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PARIS – Treatment with the SGLT2 inhibitor dapagliflozin produced a statistically significant 27% drop in cardiovascular death or heart failure events in patients with existing heart failure with reduced ejection fraction and no diabetes, results that in a stroke changed the status of dapagliflozin from fundamentally a drug that treats diabetes to a drug that treats heart failure.

Mitchel L. Zoler/MDedge News

“Dapagliflozin offers a new approach to the treatment of heart failure with reduced ejection fraction” (HFrEF), John McMurray, MD, said at the annual congress of the European Society of Cardiology.

The results he reported from the DAPA-HF (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure) trial showed statistically significant benefits when adding dapagliflozin to guideline-directed therapy for a list of outcomes that include a 17% drop in all-cause death compared with placebo, an 18% fall in cardiovascular death, and a 25% relative reduction in total heart failure hospitalizations plus cardiovascular deaths during a median follow-up of just over 18 months. The primary endpoint of the reduction in cardiovascular death, first heart failure hospitalization, or an urgent heart failure visit fell by 25% in the enrolled patients with diabetes (45% of the study population, all with type 2 diabetes), and by 27% in the remaining patients who had no diabetes, showing that the presence of diabetes had no impact on the heart failure benefit from dapagliflozin (Farxiga). The absolute reduction in the primary endpoint was about 5%, with a number needed to treat of 21 to prevent one primary endpoint during 18 months of treatment.

Dr. McMurray’s report of the primary endpoint as well as the finding that the drug was as effective in patients without diabetes as in those with diabetes were both met with loud applause by the packed congress audience.

The efficacy results also showed that 58% of patients on dapagliflozin had a clinically meaningful (5 point or greater) increase in their quality of life score on the Kansas City Cardiomyopathy Questionnaire after 8 months on treatment compared with a 51% rate in the placebo patients, a statistically significant difference.

The safety results showed no new signals for a drug that already has regulatory approval but was being used in a novel population. The rate of major hypoglycemia was virtually nonexistent, 0.2%, and identical in both treatment arms. All adverse events occurred at roughly equal rates in the dapagliflozin and placebo groups, with a 5% rate of adverse events leading to study discontinuation in both arms, and a serious adverse event rate of 38% in the dapaglifolzin patients and 42% in the placebo patients. The rate of worsening renal function was less than 2% in both arms and not statistically different.

“This is as close to a home run as you see in heart failure treatment,” commented Douglas L. Mann, MD, professor of medicine at Washington University, St. Louis, and a heart failure clinician and researcher.

DAPA-HF “is a landmark trial. It took a diabetes drug and used it in patients without diabetes, a concept that would have been considered outlandish 5 years ago. Scientifically it’s huge,” commented Deepak L. Bhatt, MD, professor of medicine at Harvard Medical School in Boston.

The DAPA-HF results were another step in the remarkable journey toward heart failure intervention taken by the SGLT2 (sodium glucose cotransport 2) inhibitor class of drugs that includes dapagliflozin as well as canagliflozin (Invokana) and empagliflozin(Jardiance), a path that began 4 years ago with the report of empagliflozin’s unexpected efficacy for reducing cardiovascular death and heart failure hospitalizations in a large cardiovascular-safety study, EMPA-REG OUTCOME (N Engl J Med. 2015 Nov 26;373[22]:2117-28). Subsequent reports showed similar effects benefiting heart failure and survival for canagliflozin and dapagliflozin, and now with DAPA-HF the evidence extended the benefit to heart failure patients regardless of whether they have diabetes. Additional studies now in progress are exploring the same question for empagliflozin and canagliflozin.

The results from DAPA-HF are likely a class effect for all these SGLT2 inhibitors, suggested Dr. McMurray in a video interview, a view shared by several other experts. He cautioned clinicians against using dapagliflozin to treat patients with heart failure with reduced ejection fraction (HFrEF) but without diabetes until this indication receives regulatory approval, and even then using dapagliflozin or other SGLT2 inhibitors this way may take some getting used to on the part of cardiologists and other clinicians.

“The results put dapagliflozin in the same league as [standard HFrEF drugs], but using it will require a shift in thinking. Most physicians will initially say “aren’t SGLT2 inhibitors used for treating diabetes?” Dr. Bhatt said.

“I’m sure most cardiologists are not familiar with the SGLT2 inhibitors; we’ll have to educate them,” conceded Dr. McMurray, professor of medical cardiology at the University of Glasgow. However, other aspects of dapagliflozin and this drug class in general may make the SGLT2 inhibitors particularly attractive and spur their use once labeling changes.

[email protected]

PARIS – Treatment with the SGLT2 inhibitor dapagliflozin produced a statistically significant 27% drop in cardiovascular death or heart failure events in patients with existing heart failure with reduced ejection fraction and no diabetes, results that in a stroke changed the status of dapagliflozin from fundamentally a drug that treats diabetes to a drug that treats heart failure.

Mitchel L. Zoler/MDedge News

“Dapagliflozin offers a new approach to the treatment of heart failure with reduced ejection fraction” (HFrEF), John McMurray, MD, said at the annual congress of the European Society of Cardiology.

The results he reported from the DAPA-HF (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure) trial showed statistically significant benefits when adding dapagliflozin to guideline-directed therapy for a list of outcomes that include a 17% drop in all-cause death compared with placebo, an 18% fall in cardiovascular death, and a 25% relative reduction in total heart failure hospitalizations plus cardiovascular deaths during a median follow-up of just over 18 months. The primary endpoint of the reduction in cardiovascular death, first heart failure hospitalization, or an urgent heart failure visit fell by 25% in the enrolled patients with diabetes (45% of the study population, all with type 2 diabetes), and by 27% in the remaining patients who had no diabetes, showing that the presence of diabetes had no impact on the heart failure benefit from dapagliflozin (Farxiga). The absolute reduction in the primary endpoint was about 5%, with a number needed to treat of 21 to prevent one primary endpoint during 18 months of treatment.

Dr. McMurray’s report of the primary endpoint as well as the finding that the drug was as effective in patients without diabetes as in those with diabetes were both met with loud applause by the packed congress audience.

The efficacy results also showed that 58% of patients on dapagliflozin had a clinically meaningful (5 point or greater) increase in their quality of life score on the Kansas City Cardiomyopathy Questionnaire after 8 months on treatment compared with a 51% rate in the placebo patients, a statistically significant difference.

The safety results showed no new signals for a drug that already has regulatory approval but was being used in a novel population. The rate of major hypoglycemia was virtually nonexistent, 0.2%, and identical in both treatment arms. All adverse events occurred at roughly equal rates in the dapagliflozin and placebo groups, with a 5% rate of adverse events leading to study discontinuation in both arms, and a serious adverse event rate of 38% in the dapaglifolzin patients and 42% in the placebo patients. The rate of worsening renal function was less than 2% in both arms and not statistically different.

“This is as close to a home run as you see in heart failure treatment,” commented Douglas L. Mann, MD, professor of medicine at Washington University, St. Louis, and a heart failure clinician and researcher.

DAPA-HF “is a landmark trial. It took a diabetes drug and used it in patients without diabetes, a concept that would have been considered outlandish 5 years ago. Scientifically it’s huge,” commented Deepak L. Bhatt, MD, professor of medicine at Harvard Medical School in Boston.

The DAPA-HF results were another step in the remarkable journey toward heart failure intervention taken by the SGLT2 (sodium glucose cotransport 2) inhibitor class of drugs that includes dapagliflozin as well as canagliflozin (Invokana) and empagliflozin(Jardiance), a path that began 4 years ago with the report of empagliflozin’s unexpected efficacy for reducing cardiovascular death and heart failure hospitalizations in a large cardiovascular-safety study, EMPA-REG OUTCOME (N Engl J Med. 2015 Nov 26;373[22]:2117-28). Subsequent reports showed similar effects benefiting heart failure and survival for canagliflozin and dapagliflozin, and now with DAPA-HF the evidence extended the benefit to heart failure patients regardless of whether they have diabetes. Additional studies now in progress are exploring the same question for empagliflozin and canagliflozin.

The results from DAPA-HF are likely a class effect for all these SGLT2 inhibitors, suggested Dr. McMurray in a video interview, a view shared by several other experts. He cautioned clinicians against using dapagliflozin to treat patients with heart failure with reduced ejection fraction (HFrEF) but without diabetes until this indication receives regulatory approval, and even then using dapagliflozin or other SGLT2 inhibitors this way may take some getting used to on the part of cardiologists and other clinicians.

