2018;378(25):e34.
13. Centers for Disease Control and Prevention. Tips for better sleep. Sleep and sleep disorders. www.cdc.gov/sleep/about_sleep/sleep_hygiene.html. Reviewed July 15, 2016. Accessed June 18, 2020.
14. Doumit J, Prasad B. Sleep Apnea in Type 2 Diabetes. Diabetes Spectrum. 2016; 29(1): 14-19.
15. Marso SP, Daniels GH, Brown-Frandsen K, et al; LEADER Steering Committee on behalf of the LEADER Trial Investigators. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375:311-322.
16. Perkovic V, Jardine MJ, Neal B, et al; CREDENCE Trial Investigators. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med. 2019;380(24):2295-2306.
17. Trends in Blood pressure control and treatment among type 2 diabetes with comorbid hypertension in the United States: 1988-2004. J Hypertens. 2009;27(9):1908-1916.
18. Emdin CA, Rahimi K, Neal B, et al. Blood pressure lowering in type 2 diabetes: a systematic review and meta-analysis. JAMA. 2015;313(6):603-615.
19. Vouri SM, Shaw RF, Waterbury NV, et al. Prevalence of achievement of A1c, blood pressure, and cholesterol (ABC) goal in veterans with diabetes. J Manag Care Pharm. 2011;17(4):304-312.
20. Kudo N, Yokokawa H, Fukuda H, et al. Achievement of target blood pressure levels among Japanese workers with hypertension and healthy lifestyle characteristics associated with therapeutic failure. Plos One. 2015;10(7):e0133641.
21. Carey RM, Whelton PK; 2017 ACC/AHA Hypertension Guideline Writing Committee. Prevention, detection, evaluation, and management of high blood pressure in adults: synopsis of the 2017 American College of Cardiology/American Heart Association Hypertension guideline. Ann Intern Med. 2018;168(5):351-358.
22. Deedwania PC. Blood pressure control in diabetes mellitus. Circulation. 2011;123:2776–2778.
23. Catalá-López F, Saint-Gerons DM, González-Bermejo D, et al. Cardiovascular and renal outcomes of renin-angiotensin system blockade in adult patients with diabetes mellitus: a systematic review with network meta-analyses. PLoS Med. 2016;13(3):e1001971.
24. Furberg CD, Wright JT Jr, Davis BR, et al; ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002;288(23):2981-2997.
25. Sleight P. The HOPE Study (Heart Outcomes Prevention Evaluation). J Renin-Angiotensin-Aldosterone Syst. 2000;1(1):18-20.
26. Tatti P, Pahor M, Byington RP, et al. Outcome results of the Fosinopril Versus Amlodipine Cardiovascular Events Randomized Trial (FACET) in patients with hypertension and NIDDM. Diabetes Care. 1998;21(4):597-603.
27. Schrier RW, Estacio RO, Jeffers B. Appropriate Blood Pressure Control in NIDDM (ABCD) Trial. Diabetologia. 1996;39(12):1646-1654.
28. Hansson L, Zanchetti A, Carruthers SG, et al; HOT Study Group. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) Randomised Trial. Lancet. 1998;351(9118):1755-1762.
29. Baigent C, Blackwell L, Emberson J, et al; Cholesterol Treatment Trialists’ (CTT) Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010;376(9753):1670-1681.
30. Fu AZ, Zhang Q, Davies MJ, et al. Underutilization of statins in patients with type 2 diabetes in US clinical practice: a retrospective cohort study. Curr Med Res Opin. 2011;27(5):1035-1040.
31. Cannon CP, Blazing MA, Giugliano RP, et al; IMPROVE-IT Investigators. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med. 2015; 372:2387-2397
32. Sabatine MS, Giugliano RP, Keech AC, et al; the FOURIER Steering Committee and Investigators. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713-1722.
33. Schwartz GG, Steg PG, Szarek M, et al; ODYSSEY OUTCOMES Committees and Investigators. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome | NEJM. N Engl J Med. 2018;379:2097-2107.
34. Icosapent ethyl [package insert]. Bridgewater, NJ: Amarin Pharma, Inc.; 2019.
35. Bhatt DL, Steg PG, Miller M, et al; REDUCE-IT Investigators. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. 2019;380:11-22
36. Bolton WK. Renal Physicians Association Clinical practice guideline: appropriate patient preparation for renal replacement therapy: guideline number 3. J Am Soc Nephrol. 2003;14(5):1406-1410.
37. American Diabetes Association. Pharmacologic Approaches to glycemic treatment: standards of medical care in diabetes—2020. Diabetes Care. 2020;43(suppl 1):S98-S110.
38. Qaseem A, Barry MJ, Humphrey LL, Forciea MA; Clinical Guidelines Committee of the American College of Physicians. Oral pharmacologic treatment of type 2 diabetes mellitus: a clinical practice guideline update from the American College of Physicians. Ann Intern Med. 2017;166(4):279-290.
39. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease–mineral and bone disorder (CKD-MBD). Kidney Int Suppl (2011). 2017;7(1):1-59.
40. Pop-Busui R, Boulton AJM, Feldman EL, et al. Diabetic neuropathy: a position statement by the American Diabetes Association. Diabetes Care. 2017;40(1):136-154.
41. Gupta V, Bansal R, Gupta A, Bhansali A. The sensitivity and specificity of nonmydriatic digital stereoscopic retinal imaging in detecting diabetic retinopathy. Indian J Ophthalmol. 2014;62(8):851-856.
42. Pérez MA, Bruce BB, Newman NJ, Biousse V. The use of retinal photography in non-ophthalmic settings and its potential for neurology. The Neurologist. 2012;18(6):350-355.
1. Centers for Disease Control and Prevention. Diabetes incidence and prevalence. Diabetes Report Card 2017. www.cdc.gov/diabetes/library/reports/reportcard/incidence-2017.html. Published 2018. Accessed June 18, 2020.
2. Standards of Medical Care in Diabetes—2020 Abridged for Primary Care Providers. American Diabetes Association Clinical Diabetes. 2020;38(1):10-38.
3. Chen Y, Sloan FA, Yashkin AP. Adherence to diabetes guidelines for screening, physical activity and medication and onset of complications and death. J Diabetes Complications. 2015;29(8):1228-1233.
4. Mehta S, Mocarski M, Wisniewski T, et al. Primary care physicians’ utilization of type 2 diabetes screening guidelines and referrals to behavioral interventions: a survey-linked retrospective study. BMJ Open Diabetes Res Care. 2017;5(1):e000406.
5. Center for Disease Control and Prevention. Preventive care practices. Diabetes Report Card 2017. www.cdc.gov/diabetes/library/reports/reportcard/preventive-care.html. Published 2018. Accessed June 18, 2020.
6. Arnold SV, de Lemos JA, Rosenson RS, et al; GOULD Investigators. Use of guideline-recommended risk reduction strategies among patients with diabetes and atherosclerotic cardiovascular disease. Circulation. 2019;140(7):618-620.
7. Garber AJ, Handelsman Y, Grunberger G, et al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm—2020 executive summary. Endocr Pract Endocr Pract. 2020;26(1):107-139.
8. American Diabetes Association. Comprehensive medical evaluation and assessment of comorbidities: standards of medical care in diabetes—2020. Diabetes Care. 2020;43(suppl 1):S37-S47.
9. Beck J, Greenwood DA, Blanton L, et al; 2017 Standards Revision Task Force. 2017 National Standards for diabetes self-management education and support. Diabetes Educ. 2017;43(5): 449-464.
10. Chrvala CA, Sherr D, Lipman RD. Diabetes self-management education for adults with type 2 diabetes mellitus: a systematic review of the effect on glycemic control. Patient Educ Couns. 2016;99(6):926-943.
11. Association of Diabetes Care & Education Specialists. Find a diabetes education program in your area. www.diabeteseducator.org/living-with-diabetes/find-an-education-program. Accessed June 15, 2020.
12. Estruch R, Ros E, Salas-Salvadó J, et al; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet supplemented with extra-virgin olive oil or nuts. NEJM. 2018;378(25):e34.
13. Centers for Disease Control and Prevention. Tips for better sleep. Sleep and sleep disorders. www.cdc.gov/sleep/about_sleep/sleep_hygiene.html. Reviewed July 15, 2016. Accessed June 18, 2020.
14. Doumit J, Prasad B. Sleep Apnea in Type 2 Diabetes. Diabetes Spectrum. 2016; 29(1): 14-19.
15. Marso SP, Daniels GH, Brown-Frandsen K, et al; LEADER Steering Committee on behalf of the LEADER Trial Investigators. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375:311-322.
16. Perkovic V, Jardine MJ, Neal B, et al; CREDENCE Trial Investigators. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med. 2019;380(24):2295-2306.
17. Trends in Blood pressure control and treatment among type 2 diabetes with comorbid hypertension in the United States: 1988-2004. J Hypertens. 2009;27(9):1908-1916.
18. Emdin CA, Rahimi K, Neal B, et al. Blood pressure lowering in type 2 diabetes: a systematic review and meta-analysis. JAMA. 2015;313(6):603-615.
19. Vouri SM, Shaw RF, Waterbury NV, et al. Prevalence of achievement of A1c, blood pressure, and cholesterol (ABC) goal in veterans with diabetes. J Manag Care Pharm. 2011;17(4):304-312.
20. Kudo N, Yokokawa H, Fukuda H, et al. Achievement of target blood pressure levels among Japanese workers with hypertension and healthy lifestyle characteristics associated with therapeutic failure. Plos One. 2015;10(7):e0133641.
21. Carey RM, Whelton PK; 2017 ACC/AHA Hypertension Guideline Writing Committee. Prevention, detection, evaluation, and management of high blood pressure in adults: synopsis of the 2017 American College of Cardiology/American Heart Association Hypertension guideline. Ann Intern Med. 2018;168(5):351-358.
22. Deedwania PC. Blood pressure control in diabetes mellitus. Circulation. 2011;123:2776–2778.
23. Catalá-López F, Saint-Gerons DM, González-Bermejo D, et al. Cardiovascular and renal outcomes of renin-angiotensin system blockade in adult patients with diabetes mellitus: a systematic review with network meta-analyses. PLoS Med. 2016;13(3):e1001971.
24. Furberg CD, Wright JT Jr, Davis BR, et al; ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002;288(23):2981-2997.
25. Sleight P. The HOPE Study (Heart Outcomes Prevention Evaluation). J Renin-Angiotensin-Aldosterone Syst. 2000;1(1):18-20.
26. Tatti P, Pahor M, Byington RP, et al. Outcome results of the Fosinopril Versus Amlodipine Cardiovascular Events Randomized Trial (FACET) in patients with hypertension and NIDDM. Diabetes Care. 1998;21(4):597-603.
27. Schrier RW, Estacio RO, Jeffers B. Appropriate Blood Pressure Control in NIDDM (ABCD) Trial. Diabetologia. 1996;39(12):1646-1654.
28. Hansson L, Zanchetti A, Carruthers SG, et al; HOT Study Group. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) Randomised Trial. Lancet. 1998;351(9118):1755-1762.
29. Baigent C, Blackwell L, Emberson J, et al; Cholesterol Treatment Trialists’ (CTT) Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010;376(9753):1670-1681.
30. Fu AZ, Zhang Q, Davies MJ, et al. Underutilization of statins in patients with type 2 diabetes in US clinical practice: a retrospective cohort study. Curr Med Res Opin. 2011;27(5):1035-1040.
31. Cannon CP, Blazing MA, Giugliano RP, et al; IMPROVE-IT Investigators. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med. 2015; 372:2387-2397
32. Sabatine MS, Giugliano RP, Keech AC, et al; the FOURIER Steering Committee and Investigators. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713-1722.
33. Schwartz GG, Steg PG, Szarek M, et al; ODYSSEY OUTCOMES Committees and Investigators. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome | NEJM. N Engl J Med. 2018;379:2097-2107.
34. Icosapent ethyl [package insert]. Bridgewater, NJ: Amarin Pharma, Inc.; 2019.
35. Bhatt DL, Steg PG, Miller M, et al; REDUCE-IT Investigators. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. 2019;380:11-22
36. Bolton WK. Renal Physicians Association Clinical practice guideline: appropriate patient preparation for renal replacement therapy: guideline number 3. J Am Soc Nephrol. 2003;14(5):1406-1410.
37. American Diabetes Association. Pharmacologic Approaches to glycemic treatment: standards of medical care in diabetes—2020. Diabetes Care. 2020;43(suppl 1):S98-S110.
38. Qaseem A, Barry MJ, Humphrey LL, Forciea MA; Clinical Guidelines Committee of the American College of Physicians. Oral pharmacologic treatment of type 2 diabetes mellitus: a clinical practice guideline update from the American College of Physicians. Ann Intern Med. 2017;166(4):279-290.
39. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease–mineral and bone disorder (CKD-MBD). Kidney Int Suppl (2011). 2017;7(1):1-59.
40. Pop-Busui R, Boulton AJM, Feldman EL, et al. Diabetic neuropathy: a position statement by the American Diabetes Association. Diabetes Care. 2017;40(1):136-154.
41. Gupta V, Bansal R, Gupta A, Bhansali A. The sensitivity and specificity of nonmydriatic digital stereoscopic retinal imaging in detecting diabetic retinopathy. Indian J Ophthalmol. 2014;62(8):851-856.
42. Pérez MA, Bruce BB, Newman NJ, Biousse V. The use of retinal photography in non-ophthalmic settings and its potential for neurology. The Neurologist. 2012;18(6):350-355.
Cognitive deficits complex in youths with type 2 diabetes
Teens and young adults with diabetes have cognitive deficits that vary by diabetes type and could negatively impact their medical literacy and self-care, an investigator reported at the virtual annual scientific sessions of the American Diabetes Association.
Individuals with youth-onset type 1 or 2 diabetes all performed below average on tests that measure flexible thinking and problem solving, according to the investigator, who reported an analysis including 1,380 individuals enrolled in the SEARCH for Diabetes in Youth study.
That finding suggests that diabetes diagnosed before age 20 contributes to poor fluid cognitive function, which consists of skills that facilitate goal-directed behaviors, according to investigator Allison Shapiro, MPH, PhD, of the University of Colorado at Denver, Aurora.
However, individuals with type 2 diabetes (T2D) performed even worse than those with type 1 diabetes (T1D) on the fluid cognitive function tests, even after adjustment for demographic factors and other confounders, Dr. Shapiro said in her presentation.
Further analysis revealed that individuals with T2D performed significantly worse on measures of crystallized cognition, a domain that includes skills such as vocabulary and language. That suggests the poor fluid cognitive abilities in youths with diabetes may in fact be a result of poor crystallized cognitive development, according to the investigator.
“Among adolescents and young adults with youth-onset type 2 diabetes specifically, intervention should focus on developing both fluid cognitive skills and crystallized cognitive skills,” Dr. Shapiro said.
Deficits in fluid cognitive function (such as reasoning or processing speed) can negatively affect diabetes self-care, thereby potentially increasing the risk of diabetes-related complications, while deficits in crystallized cognitive function (such as vocabulary and understanding of language) could impact medical literacy further compounding the self-care issues.
The study is believed to be one of the first to compare cognitive function deficits in youths with type 1 or 2 diabetes. Although studies in adults clearly show a detrimental relationship between diabetes and cognitive function, according to Dr. Shapiro, the bulk of the research in youths has focused on T1D.
“While limited work has been done in youth-onset type 2 diabetes, cognitive deficits are consistently observed, compared to youth without diabetes,” she said.
Results of this study emphasize the importance of dietary changes and other lifestyle interventions in young patients with diabetes, according to David Della-Morte, MD, PhD, associate professor of neurology at the University of Miami.
“Even the youngest patients may develop cognitive dysfunction,” Dr. Della-Morte said in an interview. “That means that lifestyle is very important, especially in obese patients that are prone to develop type 2 diabetes.”
The analysis by Dr. Shapiro and coinvestigators included 1,095 youths and young adults with T1D and 285 with T2D who had undergone a cognition assessment as part of a study visit. They were aged an average of 22 years, and had an average diabetes duration of 11 years.
The overall fluid cognition score was significantly lower in those individuals with T2D, compared with those with T1D, investigators found. Compared with the national average score of 100, the T2D group scored 84.7, or a full standard deviation below that average, said Dr. Shapiro, while those with T1D scored 95.5 (P < .001).
Participants with T2D also scored significantly lower in individual measures of fluid cognition, including processing speed, inhibitory control and attention, working memory, and episodic memory, she reported. At first glance, that suggested youth-onset T2D has a specific effect on fluid cognition; however, the story remains incomplete without looking at crystallized cognition markers such as vocabulary and language.
Toward that end, a picture vocabulary test conducted as part of the cognitive assessment showed a significant difference between those with T2D, who on average scored 91.5, and those with T1D, who scored 103.6 (P < .001). Accounting for those picture vocabulary scores attenuated the differences between groups in fluid cognitive scores, suggesting that differences in crystallized cognitive function underly the observed differences in fluid cognitive function between groups, Dr. Shapiro said.
Skills such as vocabulary and language are thought to be stable and not influenced by neurologic changes brought on by disease processes such as youth-onset diabetes, but rather, influenced by factors such as childcare and education, according to Dr. Shapiro.
“Crystallized cognition therefore provides a window into an individual’s cognitive functioning, independent of their disease or premorbid to the onset of their disease,” she said.
Dr. Shapiro said she had no conflicts of interest to disclose.
SOURCE: Shapiro A et al. ADA 2020, Abstract 279-OR.
Teens and young adults with diabetes have cognitive deficits that vary by diabetes type and could negatively impact their medical literacy and self-care, an investigator reported at the virtual annual scientific sessions of the American Diabetes Association.
Individuals with youth-onset type 1 or 2 diabetes all performed below average on tests that measure flexible thinking and problem solving, according to the investigator, who reported an analysis including 1,380 individuals enrolled in the SEARCH for Diabetes in Youth study.
That finding suggests that diabetes diagnosed before age 20 contributes to poor fluid cognitive function, which consists of skills that facilitate goal-directed behaviors, according to investigator Allison Shapiro, MPH, PhD, of the University of Colorado at Denver, Aurora.
However, individuals with type 2 diabetes (T2D) performed even worse than those with type 1 diabetes (T1D) on the fluid cognitive function tests, even after adjustment for demographic factors and other confounders, Dr. Shapiro said in her presentation.
Further analysis revealed that individuals with T2D performed significantly worse on measures of crystallized cognition, a domain that includes skills such as vocabulary and language. That suggests the poor fluid cognitive abilities in youths with diabetes may in fact be a result of poor crystallized cognitive development, according to the investigator.
“Among adolescents and young adults with youth-onset type 2 diabetes specifically, intervention should focus on developing both fluid cognitive skills and crystallized cognitive skills,” Dr. Shapiro said.
Deficits in fluid cognitive function (such as reasoning or processing speed) can negatively affect diabetes self-care, thereby potentially increasing the risk of diabetes-related complications, while deficits in crystallized cognitive function (such as vocabulary and understanding of language) could impact medical literacy further compounding the self-care issues.
The study is believed to be one of the first to compare cognitive function deficits in youths with type 1 or 2 diabetes. Although studies in adults clearly show a detrimental relationship between diabetes and cognitive function, according to Dr. Shapiro, the bulk of the research in youths has focused on T1D.
“While limited work has been done in youth-onset type 2 diabetes, cognitive deficits are consistently observed, compared to youth without diabetes,” she said.
Results of this study emphasize the importance of dietary changes and other lifestyle interventions in young patients with diabetes, according to David Della-Morte, MD, PhD, associate professor of neurology at the University of Miami.
“Even the youngest patients may develop cognitive dysfunction,” Dr. Della-Morte said in an interview. “That means that lifestyle is very important, especially in obese patients that are prone to develop type 2 diabetes.”
The analysis by Dr. Shapiro and coinvestigators included 1,095 youths and young adults with T1D and 285 with T2D who had undergone a cognition assessment as part of a study visit. They were aged an average of 22 years, and had an average diabetes duration of 11 years.
The overall fluid cognition score was significantly lower in those individuals with T2D, compared with those with T1D, investigators found. Compared with the national average score of 100, the T2D group scored 84.7, or a full standard deviation below that average, said Dr. Shapiro, while those with T1D scored 95.5 (P < .001).
Participants with T2D also scored significantly lower in individual measures of fluid cognition, including processing speed, inhibitory control and attention, working memory, and episodic memory, she reported. At first glance, that suggested youth-onset T2D has a specific effect on fluid cognition; however, the story remains incomplete without looking at crystallized cognition markers such as vocabulary and language.
Toward that end, a picture vocabulary test conducted as part of the cognitive assessment showed a significant difference between those with T2D, who on average scored 91.5, and those with T1D, who scored 103.6 (P < .001). Accounting for those picture vocabulary scores attenuated the differences between groups in fluid cognitive scores, suggesting that differences in crystallized cognitive function underly the observed differences in fluid cognitive function between groups, Dr. Shapiro said.
Skills such as vocabulary and language are thought to be stable and not influenced by neurologic changes brought on by disease processes such as youth-onset diabetes, but rather, influenced by factors such as childcare and education, according to Dr. Shapiro.
“Crystallized cognition therefore provides a window into an individual’s cognitive functioning, independent of their disease or premorbid to the onset of their disease,” she said.
Dr. Shapiro said she had no conflicts of interest to disclose.
SOURCE: Shapiro A et al. ADA 2020, Abstract 279-OR.
Teens and young adults with diabetes have cognitive deficits that vary by diabetes type and could negatively impact their medical literacy and self-care, an investigator reported at the virtual annual scientific sessions of the American Diabetes Association.
Individuals with youth-onset type 1 or 2 diabetes all performed below average on tests that measure flexible thinking and problem solving, according to the investigator, who reported an analysis including 1,380 individuals enrolled in the SEARCH for Diabetes in Youth study.
That finding suggests that diabetes diagnosed before age 20 contributes to poor fluid cognitive function, which consists of skills that facilitate goal-directed behaviors, according to investigator Allison Shapiro, MPH, PhD, of the University of Colorado at Denver, Aurora.
However, individuals with type 2 diabetes (T2D) performed even worse than those with type 1 diabetes (T1D) on the fluid cognitive function tests, even after adjustment for demographic factors and other confounders, Dr. Shapiro said in her presentation.
Further analysis revealed that individuals with T2D performed significantly worse on measures of crystallized cognition, a domain that includes skills such as vocabulary and language. That suggests the poor fluid cognitive abilities in youths with diabetes may in fact be a result of poor crystallized cognitive development, according to the investigator.
“Among adolescents and young adults with youth-onset type 2 diabetes specifically, intervention should focus on developing both fluid cognitive skills and crystallized cognitive skills,” Dr. Shapiro said.
Deficits in fluid cognitive function (such as reasoning or processing speed) can negatively affect diabetes self-care, thereby potentially increasing the risk of diabetes-related complications, while deficits in crystallized cognitive function (such as vocabulary and understanding of language) could impact medical literacy further compounding the self-care issues.
The study is believed to be one of the first to compare cognitive function deficits in youths with type 1 or 2 diabetes. Although studies in adults clearly show a detrimental relationship between diabetes and cognitive function, according to Dr. Shapiro, the bulk of the research in youths has focused on T1D.
“While limited work has been done in youth-onset type 2 diabetes, cognitive deficits are consistently observed, compared to youth without diabetes,” she said.
Results of this study emphasize the importance of dietary changes and other lifestyle interventions in young patients with diabetes, according to David Della-Morte, MD, PhD, associate professor of neurology at the University of Miami.
“Even the youngest patients may develop cognitive dysfunction,” Dr. Della-Morte said in an interview. “That means that lifestyle is very important, especially in obese patients that are prone to develop type 2 diabetes.”
The analysis by Dr. Shapiro and coinvestigators included 1,095 youths and young adults with T1D and 285 with T2D who had undergone a cognition assessment as part of a study visit. They were aged an average of 22 years, and had an average diabetes duration of 11 years.
The overall fluid cognition score was significantly lower in those individuals with T2D, compared with those with T1D, investigators found. Compared with the national average score of 100, the T2D group scored 84.7, or a full standard deviation below that average, said Dr. Shapiro, while those with T1D scored 95.5 (P < .001).
Participants with T2D also scored significantly lower in individual measures of fluid cognition, including processing speed, inhibitory control and attention, working memory, and episodic memory, she reported. At first glance, that suggested youth-onset T2D has a specific effect on fluid cognition; however, the story remains incomplete without looking at crystallized cognition markers such as vocabulary and language.
Toward that end, a picture vocabulary test conducted as part of the cognitive assessment showed a significant difference between those with T2D, who on average scored 91.5, and those with T1D, who scored 103.6 (P < .001). Accounting for those picture vocabulary scores attenuated the differences between groups in fluid cognitive scores, suggesting that differences in crystallized cognitive function underly the observed differences in fluid cognitive function between groups, Dr. Shapiro said.
Skills such as vocabulary and language are thought to be stable and not influenced by neurologic changes brought on by disease processes such as youth-onset diabetes, but rather, influenced by factors such as childcare and education, according to Dr. Shapiro.
“Crystallized cognition therefore provides a window into an individual’s cognitive functioning, independent of their disease or premorbid to the onset of their disease,” she said.
Dr. Shapiro said she had no conflicts of interest to disclose.
SOURCE: Shapiro A et al. ADA 2020, Abstract 279-OR.
FROM ADA 2020
Part 1: Self-care for Diabetes Patients
Diabetes mellitus is prevalent in our society; 1 in 10 Americans has the condition and > 1 in 3 has prediabetes.1 Due to the widespread comorbidities and complications of this disease, the American Diabetes Association (ADA) recommends that diabetes management focus on evaluation and treatment of complications.2 Diabetes-related complications can be life-altering and challenging for patients because their quality of life suffers.
For providers, there are several evidence-based screening tools and preventive practices (in and beyond glycemic control) that reduce diabetes complications such as congestive heart failure, kidney failure, lower extremity amputation, and stroke.3 We as providers can treat patients by implementing appropriate goal-directed therapy.4-6
In this 5-part series, I will explore the evidence and recommendations for a multimodal approach in a patient with type 2 diabetes. Here—in Part 1—I explore the self-care behaviors our patients can adopt to improve their symptoms of diabetes.
Case Report
Mr. W is an overweight 64-year-old man with hypertension, hyperlipidemia, and type 2 diabetes mellitus. He visits the clinic for his yearly physical exam. He is concerned because his father, who had diabetes, developed renal failure and had multiple amputations near the end of his life. He is worried that he might face the same outcomes and asks you what he can do to avoid his father’s fate.
Advising Your Patient on Self-care
The cornerstone of diabetes management is appropriate self-care. Both the ADA and the American Association of Clinical Endocrinologists (AACE) recommend that treatment plans should encourage the patient to adopt healthy lifestyle behaviors, including a healthy diet, regular exercise, weight control, and avoidance of tobacco.2,7,8 These interventions have positive effects on blood pressure, glucose control, and lipid levels. They can also reduce the risk for diabetic complications, including atherosclerotic cardiovascular disease (ASCVD), which is the foremost cause of death among patients with diabetes. During a patient visit, clinicians can suggest the following self-care interventions for improving long-term outcomes.
Education sessions. The ADA recommends that individuals with diabetes participate in diabetes self-management education and support (DSMES) sessions.2 In these sessions, patients with diabetes are instructed on a variety of self-care behaviors, including lifestyle interventions, medication management, self-monitoring, and problem-solving.9 These programs—often paid for in part by health insurance—are taught by health care professionals such as registered dieticians, nutritionists, or certified diabetes educators.9,10 Evidence suggests DSMES increases patients’ sense of self-efficacy and may improve blood sugar management.10 Clinicians can help guide their patients through the Association of Diabetes Care & Education Specialists’ online database to identify a DSMES program near them (see www.diabeteseducator.org/living-with-diabetes/find-an-education-program).11
Diet. The AACE recommends a plant-based diet high in polyunsaturated and monounsaturated fatty acids and limited in trans fatty acids and saturated fats.7 Evidence strongly suggests that a Mediterranean diet with high vegetable intake and decreased saturated fats helps to reduce the risk for major cardiovascular events (myocardial infarction and stroke).12
Continue to: Exercise
Exercise. Both the ADA and AACE recommend that most adults with diabetes engage in at least 150 min/week of moderate-to-vigorous aerobic and strength-training exercises.2,7 Clinicians should evaluate patients with sedentary lifestyles prior to them engaging in vigorous physical activity beyond simple walking.2 The ADA also recommends that patients should avoid sitting for long periods of time by engaging in physical activity at least every 30 minutes.2 For adults who may not be able to participate in moderate-to-vigorous exercise, recommend alternative flexibility and balance-training activities, such as yoga or tai chi, 2 to 3 times per week.2
Weight management—a combined effort of diet, exercise, and behavioral therapy—is pivotal in the management of type 2 diabetes due to the potential benefits in insulin resistance, blood pressure, hyperlipidemia, and other factors.2 Weight loss may also improve glycemic control and reduce the need for glucose-lowering medications.2 For patients who struggle with weight loss, consider prescribing FDA-approved weight-loss medications (phentermine, orlistat, lorcaserin, naltrexone/bupropion, liraglutide) or, in some cases, referring for bariatric surgery.2,7
Sleep hygiene is an important element in any preventive treatment plan. This includes interventions as simple as going to bed at the same time every night, sleeping in a dark room, sleeping for at least 7 hours, and removing electronic devices from the bedroom.13 Patients should avoid alcohol, caffeine, and large meals before bedtime.13
Additionally, obstructive sleep apnea (OSA) is often underdiagnosed in patients with diabetes and contributes to insulin resistance, inflammation, and elevated blood pressure.7,14 For early identification of OSA, order a sleep study when appropriate and refer patients to sleep specialists if needed. Patients who are recommended for treatment should be monitored for increasing compliance with care and to ensure benefit from treatment.
In Part 2, we’ll check in with Mr. W as I discuss the role of blood pressure monitoring and antihypertensive medications in reducing cardiovascular risks in patients with diabetes.
1. Centers for Disease Control and Prevention. Diabetes incidence and prevalence. Diabetes Report Card 2017. www.cdc.gov/diabetes/library/reports/reportcard/incidence-2017.html. Published 2018. Accessed June 18, 2020.
2. Standards of Medical Care in Diabetes—2020 Abridged for Primary Care Providers. American Diabetes Association Clinical Diabetes. 2020;38(1):10-38.
3. Chen Y, Sloan FA, Yashkin AP. Adherence to diabetes guidelines for screening, physical activity and medication and onset of complications and death. J Diabetes Complications. 2015;29(8):1228-1233.
4. Mehta S, Mocarski M, Wisniewski T, et al. Primary care physicians’ utilization of type 2 diabetes screening guidelines and referrals to behavioral interventions: a survey-linked retrospective study. BMJ Open Diabetes Res Care. 2017;5(1):e000406.
5. Center for Disease Control and Prevention. Preventive care practices. Diabetes Report Card 2017. www.cdc.gov/diabetes/library/reports/reportcard/preventive-care.html. Published 2018. Accessed June 18, 2020.
6. Arnold SV, de Lemos JA, Rosenson RS, et al; GOULD Investigators. Use of guideline-recommended risk reduction strategies among patients with diabetes and atherosclerotic cardiovascular disease. Circulation. 2019;140(7):618-620.
7. Garber AJ, Handelsman Y, Grunberger G, et al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm—2020 executive summary. Endocr Pract Endocr Pract. 2020;26(1):107-139.
8. American Diabetes Association. Comprehensive medical evaluation and assessment of comorbidities: standards of medical care in diabetes—2020. Diabetes Care. 2020;43(suppl 1):S37-S47.
9. Beck J, Greenwood DA, Blanton L, et al; 2017 Standards Revision Task Force. 2017 National Standards for diabetes self-management education and support. Diabetes Educ. 2017;43(5): 449-464.
10. Chrvala CA, Sherr D, Lipman RD. Diabetes self-management education for adults with type 2 diabetes mellitus: a systematic review of the effect on glycemic control. Patient Educ Couns. 2016;99(6):926-943.
11. Association of Diabetes Care & Education Specialists. Find a diabetes education program in your area. www.diabeteseducator.org/living-with-diabetes/find-an-education-program. Accessed June 15, 2020.
12. Estruch R, Ros E, Salas-Salvadó J, et al; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet supplemented with extra-virgin olive oil or nuts. NEJM. 2018;378(25):e34.
13. Centers for Disease Control and Prevention. Tips for better sleep. Sleep and sleep disorders. www.cdc.gov/sleep/about_sleep/sleep_hygiene.html. Reviewed July 15, 2016. Accessed June 18, 2020.
14. Doumit J, Prasad B. Sleep Apnea in Type 2 Diabetes. Diabetes Spectrum. 2016; 29(1): 14-19.
15. Marso SP, Daniels GH, Brown-Frandsen K, et al; LEADER Steering Committee on behalf of the LEADER Trial Investigators. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375:311-322.
16. Perkovic V, Jardine MJ, Neal B, et al; CREDENCE Trial Investigators. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med. 2019;380(24):2295-2306.
17. Trends in Blood pressure control and treatment among type 2 diabetes with comorbid hypertension in the United States: 1988-2004. J Hypertens. 2009;27(9):1908-1916.
18. Emdin CA, Rahimi K, Neal B, et al. Blood pressure lowering in type 2 diabetes: a systematic review and meta-analysis. JAMA. 2015;313(6):603-615.
19. Vouri SM, Shaw RF, Waterbury NV, et al. Prevalence of achievement of A1c, blood pressure, and cholesterol (ABC) goal in veterans with diabetes. J Manag Care Pharm. 2011;17(4):304-312.
20. Kudo N, Yokokawa H, Fukuda H, et al. Achievement of target blood pressure levels among Japanese workers with hypertension and healthy lifestyle characteristics associated with therapeutic failure. Plos One. 2015;10(7):e0133641.
21. Carey RM, Whelton PK; 2017 ACC/AHA Hypertension Guideline Writing Committee. Prevention, detection, evaluation, and management of high blood pressure in adults: synopsis of the 2017 American College of Cardiology/American Heart Association Hypertension guideline. Ann Intern Med. 2018;168(5):351-358.
22. Deedwania PC. Blood pressure control in diabetes mellitus. Circulation. 2011;123:2776–2778.
23. Catalá-López F, Saint-Gerons DM, González-Bermejo D, et al. Cardiovascular and renal outcomes of renin-angiotensin system blockade in adult patients with diabetes mellitus: a systematic review with network meta-analyses. PLoS Med. 2016;13(3):e1001971.
24. Furberg CD, Wright JT Jr, Davis BR, et al; ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002;288(23):2981-2997.
25. Sleight P. The HOPE Study (Heart Outcomes Prevention Evaluation). J Renin-Angiotensin-Aldosterone Syst. 2000;1(1):18-20.
26. Tatti P, Pahor M, Byington RP, et al. Outcome results of the Fosinopril Versus Amlodipine Cardiovascular Events Randomized Trial (FACET) in patients with hypertension and NIDDM. Diabetes Care. 1998;21(4):597-603.
27. Schrier RW, Estacio RO, Jeffers B. Appropriate Blood Pressure Control in NIDDM (ABCD) Trial. Diabetologia. 1996;39(12):1646-1654.
28. Hansson L, Zanchetti A, Carruthers SG, et al; HOT Study Group. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) Randomised Trial. Lancet. 1998;351(9118):1755-1762.
29. Baigent C, Blackwell L, Emberson J, et al; Cholesterol Treatment Trialists’ (CTT) Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010;376(9753):1670-1681.
30. Fu AZ, Zhang Q, Davies MJ, et al. Underutilization of statins in patients with type 2 diabetes in US clinical practice: a retrospective cohort study. Curr Med Res Opin. 2011;27(5):1035-1040.
31. Cannon CP, Blazing MA, Giugliano RP, et al; IMPROVE-IT Investigators. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med. 2015; 372:2387-2397
32. Sabatine MS, Giugliano RP, Keech AC, et al; the FOURIER Steering Committee and Investigators. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713-1722.
33. Schwartz GG, Steg PG, Szarek M, et al; ODYSSEY OUTCOMES Committees and Investigators. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome | NEJM. N Engl J Med. 2018;379:2097-2107.
34. Icosapent ethyl [package insert]. Bridgewater, NJ: Amarin Pharma, Inc.; 2019.
35. Bhatt DL, Steg PG, Miller M, et al; REDUCE-IT Investigators. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. 2019;380:11-22
36. Bolton WK. Renal Physicians Association Clinical practice guideline: appropriate patient preparation for renal replacement therapy: guideline number 3. J Am Soc Nephrol. 2003;14(5):1406-1410.
37. American Diabetes Association. Pharmacologic Approaches to glycemic treatment: standards of medical care in diabetes—2020. Diabetes Care. 2020;43(suppl 1):S98-S110.
38. Qaseem A, Barry MJ, Humphrey LL, Forciea MA; Clinical Guidelines Committee of the American College of Physicians. Oral pharmacologic treatment of type 2 diabetes mellitus: a clinical practice guideline update from the American College of Physicians. Ann Intern Med. 2017;166(4):279-290.
39. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease–mineral and bone disorder (CKD-MBD). Kidney Int Suppl (2011). 2017;7(1):1-59.