“The results put dapagliflozin in the same league as [standard HFrEF drugs], but using it will require a shift in thinking. Most physicians will initially say “aren’t SGLT2 inhibitors used for treating diabetes?” Dr. Bhatt said.

“I’m sure most cardiologists are not familiar with the SGLT2 inhibitors; we’ll have to educate them,” conceded Dr. McMurray, professor of medical cardiology at the University of Glasgow. However, other aspects of dapagliflozin and this drug class in general may make the SGLT2 inhibitors particularly attractive and spur their use once labeling changes.

[email protected]

PARIS – Treatment with the SGLT2 inhibitor dapagliflozin produced a statistically significant 27% drop in cardiovascular death or heart failure events in patients with existing heart failure with reduced ejection fraction and no diabetes, results that in a stroke changed the status of dapagliflozin from fundamentally a drug that treats diabetes to a drug that treats heart failure.

Mitchel L. Zoler/MDedge News

“Dapagliflozin offers a new approach to the treatment of heart failure with reduced ejection fraction” (HFrEF), John McMurray, MD, said at the annual congress of the European Society of Cardiology.

The results he reported from the DAPA-HF (Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure) trial showed statistically significant benefits when adding dapagliflozin to guideline-directed therapy for a list of outcomes that include a 17% drop in all-cause death compared with placebo, an 18% fall in cardiovascular death, and a 25% relative reduction in total heart failure hospitalizations plus cardiovascular deaths during a median follow-up of just over 18 months. The primary endpoint of the reduction in cardiovascular death, first heart failure hospitalization, or an urgent heart failure visit fell by 25% in the enrolled patients with diabetes (45% of the study population, all with type 2 diabetes), and by 27% in the remaining patients who had no diabetes, showing that the presence of diabetes had no impact on the heart failure benefit from dapagliflozin (Farxiga). The absolute reduction in the primary endpoint was about 5%, with a number needed to treat of 21 to prevent one primary endpoint during 18 months of treatment.

Dr. McMurray’s report of the primary endpoint as well as the finding that the drug was as effective in patients without diabetes as in those with diabetes were both met with loud applause by the packed congress audience.

The efficacy results also showed that 58% of patients on dapagliflozin had a clinically meaningful (5 point or greater) increase in their quality of life score on the Kansas City Cardiomyopathy Questionnaire after 8 months on treatment compared with a 51% rate in the placebo patients, a statistically significant difference.

The safety results showed no new signals for a drug that already has regulatory approval but was being used in a novel population. The rate of major hypoglycemia was virtually nonexistent, 0.2%, and identical in both treatment arms. All adverse events occurred at roughly equal rates in the dapagliflozin and placebo groups, with a 5% rate of adverse events leading to study discontinuation in both arms, and a serious adverse event rate of 38% in the dapaglifolzin patients and 42% in the placebo patients. The rate of worsening renal function was less than 2% in both arms and not statistically different.

“This is as close to a home run as you see in heart failure treatment,” commented Douglas L. Mann, MD, professor of medicine at Washington University, St. Louis, and a heart failure clinician and researcher.

DAPA-HF “is a landmark trial. It took a diabetes drug and used it in patients without diabetes, a concept that would have been considered outlandish 5 years ago. Scientifically it’s huge,” commented Deepak L. Bhatt, MD, professor of medicine at Harvard Medical School in Boston.

The DAPA-HF results were another step in the remarkable journey toward heart failure intervention taken by the SGLT2 (sodium glucose cotransport 2) inhibitor class of drugs that includes dapagliflozin as well as canagliflozin (Invokana) and empagliflozin(Jardiance), a path that began 4 years ago with the report of empagliflozin’s unexpected efficacy for reducing cardiovascular death and heart failure hospitalizations in a large cardiovascular-safety study, EMPA-REG OUTCOME (N Engl J Med. 2015 Nov 26;373[22]:2117-28). Subsequent reports showed similar effects benefiting heart failure and survival for canagliflozin and dapagliflozin, and now with DAPA-HF the evidence extended the benefit to heart failure patients regardless of whether they have diabetes. Additional studies now in progress are exploring the same question for empagliflozin and canagliflozin.

The results from DAPA-HF are likely a class effect for all these SGLT2 inhibitors, suggested Dr. McMurray in a video interview, a view shared by several other experts. He cautioned clinicians against using dapagliflozin to treat patients with heart failure with reduced ejection fraction (HFrEF) but without diabetes until this indication receives regulatory approval, and even then using dapagliflozin or other SGLT2 inhibitors this way may take some getting used to on the part of cardiologists and other clinicians.

“The results put dapagliflozin in the same league as [standard HFrEF drugs], but using it will require a shift in thinking. Most physicians will initially say “aren’t SGLT2 inhibitors used for treating diabetes?” Dr. Bhatt said.

“I’m sure most cardiologists are not familiar with the SGLT2 inhibitors; we’ll have to educate them,” conceded Dr. McMurray, professor of medical cardiology at the University of Glasgow. However, other aspects of dapagliflozin and this drug class in general may make the SGLT2 inhibitors particularly attractive and spur their use once labeling changes.

[email protected]

Weight-loss surgery in people with type 2 diabetes and obesity is associated with significant reductions in major adverse cardiovascular events, compared with nonsurgical management, according to data presented at the annual congress of the European Society of Cardiology.

The retrospective cohort study, simultaneously published in JAMA, looked at outcomes in 13,722 individuals with type 2 diabetes and obesity, 2,287 of whom underwent metabolic surgery and the rest of the matched cohort receiving usual care.

At 8 years of follow-up, the cumulative incidence of the primary endpoint – a composite of first occurrence of all-cause mortality, coronary artery events, cerebrovascular events, heart failure, nephropathy, and atrial fibrillation – was 30.8% in the weight loss–surgery group and 47.7% in the nonsurgical-control group, representing a 39% lower risk with weight loss surgery (P less than .001).

The analysis failed to find any interaction with sex, age, body mass index (BMI), HbA_1c level, estimated glomerular filtration rate, or use of insulin, sulfonylureas, or lipid-lowering medications.

Metabolic surgery was also associated with a significantly lower cumulative incidence of myocardial infarction, ischemic stroke and mortality than usual care (17% vs. 27.6%).

In particular, researchers saw a significant 41% reduction in the risk of death at eight years in the surgical group compared to usual care (10% vs. 17.8%), a 62% reduction in the risk of heart failure, a 31% reduction in the risk of coronary artery disease, and a 60% reduction in nephropathy risk. Metabolic surgery was also associated with a 33% reduction in cerebrovascular disease risk, and a 22% lower risk of atrial fibrillation.

In the group that underwent metabolic surgery, mean bodyweight at 8 years was reduced by 29.1 kg, compared with 8.7 kg in the control group. At baseline, 75% of the metabolic surgery group had a BMI of 40 kg/m² or above, 20% had a BMI between 35-39.9, and 5% had a BMI between 30-34.9.

The surgery was also associated with significantly greater reductions in HbA_1c, and in the use of noninsulin diabetes medications, insulin, antihypertensive medications, lipid-lowering therapies, and aspirin.

The most common surgical weight loss procedure was Roux-en-Y gastric bypass (63%), followed by sleeve gastrectomy (32%), and adjustable gastric banding (5%). Five patients underwent duodenal switch.

In the 90 days after surgery, 3% of patients experienced bleeding that required transfusion, 2.5% experienced pulmonary adverse events, 1% experienced venous thromboembolism, 0.7% experienced cardiac events, and 0.2% experienced renal failure that required dialysis. There were also 15 deaths (0.7%) in the surgical group, and 4.8% of patients required abdominal surgical intervention.

“We speculate that the lower rate of [major adverse cardiovascular events] after metabolic surgery observed in this study may be related to substantial and sustained weight loss with subsequent improvement in metabolic, structural, hemodynamic, and neurohormonal abnormalities,” wrote Ali Aminian, MD, of the Bariatric and Metabolic Institute at the Cleveland Clinic, and coauthors.

“Although large and sustained surgically induced weight loss has profound physiologic effects, a growing body of evidence indicates that some of the beneficial metabolic and neurohormonal changes that occur after metabolic surgical procedures are related to anatomical changes in the gastrointestinal tract that are partially independent of weight loss,” they wrote.

The authors, however, were also keen to point out that their study was observational, and should therefore be considered “hypothesis generating.” While the two study groups were matched on 37 baseline covariates, those in the surgical group did have a higher body weight, higher BMI, higher rates of dyslipidemia, and higher rates of hypertension.

“The findings from this observational study must be confirmed in randomized clinical trials,” they noted.

The study was partly funded by Medtronic, and one author was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Five authors declared funding and support from private industry, including from Medtronic, and one author declared institutional grants.

SOURCE: Aminian A et al. JAMA 2019, Sept 2. DOI: 10.1001/jama.2019.14231.

Weight-loss surgery in people with type 2 diabetes and obesity is associated with significant reductions in major adverse cardiovascular events, compared with nonsurgical management, according to data presented at the annual congress of the European Society of Cardiology.

The retrospective cohort study, simultaneously published in JAMA, looked at outcomes in 13,722 individuals with type 2 diabetes and obesity, 2,287 of whom underwent metabolic surgery and the rest of the matched cohort receiving usual care.

At 8 years of follow-up, the cumulative incidence of the primary endpoint – a composite of first occurrence of all-cause mortality, coronary artery events, cerebrovascular events, heart failure, nephropathy, and atrial fibrillation – was 30.8% in the weight loss–surgery group and 47.7% in the nonsurgical-control group, representing a 39% lower risk with weight loss surgery (P less than .001).

The analysis failed to find any interaction with sex, age, body mass index (BMI), HbA_1c level, estimated glomerular filtration rate, or use of insulin, sulfonylureas, or lipid-lowering medications.

Metabolic surgery was also associated with a significantly lower cumulative incidence of myocardial infarction, ischemic stroke and mortality than usual care (17% vs. 27.6%).

In particular, researchers saw a significant 41% reduction in the risk of death at eight years in the surgical group compared to usual care (10% vs. 17.8%), a 62% reduction in the risk of heart failure, a 31% reduction in the risk of coronary artery disease, and a 60% reduction in nephropathy risk. Metabolic surgery was also associated with a 33% reduction in cerebrovascular disease risk, and a 22% lower risk of atrial fibrillation.

In the group that underwent metabolic surgery, mean bodyweight at 8 years was reduced by 29.1 kg, compared with 8.7 kg in the control group. At baseline, 75% of the metabolic surgery group had a BMI of 40 kg/m² or above, 20% had a BMI between 35-39.9, and 5% had a BMI between 30-34.9.

The surgery was also associated with significantly greater reductions in HbA_1c, and in the use of noninsulin diabetes medications, insulin, antihypertensive medications, lipid-lowering therapies, and aspirin.

The most common surgical weight loss procedure was Roux-en-Y gastric bypass (63%), followed by sleeve gastrectomy (32%), and adjustable gastric banding (5%). Five patients underwent duodenal switch.

In the 90 days after surgery, 3% of patients experienced bleeding that required transfusion, 2.5% experienced pulmonary adverse events, 1% experienced venous thromboembolism, 0.7% experienced cardiac events, and 0.2% experienced renal failure that required dialysis. There were also 15 deaths (0.7%) in the surgical group, and 4.8% of patients required abdominal surgical intervention.

“We speculate that the lower rate of [major adverse cardiovascular events] after metabolic surgery observed in this study may be related to substantial and sustained weight loss with subsequent improvement in metabolic, structural, hemodynamic, and neurohormonal abnormalities,” wrote Ali Aminian, MD, of the Bariatric and Metabolic Institute at the Cleveland Clinic, and coauthors.

“Although large and sustained surgically induced weight loss has profound physiologic effects, a growing body of evidence indicates that some of the beneficial metabolic and neurohormonal changes that occur after metabolic surgical procedures are related to anatomical changes in the gastrointestinal tract that are partially independent of weight loss,” they wrote.

The authors, however, were also keen to point out that their study was observational, and should therefore be considered “hypothesis generating.” While the two study groups were matched on 37 baseline covariates, those in the surgical group did have a higher body weight, higher BMI, higher rates of dyslipidemia, and higher rates of hypertension.

“The findings from this observational study must be confirmed in randomized clinical trials,” they noted.

The study was partly funded by Medtronic, and one author was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Five authors declared funding and support from private industry, including from Medtronic, and one author declared institutional grants.

SOURCE: Aminian A et al. JAMA 2019, Sept 2. DOI: 10.1001/jama.2019.14231.

Weight-loss surgery in people with type 2 diabetes and obesity is associated with significant reductions in major adverse cardiovascular events, compared with nonsurgical management, according to data presented at the annual congress of the European Society of Cardiology.

The retrospective cohort study, simultaneously published in JAMA, looked at outcomes in 13,722 individuals with type 2 diabetes and obesity, 2,287 of whom underwent metabolic surgery and the rest of the matched cohort receiving usual care.

At 8 years of follow-up, the cumulative incidence of the primary endpoint – a composite of first occurrence of all-cause mortality, coronary artery events, cerebrovascular events, heart failure, nephropathy, and atrial fibrillation – was 30.8% in the weight loss–surgery group and 47.7% in the nonsurgical-control group, representing a 39% lower risk with weight loss surgery (P less than .001).

The analysis failed to find any interaction with sex, age, body mass index (BMI), HbA_1c level, estimated glomerular filtration rate, or use of insulin, sulfonylureas, or lipid-lowering medications.

Metabolic surgery was also associated with a significantly lower cumulative incidence of myocardial infarction, ischemic stroke and mortality than usual care (17% vs. 27.6%).

In particular, researchers saw a significant 41% reduction in the risk of death at eight years in the surgical group compared to usual care (10% vs. 17.8%), a 62% reduction in the risk of heart failure, a 31% reduction in the risk of coronary artery disease, and a 60% reduction in nephropathy risk. Metabolic surgery was also associated with a 33% reduction in cerebrovascular disease risk, and a 22% lower risk of atrial fibrillation.

In the group that underwent metabolic surgery, mean bodyweight at 8 years was reduced by 29.1 kg, compared with 8.7 kg in the control group. At baseline, 75% of the metabolic surgery group had a BMI of 40 kg/m² or above, 20% had a BMI between 35-39.9, and 5% had a BMI between 30-34.9.

The surgery was also associated with significantly greater reductions in HbA_1c, and in the use of noninsulin diabetes medications, insulin, antihypertensive medications, lipid-lowering therapies, and aspirin.

The most common surgical weight loss procedure was Roux-en-Y gastric bypass (63%), followed by sleeve gastrectomy (32%), and adjustable gastric banding (5%). Five patients underwent duodenal switch.

In the 90 days after surgery, 3% of patients experienced bleeding that required transfusion, 2.5% experienced pulmonary adverse events, 1% experienced venous thromboembolism, 0.7% experienced cardiac events, and 0.2% experienced renal failure that required dialysis. There were also 15 deaths (0.7%) in the surgical group, and 4.8% of patients required abdominal surgical intervention.

“We speculate that the lower rate of [major adverse cardiovascular events] after metabolic surgery observed in this study may be related to substantial and sustained weight loss with subsequent improvement in metabolic, structural, hemodynamic, and neurohormonal abnormalities,” wrote Ali Aminian, MD, of the Bariatric and Metabolic Institute at the Cleveland Clinic, and coauthors.

“Although large and sustained surgically induced weight loss has profound physiologic effects, a growing body of evidence indicates that some of the beneficial metabolic and neurohormonal changes that occur after metabolic surgical procedures are related to anatomical changes in the gastrointestinal tract that are partially independent of weight loss,” they wrote.

The authors, however, were also keen to point out that their study was observational, and should therefore be considered “hypothesis generating.” While the two study groups were matched on 37 baseline covariates, those in the surgical group did have a higher body weight, higher BMI, higher rates of dyslipidemia, and higher rates of hypertension.

“The findings from this observational study must be confirmed in randomized clinical trials,” they noted.

The study was partly funded by Medtronic, and one author was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Five authors declared funding and support from private industry, including from Medtronic, and one author declared institutional grants.

SOURCE: Aminian A et al. JAMA 2019, Sept 2. DOI: 10.1001/jama.2019.14231.

PARIS – Patients with stable coronary artery disease and type 2 diabetes saw fewer ischemic cardiovascular events when they received dual antiplatelet therapy with ticagrelor plus aspirin, though they also had more major bleeding events than patients receiving placebo plus aspirin.

The subset of patients who had received prior percutaneous coronary intervention (PCI) stood to benefit more from extended dual antiplatelet therapy (DAPT), according to clinical trial results presented to an overflow crowd at the annual congress of the European Society of Cardiology.