40. Pop-Busui R, Boulton AJM, Feldman EL, et al. Diabetic neuropathy: a position statement by the American Diabetes Association. Diabetes Care. 2017;40(1):136-154.
41. Gupta V, Bansal R, Gupta A, Bhansali A. The sensitivity and specificity of nonmydriatic digital stereoscopic retinal imaging in detecting diabetic retinopathy. Indian J Ophthalmol. 2014;62(8):851-856.
42. Pérez MA, Bruce BB, Newman NJ, Biousse V. The use of retinal photography in non-ophthalmic settings and its potential for neurology. The Neurologist. 2012;18(6):350-355.
Clinician Reviews in partnership with
Courtney Bennett Wilke is an Assistant Professor at Florida State University College of Medicine, School of Physician Assistant Practice, Tallahassee.
Clinician Reviews in partnership with
Courtney Bennett Wilke is an Assistant Professor at Florida State University College of Medicine, School of Physician Assistant Practice, Tallahassee.
Clinician Reviews in partnership with
Courtney Bennett Wilke is an Assistant Professor at Florida State University College of Medicine, School of Physician Assistant Practice, Tallahassee.
Diabetes mellitus is prevalent in our society; 1 in 10 Americans has the condition and > 1 in 3 has prediabetes.1 Due to the widespread comorbidities and complications of this disease, the American Diabetes Association (ADA) recommends that diabetes management focus on evaluation and treatment of complications.2 Diabetes-related complications can be life-altering and challenging for patients because their quality of life suffers.
For providers, there are several evidence-based screening tools and preventive practices (in and beyond glycemic control) that reduce diabetes complications such as congestive heart failure, kidney failure, lower extremity amputation, and stroke.3 We as providers can treat patients by implementing appropriate goal-directed therapy.4-6
In this 5-part series, I will explore the evidence and recommendations for a multimodal approach in a patient with type 2 diabetes. Here—in Part 1—I explore the self-care behaviors our patients can adopt to improve their symptoms of diabetes.
Case Report
Mr. W is an overweight 64-year-old man with hypertension, hyperlipidemia, and type 2 diabetes mellitus. He visits the clinic for his yearly physical exam. He is concerned because his father, who had diabetes, developed renal failure and had multiple amputations near the end of his life. He is worried that he might face the same outcomes and asks you what he can do to avoid his father’s fate.
Advising Your Patient on Self-care
The cornerstone of diabetes management is appropriate self-care. Both the ADA and the American Association of Clinical Endocrinologists (AACE) recommend that treatment plans should encourage the patient to adopt healthy lifestyle behaviors, including a healthy diet, regular exercise, weight control, and avoidance of tobacco.2,7,8 These interventions have positive effects on blood pressure, glucose control, and lipid levels. They can also reduce the risk for diabetic complications, including atherosclerotic cardiovascular disease (ASCVD), which is the foremost cause of death among patients with diabetes. During a patient visit, clinicians can suggest the following self-care interventions for improving long-term outcomes.
Education sessions. The ADA recommends that individuals with diabetes participate in diabetes self-management education and support (DSMES) sessions.2 In these sessions, patients with diabetes are instructed on a variety of self-care behaviors, including lifestyle interventions, medication management, self-monitoring, and problem-solving.9 These programs—often paid for in part by health insurance—are taught by health care professionals such as registered dieticians, nutritionists, or certified diabetes educators.9,10 Evidence suggests DSMES increases patients’ sense of self-efficacy and may improve blood sugar management.10 Clinicians can help guide their patients through the Association of Diabetes Care & Education Specialists’ online database to identify a DSMES program near them (see www.diabeteseducator.org/living-with-diabetes/find-an-education-program).11
Diet. The AACE recommends a plant-based diet high in polyunsaturated and monounsaturated fatty acids and limited in trans fatty acids and saturated fats.7 Evidence strongly suggests that a Mediterranean diet with high vegetable intake and decreased saturated fats helps to reduce the risk for major cardiovascular events (myocardial infarction and stroke).12
Continue to: Exercise
Exercise. Both the ADA and AACE recommend that most adults with diabetes engage in at least 150 min/week of moderate-to-vigorous aerobic and strength-training exercises.2,7 Clinicians should evaluate patients with sedentary lifestyles prior to them engaging in vigorous physical activity beyond simple walking.2 The ADA also recommends that patients should avoid sitting for long periods of time by engaging in physical activity at least every 30 minutes.2 For adults who may not be able to participate in moderate-to-vigorous exercise, recommend alternative flexibility and balance-training activities, such as yoga or tai chi, 2 to 3 times per week.2
Weight management—a combined effort of diet, exercise, and behavioral therapy—is pivotal in the management of type 2 diabetes due to the potential benefits in insulin resistance, blood pressure, hyperlipidemia, and other factors.2 Weight loss may also improve glycemic control and reduce the need for glucose-lowering medications.2 For patients who struggle with weight loss, consider prescribing FDA-approved weight-loss medications (phentermine, orlistat, lorcaserin, naltrexone/bupropion, liraglutide) or, in some cases, referring for bariatric surgery.2,7
Sleep hygiene is an important element in any preventive treatment plan. This includes interventions as simple as going to bed at the same time every night, sleeping in a dark room, sleeping for at least 7 hours, and removing electronic devices from the bedroom.13 Patients should avoid alcohol, caffeine, and large meals before bedtime.13
Additionally, obstructive sleep apnea (OSA) is often underdiagnosed in patients with diabetes and contributes to insulin resistance, inflammation, and elevated blood pressure.7,14 For early identification of OSA, order a sleep study when appropriate and refer patients to sleep specialists if needed. Patients who are recommended for treatment should be monitored for increasing compliance with care and to ensure benefit from treatment.
In Part 2, we’ll check in with Mr. W as I discuss the role of blood pressure monitoring and antihypertensive medications in reducing cardiovascular risks in patients with diabetes.
Diabetes mellitus is prevalent in our society; 1 in 10 Americans has the condition and > 1 in 3 has prediabetes.1 Due to the widespread comorbidities and complications of this disease, the American Diabetes Association (ADA) recommends that diabetes management focus on evaluation and treatment of complications.2 Diabetes-related complications can be life-altering and challenging for patients because their quality of life suffers.
For providers, there are several evidence-based screening tools and preventive practices (in and beyond glycemic control) that reduce diabetes complications such as congestive heart failure, kidney failure, lower extremity amputation, and stroke.3 We as providers can treat patients by implementing appropriate goal-directed therapy.4-6
In this 5-part series, I will explore the evidence and recommendations for a multimodal approach in a patient with type 2 diabetes. Here—in Part 1—I explore the self-care behaviors our patients can adopt to improve their symptoms of diabetes.
Case Report
Mr. W is an overweight 64-year-old man with hypertension, hyperlipidemia, and type 2 diabetes mellitus. He visits the clinic for his yearly physical exam. He is concerned because his father, who had diabetes, developed renal failure and had multiple amputations near the end of his life. He is worried that he might face the same outcomes and asks you what he can do to avoid his father’s fate.
Advising Your Patient on Self-care
The cornerstone of diabetes management is appropriate self-care. Both the ADA and the American Association of Clinical Endocrinologists (AACE) recommend that treatment plans should encourage the patient to adopt healthy lifestyle behaviors, including a healthy diet, regular exercise, weight control, and avoidance of tobacco.2,7,8 These interventions have positive effects on blood pressure, glucose control, and lipid levels. They can also reduce the risk for diabetic complications, including atherosclerotic cardiovascular disease (ASCVD), which is the foremost cause of death among patients with diabetes. During a patient visit, clinicians can suggest the following self-care interventions for improving long-term outcomes.
Education sessions. The ADA recommends that individuals with diabetes participate in diabetes self-management education and support (DSMES) sessions.2 In these sessions, patients with diabetes are instructed on a variety of self-care behaviors, including lifestyle interventions, medication management, self-monitoring, and problem-solving.9 These programs—often paid for in part by health insurance—are taught by health care professionals such as registered dieticians, nutritionists, or certified diabetes educators.9,10 Evidence suggests DSMES increases patients’ sense of self-efficacy and may improve blood sugar management.10 Clinicians can help guide their patients through the Association of Diabetes Care & Education Specialists’ online database to identify a DSMES program near them (see www.diabeteseducator.org/living-with-diabetes/find-an-education-program).11
Diet. The AACE recommends a plant-based diet high in polyunsaturated and monounsaturated fatty acids and limited in trans fatty acids and saturated fats.7 Evidence strongly suggests that a Mediterranean diet with high vegetable intake and decreased saturated fats helps to reduce the risk for major cardiovascular events (myocardial infarction and stroke).12
Continue to: Exercise
Exercise. Both the ADA and AACE recommend that most adults with diabetes engage in at least 150 min/week of moderate-to-vigorous aerobic and strength-training exercises.2,7 Clinicians should evaluate patients with sedentary lifestyles prior to them engaging in vigorous physical activity beyond simple walking.2 The ADA also recommends that patients should avoid sitting for long periods of time by engaging in physical activity at least every 30 minutes.2 For adults who may not be able to participate in moderate-to-vigorous exercise, recommend alternative flexibility and balance-training activities, such as yoga or tai chi, 2 to 3 times per week.2
Weight management—a combined effort of diet, exercise, and behavioral therapy—is pivotal in the management of type 2 diabetes due to the potential benefits in insulin resistance, blood pressure, hyperlipidemia, and other factors.2 Weight loss may also improve glycemic control and reduce the need for glucose-lowering medications.2 For patients who struggle with weight loss, consider prescribing FDA-approved weight-loss medications (phentermine, orlistat, lorcaserin, naltrexone/bupropion, liraglutide) or, in some cases, referring for bariatric surgery.2,7
Sleep hygiene is an important element in any preventive treatment plan. This includes interventions as simple as going to bed at the same time every night, sleeping in a dark room, sleeping for at least 7 hours, and removing electronic devices from the bedroom.13 Patients should avoid alcohol, caffeine, and large meals before bedtime.13
Additionally, obstructive sleep apnea (OSA) is often underdiagnosed in patients with diabetes and contributes to insulin resistance, inflammation, and elevated blood pressure.7,14 For early identification of OSA, order a sleep study when appropriate and refer patients to sleep specialists if needed. Patients who are recommended for treatment should be monitored for increasing compliance with care and to ensure benefit from treatment.
In Part 2, we’ll check in with Mr. W as I discuss the role of blood pressure monitoring and antihypertensive medications in reducing cardiovascular risks in patients with diabetes.
1. Centers for Disease Control and Prevention. Diabetes incidence and prevalence. Diabetes Report Card 2017. www.cdc.gov/diabetes/library/reports/reportcard/incidence-2017.html. Published 2018. Accessed June 18, 2020.
2. Standards of Medical Care in Diabetes—2020 Abridged for Primary Care Providers. American Diabetes Association Clinical Diabetes. 2020;38(1):10-38.
3. Chen Y, Sloan FA, Yashkin AP. Adherence to diabetes guidelines for screening, physical activity and medication and onset of complications and death. J Diabetes Complications. 2015;29(8):1228-1233.
4. Mehta S, Mocarski M, Wisniewski T, et al. Primary care physicians’ utilization of type 2 diabetes screening guidelines and referrals to behavioral interventions: a survey-linked retrospective study. BMJ Open Diabetes Res Care. 2017;5(1):e000406.
5. Center for Disease Control and Prevention. Preventive care practices. Diabetes Report Card 2017. www.cdc.gov/diabetes/library/reports/reportcard/preventive-care.html. Published 2018. Accessed June 18, 2020.
6. Arnold SV, de Lemos JA, Rosenson RS, et al; GOULD Investigators. Use of guideline-recommended risk reduction strategies among patients with diabetes and atherosclerotic cardiovascular disease. Circulation. 2019;140(7):618-620.
7. Garber AJ, Handelsman Y, Grunberger G, et al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm—2020 executive summary. Endocr Pract Endocr Pract. 2020;26(1):107-139.
8. American Diabetes Association. Comprehensive medical evaluation and assessment of comorbidities: standards of medical care in diabetes—2020. Diabetes Care. 2020;43(suppl 1):S37-S47.
9. Beck J, Greenwood DA, Blanton L, et al; 2017 Standards Revision Task Force. 2017 National Standards for diabetes self-management education and support. Diabetes Educ. 2017;43(5): 449-464.
10. Chrvala CA, Sherr D, Lipman RD. Diabetes self-management education for adults with type 2 diabetes mellitus: a systematic review of the effect on glycemic control. Patient Educ Couns. 2016;99(6):926-943.
11. Association of Diabetes Care & Education Specialists. Find a diabetes education program in your area. www.diabeteseducator.org/living-with-diabetes/find-an-education-program. Accessed June 15, 2020.
12. Estruch R, Ros E, Salas-Salvadó J, et al; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet supplemented with extra-virgin olive oil or nuts. NEJM. 2018;378(25):e34.
13. Centers for Disease Control and Prevention. Tips for better sleep. Sleep and sleep disorders. www.cdc.gov/sleep/about_sleep/sleep_hygiene.html. Reviewed July 15, 2016. Accessed June 18, 2020.
14. Doumit J, Prasad B. Sleep Apnea in Type 2 Diabetes. Diabetes Spectrum. 2016; 29(1): 14-19.
15. Marso SP, Daniels GH, Brown-Frandsen K, et al; LEADER Steering Committee on behalf of the LEADER Trial Investigators. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375:311-322.
16. Perkovic V, Jardine MJ, Neal B, et al; CREDENCE Trial Investigators. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med. 2019;380(24):2295-2306.
17. Trends in Blood pressure control and treatment among type 2 diabetes with comorbid hypertension in the United States: 1988-2004. J Hypertens. 2009;27(9):1908-1916.
18. Emdin CA, Rahimi K, Neal B, et al. Blood pressure lowering in type 2 diabetes: a systematic review and meta-analysis. JAMA. 2015;313(6):603-615.
19. Vouri SM, Shaw RF, Waterbury NV, et al. Prevalence of achievement of A1c, blood pressure, and cholesterol (ABC) goal in veterans with diabetes. J Manag Care Pharm. 2011;17(4):304-312.
20. Kudo N, Yokokawa H, Fukuda H, et al. Achievement of target blood pressure levels among Japanese workers with hypertension and healthy lifestyle characteristics associated with therapeutic failure. Plos One. 2015;10(7):e0133641.
21. Carey RM, Whelton PK; 2017 ACC/AHA Hypertension Guideline Writing Committee. Prevention, detection, evaluation, and management of high blood pressure in adults: synopsis of the 2017 American College of Cardiology/American Heart Association Hypertension guideline. Ann Intern Med. 2018;168(5):351-358.
22. Deedwania PC. Blood pressure control in diabetes mellitus. Circulation. 2011;123:2776–2778.
23. Catalá-López F, Saint-Gerons DM, González-Bermejo D, et al. Cardiovascular and renal outcomes of renin-angiotensin system blockade in adult patients with diabetes mellitus: a systematic review with network meta-analyses. PLoS Med. 2016;13(3):e1001971.
24. Furberg CD, Wright JT Jr, Davis BR, et al; ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002;288(23):2981-2997.
25. Sleight P. The HOPE Study (Heart Outcomes Prevention Evaluation). J Renin-Angiotensin-Aldosterone Syst. 2000;1(1):18-20.
26. Tatti P, Pahor M, Byington RP, et al. Outcome results of the Fosinopril Versus Amlodipine Cardiovascular Events Randomized Trial (FACET) in patients with hypertension and NIDDM. Diabetes Care. 1998;21(4):597-603.
27. Schrier RW, Estacio RO, Jeffers B. Appropriate Blood Pressure Control in NIDDM (ABCD) Trial. Diabetologia. 1996;39(12):1646-1654.
28. Hansson L, Zanchetti A, Carruthers SG, et al; HOT Study Group. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) Randomised Trial. Lancet. 1998;351(9118):1755-1762.
29. Baigent C, Blackwell L, Emberson J, et al; Cholesterol Treatment Trialists’ (CTT) Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010;376(9753):1670-1681.
30. Fu AZ, Zhang Q, Davies MJ, et al. Underutilization of statins in patients with type 2 diabetes in US clinical practice: a retrospective cohort study. Curr Med Res Opin. 2011;27(5):1035-1040.
31. Cannon CP, Blazing MA, Giugliano RP, et al; IMPROVE-IT Investigators. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med. 2015; 372:2387-2397
32. Sabatine MS, Giugliano RP, Keech AC, et al; the FOURIER Steering Committee and Investigators. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713-1722.
33. Schwartz GG, Steg PG, Szarek M, et al; ODYSSEY OUTCOMES Committees and Investigators. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome | NEJM. N Engl J Med. 2018;379:2097-2107.
34. Icosapent ethyl [package insert]. Bridgewater, NJ: Amarin Pharma, Inc.; 2019.
35. Bhatt DL, Steg PG, Miller M, et al; REDUCE-IT Investigators. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. 2019;380:11-22
36. Bolton WK. Renal Physicians Association Clinical practice guideline: appropriate patient preparation for renal replacement therapy: guideline number 3. J Am Soc Nephrol. 2003;14(5):1406-1410.
37. American Diabetes Association. Pharmacologic Approaches to glycemic treatment: standards of medical care in diabetes—2020. Diabetes Care. 2020;43(suppl 1):S98-S110.
38. Qaseem A, Barry MJ, Humphrey LL, Forciea MA; Clinical Guidelines Committee of the American College of Physicians. Oral pharmacologic treatment of type 2 diabetes mellitus: a clinical practice guideline update from the American College of Physicians. Ann Intern Med. 2017;166(4):279-290.
39. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease–mineral and bone disorder (CKD-MBD). Kidney Int Suppl (2011). 2017;7(1):1-59.
40. Pop-Busui R, Boulton AJM, Feldman EL, et al. Diabetic neuropathy: a position statement by the American Diabetes Association. Diabetes Care. 2017;40(1):136-154.
41. Gupta V, Bansal R, Gupta A, Bhansali A. The sensitivity and specificity of nonmydriatic digital stereoscopic retinal imaging in detecting diabetic retinopathy. Indian J Ophthalmol. 2014;62(8):851-856.
42. Pérez MA, Bruce BB, Newman NJ, Biousse V. The use of retinal photography in non-ophthalmic settings and its potential for neurology. The Neurologist. 2012;18(6):350-355.
1. Centers for Disease Control and Prevention. Diabetes incidence and prevalence. Diabetes Report Card 2017. www.cdc.gov/diabetes/library/reports/reportcard/incidence-2017.html. Published 2018. Accessed June 18, 2020.
2. Standards of Medical Care in Diabetes—2020 Abridged for Primary Care Providers. American Diabetes Association Clinical Diabetes. 2020;38(1):10-38.