Findings from the full study, named The Effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study (THEMIS), and from the PCI subgroup analysis were published concurrently with the presentation (N Engl J Med. 2019 Sep 1: DOI: 10.1056/NEJMoa1908077; Lancet. 2019 Sep 1: DOI:https://doi.org/10.1016/S0140-6736(19)31887-2).

“This strategy of long-term dual antiplatelet therapy may be beneficial in selected patients at low risk of bleeding, but at high risk of ischemic events,” said the study’s co-principal investigator Deepak Bhatt, MD, professor of medicine at Harvard Medical School, Boston, and executive director of interventional cardiology programs at Boston’s Brigham and Women’s Hospital. In a video interview, he hypothesized that “prior PCI may serve as a sort of ‘stress test’ for bleeding,” thus identifying a subset of patients who might benefit from long-term DAPT.

Ischemic events, the primary efficacy outcome of THEMIS, occurred in 7.7% of patients taking the P2Y12 receptor antagonist ticagrelor and 8.5% of those receiving placebo, for a hazard ratio of 0.90 favoring ticagrelor (P = .04). Ischemic events included cardiovascular deaths, myocardial infarctions (MIs), and stroke.

Looking at secondary endpoints, Dr. Bhatt said that there was no difference in cardiovascular deaths between study arms, but that ischemic strokes, all MIs, and ST segment elevation MIs were all less common for patients taking ticagrelor. All-cause mortality was similar between study groups.

Though ischemic events dropped, “This benefit was achieved at the expense of more bleeding,” said Dr. Bhatt. Major bleeding, the primary safety outcome, was seen in 2.2% of those taking ticagrelor and 1.0% of the placebo group, for a hazard ratio of 2.32 (P less than .001). Dr. Bhatt and his collaborators used the Thrombolysis in Myocardial Infarction (TIMI) criteria for major bleeding for ascertainment of this outcome.

Intracranial hemorrhage was also more common for patients on ticagrelor, though incidence was low and the absolute difference was small between groups. This complication occurred in 0.7% of ticagrelor patients and 0.5% of placebo patients, yielding a hazard ratio of 1.71 (P = .0005). “This excess wasn’t in spontaneous or procedural intracranial bleeding, but rather in traumatic intracranial hemorrhage,” said Dr. Bhatt.

Fatal bleeds affected just 0.2% of those on ticagrelor and 0.1% of those receiving placebo; this difference wasn’t statistically significant.

koakes@mdedgecom

Source: Steg PG et al. N Engl J Med. 2019 Sep 1: DOI: 10.1056/NEJMoa1908077; Bhatt DL et al.Lancet. 2019 Sep 1: DOI:https://doi.org/10.1016/S0140-6736(19)31887-2)

PARIS – Patients with stable coronary artery disease and type 2 diabetes saw fewer ischemic cardiovascular events when they received dual antiplatelet therapy with ticagrelor plus aspirin, though they also had more major bleeding events than patients receiving placebo plus aspirin.

The subset of patients who had received prior percutaneous coronary intervention (PCI) stood to benefit more from extended dual antiplatelet therapy (DAPT), according to clinical trial results presented to an overflow crowd at the annual congress of the European Society of Cardiology.

Findings from the full study, named The Effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study (THEMIS), and from the PCI subgroup analysis were published concurrently with the presentation (N Engl J Med. 2019 Sep 1: DOI: 10.1056/NEJMoa1908077; Lancet. 2019 Sep 1: DOI:https://doi.org/10.1016/S0140-6736(19)31887-2).

“This strategy of long-term dual antiplatelet therapy may be beneficial in selected patients at low risk of bleeding, but at high risk of ischemic events,” said the study’s co-principal investigator Deepak Bhatt, MD, professor of medicine at Harvard Medical School, Boston, and executive director of interventional cardiology programs at Boston’s Brigham and Women’s Hospital. In a video interview, he hypothesized that “prior PCI may serve as a sort of ‘stress test’ for bleeding,” thus identifying a subset of patients who might benefit from long-term DAPT.

Ischemic events, the primary efficacy outcome of THEMIS, occurred in 7.7% of patients taking the P2Y12 receptor antagonist ticagrelor and 8.5% of those receiving placebo, for a hazard ratio of 0.90 favoring ticagrelor (P = .04). Ischemic events included cardiovascular deaths, myocardial infarctions (MIs), and stroke.

Looking at secondary endpoints, Dr. Bhatt said that there was no difference in cardiovascular deaths between study arms, but that ischemic strokes, all MIs, and ST segment elevation MIs were all less common for patients taking ticagrelor. All-cause mortality was similar between study groups.

Though ischemic events dropped, “This benefit was achieved at the expense of more bleeding,” said Dr. Bhatt. Major bleeding, the primary safety outcome, was seen in 2.2% of those taking ticagrelor and 1.0% of the placebo group, for a hazard ratio of 2.32 (P less than .001). Dr. Bhatt and his collaborators used the Thrombolysis in Myocardial Infarction (TIMI) criteria for major bleeding for ascertainment of this outcome.

Intracranial hemorrhage was also more common for patients on ticagrelor, though incidence was low and the absolute difference was small between groups. This complication occurred in 0.7% of ticagrelor patients and 0.5% of placebo patients, yielding a hazard ratio of 1.71 (P = .0005). “This excess wasn’t in spontaneous or procedural intracranial bleeding, but rather in traumatic intracranial hemorrhage,” said Dr. Bhatt.

Fatal bleeds affected just 0.2% of those on ticagrelor and 0.1% of those receiving placebo; this difference wasn’t statistically significant.

koakes@mdedgecom

Source: Steg PG et al. N Engl J Med. 2019 Sep 1: DOI: 10.1056/NEJMoa1908077; Bhatt DL et al.Lancet. 2019 Sep 1: DOI:https://doi.org/10.1016/S0140-6736(19)31887-2)

PARIS – Patients with stable coronary artery disease and type 2 diabetes saw fewer ischemic cardiovascular events when they received dual antiplatelet therapy with ticagrelor plus aspirin, though they also had more major bleeding events than patients receiving placebo plus aspirin.

The subset of patients who had received prior percutaneous coronary intervention (PCI) stood to benefit more from extended dual antiplatelet therapy (DAPT), according to clinical trial results presented to an overflow crowd at the annual congress of the European Society of Cardiology.

Findings from the full study, named The Effect of Ticagrelor on Health Outcomes in Diabetes Mellitus Patients Intervention Study (THEMIS), and from the PCI subgroup analysis were published concurrently with the presentation (N Engl J Med. 2019 Sep 1: DOI: 10.1056/NEJMoa1908077; Lancet. 2019 Sep 1: DOI:https://doi.org/10.1016/S0140-6736(19)31887-2).

“This strategy of long-term dual antiplatelet therapy may be beneficial in selected patients at low risk of bleeding, but at high risk of ischemic events,” said the study’s co-principal investigator Deepak Bhatt, MD, professor of medicine at Harvard Medical School, Boston, and executive director of interventional cardiology programs at Boston’s Brigham and Women’s Hospital. In a video interview, he hypothesized that “prior PCI may serve as a sort of ‘stress test’ for bleeding,” thus identifying a subset of patients who might benefit from long-term DAPT.

Ischemic events, the primary efficacy outcome of THEMIS, occurred in 7.7% of patients taking the P2Y12 receptor antagonist ticagrelor and 8.5% of those receiving placebo, for a hazard ratio of 0.90 favoring ticagrelor (P = .04). Ischemic events included cardiovascular deaths, myocardial infarctions (MIs), and stroke.

Looking at secondary endpoints, Dr. Bhatt said that there was no difference in cardiovascular deaths between study arms, but that ischemic strokes, all MIs, and ST segment elevation MIs were all less common for patients taking ticagrelor. All-cause mortality was similar between study groups.

Though ischemic events dropped, “This benefit was achieved at the expense of more bleeding,” said Dr. Bhatt. Major bleeding, the primary safety outcome, was seen in 2.2% of those taking ticagrelor and 1.0% of the placebo group, for a hazard ratio of 2.32 (P less than .001). Dr. Bhatt and his collaborators used the Thrombolysis in Myocardial Infarction (TIMI) criteria for major bleeding for ascertainment of this outcome.

Intracranial hemorrhage was also more common for patients on ticagrelor, though incidence was low and the absolute difference was small between groups. This complication occurred in 0.7% of ticagrelor patients and 0.5% of placebo patients, yielding a hazard ratio of 1.71 (P = .0005). “This excess wasn’t in spontaneous or procedural intracranial bleeding, but rather in traumatic intracranial hemorrhage,” said Dr. Bhatt.