3. Chen Y, Sloan FA, Yashkin AP. Adherence to diabetes guidelines for screening, physical activity and medication and onset of complications and death. J Diabetes Complications. 2015;29(8):1228-1233.
4. Mehta S, Mocarski M, Wisniewski T, et al. Primary care physicians’ utilization of type 2 diabetes screening guidelines and referrals to behavioral interventions: a survey-linked retrospective study. BMJ Open Diabetes Res Care. 2017;5(1):e000406.
5. Center for Disease Control and Prevention. Preventive care practices. Diabetes Report Card 2017. www.cdc.gov/diabetes/library/reports/reportcard/preventive-care.html. Published 2018. Accessed June 18, 2020.
6. Arnold SV, de Lemos JA, Rosenson RS, et al; GOULD Investigators. Use of guideline-recommended risk reduction strategies among patients with diabetes and atherosclerotic cardiovascular disease. Circulation. 2019;140(7):618-620.
7. Garber AJ, Handelsman Y, Grunberger G, et al. Consensus Statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm—2020 executive summary. Endocr Pract Endocr Pract. 2020;26(1):107-139.
8. American Diabetes Association. Comprehensive medical evaluation and assessment of comorbidities: standards of medical care in diabetes—2020. Diabetes Care. 2020;43(suppl 1):S37-S47.
9. Beck J, Greenwood DA, Blanton L, et al; 2017 Standards Revision Task Force. 2017 National Standards for diabetes self-management education and support. Diabetes Educ. 2017;43(5): 449-464.
10. Chrvala CA, Sherr D, Lipman RD. Diabetes self-management education for adults with type 2 diabetes mellitus: a systematic review of the effect on glycemic control. Patient Educ Couns. 2016;99(6):926-943.
11. Association of Diabetes Care & Education Specialists. Find a diabetes education program in your area. www.diabeteseducator.org/living-with-diabetes/find-an-education-program. Accessed June 15, 2020.
12. Estruch R, Ros E, Salas-Salvadó J, et al; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet supplemented with extra-virgin olive oil or nuts. NEJM. 2018;378(25):e34.
13. Centers for Disease Control and Prevention. Tips for better sleep. Sleep and sleep disorders. www.cdc.gov/sleep/about_sleep/sleep_hygiene.html. Reviewed July 15, 2016. Accessed June 18, 2020.
14. Doumit J, Prasad B. Sleep Apnea in Type 2 Diabetes. Diabetes Spectrum. 2016; 29(1): 14-19.
15. Marso SP, Daniels GH, Brown-Frandsen K, et al; LEADER Steering Committee on behalf of the LEADER Trial Investigators. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375:311-322.
16. Perkovic V, Jardine MJ, Neal B, et al; CREDENCE Trial Investigators. Canagliflozin and renal outcomes in type 2 diabetes and nephropathy. N Engl J Med. 2019;380(24):2295-2306.
17. Trends in Blood pressure control and treatment among type 2 diabetes with comorbid hypertension in the United States: 1988-2004. J Hypertens. 2009;27(9):1908-1916.
18. Emdin CA, Rahimi K, Neal B, et al. Blood pressure lowering in type 2 diabetes: a systematic review and meta-analysis. JAMA. 2015;313(6):603-615.
19. Vouri SM, Shaw RF, Waterbury NV, et al. Prevalence of achievement of A1c, blood pressure, and cholesterol (ABC) goal in veterans with diabetes. J Manag Care Pharm. 2011;17(4):304-312.
20. Kudo N, Yokokawa H, Fukuda H, et al. Achievement of target blood pressure levels among Japanese workers with hypertension and healthy lifestyle characteristics associated with therapeutic failure. Plos One. 2015;10(7):e0133641.
21. Carey RM, Whelton PK; 2017 ACC/AHA Hypertension Guideline Writing Committee. Prevention, detection, evaluation, and management of high blood pressure in adults: synopsis of the 2017 American College of Cardiology/American Heart Association Hypertension guideline. Ann Intern Med. 2018;168(5):351-358.
22. Deedwania PC. Blood pressure control in diabetes mellitus. Circulation. 2011;123:2776–2778.
23. Catalá-López F, Saint-Gerons DM, González-Bermejo D, et al. Cardiovascular and renal outcomes of renin-angiotensin system blockade in adult patients with diabetes mellitus: a systematic review with network meta-analyses. PLoS Med. 2016;13(3):e1001971.
24. Furberg CD, Wright JT Jr, Davis BR, et al; ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002;288(23):2981-2997.
25. Sleight P. The HOPE Study (Heart Outcomes Prevention Evaluation). J Renin-Angiotensin-Aldosterone Syst. 2000;1(1):18-20.
26. Tatti P, Pahor M, Byington RP, et al. Outcome results of the Fosinopril Versus Amlodipine Cardiovascular Events Randomized Trial (FACET) in patients with hypertension and NIDDM. Diabetes Care. 1998;21(4):597-603.
27. Schrier RW, Estacio RO, Jeffers B. Appropriate Blood Pressure Control in NIDDM (ABCD) Trial. Diabetologia. 1996;39(12):1646-1654.
28. Hansson L, Zanchetti A, Carruthers SG, et al; HOT Study Group. Effects of intensive blood-pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) Randomised Trial. Lancet. 1998;351(9118):1755-1762.
29. Baigent C, Blackwell L, Emberson J, et al; Cholesterol Treatment Trialists’ (CTT) Collaboration. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010;376(9753):1670-1681.
30. Fu AZ, Zhang Q, Davies MJ, et al. Underutilization of statins in patients with type 2 diabetes in US clinical practice: a retrospective cohort study. Curr Med Res Opin. 2011;27(5):1035-1040.
31. Cannon CP, Blazing MA, Giugliano RP, et al; IMPROVE-IT Investigators. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med. 2015; 372:2387-2397
32. Sabatine MS, Giugliano RP, Keech AC, et al; the FOURIER Steering Committee and Investigators. Evolocumab and clinical outcomes in patients with cardiovascular disease. N Engl J Med. 2017;376:1713-1722.
33. Schwartz GG, Steg PG, Szarek M, et al; ODYSSEY OUTCOMES Committees and Investigators. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome | NEJM. N Engl J Med. 2018;379:2097-2107.
34. Icosapent ethyl [package insert]. Bridgewater, NJ: Amarin Pharma, Inc.; 2019.
35. Bhatt DL, Steg PG, Miller M, et al; REDUCE-IT Investigators. Cardiovascular risk reduction with icosapent ethyl for hypertriglyceridemia. N Engl J Med. 2019;380:11-22
36. Bolton WK. Renal Physicians Association Clinical practice guideline: appropriate patient preparation for renal replacement therapy: guideline number 3. J Am Soc Nephrol. 2003;14(5):1406-1410.
37. American Diabetes Association. Pharmacologic Approaches to glycemic treatment: standards of medical care in diabetes—2020. Diabetes Care. 2020;43(suppl 1):S98-S110.
38. Qaseem A, Barry MJ, Humphrey LL, Forciea MA; Clinical Guidelines Committee of the American College of Physicians. Oral pharmacologic treatment of type 2 diabetes mellitus: a clinical practice guideline update from the American College of Physicians. Ann Intern Med. 2017;166(4):279-290.
39. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease–mineral and bone disorder (CKD-MBD). Kidney Int Suppl (2011). 2017;7(1):1-59.
40. Pop-Busui R, Boulton AJM, Feldman EL, et al. Diabetic neuropathy: a position statement by the American Diabetes Association. Diabetes Care. 2017;40(1):136-154.
41. Gupta V, Bansal R, Gupta A, Bhansali A. The sensitivity and specificity of nonmydriatic digital stereoscopic retinal imaging in detecting diabetic retinopathy. Indian J Ophthalmol. 2014;62(8):851-856.
42. Pérez MA, Bruce BB, Newman NJ, Biousse V. The use of retinal photography in non-ophthalmic settings and its potential for neurology. The Neurologist. 2012;18(6):350-355.
Dapagliflozin benefits low-EF heart failure regardless of diuretic dose: DAPA-HF
The DAPA-HF trial has already changed cardiology in opening up a new class of drugs to patients with heart failure (HF), whether or not they have diabetes. Now the trial is yielding clues as to how it benefits them. For now, it’s doing so by process of elimination.
A new analysis suggests that dapagliflozin (Farxiga, AstraZeneca) didn’t need help from loop diuretics to cut the risk for clinical events in patients with HF with reduced ejection fraction (HFrEF), a benefit seen across the spectrum of glycosylated hemoglobin levels and without compromising renal function, said DAPA-HF investigators. Also, use of dapagliflozin and its clinical effects were not associated with changes in loop diuretic dosage. Those findings and others suggest the drug helps in HFrEF at least partly by some other mechanism than its own diuretic effect, the researchers say.
Such insights will likely be important to case-by-case decisions on whether to use the drug, a sodium-glucose cotransporter 2 (SGLT2) inhibitor once reserved for patients with diabetes, given the recently broader landscape of HF treatment options.
As previously reported from DAPA-HF, with more than 4,700 patients, those who received dapagliflozin showed significant reductions in the primary end point, a composite of cardiovascular (CV) death, HF hospitalization, and urgent HF visit requiring IV therapy over about 18 months. The 45% of patients with and 55% without type 2 diabetes enjoyed about equal benefit in the placebo-controlled trial for that end point, as well as for all-cause mortality.
SGLT2 inhibitors work in diabetes by promoting urinary glucose excretion. That had led some to speculate that its benefit in HFrEF comes primarily from a diuretic effect; the current findings largely put that question to rest.
“Our findings show that treatment with dapagliflozin was effective regardless of diuretic use or diuretic dose. They also show that dapagliflozin did not lead to an increase in renal adverse events or discontinuation of therapy in patients treated with a diuretic,” trialist Alice M. Jackson, MB, ChB, said in an interview.
“In fact, renal adverse events were generally less common in patients treated with dapagliflozin, across the diuretic categories,” said Dr. Jackson, from the University of Glasgow.
Dr. Jackson presented the new analysis at a Late-Breaking Science Session during the European Society of Cardiology Heart Failure Discoveries virtual meeting. The HFA sessions were conducted virtually this year due to the COVID-19 pandemic.
At baseline, 84% of patients were on conventional diuretics. The post hoc analysis broke out all patients by loop-diuretic dosage level: none; less than 40 mg furosemide equivalents (FE); 40 mg FE; or more than 40 mg FE. Clinical outcomes were similar across the four groups.
Clinicians in the trial “were not given specific advice about adjusting diuretic doses, but were encouraged to assess volume status and make changes to medical therapy based on this, if necessary,” Dr. Jackson said. “This suggests that, for most patients, starting dapagliflozin will not necessitate a change in diuretic dose.”
With the caveat that the event rate was low in the relatively few patients not prescribed loop diuretics, she said, “the magnitude of the benefit from dapagliflozin appeared to be larger in patients not treated with a diuretic.”
There was no suggestion of a diuretic dose–response effect or statistical interaction between diuretic use and clinical outcomes on dapagliflozin, Dr. Jackson observed in the interview.
Of note in the analysis, hematocrit levels shot up soon after patients started active therapy, but they didn’t rise much in the placebo group. The sustained hematocrit elevation on dapagliflozin, seen at all diuretic dosage levels, persisted even after dosage reductions at 6 months, she said.
“Dapagliflozin is effective in HFrEF irrespective of background diuretic therapy; therefore, it is almost certainly not purely acting as a diuretic,” Andrew J. Coats, MD, DSc, MBA, said in an interview.
The findings also “lessen the concern that dapagliflozin’s beneficial effects are only seen only in patients without effective diuretic dosing,” said Dr. Coats, from University of Warwick, Coventry, England.
“Altogether, these data give further reassurance that dapagliflozin can safely be used in heart failure, and has a beneficial effect independent of the use of diuretic drugs,” invited discussant Wolfram Doehner, MD, PhD, Charité-Universitätsmedizin Berlin, said after Dr. Jackson’s presentation of the analysis.
He made special mention of the sustained hematocrit elevation on dapagliflozin. “While this effect may likely relate to the mild reduction in plasma volume secondary to dapagliflozin therapy, it is noted that the increase in hematocrit was independent of any change of the diuretic dose,” Doehner said. “If additional mechanisms have a role for this observed increase in hematocrit, it may be of interest in further investigations.”
Dr. Jackson pointed to several observations that suggest the hematocrit finding isn’t explained by hemoconcentration from reduced plasma volume, at least not entirely.
For example, hematocrit levels rose “without any suggestion of a relationship between diuretic dose and degree of hematocrit elevation with dapagliflozin,” she said.
The elevations persisted even with diuretic dose reductions at 6 and 12 months, “which should have led to a decrease in hemoconcentration if it was caused by volume contraction.”
Also, she said, “among patients not taking a diuretic, volume depletion occurred less frequently in the dapagliflozin group than in the placebo group, but there was still a similar rise in hematocrit with dapagliflozin.”
Both Dr. Jackson and Dr. Coats said the sustained elevation in hematocrit on the drug is unlikely to pose a major hazard.
Dr. Coats said that, theoretically, “increased hematocrit could reduce peripheral vessel blood flow, making ischemia and thrombosis more likely. But the size of the effect is small and unlikely to be clinically important.”
A diuretic dose could not be determined for 128 of the trial’s 4,744 randomized patients with HFrEF, so the post hoc analysis was limited to the remaining 4,616. Of those, 746 were not on diuretics at baseline, 1,311 were on loop diuretics at less than 40 mg FE or on non-loop diuretics only, 1,365 were taking 40 mg FE, and 1,204 were on higher doses of loop diuretics.
The mean baseline dosage was 60 mg FE, which rose slightly throughout the trial. But the baseline dosage and the increases were both similar in the placebo and dapagliflozin groups. Dr. Jackson said 84% and 83% of patients on dapagliflozin and placebo, respectively, maintained their baseline dose at 6 months and about 77% in both groups at 12 months.
The overall trial’s significant primary endpoint reduction for dapagliflozin versus placebo applied similarly to patients not on a diuretics and to those on any dose of diuretic, with an interaction P value of .23 for the effect of diuretic use. The hazard ratios (95% confidence interval) were 0.57 (0.36-0.92) for patients not on diuretics, 0.78 (0.68-0.90) for patients on any diuretic dosage, and 0.74 (0.65-0.85) overall
Dr. Jackson said during her formal online presentation that patients on diuretics showed a “tendency toward slightly more volume depletion in those on dapagliflozin than in those on placebo, but the excess was small and not greater than approximately 3% in those taking 40 mg furosemide equivalent diuretic. And fortunately, this did not result in an increase in frequency in renal adverse events nor of discontinuation of study drug.”
Renal adverse events were similarly prevalent in the two treatment groups, as were such events leading to treatment discontinuation. But serious renal events were less common in the dapagliflozin group (1.6% vs 2.7%; P = .009), as was investigator-reported serious acute kidney injury (1.0% vs 1.9%; P = .007).
“Overall, renal events were infrequent,” Dr. Jackson said, and “because of the small number of events, it is very difficult to draw conclusions about the impact of dapagliflozin on renal function according to diuretic-dose subgroups.”
Still, she said, worsening renal function was less common on dapagliflozin in three of the four groups by diuretic dosage; the exception was the less than 40 mg FE group, “but the absolute difference in this group was only two events.”
There seem to be dapagliflozin mechanisms “underneath the surface that need to be unraveled,” Dr. Doehner said as discussant, processes that are favorable for the treatment of HFrEF in which “diuretics play no big role.”
Dr. Jackson has no disclosures. Dr. Coats has disclosed receiving personal fees from Actimed, AstraZeneca, Faraday, WL Gore, Menarini, Novartis, Nutricia, Respicardia, Servier, Stealth Peptides, Verona, and Vifor. Dr. Doener has recently disclosed receiving grants and personal fees from Vifor, Pfizer, Boehringer Ingelheim, Sphingotec, ZS Pharma, Bayer, and Medtronic.
A version of this article originally appeared on Medscape.com.
The DAPA-HF trial has already changed cardiology in opening up a new class of drugs to patients with heart failure (HF), whether or not they have diabetes. Now the trial is yielding clues as to how it benefits them. For now, it’s doing so by process of elimination.
A new analysis suggests that dapagliflozin (Farxiga, AstraZeneca) didn’t need help from loop diuretics to cut the risk for clinical events in patients with HF with reduced ejection fraction (HFrEF), a benefit seen across the spectrum of glycosylated hemoglobin levels and without compromising renal function, said DAPA-HF investigators. Also, use of dapagliflozin and its clinical effects were not associated with changes in loop diuretic dosage. Those findings and others suggest the drug helps in HFrEF at least partly by some other mechanism than its own diuretic effect, the researchers say.
Such insights will likely be important to case-by-case decisions on whether to use the drug, a sodium-glucose cotransporter 2 (SGLT2) inhibitor once reserved for patients with diabetes, given the recently broader landscape of HF treatment options.
As previously reported from DAPA-HF, with more than 4,700 patients, those who received dapagliflozin showed significant reductions in the primary end point, a composite of cardiovascular (CV) death, HF hospitalization, and urgent HF visit requiring IV therapy over about 18 months. The 45% of patients with and 55% without type 2 diabetes enjoyed about equal benefit in the placebo-controlled trial for that end point, as well as for all-cause mortality.
SGLT2 inhibitors work in diabetes by promoting urinary glucose excretion. That had led some to speculate that its benefit in HFrEF comes primarily from a diuretic effect; the current findings largely put that question to rest.
“Our findings show that treatment with dapagliflozin was effective regardless of diuretic use or diuretic dose. They also show that dapagliflozin did not lead to an increase in renal adverse events or discontinuation of therapy in patients treated with a diuretic,” trialist Alice M. Jackson, MB, ChB, said in an interview.
“In fact, renal adverse events were generally less common in patients treated with dapagliflozin, across the diuretic categories,” said Dr. Jackson, from the University of Glasgow.
Dr. Jackson presented the new analysis at a Late-Breaking Science Session during the European Society of Cardiology Heart Failure Discoveries virtual meeting. The HFA sessions were conducted virtually this year due to the COVID-19 pandemic.
At baseline, 84% of patients were on conventional diuretics. The post hoc analysis broke out all patients by loop-diuretic dosage level: none; less than 40 mg furosemide equivalents (FE); 40 mg FE; or more than 40 mg FE. Clinical outcomes were similar across the four groups.
Clinicians in the trial “were not given specific advice about adjusting diuretic doses, but were encouraged to assess volume status and make changes to medical therapy based on this, if necessary,” Dr. Jackson said. “This suggests that, for most patients, starting dapagliflozin will not necessitate a change in diuretic dose.”
With the caveat that the event rate was low in the relatively few patients not prescribed loop diuretics, she said, “the magnitude of the benefit from dapagliflozin appeared to be larger in patients not treated with a diuretic.”
There was no suggestion of a diuretic dose–response effect or statistical interaction between diuretic use and clinical outcomes on dapagliflozin, Dr. Jackson observed in the interview.
Of note in the analysis, hematocrit levels shot up soon after patients started active therapy, but they didn’t rise much in the placebo group. The sustained hematocrit elevation on dapagliflozin, seen at all diuretic dosage levels, persisted even after dosage reductions at 6 months, she said.
“Dapagliflozin is effective in HFrEF irrespective of background diuretic therapy; therefore, it is almost certainly not purely acting as a diuretic,” Andrew J. Coats, MD, DSc, MBA, said in an interview.
The findings also “lessen the concern that dapagliflozin’s beneficial effects are only seen only in patients without effective diuretic dosing,” said Dr. Coats, from University of Warwick, Coventry, England.
“Altogether, these data give further reassurance that dapagliflozin can safely be used in heart failure, and has a beneficial effect independent of the use of diuretic drugs,” invited discussant Wolfram Doehner, MD, PhD, Charité-Universitätsmedizin Berlin, said after Dr. Jackson’s presentation of the analysis.
He made special mention of the sustained hematocrit elevation on dapagliflozin. “While this effect may likely relate to the mild reduction in plasma volume secondary to dapagliflozin therapy, it is noted that the increase in hematocrit was independent of any change of the diuretic dose,” Doehner said. “If additional mechanisms have a role for this observed increase in hematocrit, it may be of interest in further investigations.”
Dr. Jackson pointed to several observations that suggest the hematocrit finding isn’t explained by hemoconcentration from reduced plasma volume, at least not entirely.
For example, hematocrit levels rose “without any suggestion of a relationship between diuretic dose and degree of hematocrit elevation with dapagliflozin,” she said.
The elevations persisted even with diuretic dose reductions at 6 and 12 months, “which should have led to a decrease in hemoconcentration if it was caused by volume contraction.”
Also, she said, “among patients not taking a diuretic, volume depletion occurred less frequently in the dapagliflozin group than in the placebo group, but there was still a similar rise in hematocrit with dapagliflozin.”
Both Dr. Jackson and Dr. Coats said the sustained elevation in hematocrit on the drug is unlikely to pose a major hazard.
Dr. Coats said that, theoretically, “increased hematocrit could reduce peripheral vessel blood flow, making ischemia and thrombosis more likely. But the size of the effect is small and unlikely to be clinically important.”
A diuretic dose could not be determined for 128 of the trial’s 4,744 randomized patients with HFrEF, so the post hoc analysis was limited to the remaining 4,616. Of those, 746 were not on diuretics at baseline, 1,311 were on loop diuretics at less than 40 mg FE or on non-loop diuretics only, 1,365 were taking 40 mg FE, and 1,204 were on higher doses of loop diuretics.
The mean baseline dosage was 60 mg FE, which rose slightly throughout the trial. But the baseline dosage and the increases were both similar in the placebo and dapagliflozin groups. Dr. Jackson said 84% and 83% of patients on dapagliflozin and placebo, respectively, maintained their baseline dose at 6 months and about 77% in both groups at 12 months.
The overall trial’s significant primary endpoint reduction for dapagliflozin versus placebo applied similarly to patients not on a diuretics and to those on any dose of diuretic, with an interaction P value of .23 for the effect of diuretic use. The hazard ratios (95% confidence interval) were 0.57 (0.36-0.92) for patients not on diuretics, 0.78 (0.68-0.90) for patients on any diuretic dosage, and 0.74 (0.65-0.85) overall
Dr. Jackson said during her formal online presentation that patients on diuretics showed a “tendency toward slightly more volume depletion in those on dapagliflozin than in those on placebo, but the excess was small and not greater than approximately 3% in those taking 40 mg furosemide equivalent diuretic. And fortunately, this did not result in an increase in frequency in renal adverse events nor of discontinuation of study drug.”
Renal adverse events were similarly prevalent in the two treatment groups, as were such events leading to treatment discontinuation. But serious renal events were less common in the dapagliflozin group (1.6% vs 2.7%; P = .009), as was investigator-reported serious acute kidney injury (1.0% vs 1.9%; P = .007).
“Overall, renal events were infrequent,” Dr. Jackson said, and “because of the small number of events, it is very difficult to draw conclusions about the impact of dapagliflozin on renal function according to diuretic-dose subgroups.”
Still, she said, worsening renal function was less common on dapagliflozin in three of the four groups by diuretic dosage; the exception was the less than 40 mg FE group, “but the absolute difference in this group was only two events.”
There seem to be dapagliflozin mechanisms “underneath the surface that need to be unraveled,” Dr. Doehner said as discussant, processes that are favorable for the treatment of HFrEF in which “diuretics play no big role.”
Dr. Jackson has no disclosures. Dr. Coats has disclosed receiving personal fees from Actimed, AstraZeneca, Faraday, WL Gore, Menarini, Novartis, Nutricia, Respicardia, Servier, Stealth Peptides, Verona, and Vifor. Dr. Doener has recently disclosed receiving grants and personal fees from Vifor, Pfizer, Boehringer Ingelheim, Sphingotec, ZS Pharma, Bayer, and Medtronic.
A version of this article originally appeared on Medscape.com.
The DAPA-HF trial has already changed cardiology in opening up a new class of drugs to patients with heart failure (HF), whether or not they have diabetes. Now the trial is yielding clues as to how it benefits them. For now, it’s doing so by process of elimination.
A new analysis suggests that dapagliflozin (Farxiga, AstraZeneca) didn’t need help from loop diuretics to cut the risk for clinical events in patients with HF with reduced ejection fraction (HFrEF), a benefit seen across the spectrum of glycosylated hemoglobin levels and without compromising renal function, said DAPA-HF investigators. Also, use of dapagliflozin and its clinical effects were not associated with changes in loop diuretic dosage. Those findings and others suggest the drug helps in HFrEF at least partly by some other mechanism than its own diuretic effect, the researchers say.
Such insights will likely be important to case-by-case decisions on whether to use the drug, a sodium-glucose cotransporter 2 (SGLT2) inhibitor once reserved for patients with diabetes, given the recently broader landscape of HF treatment options.
As previously reported from DAPA-HF, with more than 4,700 patients, those who received dapagliflozin showed significant reductions in the primary end point, a composite of cardiovascular (CV) death, HF hospitalization, and urgent HF visit requiring IV therapy over about 18 months. The 45% of patients with and 55% without type 2 diabetes enjoyed about equal benefit in the placebo-controlled trial for that end point, as well as for all-cause mortality.
SGLT2 inhibitors work in diabetes by promoting urinary glucose excretion. That had led some to speculate that its benefit in HFrEF comes primarily from a diuretic effect; the current findings largely put that question to rest.
“Our findings show that treatment with dapagliflozin was effective regardless of diuretic use or diuretic dose. They also show that dapagliflozin did not lead to an increase in renal adverse events or discontinuation of therapy in patients treated with a diuretic,” trialist Alice M. Jackson, MB, ChB, said in an interview.
“In fact, renal adverse events were generally less common in patients treated with dapagliflozin, across the diuretic categories,” said Dr. Jackson, from the University of Glasgow.
Dr. Jackson presented the new analysis at a Late-Breaking Science Session during the European Society of Cardiology Heart Failure Discoveries virtual meeting. The HFA sessions were conducted virtually this year due to the COVID-19 pandemic.
At baseline, 84% of patients were on conventional diuretics. The post hoc analysis broke out all patients by loop-diuretic dosage level: none; less than 40 mg furosemide equivalents (FE); 40 mg FE; or more than 40 mg FE. Clinical outcomes were similar across the four groups.
Clinicians in the trial “were not given specific advice about adjusting diuretic doses, but were encouraged to assess volume status and make changes to medical therapy based on this, if necessary,” Dr. Jackson said. “This suggests that, for most patients, starting dapagliflozin will not necessitate a change in diuretic dose.”
With the caveat that the event rate was low in the relatively few patients not prescribed loop diuretics, she said, “the magnitude of the benefit from dapagliflozin appeared to be larger in patients not treated with a diuretic.”
There was no suggestion of a diuretic dose–response effect or statistical interaction between diuretic use and clinical outcomes on dapagliflozin, Dr. Jackson observed in the interview.
Of note in the analysis, hematocrit levels shot up soon after patients started active therapy, but they didn’t rise much in the placebo group. The sustained hematocrit elevation on dapagliflozin, seen at all diuretic dosage levels, persisted even after dosage reductions at 6 months, she said.
“Dapagliflozin is effective in HFrEF irrespective of background diuretic therapy; therefore, it is almost certainly not purely acting as a diuretic,” Andrew J. Coats, MD, DSc, MBA, said in an interview.
The findings also “lessen the concern that dapagliflozin’s beneficial effects are only seen only in patients without effective diuretic dosing,” said Dr. Coats, from University of Warwick, Coventry, England.
“Altogether, these data give further reassurance that dapagliflozin can safely be used in heart failure, and has a beneficial effect independent of the use of diuretic drugs,” invited discussant Wolfram Doehner, MD, PhD, Charité-Universitätsmedizin Berlin, said after Dr. Jackson’s presentation of the analysis.
He made special mention of the sustained hematocrit elevation on dapagliflozin. “While this effect may likely relate to the mild reduction in plasma volume secondary to dapagliflozin therapy, it is noted that the increase in hematocrit was independent of any change of the diuretic dose,” Doehner said. “If additional mechanisms have a role for this observed increase in hematocrit, it may be of interest in further investigations.”
Dr. Jackson pointed to several observations that suggest the hematocrit finding isn’t explained by hemoconcentration from reduced plasma volume, at least not entirely.
For example, hematocrit levels rose “without any suggestion of a relationship between diuretic dose and degree of hematocrit elevation with dapagliflozin,” she said.
The elevations persisted even with diuretic dose reductions at 6 and 12 months, “which should have led to a decrease in hemoconcentration if it was caused by volume contraction.”
Also, she said, “among patients not taking a diuretic, volume depletion occurred less frequently in the dapagliflozin group than in the placebo group, but there was still a similar rise in hematocrit with dapagliflozin.”
Both Dr. Jackson and Dr. Coats said the sustained elevation in hematocrit on the drug is unlikely to pose a major hazard.
Dr. Coats said that, theoretically, “increased hematocrit could reduce peripheral vessel blood flow, making ischemia and thrombosis more likely. But the size of the effect is small and unlikely to be clinically important.”
A diuretic dose could not be determined for 128 of the trial’s 4,744 randomized patients with HFrEF, so the post hoc analysis was limited to the remaining 4,616. Of those, 746 were not on diuretics at baseline, 1,311 were on loop diuretics at less than 40 mg FE or on non-loop diuretics only, 1,365 were taking 40 mg FE, and 1,204 were on higher doses of loop diuretics.
The mean baseline dosage was 60 mg FE, which rose slightly throughout the trial. But the baseline dosage and the increases were both similar in the placebo and dapagliflozin groups. Dr. Jackson said 84% and 83% of patients on dapagliflozin and placebo, respectively, maintained their baseline dose at 6 months and about 77% in both groups at 12 months.
The overall trial’s significant primary endpoint reduction for dapagliflozin versus placebo applied similarly to patients not on a diuretics and to those on any dose of diuretic, with an interaction P value of .23 for the effect of diuretic use. The hazard ratios (95% confidence interval) were 0.57 (0.36-0.92) for patients not on diuretics, 0.78 (0.68-0.90) for patients on any diuretic dosage, and 0.74 (0.65-0.85) overall
Dr. Jackson said during her formal online presentation that patients on diuretics showed a “tendency toward slightly more volume depletion in those on dapagliflozin than in those on placebo, but the excess was small and not greater than approximately 3% in those taking 40 mg furosemide equivalent diuretic. And fortunately, this did not result in an increase in frequency in renal adverse events nor of discontinuation of study drug.”
Renal adverse events were similarly prevalent in the two treatment groups, as were such events leading to treatment discontinuation. But serious renal events were less common in the dapagliflozin group (1.6% vs 2.7%; P = .009), as was investigator-reported serious acute kidney injury (1.0% vs 1.9%; P = .007).
“Overall, renal events were infrequent,” Dr. Jackson said, and “because of the small number of events, it is very difficult to draw conclusions about the impact of dapagliflozin on renal function according to diuretic-dose subgroups.”
Still, she said, worsening renal function was less common on dapagliflozin in three of the four groups by diuretic dosage; the exception was the less than 40 mg FE group, “but the absolute difference in this group was only two events.”
There seem to be dapagliflozin mechanisms “underneath the surface that need to be unraveled,” Dr. Doehner said as discussant, processes that are favorable for the treatment of HFrEF in which “diuretics play no big role.”
Dr. Jackson has no disclosures. Dr. Coats has disclosed receiving personal fees from Actimed, AstraZeneca, Faraday, WL Gore, Menarini, Novartis, Nutricia, Respicardia, Servier, Stealth Peptides, Verona, and Vifor. Dr. Doener has recently disclosed receiving grants and personal fees from Vifor, Pfizer, Boehringer Ingelheim, Sphingotec, ZS Pharma, Bayer, and Medtronic.
A version of this article originally appeared on Medscape.com.
FROM ESC HEART FAILURE 2020
Diabetes control in U.S. youth has worsened over time
Glycemic control among youth with diabetes is no better today than it was in 2002 and in some subgroups it’s worse, despite increased availability of diabetes technology, newer therapies, and more aggressive recommended blood glucose targets, new research finds.
The sobering data from 6,399 participants in the longitudinal SEARCH for Diabetes in Youth study were presented June 15 at the virtual American Diabetes Association 80th Scientific Sessions by Faisal S. Malik, MD, of the University of Washington, Seattle, and Seattle Children’s Research Institute.
“Our finding that current youth and young adults with diabetes are not demonstrating improved glycemic control, compared to earlier cohorts in the SEARCH study was surprising given how the landscape of diabetes management has changed dramatically over the past decade,” Dr. Malik said in an interview.
Urgent need to improve glycemic control in youth with diabetes
The SEARCH study, funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Centers for Disease Control and Prevention, is the largest and most diverse study of diabetes in youth in the United States. It has over 27,000 participants seen at five study sites in California, Colorado, Ohio, South Carolina, and Washington state.
Among youth with type 1 diabetes in the study, average hemoglobin A1c rose from 8.6% in 2002-2007 (n = 3,451) to 8.8% in 2008-2014 (n = 2,254), and remained at 8.8% in 2014-2019 (n = 1,651).
Among those with type 2 diabetes, A1c levels fluctuated from 8.8% (n = 379) to 8.4% (n = 327) to 8.5% (n = 469) in the three time periods, respectively.
By contrast, in 2014 the ADA recommended an A1c of less than 7.5% for youth of all ages with type 1 diabetes, down from prior less stringent targets.
In 2018, the ADA advised A1c levels below 7% for youth with type 2 diabetes. In both cases, targets may be adjusted based on individual circumstances.
A particularly striking data point was seen among youth who had type 2 diabetes for 10 years or more: average A1c skyrocketed from 7.9% in 2008-2013 to 10.1% in 2014-2019. The numbers were small, 25 patients in the earlier cohort and 149 patients in the later, yet the difference was still significant (P < .01). And in those with type 1 diabetes for 5-9 years, average A1c rose from 8.7% in 2002-2007 (n = 769) to 9.2% in 2014-2019 (n = 654) (P < .01).
“These results suggest that not all youth with diabetes are directly benefiting from the increased availability of diabetes technology, newer therapies, and the use of more aggressive glycemic targets for youth with diabetes over time,” Dr. Malik said.
“Recognizing that lower A1c levels in adolescence and young adulthood is associated with lower risk and rate of microvascular and macrovascular complications, this study further underscores the urgent need for effective treatment strategies to improve glycemic control in youth and young adults with diabetes,” he added.
Asked to comment, David M. Maahs, MD, said in an interview that the type 1 diabetes data are “very consistent” with those found in the T1D Exchange registry study but that both datasets include patients seen at diabetes centers and therefore may not represent the entire population.
“I don’t think there’s reason to think we’re actually doing any better than these data indicate,” said Dr. Maahs, professor of pediatrics and division chief of pediatric endocrinology at Stanford (Calif.) University.
Other countries improving, U.S. getting worse
Dr. Maahs contrasted the U.S. situation with that of the English/Welsh National Paediatric Diabetes Audit and some European countries that have improved pediatric diabetes control and outcomes using a population-based approach.
“In the United States we have a disjointed irrational health care system that doesn’t invest in diabetes education and in the basic care and monitoring that children with diabetes need to get better glucose control,” he said.
“We’re not having systematic approaches to it as many European countries have. They have gotten better results over this same time period. In the United States we’re getting worse,” Dr. Maahs observed.
And as far as diabetes technology is concerned, Dr. Maahs said, “there’s more to it than just throwing technology at it. People who are using technology are getting better outcomes, but there are a lot of people who don’t get access to it.”
Indeed, Dr. Malik pointed out, “while the recent SEARCH [type 1 diabetes] cohorts had increased insulin pump use, it’s worth noting that more than half of the participants in the most recent cohort were not using diabetes technology.” And even “fewer participants were likely using continuous glucose monitors during our study period.”
Barriers to care, type 1 diabetes is “very labor intensive”
Dr. Malik said that barriers to care include “high cost, alarm fatigue, and encumbrances of wearing a mechanical device [that] continue to present challenges around technology use,” as well as “inequities in the use of these technologies across socioeconomic status, health insurance, and race/ethnicity, which need to be addressed.”
Dr. Maahs did have a recommendation for U.S. primary care physicians who are managing youth with either type of diabetes: a tele-education program called Project ECHO (Extension for Community Healthcare Outcomes), which uses a train-the-trainer model, rather than direct telehealth, to bring tele-education to primary care providers.
Such programs in diabetes have shown some success, he said.
Type 1 diabetes, Dr. Malik noted, “is very labor intensive. Frequent or constant monitoring of glucose and multiple daily doses of basal and bolus insulin are commonly recommended by type 1 diabetes care providers in the United States.”
“This has led to increasingly burdensome management for children and their caregivers, which often results in suboptimal adherence, suboptimal glycemic control, and greater risk of complications.”
Dr. Malik encourages providers “to engage in person-centered collaborative care as recommended by the ADA, which is guided by shared decision-making in treatment regimen selection, facilitation of obtaining needed medical and psychosocial resources, and shared monitoring of agreed-upon regimen and lifestyle.”
Dr. Malik has reported no relevant financial relationships. Dr. Maahs has reported being on advisory boards for Medtronic, Lilly, and Abbott.
A version of this article originally appeared on Medscape.com.
Glycemic control among youth with diabetes is no better today than it was in 2002 and in some subgroups it’s worse, despite increased availability of diabetes technology, newer therapies, and more aggressive recommended blood glucose targets, new research finds.