Fatal bleeds affected just 0.2% of those on ticagrelor and 0.1% of those receiving placebo; this difference wasn’t statistically significant.

koakes@mdedgecom

Source: Steg PG et al. N Engl J Med. 2019 Sep 1: DOI: 10.1056/NEJMoa1908077; Bhatt DL et al.Lancet. 2019 Sep 1: DOI:https://doi.org/10.1016/S0140-6736(19)31887-2)

Colorectal cancer (CRC) survivor rates are improving, which means people are living long enough after the cancer to have other chronic conditions. CRC is the third most commonly diagnosed cancer among users of the US Department of Veterans Affairs (VA) health care system, according to VA researchers, and there is a high prevalence of cardiovascular disease (CVD). The researchers also say emerging evidence suggests that survivors of CRC may be more likely to develop diabetes mellitus (DM) in the 5 years following their cancer diagnosis. But they add that there is a paucity of research about control of CVD-related chronic conditions among survivors of CRC.

In a retrospective study, the researchers compared 9,758 nonmetastatic patients with CRC with 29,066 people who had not had cancer. At baseline, 69% of the survivors of CRC and the matched controls were diagnosed with hypertension, 52% with hyperlipidemia, and 37% with DM.

But somewhat contrary to expectations, the researchers found no significant differences between the 2 groups for DM in the year following the baseline assessment. The researchers point to the VA’s “strong history” of DM risk reduction research and 2 national programs targeting DM, although they do not know whether the people in their study participated in those.

The survivors of CRC also had half the odds of being diagnosed with hyperlipidemia. However, they did have 57% higher odds of being diagnosed with hypertension.

Although the researchers acknowledge that hypertension is a transient adverse effect of certain chemotherapy regimens, they found only 7 survivors of CRC and 11 controls were treated with bevacizumab during their first year postanchor date.

The relationship between nonmetastatic CRC and CVD risk-related chronic conditions is complex, the researchers say. But they share risk factors, including obesity, physical inactivity, and diet.

The researchers call behavioral change interventions that improve survivors of CRC physical activity, dietary habits, and body mass index a “promising beginning” but call for other similar interventions, particularly those targeting blood pressure management and adherence to antihypertensive medications (which was significantly lower among the survivors).

While the magnitude of the effect regarding hypertension seems relatively small, the researchers say, they believe it is still an important difference when considered from a population health perspective—and one that should be addressed. The researchers also note that nonmetastatic survivors of CRC and controls had very similar rates of primary care visits in the 3 years postanchor date and as a result similar opportunities to receive a hypertension diagnosis.

Colorectal cancer (CRC) survivor rates are improving, which means people are living long enough after the cancer to have other chronic conditions. CRC is the third most commonly diagnosed cancer among users of the US Department of Veterans Affairs (VA) health care system, according to VA researchers, and there is a high prevalence of cardiovascular disease (CVD). The researchers also say emerging evidence suggests that survivors of CRC may be more likely to develop diabetes mellitus (DM) in the 5 years following their cancer diagnosis. But they add that there is a paucity of research about control of CVD-related chronic conditions among survivors of CRC.

In a retrospective study, the researchers compared 9,758 nonmetastatic patients with CRC with 29,066 people who had not had cancer. At baseline, 69% of the survivors of CRC and the matched controls were diagnosed with hypertension, 52% with hyperlipidemia, and 37% with DM.

But somewhat contrary to expectations, the researchers found no significant differences between the 2 groups for DM in the year following the baseline assessment. The researchers point to the VA’s “strong history” of DM risk reduction research and 2 national programs targeting DM, although they do not know whether the people in their study participated in those.

The survivors of CRC also had half the odds of being diagnosed with hyperlipidemia. However, they did have 57% higher odds of being diagnosed with hypertension.

Although the researchers acknowledge that hypertension is a transient adverse effect of certain chemotherapy regimens, they found only 7 survivors of CRC and 11 controls were treated with bevacizumab during their first year postanchor date.

The relationship between nonmetastatic CRC and CVD risk-related chronic conditions is complex, the researchers say. But they share risk factors, including obesity, physical inactivity, and diet.

The researchers call behavioral change interventions that improve survivors of CRC physical activity, dietary habits, and body mass index a “promising beginning” but call for other similar interventions, particularly those targeting blood pressure management and adherence to antihypertensive medications (which was significantly lower among the survivors).

While the magnitude of the effect regarding hypertension seems relatively small, the researchers say, they believe it is still an important difference when considered from a population health perspective—and one that should be addressed. The researchers also note that nonmetastatic survivors of CRC and controls had very similar rates of primary care visits in the 3 years postanchor date and as a result similar opportunities to receive a hypertension diagnosis.

Colorectal cancer (CRC) survivor rates are improving, which means people are living long enough after the cancer to have other chronic conditions. CRC is the third most commonly diagnosed cancer among users of the US Department of Veterans Affairs (VA) health care system, according to VA researchers, and there is a high prevalence of cardiovascular disease (CVD). The researchers also say emerging evidence suggests that survivors of CRC may be more likely to develop diabetes mellitus (DM) in the 5 years following their cancer diagnosis. But they add that there is a paucity of research about control of CVD-related chronic conditions among survivors of CRC.

In a retrospective study, the researchers compared 9,758 nonmetastatic patients with CRC with 29,066 people who had not had cancer. At baseline, 69% of the survivors of CRC and the matched controls were diagnosed with hypertension, 52% with hyperlipidemia, and 37% with DM.

But somewhat contrary to expectations, the researchers found no significant differences between the 2 groups for DM in the year following the baseline assessment. The researchers point to the VA’s “strong history” of DM risk reduction research and 2 national programs targeting DM, although they do not know whether the people in their study participated in those.

The survivors of CRC also had half the odds of being diagnosed with hyperlipidemia. However, they did have 57% higher odds of being diagnosed with hypertension.

Although the researchers acknowledge that hypertension is a transient adverse effect of certain chemotherapy regimens, they found only 7 survivors of CRC and 11 controls were treated with bevacizumab during their first year postanchor date.

The relationship between nonmetastatic CRC and CVD risk-related chronic conditions is complex, the researchers say. But they share risk factors, including obesity, physical inactivity, and diet.

The researchers call behavioral change interventions that improve survivors of CRC physical activity, dietary habits, and body mass index a “promising beginning” but call for other similar interventions, particularly those targeting blood pressure management and adherence to antihypertensive medications (which was significantly lower among the survivors).

While the magnitude of the effect regarding hypertension seems relatively small, the researchers say, they believe it is still an important difference when considered from a population health perspective—and one that should be addressed. The researchers also note that nonmetastatic survivors of CRC and controls had very similar rates of primary care visits in the 3 years postanchor date and as a result similar opportunities to receive a hypertension diagnosis.

Postmenopausal women with a first-degree family history of diabetes (FHD) had higher bone mineral density (BMD) than did those without such a history, according to results of a study.

Lijuan Yang, MD, of First Affiliated Hospital of Wenzhou (China) Medical University and colleagues reported the results in Menopause. The cross-sectional study included 892 normoglycemic postmenopausal women, of whom 147 had a first-degree FHD; the mean age was 55 years among both those with and those without first-degree FHD. The investigators assessed BMDs of the femoral neck and lumbar spine with dual-energy x-ray absorptiometry and insulin resistance with Homeostasis Model Assessment of Insulin Resistance (HOMA-IR).

Lumbar spine BMD was higher in those with first-degree FHD than in those without, at 1.077 and 1.034 g/cm², respectively; femoral neck BMD was similarly higher at 0.89 vs. 0.85 g/cm², respectively. HOMA-IR also was higher among those with first-degree FHD than among those without, at 1.85 and 1.60, respectively.

Spearman’s correlation analyses showed that lumbar spine BMD was positively associated with first-degree FHD (P = .008) and HOMA-IR (P = .041), as was femoral neck BMD (P = .013 and P = .005, respectively). Results of multiple stepwise regression analysis showed that first-degree FHD and HOMA-IR were independent factors positively associated with femoral neck BMD (P = .029 and P = .0009, respectively) and lumbar spine BMD (P = .029 and P = .002).

“The present study demonstrated that lumbar spine BMD and femoral neck BMD were positively associated with HOMA-IR in postmenopausal women and that individuals with a first-degree FHD were more likely to have high HOMA-IR,” the investigators said. “We suggest that the elevated BMD in individuals with a first-degree FHD could be attributed to insulin resistance,” which appears to be inherited by persons with a first-degree FHD.