The sobering data from 6,399 participants in the longitudinal SEARCH for Diabetes in Youth study were presented June 15 at the virtual American Diabetes Association 80th Scientific Sessions by Faisal S. Malik, MD, of the University of Washington, Seattle, and Seattle Children’s Research Institute.
“Our finding that current youth and young adults with diabetes are not demonstrating improved glycemic control, compared to earlier cohorts in the SEARCH study was surprising given how the landscape of diabetes management has changed dramatically over the past decade,” Dr. Malik said in an interview.
Urgent need to improve glycemic control in youth with diabetes
The SEARCH study, funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Centers for Disease Control and Prevention, is the largest and most diverse study of diabetes in youth in the United States. It has over 27,000 participants seen at five study sites in California, Colorado, Ohio, South Carolina, and Washington state.
Among youth with type 1 diabetes in the study, average hemoglobin A1c rose from 8.6% in 2002-2007 (n = 3,451) to 8.8% in 2008-2014 (n = 2,254), and remained at 8.8% in 2014-2019 (n = 1,651).
Among those with type 2 diabetes, A1c levels fluctuated from 8.8% (n = 379) to 8.4% (n = 327) to 8.5% (n = 469) in the three time periods, respectively.
By contrast, in 2014 the ADA recommended an A1c of less than 7.5% for youth of all ages with type 1 diabetes, down from prior less stringent targets.
In 2018, the ADA advised A1c levels below 7% for youth with type 2 diabetes. In both cases, targets may be adjusted based on individual circumstances.
A particularly striking data point was seen among youth who had type 2 diabetes for 10 years or more: average A1c skyrocketed from 7.9% in 2008-2013 to 10.1% in 2014-2019. The numbers were small, 25 patients in the earlier cohort and 149 patients in the later, yet the difference was still significant (P < .01). And in those with type 1 diabetes for 5-9 years, average A1c rose from 8.7% in 2002-2007 (n = 769) to 9.2% in 2014-2019 (n = 654) (P < .01).
“These results suggest that not all youth with diabetes are directly benefiting from the increased availability of diabetes technology, newer therapies, and the use of more aggressive glycemic targets for youth with diabetes over time,” Dr. Malik said.
“Recognizing that lower A1c levels in adolescence and young adulthood is associated with lower risk and rate of microvascular and macrovascular complications, this study further underscores the urgent need for effective treatment strategies to improve glycemic control in youth and young adults with diabetes,” he added.
Asked to comment, David M. Maahs, MD, said in an interview that the type 1 diabetes data are “very consistent” with those found in the T1D Exchange registry study but that both datasets include patients seen at diabetes centers and therefore may not represent the entire population.
“I don’t think there’s reason to think we’re actually doing any better than these data indicate,” said Dr. Maahs, professor of pediatrics and division chief of pediatric endocrinology at Stanford (Calif.) University.
Other countries improving, U.S. getting worse
Dr. Maahs contrasted the U.S. situation with that of the English/Welsh National Paediatric Diabetes Audit and some European countries that have improved pediatric diabetes control and outcomes using a population-based approach.
“In the United States we have a disjointed irrational health care system that doesn’t invest in diabetes education and in the basic care and monitoring that children with diabetes need to get better glucose control,” he said.
“We’re not having systematic approaches to it as many European countries have. They have gotten better results over this same time period. In the United States we’re getting worse,” Dr. Maahs observed.
And as far as diabetes technology is concerned, Dr. Maahs said, “there’s more to it than just throwing technology at it. People who are using technology are getting better outcomes, but there are a lot of people who don’t get access to it.”
Indeed, Dr. Malik pointed out, “while the recent SEARCH [type 1 diabetes] cohorts had increased insulin pump use, it’s worth noting that more than half of the participants in the most recent cohort were not using diabetes technology.” And even “fewer participants were likely using continuous glucose monitors during our study period.”
Barriers to care, type 1 diabetes is “very labor intensive”
Dr. Malik said that barriers to care include “high cost, alarm fatigue, and encumbrances of wearing a mechanical device [that] continue to present challenges around technology use,” as well as “inequities in the use of these technologies across socioeconomic status, health insurance, and race/ethnicity, which need to be addressed.”
Dr. Maahs did have a recommendation for U.S. primary care physicians who are managing youth with either type of diabetes: a tele-education program called Project ECHO (Extension for Community Healthcare Outcomes), which uses a train-the-trainer model, rather than direct telehealth, to bring tele-education to primary care providers.
Such programs in diabetes have shown some success, he said.
Type 1 diabetes, Dr. Malik noted, “is very labor intensive. Frequent or constant monitoring of glucose and multiple daily doses of basal and bolus insulin are commonly recommended by type 1 diabetes care providers in the United States.”
“This has led to increasingly burdensome management for children and their caregivers, which often results in suboptimal adherence, suboptimal glycemic control, and greater risk of complications.”
Dr. Malik encourages providers “to engage in person-centered collaborative care as recommended by the ADA, which is guided by shared decision-making in treatment regimen selection, facilitation of obtaining needed medical and psychosocial resources, and shared monitoring of agreed-upon regimen and lifestyle.”
Dr. Malik has reported no relevant financial relationships. Dr. Maahs has reported being on advisory boards for Medtronic, Lilly, and Abbott.
A version of this article originally appeared on Medscape.com.
Glycemic control among youth with diabetes is no better today than it was in 2002 and in some subgroups it’s worse, despite increased availability of diabetes technology, newer therapies, and more aggressive recommended blood glucose targets, new research finds.
The sobering data from 6,399 participants in the longitudinal SEARCH for Diabetes in Youth study were presented June 15 at the virtual American Diabetes Association 80th Scientific Sessions by Faisal S. Malik, MD, of the University of Washington, Seattle, and Seattle Children’s Research Institute.
“Our finding that current youth and young adults with diabetes are not demonstrating improved glycemic control, compared to earlier cohorts in the SEARCH study was surprising given how the landscape of diabetes management has changed dramatically over the past decade,” Dr. Malik said in an interview.
Urgent need to improve glycemic control in youth with diabetes
The SEARCH study, funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Centers for Disease Control and Prevention, is the largest and most diverse study of diabetes in youth in the United States. It has over 27,000 participants seen at five study sites in California, Colorado, Ohio, South Carolina, and Washington state.
Among youth with type 1 diabetes in the study, average hemoglobin A1c rose from 8.6% in 2002-2007 (n = 3,451) to 8.8% in 2008-2014 (n = 2,254), and remained at 8.8% in 2014-2019 (n = 1,651).
Among those with type 2 diabetes, A1c levels fluctuated from 8.8% (n = 379) to 8.4% (n = 327) to 8.5% (n = 469) in the three time periods, respectively.
By contrast, in 2014 the ADA recommended an A1c of less than 7.5% for youth of all ages with type 1 diabetes, down from prior less stringent targets.
In 2018, the ADA advised A1c levels below 7% for youth with type 2 diabetes. In both cases, targets may be adjusted based on individual circumstances.
A particularly striking data point was seen among youth who had type 2 diabetes for 10 years or more: average A1c skyrocketed from 7.9% in 2008-2013 to 10.1% in 2014-2019. The numbers were small, 25 patients in the earlier cohort and 149 patients in the later, yet the difference was still significant (P < .01). And in those with type 1 diabetes for 5-9 years, average A1c rose from 8.7% in 2002-2007 (n = 769) to 9.2% in 2014-2019 (n = 654) (P < .01).
“These results suggest that not all youth with diabetes are directly benefiting from the increased availability of diabetes technology, newer therapies, and the use of more aggressive glycemic targets for youth with diabetes over time,” Dr. Malik said.
“Recognizing that lower A1c levels in adolescence and young adulthood is associated with lower risk and rate of microvascular and macrovascular complications, this study further underscores the urgent need for effective treatment strategies to improve glycemic control in youth and young adults with diabetes,” he added.
Asked to comment, David M. Maahs, MD, said in an interview that the type 1 diabetes data are “very consistent” with those found in the T1D Exchange registry study but that both datasets include patients seen at diabetes centers and therefore may not represent the entire population.
“I don’t think there’s reason to think we’re actually doing any better than these data indicate,” said Dr. Maahs, professor of pediatrics and division chief of pediatric endocrinology at Stanford (Calif.) University.
Other countries improving, U.S. getting worse
Dr. Maahs contrasted the U.S. situation with that of the English/Welsh National Paediatric Diabetes Audit and some European countries that have improved pediatric diabetes control and outcomes using a population-based approach.
“In the United States we have a disjointed irrational health care system that doesn’t invest in diabetes education and in the basic care and monitoring that children with diabetes need to get better glucose control,” he said.
“We’re not having systematic approaches to it as many European countries have. They have gotten better results over this same time period. In the United States we’re getting worse,” Dr. Maahs observed.
And as far as diabetes technology is concerned, Dr. Maahs said, “there’s more to it than just throwing technology at it. People who are using technology are getting better outcomes, but there are a lot of people who don’t get access to it.”
Indeed, Dr. Malik pointed out, “while the recent SEARCH [type 1 diabetes] cohorts had increased insulin pump use, it’s worth noting that more than half of the participants in the most recent cohort were not using diabetes technology.” And even “fewer participants were likely using continuous glucose monitors during our study period.”
Barriers to care, type 1 diabetes is “very labor intensive”
Dr. Malik said that barriers to care include “high cost, alarm fatigue, and encumbrances of wearing a mechanical device [that] continue to present challenges around technology use,” as well as “inequities in the use of these technologies across socioeconomic status, health insurance, and race/ethnicity, which need to be addressed.”
Dr. Maahs did have a recommendation for U.S. primary care physicians who are managing youth with either type of diabetes: a tele-education program called Project ECHO (Extension for Community Healthcare Outcomes), which uses a train-the-trainer model, rather than direct telehealth, to bring tele-education to primary care providers.
Such programs in diabetes have shown some success, he said.
Type 1 diabetes, Dr. Malik noted, “is very labor intensive. Frequent or constant monitoring of glucose and multiple daily doses of basal and bolus insulin are commonly recommended by type 1 diabetes care providers in the United States.”
“This has led to increasingly burdensome management for children and their caregivers, which often results in suboptimal adherence, suboptimal glycemic control, and greater risk of complications.”
Dr. Malik encourages providers “to engage in person-centered collaborative care as recommended by the ADA, which is guided by shared decision-making in treatment regimen selection, facilitation of obtaining needed medical and psychosocial resources, and shared monitoring of agreed-upon regimen and lifestyle.”
Dr. Malik has reported no relevant financial relationships. Dr. Maahs has reported being on advisory boards for Medtronic, Lilly, and Abbott.
A version of this article originally appeared on Medscape.com.
FROM ADA 2020
Daily Recap: ED visits for life-threatening conditions plummet; COVID-19 imaging strategies for kids
Here are the stories our MDedge editors across specialties think you need to know about today:
ED visits drop for life-threatening conditions
Emergency department visits for myocardial infarction, stroke, and hyperglycemic crisis dropped substantially in the 10 weeks after COVID-19 was declared a national emergency, according to new research from the Centers for Disease Control and Prevention.
Compared with the 10-week period from Jan. 5 to March 14, ED visits were down by 23% for MI, 20% for stroke, and 10% for hyperglycemic crisis from March 15 to May 23.
“A short-term decline of this magnitude … is biologically implausible for MI and stroke, especially for older adults, and unlikely for hyperglycemic crisis, and the finding suggests that patients with these conditions either could not access care or were delaying or avoiding seeking care during the early pandemic period,” the researchers wrote in the Morbidity and Mortality Weekly Report. Read more.
Expert recommendations for pediatric COVID-19 imaging
A team of pulmonologists has synthesized the clinical and imaging characteristics of COVID-19 in children, and has issued recommendations for ordering imaging studies in suspected cases of the infection.
Current recommendations from the American College of Radiology (ACR) do not include chest computed tomography (CT) or chest radiography (CXR) as an upfront test to diagnose pediatric COVID-19, but the tests may still have a role in clinical monitoring, especially in patients with a moderate to severe disease course. The potential benefits of utilizing radiologic evaluation – such as establishing a baseline for monitoring disease progression – must be balanced with potential drawbacks, including radiation exposure and reduced availability of imaging resources owing to necessary cleaning and air turnover time.
Based on the most recent international guidelines for pediatric COVID-19 patient management, the authors developed an algorithm for performing imaging studies in suspected cases of COVID-19 pneumonia. The purpose of the tool is to support clinical decision-making around the utilization of CXR and CT to evaluate pediatric COVID-19 pneumonia. “The step by step algorithm addresses the selection, sequence and timing of imaging studies with multiple images illustrating key findings of COVID-19 pneumonia in the pediatric age group,” said Mary Cataletto, MD, of NYU Langone Health in Mineola, N.Y. Read more.
Cortisol levels on COVID-19 admission may be a marker of severity
Patients with COVID-19 who have high levels of the steroid hormone cortisol on admission to the hospital have a substantially increased risk of dying, according to new study findings.
Researchers assessed 535 patients admitted to major London hospitals. Of these, 403 patients were diagnosed with COVID-19 based on a positive result on real-time polymerase chain reaction testing or a strong clinical and radiological suspicion, despite a negative test. Mean cortisol concentrations in patients with COVID-19 were significantly higher than those not diagnosed with the virus and as of May 8, significantly more patients with COVID-19 died than those without (27.8% vs 6.8%).
Measuring cortisol on admission is potentially “another simple marker to use alongside oxygen saturation levels to help us identify which patients need to be admitted immediately, and which may not,” said Waljit S. Dhillo, MBBS, PhD, head of the division of diabetes, endocrinology and metabolism at Imperial College London.
“Having an early indicator of which patients may deteriorate more quickly will help us with providing the best level of care as quickly as possible. In addition, we can also take cortisol levels into account when we are working out how best to treat our patients,” he said. Read more.
Normal-weight prediabetes patients can benefit from lifestyle changes
Adults of normal weight with prediabetes may derive at least as much benefit from lifestyle health coaching programs as adults who are overweight or obese, results of a recent nonrandomized, real-world study show.
Fasting plasma glucose (FPG) normalized in about 63% of prediabetic adults with normal body mass index (BMI) participating in a personalized coaching program that emphasized exercise, nutrition, and weight management. In contrast, FPG normalized in about 52% of overweight and 44% of obese prediabetic individuals participating in the program.
“It is interesting to note that, although the normal weight group lost the least amount of weight, they still benefited from the lifestyle health coaching program... having a resultant greatest decrease in fasting plasma glucose and normalization to a range of someone without prediabetes,” said researcher Mandy Salmon, MS, a medical student at the University of Pennsylvania, Philadelphia. She presented the findings at the virtual annual scientific sessions of the American Diabetes Association. Read more.
Diabetes-related amputations rise in older adults
The recent resurgence in diabetes-related lower-extremity amputations in the United States is not limited to younger adults, according to the author of a recent study that documents similar increases among an older population of Medicare beneficiaries.
While the rate of amputations fell among these older adults from 2000 to 2009, it increased significantly from 2009 to 2017, albeit at a “less severe rate” than recently reported in younger populations, according to study investigator Jessica Harding, PhD, an assistant professor in the department of surgery at Emory University, Atlanta. Dr. Harding reported the results at the virtual annual scientific sessions of the American Diabetes Association.
The rate of nontraumatic lower extremity amputation (NLEA) was ticking upward by more than 1% per year over the 2009-2017 period. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Here are the stories our MDedge editors across specialties think you need to know about today:
ED visits drop for life-threatening conditions
Emergency department visits for myocardial infarction, stroke, and hyperglycemic crisis dropped substantially in the 10 weeks after COVID-19 was declared a national emergency, according to new research from the Centers for Disease Control and Prevention.
Compared with the 10-week period from Jan. 5 to March 14, ED visits were down by 23% for MI, 20% for stroke, and 10% for hyperglycemic crisis from March 15 to May 23.
“A short-term decline of this magnitude … is biologically implausible for MI and stroke, especially for older adults, and unlikely for hyperglycemic crisis, and the finding suggests that patients with these conditions either could not access care or were delaying or avoiding seeking care during the early pandemic period,” the researchers wrote in the Morbidity and Mortality Weekly Report. Read more.
Expert recommendations for pediatric COVID-19 imaging
A team of pulmonologists has synthesized the clinical and imaging characteristics of COVID-19 in children, and has issued recommendations for ordering imaging studies in suspected cases of the infection.
Current recommendations from the American College of Radiology (ACR) do not include chest computed tomography (CT) or chest radiography (CXR) as an upfront test to diagnose pediatric COVID-19, but the tests may still have a role in clinical monitoring, especially in patients with a moderate to severe disease course. The potential benefits of utilizing radiologic evaluation – such as establishing a baseline for monitoring disease progression – must be balanced with potential drawbacks, including radiation exposure and reduced availability of imaging resources owing to necessary cleaning and air turnover time.
Based on the most recent international guidelines for pediatric COVID-19 patient management, the authors developed an algorithm for performing imaging studies in suspected cases of COVID-19 pneumonia. The purpose of the tool is to support clinical decision-making around the utilization of CXR and CT to evaluate pediatric COVID-19 pneumonia. “The step by step algorithm addresses the selection, sequence and timing of imaging studies with multiple images illustrating key findings of COVID-19 pneumonia in the pediatric age group,” said Mary Cataletto, MD, of NYU Langone Health in Mineola, N.Y. Read more.
Cortisol levels on COVID-19 admission may be a marker of severity
Patients with COVID-19 who have high levels of the steroid hormone cortisol on admission to the hospital have a substantially increased risk of dying, according to new study findings.
Researchers assessed 535 patients admitted to major London hospitals. Of these, 403 patients were diagnosed with COVID-19 based on a positive result on real-time polymerase chain reaction testing or a strong clinical and radiological suspicion, despite a negative test. Mean cortisol concentrations in patients with COVID-19 were significantly higher than those not diagnosed with the virus and as of May 8, significantly more patients with COVID-19 died than those without (27.8% vs 6.8%).
Measuring cortisol on admission is potentially “another simple marker to use alongside oxygen saturation levels to help us identify which patients need to be admitted immediately, and which may not,” said Waljit S. Dhillo, MBBS, PhD, head of the division of diabetes, endocrinology and metabolism at Imperial College London.
“Having an early indicator of which patients may deteriorate more quickly will help us with providing the best level of care as quickly as possible. In addition, we can also take cortisol levels into account when we are working out how best to treat our patients,” he said. Read more.
Normal-weight prediabetes patients can benefit from lifestyle changes
Adults of normal weight with prediabetes may derive at least as much benefit from lifestyle health coaching programs as adults who are overweight or obese, results of a recent nonrandomized, real-world study show.
Fasting plasma glucose (FPG) normalized in about 63% of prediabetic adults with normal body mass index (BMI) participating in a personalized coaching program that emphasized exercise, nutrition, and weight management. In contrast, FPG normalized in about 52% of overweight and 44% of obese prediabetic individuals participating in the program.
“It is interesting to note that, although the normal weight group lost the least amount of weight, they still benefited from the lifestyle health coaching program... having a resultant greatest decrease in fasting plasma glucose and normalization to a range of someone without prediabetes,” said researcher Mandy Salmon, MS, a medical student at the University of Pennsylvania, Philadelphia. She presented the findings at the virtual annual scientific sessions of the American Diabetes Association. Read more.
Diabetes-related amputations rise in older adults
The recent resurgence in diabetes-related lower-extremity amputations in the United States is not limited to younger adults, according to the author of a recent study that documents similar increases among an older population of Medicare beneficiaries.
While the rate of amputations fell among these older adults from 2000 to 2009, it increased significantly from 2009 to 2017, albeit at a “less severe rate” than recently reported in younger populations, according to study investigator Jessica Harding, PhD, an assistant professor in the department of surgery at Emory University, Atlanta. Dr. Harding reported the results at the virtual annual scientific sessions of the American Diabetes Association.
The rate of nontraumatic lower extremity amputation (NLEA) was ticking upward by more than 1% per year over the 2009-2017 period. Read more.
For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.
Here are the stories our MDedge editors across specialties think you need to know about today:
ED visits drop for life-threatening conditions
Emergency department visits for myocardial infarction, stroke, and hyperglycemic crisis dropped substantially in the 10 weeks after COVID-19 was declared a national emergency, according to new research from the Centers for Disease Control and Prevention.
Compared with the 10-week period from Jan. 5 to March 14, ED visits were down by 23% for MI, 20% for stroke, and 10% for hyperglycemic crisis from March 15 to May 23.
“A short-term decline of this magnitude … is biologically implausible for MI and stroke, especially for older adults, and unlikely for hyperglycemic crisis, and the finding suggests that patients with these conditions either could not access care or were delaying or avoiding seeking care during the early pandemic period,” the researchers wrote in the Morbidity and Mortality Weekly Report. Read more.
Expert recommendations for pediatric COVID-19 imaging
A team of pulmonologists has synthesized the clinical and imaging characteristics of COVID-19 in children, and has issued recommendations for ordering imaging studies in suspected cases of the infection.
Current recommendations from the American College of Radiology (ACR) do not include chest computed tomography (CT) or chest radiography (CXR) as an upfront test to diagnose pediatric COVID-19, but the tests may still have a role in clinical monitoring, especially in patients with a moderate to severe disease course. The potential benefits of utilizing radiologic evaluation – such as establishing a baseline for monitoring disease progression – must be balanced with potential drawbacks, including radiation exposure and reduced availability of imaging resources owing to necessary cleaning and air turnover time.
Based on the most recent international guidelines for pediatric COVID-19 patient management, the authors developed an algorithm for performing imaging studies in suspected cases of COVID-19 pneumonia. The purpose of the tool is to support clinical decision-making around the utilization of CXR and CT to evaluate pediatric COVID-19 pneumonia. “The step by step algorithm addresses the selection, sequence and timing of imaging studies with multiple images illustrating key findings of COVID-19 pneumonia in the pediatric age group,” said Mary Cataletto, MD, of NYU Langone Health in Mineola, N.Y. Read more.
Cortisol levels on COVID-19 admission may be a marker of severity
Patients with COVID-19 who have high levels of the steroid hormone cortisol on admission to the hospital have a substantially increased risk of dying, according to new study findings.
Researchers assessed 535 patients admitted to major London hospitals. Of these, 403 patients were diagnosed with COVID-19 based on a positive result on real-time polymerase chain reaction testing or a strong clinical and radiological suspicion, despite a negative test. Mean cortisol concentrations in patients with COVID-19 were significantly higher than those not diagnosed with the virus and as of May 8, significantly more patients with COVID-19 died than those without (27.8% vs 6.8%).
Measuring cortisol on admission is potentially “another simple marker to use alongside oxygen saturation levels to help us identify which patients need to be admitted immediately, and which may not,” said Waljit S. Dhillo, MBBS, PhD, head of the division of diabetes, endocrinology and metabolism at Imperial College London.
“Having an early indicator of which patients may deteriorate more quickly will help us with providing the best level of care as quickly as possible. In addition, we can also take cortisol levels into account when we are working out how best to treat our patients,” he said. Read more.
Normal-weight prediabetes patients can benefit from lifestyle changes
Adults of normal weight with prediabetes may derive at least as much benefit from lifestyle health coaching programs as adults who are overweight or obese, results of a recent nonrandomized, real-world study show.
Fasting plasma glucose (FPG) normalized in about 63% of prediabetic adults with normal body mass index (BMI) participating in a personalized coaching program that emphasized exercise, nutrition, and weight management. In contrast, FPG normalized in about 52% of overweight and 44% of obese prediabetic individuals participating in the program.
“It is interesting to note that, although the normal weight group lost the least amount of weight, they still benefited from the lifestyle health coaching program... having a resultant greatest decrease in fasting plasma glucose and normalization to a range of someone without prediabetes,” said researcher Mandy Salmon, MS, a medical student at the University of Pennsylvania, Philadelphia. She presented the findings at the virtual annual scientific sessions of the American Diabetes Association. Read more.
Diabetes-related amputations rise in older adults
The recent resurgence in diabetes-related lower-extremity amputations in the United States is not limited to younger adults, according to the author of a recent study that documents similar increases among an older population of Medicare beneficiaries.
While the rate of amputations fell among these older adults from 2000 to 2009, it increased significantly from 2009 to 2017, albeit at a “less severe rate” than recently reported in younger populations, according to study investigator Jessica Harding, PhD, an assistant professor in the department of surgery at Emory University, Atlanta. Dr. Harding reported the results at the virtual annual scientific sessions of the American Diabetes Association.
The rate of nontraumatic lower extremity amputation (NLEA) was ticking upward by more than 1% per year over the 2009-2017 period. Read more.
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Diabetes-related amputations on the rise in older adults
The recent resurgence in diabetes-related lower-extremity amputations in the United States is not limited to younger adults, according to the author of a recent study that documents similar increases among an older population of Medicare beneficiaries.
While the rate of amputations fell among these older adults from 2000 to 2009, it increased significantly from 2009 to 2017, albeit at a “less severe rate” than recently reported in younger populations, said study investigator Jessica Harding, PhD.
The rate of nontraumatic lower extremity amputation (NLEA) was ticking upward by more than 1% per year over the 2009-2017 period, according to Dr. Harding, assistant professor in the department of surgery at Emory University, Atlanta.
This latest report follows one from last year, published in Diabetes Care, that documented an annual percentage increase approaching 6% between 2009 and 2015, driven by larger increases among adults 18-64 years of age, as well as an increase among men.
It’s not clear why rates of NLEA would be on the rise among younger and older adults in the United States, Dr. Harding said, though factors she said could be implicated include changes in amputation practice, increased comorbidities, higher insulin costs, or shortcomings in early prevention programs.
“We need large-scale studies with granular data to tease out key risk factors that could help identify the drivers of these increases in amputations,” Dr. Harding said in a presentation at the virtual annual scientific sessions of the American Diabetes Association.
“In the interim, increased attention to preventive foot care across the age spectrum could benefit adults with diabetes,” she added.
Devastating complication in older adults
The latest findings from Dr. Harding and coauthors emphasize the importance of a “team approach” to early prevention in older adults with diabetes, said Derek LeRoith, MD, PhD, director of research in the division of endocrinology, diabetes, and bone diseases with Icahn School of Medicine at Mount Sinai, New York.
“If you take a 75-year-old or even an 80-year-old, their life expectancy can still be a good 10 years or more,” Dr. LeRoith said in an interview. “We shouldn’t give up on them – we should be treating them to prevent complications.”
Lower-extremity amputation is a “particularly devastating” complication that can compromise mobility, ability to exercise, and motivation, according to Dr. LeRoith, lead author of a recent Endocrine Society clinical practice guideline that urges referral of older adults with diabetes to a podiatrist, orthopedist, or vascular specialist for preventive care.
“Quite often, treating their glucose or high blood pressure will be much more difficult because of these changes,” he said.
Lower extremity amputation trends upward
Rates of NLEA declined for years, only to rebound by 50%, according to authors of a recent analysis of Nationwide Inpatient Sample (NIS) data reported last year. In their report, the age-standardized diabetes-related NLEA rate per 1,000 adults with diabetes went from 5.30 in 2000, down to 3.07 in 2009/2010, and back up to 4.62 by 2015 (Diabetes Care. 2019 Jan;42:50-4).
The resurgence was fueled mainly by an increased rate of amputations in younger and middle-aged adults and men, and through increases in minor amputations, notably the toe, according to the investigators. “These changes in trend are concerning because of the disabling and costly consequences of NLEAs as well as what they may mean for the direction of efforts to reduce diabetes-related complications,” authors of that report said at the time.
In the current study, Dr. Harding and colleagues included Medicare Parts A and B claims data for beneficiaries enrolled from 2000 to 2017. There were 4.6 million Medicare fee-for-service beneficiaries with diabetes in 2000, increasing to 6.9 million in 2017, she reported at the virtual ADA meeting.
Rates of NLEA followed a trajectory similar to what was seen in the earlier NIS report, falling from 8.5 per 1,000 persons in 2000 to 4.4 in 2009, for an annual percentage change of –7.9 (P < .001), Dr. Harding said. Then rates ticked upward again, to 4.8 in 2017, for an annual percentage change of 1.2 over that later period (P < .001).
While the trend was similar for most subgroups analyzed, the absolute rates were highest among men and black individuals in this older patient population, reported Dr. Harding and coauthors.
Dr. Harding said she and coauthors had no disclosures related to the research, which was performed as a collaboration between Emory University and the Centers for Disease Control and Prevention Division of Diabetes Translation.
SOURCE: Harding J. ADA 2020, Abstract 106-OR.
The recent resurgence in diabetes-related lower-extremity amputations in the United States is not limited to younger adults, according to the author of a recent study that documents similar increases among an older population of Medicare beneficiaries.
While the rate of amputations fell among these older adults from 2000 to 2009, it increased significantly from 2009 to 2017, albeit at a “less severe rate” than recently reported in younger populations, said study investigator Jessica Harding, PhD.
The rate of nontraumatic lower extremity amputation (NLEA) was ticking upward by more than 1% per year over the 2009-2017 period, according to Dr. Harding, assistant professor in the department of surgery at Emory University, Atlanta.
This latest report follows one from last year, published in Diabetes Care, that documented an annual percentage increase approaching 6% between 2009 and 2015, driven by larger increases among adults 18-64 years of age, as well as an increase among men.
It’s not clear why rates of NLEA would be on the rise among younger and older adults in the United States, Dr. Harding said, though factors she said could be implicated include changes in amputation practice, increased comorbidities, higher insulin costs, or shortcomings in early prevention programs.
“We need large-scale studies with granular data to tease out key risk factors that could help identify the drivers of these increases in amputations,” Dr. Harding said in a presentation at the virtual annual scientific sessions of the American Diabetes Association.
“In the interim, increased attention to preventive foot care across the age spectrum could benefit adults with diabetes,” she added.
Devastating complication in older adults
The latest findings from Dr. Harding and coauthors emphasize the importance of a “team approach” to early prevention in older adults with diabetes, said Derek LeRoith, MD, PhD, director of research in the division of endocrinology, diabetes, and bone diseases with Icahn School of Medicine at Mount Sinai, New York.
“If you take a 75-year-old or even an 80-year-old, their life expectancy can still be a good 10 years or more,” Dr. LeRoith said in an interview. “We shouldn’t give up on them – we should be treating them to prevent complications.”
Lower-extremity amputation is a “particularly devastating” complication that can compromise mobility, ability to exercise, and motivation, according to Dr. LeRoith, lead author of a recent Endocrine Society clinical practice guideline that urges referral of older adults with diabetes to a podiatrist, orthopedist, or vascular specialist for preventive care.
“Quite often, treating their glucose or high blood pressure will be much more difficult because of these changes,” he said.
Lower extremity amputation trends upward
Rates of NLEA declined for years, only to rebound by 50%, according to authors of a recent analysis of Nationwide Inpatient Sample (NIS) data reported last year. In their report, the age-standardized diabetes-related NLEA rate per 1,000 adults with diabetes went from 5.30 in 2000, down to 3.07 in 2009/2010, and back up to 4.62 by 2015 (Diabetes Care. 2019 Jan;42:50-4).
The resurgence was fueled mainly by an increased rate of amputations in younger and middle-aged adults and men, and through increases in minor amputations, notably the toe, according to the investigators. “These changes in trend are concerning because of the disabling and costly consequences of NLEAs as well as what they may mean for the direction of efforts to reduce diabetes-related complications,” authors of that report said at the time.
In the current study, Dr. Harding and colleagues included Medicare Parts A and B claims data for beneficiaries enrolled from 2000 to 2017. There were 4.6 million Medicare fee-for-service beneficiaries with diabetes in 2000, increasing to 6.9 million in 2017, she reported at the virtual ADA meeting.
Rates of NLEA followed a trajectory similar to what was seen in the earlier NIS report, falling from 8.5 per 1,000 persons in 2000 to 4.4 in 2009, for an annual percentage change of –7.9 (P < .001), Dr. Harding said. Then rates ticked upward again, to 4.8 in 2017, for an annual percentage change of 1.2 over that later period (P < .001).
While the trend was similar for most subgroups analyzed, the absolute rates were highest among men and black individuals in this older patient population, reported Dr. Harding and coauthors.
Dr. Harding said she and coauthors had no disclosures related to the research, which was performed as a collaboration between Emory University and the Centers for Disease Control and Prevention Division of Diabetes Translation.
SOURCE: Harding J. ADA 2020, Abstract 106-OR.
The recent resurgence in diabetes-related lower-extremity amputations in the United States is not limited to younger adults, according to the author of a recent study that documents similar increases among an older population of Medicare beneficiaries.
While the rate of amputations fell among these older adults from 2000 to 2009, it increased significantly from 2009 to 2017, albeit at a “less severe rate” than recently reported in younger populations, said study investigator Jessica Harding, PhD.
The rate of nontraumatic lower extremity amputation (NLEA) was ticking upward by more than 1% per year over the 2009-2017 period, according to Dr. Harding, assistant professor in the department of surgery at Emory University, Atlanta.
This latest report follows one from last year, published in Diabetes Care, that documented an annual percentage increase approaching 6% between 2009 and 2015, driven by larger increases among adults 18-64 years of age, as well as an increase among men.
It’s not clear why rates of NLEA would be on the rise among younger and older adults in the United States, Dr. Harding said, though factors she said could be implicated include changes in amputation practice, increased comorbidities, higher insulin costs, or shortcomings in early prevention programs.
“We need large-scale studies with granular data to tease out key risk factors that could help identify the drivers of these increases in amputations,” Dr. Harding said in a presentation at the virtual annual scientific sessions of the American Diabetes Association.
“In the interim, increased attention to preventive foot care across the age spectrum could benefit adults with diabetes,” she added.
Devastating complication in older adults
The latest findings from Dr. Harding and coauthors emphasize the importance of a “team approach” to early prevention in older adults with diabetes, said Derek LeRoith, MD, PhD, director of research in the division of endocrinology, diabetes, and bone diseases with Icahn School of Medicine at Mount Sinai, New York.
“If you take a 75-year-old or even an 80-year-old, their life expectancy can still be a good 10 years or more,” Dr. LeRoith said in an interview. “We shouldn’t give up on them – we should be treating them to prevent complications.”
Lower-extremity amputation is a “particularly devastating” complication that can compromise mobility, ability to exercise, and motivation, according to Dr. LeRoith, lead author of a recent Endocrine Society clinical practice guideline that urges referral of older adults with diabetes to a podiatrist, orthopedist, or vascular specialist for preventive care.
“Quite often, treating their glucose or high blood pressure will be much more difficult because of these changes,” he said.
Lower extremity amputation trends upward
Rates of NLEA declined for years, only to rebound by 50%, according to authors of a recent analysis of Nationwide Inpatient Sample (NIS) data reported last year. In their report, the age-standardized diabetes-related NLEA rate per 1,000 adults with diabetes went from 5.30 in 2000, down to 3.07 in 2009/2010, and back up to 4.62 by 2015 (Diabetes Care. 2019 Jan;42:50-4).
The resurgence was fueled mainly by an increased rate of amputations in younger and middle-aged adults and men, and through increases in minor amputations, notably the toe, according to the investigators. “These changes in trend are concerning because of the disabling and costly consequences of NLEAs as well as what they may mean for the direction of efforts to reduce diabetes-related complications,” authors of that report said at the time.
In the current study, Dr. Harding and colleagues included Medicare Parts A and B claims data for beneficiaries enrolled from 2000 to 2017. There were 4.6 million Medicare fee-for-service beneficiaries with diabetes in 2000, increasing to 6.9 million in 2017, she reported at the virtual ADA meeting.
Rates of NLEA followed a trajectory similar to what was seen in the earlier NIS report, falling from 8.5 per 1,000 persons in 2000 to 4.4 in 2009, for an annual percentage change of –7.9 (P < .001), Dr. Harding said. Then rates ticked upward again, to 4.8 in 2017, for an annual percentage change of 1.2 over that later period (P < .001).
While the trend was similar for most subgroups analyzed, the absolute rates were highest among men and black individuals in this older patient population, reported Dr. Harding and coauthors.
Dr. Harding said she and coauthors had no disclosures related to the research, which was performed as a collaboration between Emory University and the Centers for Disease Control and Prevention Division of Diabetes Translation.
SOURCE: Harding J. ADA 2020, Abstract 106-OR.
FROM ADA 2020
Normal-weight prediabetes patients also benefit from lifestyle intervention
Adults with prediabetes of normal weight may derive at least as much benefit from lifestyle health coaching programs as adults who are overweight or obese, results of a recent nonrandomized, real-world study show.
Fasting plasma glucose (FPG) normalized in about 63% of prediabetic adults with normal body mass index (BMI) participating in a personalized coaching program that emphasized exercise, nutrition, and weight management, according to researcher Mandy Salmon, MS.
By contrast, FPG normalized in about 52% of overweight and 44% of obese prediabetic individuals participating in the program, according to Ms. Salmon, a medical student at the University of Pennsylvania, Philadelphia.
The normal-weight individuals didn’t lose any weight after participating in the coaching program, but they did significantly increase exercise, as did their overweight and obese counterparts, Ms. Salmon said in a presentation of her findings at virtual annual scientific sessions of the American Diabetes Association.
That means not only that normal-weight individuals shouldn’t be excluded from coaching interventions for diabetes prevention, but also that the success of such programs shouldn’t be judged solely on the magnitude of weight loss, according to the researcher.