The authors noted that the cross-sectional design is a limitations of this study. They suggested future studies might investigate the relationship between insulin resistance and bone development in these populations by assessing osteocalcin and P1NP.

The study received funding or support from National Key R&D Program of China and from the Wenzhou Science & Technology Bureau. The authors did not disclose any conflicts of interest.

[email protected]

SOURCE: Yang L et al. Menopause. 2019 Aug 19. doi: 10.1097/GME.0000000000001396.

Postmenopausal women with a first-degree family history of diabetes (FHD) had higher bone mineral density (BMD) than did those without such a history, according to results of a study.

Lijuan Yang, MD, of First Affiliated Hospital of Wenzhou (China) Medical University and colleagues reported the results in Menopause. The cross-sectional study included 892 normoglycemic postmenopausal women, of whom 147 had a first-degree FHD; the mean age was 55 years among both those with and those without first-degree FHD. The investigators assessed BMDs of the femoral neck and lumbar spine with dual-energy x-ray absorptiometry and insulin resistance with Homeostasis Model Assessment of Insulin Resistance (HOMA-IR).

Lumbar spine BMD was higher in those with first-degree FHD than in those without, at 1.077 and 1.034 g/cm², respectively; femoral neck BMD was similarly higher at 0.89 vs. 0.85 g/cm², respectively. HOMA-IR also was higher among those with first-degree FHD than among those without, at 1.85 and 1.60, respectively.

Spearman’s correlation analyses showed that lumbar spine BMD was positively associated with first-degree FHD (P = .008) and HOMA-IR (P = .041), as was femoral neck BMD (P = .013 and P = .005, respectively). Results of multiple stepwise regression analysis showed that first-degree FHD and HOMA-IR were independent factors positively associated with femoral neck BMD (P = .029 and P = .0009, respectively) and lumbar spine BMD (P = .029 and P = .002).

“The present study demonstrated that lumbar spine BMD and femoral neck BMD were positively associated with HOMA-IR in postmenopausal women and that individuals with a first-degree FHD were more likely to have high HOMA-IR,” the investigators said. “We suggest that the elevated BMD in individuals with a first-degree FHD could be attributed to insulin resistance,” which appears to be inherited by persons with a first-degree FHD.

The authors noted that the cross-sectional design is a limitations of this study. They suggested future studies might investigate the relationship between insulin resistance and bone development in these populations by assessing osteocalcin and P1NP.

The study received funding or support from National Key R&D Program of China and from the Wenzhou Science & Technology Bureau. The authors did not disclose any conflicts of interest.

[email protected]

SOURCE: Yang L et al. Menopause. 2019 Aug 19. doi: 10.1097/GME.0000000000001396.

Postmenopausal women with a first-degree family history of diabetes (FHD) had higher bone mineral density (BMD) than did those without such a history, according to results of a study.

Lijuan Yang, MD, of First Affiliated Hospital of Wenzhou (China) Medical University and colleagues reported the results in Menopause. The cross-sectional study included 892 normoglycemic postmenopausal women, of whom 147 had a first-degree FHD; the mean age was 55 years among both those with and those without first-degree FHD. The investigators assessed BMDs of the femoral neck and lumbar spine with dual-energy x-ray absorptiometry and insulin resistance with Homeostasis Model Assessment of Insulin Resistance (HOMA-IR).

Lumbar spine BMD was higher in those with first-degree FHD than in those without, at 1.077 and 1.034 g/cm², respectively; femoral neck BMD was similarly higher at 0.89 vs. 0.85 g/cm², respectively. HOMA-IR also was higher among those with first-degree FHD than among those without, at 1.85 and 1.60, respectively.

Spearman’s correlation analyses showed that lumbar spine BMD was positively associated with first-degree FHD (P = .008) and HOMA-IR (P = .041), as was femoral neck BMD (P = .013 and P = .005, respectively). Results of multiple stepwise regression analysis showed that first-degree FHD and HOMA-IR were independent factors positively associated with femoral neck BMD (P = .029 and P = .0009, respectively) and lumbar spine BMD (P = .029 and P = .002).

“The present study demonstrated that lumbar spine BMD and femoral neck BMD were positively associated with HOMA-IR in postmenopausal women and that individuals with a first-degree FHD were more likely to have high HOMA-IR,” the investigators said. “We suggest that the elevated BMD in individuals with a first-degree FHD could be attributed to insulin resistance,” which appears to be inherited by persons with a first-degree FHD.

The authors noted that the cross-sectional design is a limitations of this study. They suggested future studies might investigate the relationship between insulin resistance and bone development in these populations by assessing osteocalcin and P1NP.

The study received funding or support from National Key R&D Program of China and from the Wenzhou Science & Technology Bureau. The authors did not disclose any conflicts of interest.

[email protected]

SOURCE: Yang L et al. Menopause. 2019 Aug 19. doi: 10.1097/GME.0000000000001396.

The Food and Drug Administration has given Fast Track designation to the development of dapagliflozin (Farxiga) to delay progression of renal failure and to prevent cardiovascular and renal death in patients with chronic kidney disease with and without type 2 diabetes, according to a release from AstraZeneca.

The Fast Track designation is meant to accelerate the development and review process for the treatment of serious conditions that have unmet therapeutic needs.

Dapagliflozin, an oral daily sodium-glucose transporter 2 inhibitor, is approved both as a monotherapy and a component of combination therapy for the improvement of glycemic control in patients with type 2 diabetes, according to the release. It is given as an adjunct to diet and exercise, and has also shown additional benefits of weight loss and reduction in blood pressure.

A phase 3, randomized, placebo-controlled trial, DAPA-CVD (NCT03036150), is currently underway to evaluate the drug’s efficacy specifically in terms of renal outcomes and cardiovascular mortality in patients with chronic kidney disease, with and without type 2 diabetes. Participants receive once-daily dapagliflozin or placebo in addition to standard care.

Taking dapagliflozin carries risks of hypotension, renal impairment, hypoglycemia, and other concerns. The most common adverse reactions (5% or greater incidence) include female genital mycotic infections, nasopharyngitis, and urinary tract infections. Full prescribing information can be found on the agency’s website.
 

[email protected]

The Food and Drug Administration has given Fast Track designation to the development of dapagliflozin (Farxiga) to delay progression of renal failure and to prevent cardiovascular and renal death in patients with chronic kidney disease with and without type 2 diabetes, according to a release from AstraZeneca.

The Fast Track designation is meant to accelerate the development and review process for the treatment of serious conditions that have unmet therapeutic needs.

Dapagliflozin, an oral daily sodium-glucose transporter 2 inhibitor, is approved both as a monotherapy and a component of combination therapy for the improvement of glycemic control in patients with type 2 diabetes, according to the release. It is given as an adjunct to diet and exercise, and has also shown additional benefits of weight loss and reduction in blood pressure.

A phase 3, randomized, placebo-controlled trial, DAPA-CVD (NCT03036150), is currently underway to evaluate the drug’s efficacy specifically in terms of renal outcomes and cardiovascular mortality in patients with chronic kidney disease, with and without type 2 diabetes. Participants receive once-daily dapagliflozin or placebo in addition to standard care.

Taking dapagliflozin carries risks of hypotension, renal impairment, hypoglycemia, and other concerns. The most common adverse reactions (5% or greater incidence) include female genital mycotic infections, nasopharyngitis, and urinary tract infections. Full prescribing information can be found on the agency’s website.
 

[email protected]

The Food and Drug Administration has given Fast Track designation to the development of dapagliflozin (Farxiga) to delay progression of renal failure and to prevent cardiovascular and renal death in patients with chronic kidney disease with and without type 2 diabetes, according to a release from AstraZeneca.

The Fast Track designation is meant to accelerate the development and review process for the treatment of serious conditions that have unmet therapeutic needs.

Dapagliflozin, an oral daily sodium-glucose transporter 2 inhibitor, is approved both as a monotherapy and a component of combination therapy for the improvement of glycemic control in patients with type 2 diabetes, according to the release. It is given as an adjunct to diet and exercise, and has also shown additional benefits of weight loss and reduction in blood pressure.

A phase 3, randomized, placebo-controlled trial, DAPA-CVD (NCT03036150), is currently underway to evaluate the drug’s efficacy specifically in terms of renal outcomes and cardiovascular mortality in patients with chronic kidney disease, with and without type 2 diabetes. Participants receive once-daily dapagliflozin or placebo in addition to standard care.

Taking dapagliflozin carries risks of hypotension, renal impairment, hypoglycemia, and other concerns. The most common adverse reactions (5% or greater incidence) include female genital mycotic infections, nasopharyngitis, and urinary tract infections. Full prescribing information can be found on the agency’s website.
 

[email protected]

Innovations in care delivery, as previously introduced by Dr. Robert Gabbay, can enhance the patient and physician experience. Providing care via telemedicine can bring joy to work by introducing variety to practice. It also carries the satisfaction of easing access to care for the patient.

Vanderbilt University Medical Center

Broadly speaking, telemedicine can be seen as a tool for delivering care when a hands-on exam is not required. In direct-to-patient telemedicine, the patient can use a personal smartphone, tablet, or computer to connect with a provider in a real-time audio and/or video “visit” from home or work. The engagement can be scheduled or on demand. Although telemedicine is generally associated with the delivery of care to patients in remote or rural locations, it is increasingly being used in urban areas, especially with older patients and those for whom transport or time away from work might be difficult.
 

How the patient benefits

This built-in flexibility is appealing to patients – the easier access and convenience can translate into reduced time away from work or school and possibly a reduction in patient “no-shows.” Patients are more likely to enjoy the benefits of continuity of care with their own providers, rather than seeking independent, consumer-marketed services. In a nationwide survey of 4,345 respondents about attitudes toward telemedicine in primary care, 52% of respondents said they would like to see their own providers via telemedicine, 35% were willing to see a different provider from the same organization, and 15% said they would consider leaving their current provider to see one who offered telemedicine (BMC Health Services Research. 2017;17:784).

In addition, numerous studies have reported on the equivalent clinical outcomes and improved cost-of-care benefits in patients who receive diabetes care through telemedicine. Lui and colleagues looked at patients at the Denver VA Medical Center who were newly diagnosed with diabetes and they compared short-term glycemic control in patients who had telemedicine consultations with patients who had in-person visits. They found that the telemedicine consultations improved short-term glycemic control as effectively as the in-person visits, but with possible added financial benefits for both the patients and the health care system. (J Diabetes Sci Technol. 2016;10[5]:1079-86). Likewise, Fatehi and colleagues have reported that method of consultation – telemedicine or in-person consultation – did not affect concordance of advice between two endocrinologists (Diabetes Technol Ther. 2015;17[10]:717-25).
 

What telemedicine has to offer

There is a range of diabetes care services that can be delivered through telemedicine consultation. When appropriate diagnostic labs have already been performed, newly diagnosed patients can be counseled on their diagnosis and started on therapy. For patients who have already been diagnosed, follow-up and monitoring of therapy adherence and glycemic control can be more convenient and done more routinely, compared with in-person visits, and thus yield better outcomes.

Use of cloud-based services to review data from glucometers, insulin pumps, and continuous glucose monitors allows the clinicians to access the same data they would in the office. Combining this data review with a video visit, rather than looking at the data in isolation, allows for increased patient engagement, shared decision making, and patient counseling.

Other diagnoses that readily fit at-home telemedicine care include gestational diabetes, as these patients need frequent follow-up, and doing some of their visits via telemedicine can reduce their burden of travel. Hypothyroidism follow-ups, with labs completed before the visit, can be very efficient via telemedicine. Internal surveys of direct-to-patient services at my institution demonstrated a high level of patient satisfaction, with 91% of patients indicating they were satisfied overall, and 81% saying that connection with the provider matched that of an in-person visit.
 

Gains for the provider, the care team, and the practice

Endocrinologists can derive benefit from telemedicine engagement with their patients, which could have positive implications for other members of the care team and for the practice as a whole. For the provider, being able to streamline clinical workflows and increase practice efficiency can help reduce personal and workplace-related stress and translate into greater personal satisfaction in one’s work and delivery of better-quality care.

At the practice level, the use of telemedicine presents opportunities for expanding the patient base and perhaps working more flexible hours to better accommodate the personal and professional time demands on providers and their staff. In addition, offering telemedicine as a medium of consultation could be a practice differentiator that could give you a competitive edge. That, along with smaller changes, such as enhancing or even reducing space utilization, could contribute to reduced overheads and a boost in revenue, which would have a positive impact on the practice’s bottom line.
 

Getting started

There is important groundwork to be done before a telemedicine program can get underway. First, bear in mind that there is considerable state-based variation in regulations and insurance coverage, so you need to be sure that you are in compliance with the requirements for your state. If direct-to-patient telemedicine is not widely reimbursed in your state, direct-payment models may be feasible. Providers who accept Medicare payments need to understand restrictions on self-payment for those patients. You may also be able to negotiate with payers to include reimbursement for telemedicine visits in your contracts. Negotiation with payers and direct-pay models may be possible.

Key guidelines. In addition to understanding your state’s regulations around telemedicine, there are specific aspects of practice about which you need to be clear, for example:

• You must be licensed in the state in which your patient is located at the time of their visit.
• Understand any restrictions on prescribing via telemedicine in your state.
• Be aware that Medicare has very specific guidelines and, at this time, does not recognize home as a place of service.
• You must be sure that you use HIPAA-compliant video software.
• If in any doubt, seek guidance from an attorney or your organization’s compliance office.

Infrastructure and outlay. Your infrastructure needs will depend on the specific services that you provide, but in general, you should include a communication platform and video conferencing equipment; sufficient bandwidth and a secure, reliable Internet connection; ready access to sound IT support; and comprehensive staff training at the outset, with subsequent refresher training sessions on a regular basis. Within the practice, you will need to think about adjustments to your existing workflow to accommodate the telemedicine services you plan to offer.

Resources. Two nonprofit groups that offer nonpartisan guidance in telemedicine are the Center for Connected Health Policy and the Regional Telehealth Resource Centers.

Dr. Griffith is assistant professor of medicine and medical director, Ambulatory Telehealth Services, Vanderbilt University Medical Center, in Nashville, Tenn. This article is part of a series based on presentations from the annual meeting of the Endocrine Society in March 2019. Dr. Griffith has no disclosures. Write to her at [email protected].

Innovations in care delivery, as previously introduced by Dr. Robert Gabbay, can enhance the patient and physician experience. Providing care via telemedicine can bring joy to work by introducing variety to practice. It also carries the satisfaction of easing access to care for the patient.

Vanderbilt University Medical Center

Broadly speaking, telemedicine can be seen as a tool for delivering care when a hands-on exam is not required. In direct-to-patient telemedicine, the patient can use a personal smartphone, tablet, or computer to connect with a provider in a real-time audio and/or video “visit” from home or work. The engagement can be scheduled or on demand. Although telemedicine is generally associated with the delivery of care to patients in remote or rural locations, it is increasingly being used in urban areas, especially with older patients and those for whom transport or time away from work might be difficult.
 

How the patient benefits

This built-in flexibility is appealing to patients – the easier access and convenience can translate into reduced time away from work or school and possibly a reduction in patient “no-shows.” Patients are more likely to enjoy the benefits of continuity of care with their own providers, rather than seeking independent, consumer-marketed services. In a nationwide survey of 4,345 respondents about attitudes toward telemedicine in primary care, 52% of respondents said they would like to see their own providers via telemedicine, 35% were willing to see a different provider from the same organization, and 15% said they would consider leaving their current provider to see one who offered telemedicine (BMC Health Services Research. 2017;17:784).

In addition, numerous studies have reported on the equivalent clinical outcomes and improved cost-of-care benefits in patients who receive diabetes care through telemedicine. Lui and colleagues looked at patients at the Denver VA Medical Center who were newly diagnosed with diabetes and they compared short-term glycemic control in patients who had telemedicine consultations with patients who had in-person visits. They found that the telemedicine consultations improved short-term glycemic control as effectively as the in-person visits, but with possible added financial benefits for both the patients and the health care system. (J Diabetes Sci Technol. 2016;10[5]:1079-86). Likewise, Fatehi and colleagues have reported that method of consultation – telemedicine or in-person consultation – did not affect concordance of advice between two endocrinologists (Diabetes Technol Ther. 2015;17[10]:717-25).
 

What telemedicine has to offer

There is a range of diabetes care services that can be delivered through telemedicine consultation. When appropriate diagnostic labs have already been performed, newly diagnosed patients can be counseled on their diagnosis and started on therapy. For patients who have already been diagnosed, follow-up and monitoring of therapy adherence and glycemic control can be more convenient and done more routinely, compared with in-person visits, and thus yield better outcomes.

Use of cloud-based services to review data from glucometers, insulin pumps, and continuous glucose monitors allows the clinicians to access the same data they would in the office. Combining this data review with a video visit, rather than looking at the data in isolation, allows for increased patient engagement, shared decision making, and patient counseling.