“It is interesting to note that, although the normal weight group lost the least amount of weight, they still benefited from the lifestyle health coaching program, but having a resultant greatest decrease in fasting plasma glucose and normalization to a range of someone without prediabetes,” Ms. Salmon said.
The fact that most of those patients experienced normalization of FPG despite no weight loss emphasizes the importance of physical activity as a lifestyle intervention, according to Mark Schutta, MD, medical director of Penn Rodebaugh Diabetes Center in Philadelphia, who was not involved in the study.
“You hear these axioms that say things like, ‘you can never outexercise a bad diet,’ and that’s probably true. But all the studies will tell us that a fit, overweight diabetic has much lower risk of cardiovascular disease than an unfit overweight diabetic,” Dr. Schutta said in an interview.
Benefits in normal-weight individuals
One in three Americans has prediabetes, and of those individuals, one in five have a normal BMI, Ms. Salmon said in her virtual ADA presentation.
It’s thought that diabetes may develop in those normal-weight individuals through different pathological mechanisms than in overweight or obese individuals. In turn, that could mean that standard methods for staving off diabetes prevention may not be as effective for them, she said.
Those mechanisms are not well understood; even so, normal BMI is currently an exclusion criterion for many diabetes prevention programs, she added, including the Center for Disease Control and Prevention’s National Diabetes Prevention Program, which specifically requires that individuals have an elevated BMI to be eligible for referral.
To evaluate the potential benefits of coaching in normal-weight individuals, the investigators studied a cohort of 1,897 adults with prediabetes, defined as a baseline FPG of 100-125 mg/dL, who were participating in a lifestyle health coaching program. Of those participants, 188, or about 10% had a normal BMI of 18.5-24.9 mg/m2. Another 495 participants were overweight, with BMIs between 25 and 29.9, while 1,214 were obese, with a BMI of at least 30.
The intervention included an initial assessment to generate goals and a personalized action plan based on the individual’s risk factors, according to Ms. Salmon, along with an action plan that included one-on-one, behaviorally oriented, technology-enabled lifestyle health coaching focused on exercise and physical activity, weight management, and nutrition.
Key findings
With a mean follow-up of 145 days, weight loss in the obese group was greater than that of the overweight group, with mean BMI changes of –1.3 and –0.6, respectively, while there was no significant change in weight for the normal-weight individuals, according to Ms. Salmon.
By contrast, weekly aerobic activity increased significantly in all three groups, she added, with average increases of 95 minutes in the obese group, 98 minutes in the overweight group, and 77 minutes in the normal-weight group.
Likewise, significant decreases in FPG were seen in all 3 groups, with average changes of –6 mg/dL for the obese participants, –7 mg/dL for overweight participants, and –9 mg/dL for normal-weight participants, Ms. Salmon said.
The proportion of individuals whose FPG normalized was highest in the normal-weight group, at 62%, compared with 51.7% for overweight and 44% for obese individuals, she added.
Most previous studies of lifestyle interventions for prediabetes have excluded normal-weight individuals, according to Ms. Salmon, who said one strength of her study was that the subjects were already participating in the established lifestyle health coaching program and didn’t interact with the team of researchers.
“It was an effectiveness study in which we could see the real-world benefits of the program, rather than a theoretical efficacy study,” she said.
Ms. Salmon said she had no potential conflicts of interest to disclose. The coinvestigators of the study were members or employees of a privately held population health management company called INTERVENT International.
SOURCE: Salmon MK et al. ADA 2020, Abstract 273-OR.
Adults with prediabetes of normal weight may derive at least as much benefit from lifestyle health coaching programs as adults who are overweight or obese, results of a recent nonrandomized, real-world study show.
Fasting plasma glucose (FPG) normalized in about 63% of prediabetic adults with normal body mass index (BMI) participating in a personalized coaching program that emphasized exercise, nutrition, and weight management, according to researcher Mandy Salmon, MS.
By contrast, FPG normalized in about 52% of overweight and 44% of obese prediabetic individuals participating in the program, according to Ms. Salmon, a medical student at the University of Pennsylvania, Philadelphia.
The normal-weight individuals didn’t lose any weight after participating in the coaching program, but they did significantly increase exercise, as did their overweight and obese counterparts, Ms. Salmon said in a presentation of her findings at virtual annual scientific sessions of the American Diabetes Association.
That means not only that normal-weight individuals shouldn’t be excluded from coaching interventions for diabetes prevention, but also that the success of such programs shouldn’t be judged solely on the magnitude of weight loss, according to the researcher.
“It is interesting to note that, although the normal weight group lost the least amount of weight, they still benefited from the lifestyle health coaching program, but having a resultant greatest decrease in fasting plasma glucose and normalization to a range of someone without prediabetes,” Ms. Salmon said.
The fact that most of those patients experienced normalization of FPG despite no weight loss emphasizes the importance of physical activity as a lifestyle intervention, according to Mark Schutta, MD, medical director of Penn Rodebaugh Diabetes Center in Philadelphia, who was not involved in the study.
“You hear these axioms that say things like, ‘you can never outexercise a bad diet,’ and that’s probably true. But all the studies will tell us that a fit, overweight diabetic has much lower risk of cardiovascular disease than an unfit overweight diabetic,” Dr. Schutta said in an interview.
Benefits in normal-weight individuals
One in three Americans has prediabetes, and of those individuals, one in five have a normal BMI, Ms. Salmon said in her virtual ADA presentation.
It’s thought that diabetes may develop in those normal-weight individuals through different pathological mechanisms than in overweight or obese individuals. In turn, that could mean that standard methods for staving off diabetes prevention may not be as effective for them, she said.
Those mechanisms are not well understood; even so, normal BMI is currently an exclusion criterion for many diabetes prevention programs, she added, including the Center for Disease Control and Prevention’s National Diabetes Prevention Program, which specifically requires that individuals have an elevated BMI to be eligible for referral.
To evaluate the potential benefits of coaching in normal-weight individuals, the investigators studied a cohort of 1,897 adults with prediabetes, defined as a baseline FPG of 100-125 mg/dL, who were participating in a lifestyle health coaching program. Of those participants, 188, or about 10% had a normal BMI of 18.5-24.9 mg/m2. Another 495 participants were overweight, with BMIs between 25 and 29.9, while 1,214 were obese, with a BMI of at least 30.
The intervention included an initial assessment to generate goals and a personalized action plan based on the individual’s risk factors, according to Ms. Salmon, along with an action plan that included one-on-one, behaviorally oriented, technology-enabled lifestyle health coaching focused on exercise and physical activity, weight management, and nutrition.
Key findings
With a mean follow-up of 145 days, weight loss in the obese group was greater than that of the overweight group, with mean BMI changes of –1.3 and –0.6, respectively, while there was no significant change in weight for the normal-weight individuals, according to Ms. Salmon.
By contrast, weekly aerobic activity increased significantly in all three groups, she added, with average increases of 95 minutes in the obese group, 98 minutes in the overweight group, and 77 minutes in the normal-weight group.
Likewise, significant decreases in FPG were seen in all 3 groups, with average changes of –6 mg/dL for the obese participants, –7 mg/dL for overweight participants, and –9 mg/dL for normal-weight participants, Ms. Salmon said.
The proportion of individuals whose FPG normalized was highest in the normal-weight group, at 62%, compared with 51.7% for overweight and 44% for obese individuals, she added.
Most previous studies of lifestyle interventions for prediabetes have excluded normal-weight individuals, according to Ms. Salmon, who said one strength of her study was that the subjects were already participating in the established lifestyle health coaching program and didn’t interact with the team of researchers.
“It was an effectiveness study in which we could see the real-world benefits of the program, rather than a theoretical efficacy study,” she said.
Ms. Salmon said she had no potential conflicts of interest to disclose. The coinvestigators of the study were members or employees of a privately held population health management company called INTERVENT International.
SOURCE: Salmon MK et al. ADA 2020, Abstract 273-OR.
Adults with prediabetes of normal weight may derive at least as much benefit from lifestyle health coaching programs as adults who are overweight or obese, results of a recent nonrandomized, real-world study show.
Fasting plasma glucose (FPG) normalized in about 63% of prediabetic adults with normal body mass index (BMI) participating in a personalized coaching program that emphasized exercise, nutrition, and weight management, according to researcher Mandy Salmon, MS.
By contrast, FPG normalized in about 52% of overweight and 44% of obese prediabetic individuals participating in the program, according to Ms. Salmon, a medical student at the University of Pennsylvania, Philadelphia.
The normal-weight individuals didn’t lose any weight after participating in the coaching program, but they did significantly increase exercise, as did their overweight and obese counterparts, Ms. Salmon said in a presentation of her findings at virtual annual scientific sessions of the American Diabetes Association.
That means not only that normal-weight individuals shouldn’t be excluded from coaching interventions for diabetes prevention, but also that the success of such programs shouldn’t be judged solely on the magnitude of weight loss, according to the researcher.
“It is interesting to note that, although the normal weight group lost the least amount of weight, they still benefited from the lifestyle health coaching program, but having a resultant greatest decrease in fasting plasma glucose and normalization to a range of someone without prediabetes,” Ms. Salmon said.
The fact that most of those patients experienced normalization of FPG despite no weight loss emphasizes the importance of physical activity as a lifestyle intervention, according to Mark Schutta, MD, medical director of Penn Rodebaugh Diabetes Center in Philadelphia, who was not involved in the study.
“You hear these axioms that say things like, ‘you can never outexercise a bad diet,’ and that’s probably true. But all the studies will tell us that a fit, overweight diabetic has much lower risk of cardiovascular disease than an unfit overweight diabetic,” Dr. Schutta said in an interview.
Benefits in normal-weight individuals
One in three Americans has prediabetes, and of those individuals, one in five have a normal BMI, Ms. Salmon said in her virtual ADA presentation.
It’s thought that diabetes may develop in those normal-weight individuals through different pathological mechanisms than in overweight or obese individuals. In turn, that could mean that standard methods for staving off diabetes prevention may not be as effective for them, she said.
Those mechanisms are not well understood; even so, normal BMI is currently an exclusion criterion for many diabetes prevention programs, she added, including the Center for Disease Control and Prevention’s National Diabetes Prevention Program, which specifically requires that individuals have an elevated BMI to be eligible for referral.
To evaluate the potential benefits of coaching in normal-weight individuals, the investigators studied a cohort of 1,897 adults with prediabetes, defined as a baseline FPG of 100-125 mg/dL, who were participating in a lifestyle health coaching program. Of those participants, 188, or about 10% had a normal BMI of 18.5-24.9 mg/m2. Another 495 participants were overweight, with BMIs between 25 and 29.9, while 1,214 were obese, with a BMI of at least 30.
The intervention included an initial assessment to generate goals and a personalized action plan based on the individual’s risk factors, according to Ms. Salmon, along with an action plan that included one-on-one, behaviorally oriented, technology-enabled lifestyle health coaching focused on exercise and physical activity, weight management, and nutrition.
Key findings
With a mean follow-up of 145 days, weight loss in the obese group was greater than that of the overweight group, with mean BMI changes of –1.3 and –0.6, respectively, while there was no significant change in weight for the normal-weight individuals, according to Ms. Salmon.
By contrast, weekly aerobic activity increased significantly in all three groups, she added, with average increases of 95 minutes in the obese group, 98 minutes in the overweight group, and 77 minutes in the normal-weight group.
Likewise, significant decreases in FPG were seen in all 3 groups, with average changes of –6 mg/dL for the obese participants, –7 mg/dL for overweight participants, and –9 mg/dL for normal-weight participants, Ms. Salmon said.
The proportion of individuals whose FPG normalized was highest in the normal-weight group, at 62%, compared with 51.7% for overweight and 44% for obese individuals, she added.
Most previous studies of lifestyle interventions for prediabetes have excluded normal-weight individuals, according to Ms. Salmon, who said one strength of her study was that the subjects were already participating in the established lifestyle health coaching program and didn’t interact with the team of researchers.
“It was an effectiveness study in which we could see the real-world benefits of the program, rather than a theoretical efficacy study,” she said.
Ms. Salmon said she had no potential conflicts of interest to disclose. The coinvestigators of the study were members or employees of a privately held population health management company called INTERVENT International.
SOURCE: Salmon MK et al. ADA 2020, Abstract 273-OR.
FROM ADA 2020
ED visits for life-threatening conditions declined early in COVID-19 pandemic
ED visits for myocardial infarction, stroke, and hyperglycemic crisis dropped substantially in the 10 weeks after COVID-19 was declared a national emergency on March 13, according to the Centers for Disease Control and Prevention.
Compared with the 10-week period from Jan. 5 to March 14, ED visits were down by 23% for MI, 20% for stroke, and 10% for hyperglycemic crisis from March 15 to May 23, Samantha J. Lange, MPH, and associates at the CDC reported June 22 in the Morbidity and Mortality Weekly Report.
“A short-term decline of this magnitude … is biologically implausible for MI and stroke, especially for older adults, and unlikely for hyperglycemic crisis, and the finding suggests that patients with these conditions either could not access care or were delaying or avoiding seeking care during the early pandemic period,” they wrote.
The largest decreases in the actual number of visits for MI occurred among both men (down by 2,114, –24%) and women (down by 1,459, –25%) aged 65-74 years. For stroke, men aged 65-74 years had 1,406 (–19%) fewer visits to the ED and women 75-84 years had 1,642 (–23%) fewer visits, the CDC researchers said.
For hypoglycemic crisis, the largest declines during the early pandemic period occurred among younger adults: ED visits for men and women aged 18-44 years were down, respectively, by 419 (–8%) and 775 (–16%), they reported based on data from the National Syndromic Surveillance Program.
“Decreases in ED visits for hyperglycemic crisis might be less striking because patient recognition of this crisis is typically augmented by home glucose monitoring and not reliant upon symptoms alone, as is the case for MI and stroke,” Ms. Lange and her associates noted.
Charting weekly visit numbers showed that the drop for all three conditions actually started the week before the emergency was declared and reached its nadir the week after (March 22) for MI and 2 weeks later (March 29) for stroke and hypoglycemic crisis.
Visits for hypoglycemic crisis have largely returned to normal since those low points, but MI and stroke visits “remain below prepandemic levels” despite gradual increases through April and May, they said.
It has been reported that “deaths not associated with confirmed or probable COVID-19 might have been directly or indirectly attributed to the pandemic. The striking decline in ED visits for acute life-threatening conditions might partially explain observed excess mortality not associated with COVID-19,” the investigators wrote.
ED visits for myocardial infarction, stroke, and hyperglycemic crisis dropped substantially in the 10 weeks after COVID-19 was declared a national emergency on March 13, according to the Centers for Disease Control and Prevention.
Compared with the 10-week period from Jan. 5 to March 14, ED visits were down by 23% for MI, 20% for stroke, and 10% for hyperglycemic crisis from March 15 to May 23, Samantha J. Lange, MPH, and associates at the CDC reported June 22 in the Morbidity and Mortality Weekly Report.
“A short-term decline of this magnitude … is biologically implausible for MI and stroke, especially for older adults, and unlikely for hyperglycemic crisis, and the finding suggests that patients with these conditions either could not access care or were delaying or avoiding seeking care during the early pandemic period,” they wrote.
The largest decreases in the actual number of visits for MI occurred among both men (down by 2,114, –24%) and women (down by 1,459, –25%) aged 65-74 years. For stroke, men aged 65-74 years had 1,406 (–19%) fewer visits to the ED and women 75-84 years had 1,642 (–23%) fewer visits, the CDC researchers said.
For hypoglycemic crisis, the largest declines during the early pandemic period occurred among younger adults: ED visits for men and women aged 18-44 years were down, respectively, by 419 (–8%) and 775 (–16%), they reported based on data from the National Syndromic Surveillance Program.
“Decreases in ED visits for hyperglycemic crisis might be less striking because patient recognition of this crisis is typically augmented by home glucose monitoring and not reliant upon symptoms alone, as is the case for MI and stroke,” Ms. Lange and her associates noted.
Charting weekly visit numbers showed that the drop for all three conditions actually started the week before the emergency was declared and reached its nadir the week after (March 22) for MI and 2 weeks later (March 29) for stroke and hypoglycemic crisis.
Visits for hypoglycemic crisis have largely returned to normal since those low points, but MI and stroke visits “remain below prepandemic levels” despite gradual increases through April and May, they said.
It has been reported that “deaths not associated with confirmed or probable COVID-19 might have been directly or indirectly attributed to the pandemic. The striking decline in ED visits for acute life-threatening conditions might partially explain observed excess mortality not associated with COVID-19,” the investigators wrote.
ED visits for myocardial infarction, stroke, and hyperglycemic crisis dropped substantially in the 10 weeks after COVID-19 was declared a national emergency on March 13, according to the Centers for Disease Control and Prevention.
Compared with the 10-week period from Jan. 5 to March 14, ED visits were down by 23% for MI, 20% for stroke, and 10% for hyperglycemic crisis from March 15 to May 23, Samantha J. Lange, MPH, and associates at the CDC reported June 22 in the Morbidity and Mortality Weekly Report.
“A short-term decline of this magnitude … is biologically implausible for MI and stroke, especially for older adults, and unlikely for hyperglycemic crisis, and the finding suggests that patients with these conditions either could not access care or were delaying or avoiding seeking care during the early pandemic period,” they wrote.
The largest decreases in the actual number of visits for MI occurred among both men (down by 2,114, –24%) and women (down by 1,459, –25%) aged 65-74 years. For stroke, men aged 65-74 years had 1,406 (–19%) fewer visits to the ED and women 75-84 years had 1,642 (–23%) fewer visits, the CDC researchers said.
For hypoglycemic crisis, the largest declines during the early pandemic period occurred among younger adults: ED visits for men and women aged 18-44 years were down, respectively, by 419 (–8%) and 775 (–16%), they reported based on data from the National Syndromic Surveillance Program.
“Decreases in ED visits for hyperglycemic crisis might be less striking because patient recognition of this crisis is typically augmented by home glucose monitoring and not reliant upon symptoms alone, as is the case for MI and stroke,” Ms. Lange and her associates noted.
Charting weekly visit numbers showed that the drop for all three conditions actually started the week before the emergency was declared and reached its nadir the week after (March 22) for MI and 2 weeks later (March 29) for stroke and hypoglycemic crisis.
Visits for hypoglycemic crisis have largely returned to normal since those low points, but MI and stroke visits “remain below prepandemic levels” despite gradual increases through April and May, they said.
It has been reported that “deaths not associated with confirmed or probable COVID-19 might have been directly or indirectly attributed to the pandemic. The striking decline in ED visits for acute life-threatening conditions might partially explain observed excess mortality not associated with COVID-19,” the investigators wrote.
FROM MMWR