Other diagnoses that readily fit at-home telemedicine care include gestational diabetes, as these patients need frequent follow-up, and doing some of their visits via telemedicine can reduce their burden of travel. Hypothyroidism follow-ups, with labs completed before the visit, can be very efficient via telemedicine. Internal surveys of direct-to-patient services at my institution demonstrated a high level of patient satisfaction, with 91% of patients indicating they were satisfied overall, and 81% saying that connection with the provider matched that of an in-person visit.
 

Gains for the provider, the care team, and the practice

Endocrinologists can derive benefit from telemedicine engagement with their patients, which could have positive implications for other members of the care team and for the practice as a whole. For the provider, being able to streamline clinical workflows and increase practice efficiency can help reduce personal and workplace-related stress and translate into greater personal satisfaction in one’s work and delivery of better-quality care.

At the practice level, the use of telemedicine presents opportunities for expanding the patient base and perhaps working more flexible hours to better accommodate the personal and professional time demands on providers and their staff. In addition, offering telemedicine as a medium of consultation could be a practice differentiator that could give you a competitive edge. That, along with smaller changes, such as enhancing or even reducing space utilization, could contribute to reduced overheads and a boost in revenue, which would have a positive impact on the practice’s bottom line.
 

Getting started

There is important groundwork to be done before a telemedicine program can get underway. First, bear in mind that there is considerable state-based variation in regulations and insurance coverage, so you need to be sure that you are in compliance with the requirements for your state. If direct-to-patient telemedicine is not widely reimbursed in your state, direct-payment models may be feasible. Providers who accept Medicare payments need to understand restrictions on self-payment for those patients. You may also be able to negotiate with payers to include reimbursement for telemedicine visits in your contracts. Negotiation with payers and direct-pay models may be possible.

Key guidelines. In addition to understanding your state’s regulations around telemedicine, there are specific aspects of practice about which you need to be clear, for example:

• You must be licensed in the state in which your patient is located at the time of their visit.
• Understand any restrictions on prescribing via telemedicine in your state.
• Be aware that Medicare has very specific guidelines and, at this time, does not recognize home as a place of service.
• You must be sure that you use HIPAA-compliant video software.
• If in any doubt, seek guidance from an attorney or your organization’s compliance office.

Infrastructure and outlay. Your infrastructure needs will depend on the specific services that you provide, but in general, you should include a communication platform and video conferencing equipment; sufficient bandwidth and a secure, reliable Internet connection; ready access to sound IT support; and comprehensive staff training at the outset, with subsequent refresher training sessions on a regular basis. Within the practice, you will need to think about adjustments to your existing workflow to accommodate the telemedicine services you plan to offer.

Resources. Two nonprofit groups that offer nonpartisan guidance in telemedicine are the Center for Connected Health Policy and the Regional Telehealth Resource Centers.

Dr. Griffith is assistant professor of medicine and medical director, Ambulatory Telehealth Services, Vanderbilt University Medical Center, in Nashville, Tenn. This article is part of a series based on presentations from the annual meeting of the Endocrine Society in March 2019. Dr. Griffith has no disclosures. Write to her at [email protected].

Innovations in care delivery, as previously introduced by Dr. Robert Gabbay, can enhance the patient and physician experience. Providing care via telemedicine can bring joy to work by introducing variety to practice. It also carries the satisfaction of easing access to care for the patient.

Vanderbilt University Medical Center

Broadly speaking, telemedicine can be seen as a tool for delivering care when a hands-on exam is not required. In direct-to-patient telemedicine, the patient can use a personal smartphone, tablet, or computer to connect with a provider in a real-time audio and/or video “visit” from home or work. The engagement can be scheduled or on demand. Although telemedicine is generally associated with the delivery of care to patients in remote or rural locations, it is increasingly being used in urban areas, especially with older patients and those for whom transport or time away from work might be difficult.
 

How the patient benefits

This built-in flexibility is appealing to patients – the easier access and convenience can translate into reduced time away from work or school and possibly a reduction in patient “no-shows.” Patients are more likely to enjoy the benefits of continuity of care with their own providers, rather than seeking independent, consumer-marketed services. In a nationwide survey of 4,345 respondents about attitudes toward telemedicine in primary care, 52% of respondents said they would like to see their own providers via telemedicine, 35% were willing to see a different provider from the same organization, and 15% said they would consider leaving their current provider to see one who offered telemedicine (BMC Health Services Research. 2017;17:784).

In addition, numerous studies have reported on the equivalent clinical outcomes and improved cost-of-care benefits in patients who receive diabetes care through telemedicine. Lui and colleagues looked at patients at the Denver VA Medical Center who were newly diagnosed with diabetes and they compared short-term glycemic control in patients who had telemedicine consultations with patients who had in-person visits. They found that the telemedicine consultations improved short-term glycemic control as effectively as the in-person visits, but with possible added financial benefits for both the patients and the health care system. (J Diabetes Sci Technol. 2016;10[5]:1079-86). Likewise, Fatehi and colleagues have reported that method of consultation – telemedicine or in-person consultation – did not affect concordance of advice between two endocrinologists (Diabetes Technol Ther. 2015;17[10]:717-25).
 

What telemedicine has to offer

There is a range of diabetes care services that can be delivered through telemedicine consultation. When appropriate diagnostic labs have already been performed, newly diagnosed patients can be counseled on their diagnosis and started on therapy. For patients who have already been diagnosed, follow-up and monitoring of therapy adherence and glycemic control can be more convenient and done more routinely, compared with in-person visits, and thus yield better outcomes.

Use of cloud-based services to review data from glucometers, insulin pumps, and continuous glucose monitors allows the clinicians to access the same data they would in the office. Combining this data review with a video visit, rather than looking at the data in isolation, allows for increased patient engagement, shared decision making, and patient counseling.

Other diagnoses that readily fit at-home telemedicine care include gestational diabetes, as these patients need frequent follow-up, and doing some of their visits via telemedicine can reduce their burden of travel. Hypothyroidism follow-ups, with labs completed before the visit, can be very efficient via telemedicine. Internal surveys of direct-to-patient services at my institution demonstrated a high level of patient satisfaction, with 91% of patients indicating they were satisfied overall, and 81% saying that connection with the provider matched that of an in-person visit.
 

Gains for the provider, the care team, and the practice

Endocrinologists can derive benefit from telemedicine engagement with their patients, which could have positive implications for other members of the care team and for the practice as a whole. For the provider, being able to streamline clinical workflows and increase practice efficiency can help reduce personal and workplace-related stress and translate into greater personal satisfaction in one’s work and delivery of better-quality care.

At the practice level, the use of telemedicine presents opportunities for expanding the patient base and perhaps working more flexible hours to better accommodate the personal and professional time demands on providers and their staff. In addition, offering telemedicine as a medium of consultation could be a practice differentiator that could give you a competitive edge. That, along with smaller changes, such as enhancing or even reducing space utilization, could contribute to reduced overheads and a boost in revenue, which would have a positive impact on the practice’s bottom line.
 

Getting started

There is important groundwork to be done before a telemedicine program can get underway. First, bear in mind that there is considerable state-based variation in regulations and insurance coverage, so you need to be sure that you are in compliance with the requirements for your state. If direct-to-patient telemedicine is not widely reimbursed in your state, direct-payment models may be feasible. Providers who accept Medicare payments need to understand restrictions on self-payment for those patients. You may also be able to negotiate with payers to include reimbursement for telemedicine visits in your contracts. Negotiation with payers and direct-pay models may be possible.

Key guidelines. In addition to understanding your state’s regulations around telemedicine, there are specific aspects of practice about which you need to be clear, for example:

• You must be licensed in the state in which your patient is located at the time of their visit.
• Understand any restrictions on prescribing via telemedicine in your state.
• Be aware that Medicare has very specific guidelines and, at this time, does not recognize home as a place of service.
• You must be sure that you use HIPAA-compliant video software.
• If in any doubt, seek guidance from an attorney or your organization’s compliance office.

Infrastructure and outlay. Your infrastructure needs will depend on the specific services that you provide, but in general, you should include a communication platform and video conferencing equipment; sufficient bandwidth and a secure, reliable Internet connection; ready access to sound IT support; and comprehensive staff training at the outset, with subsequent refresher training sessions on a regular basis. Within the practice, you will need to think about adjustments to your existing workflow to accommodate the telemedicine services you plan to offer.

Resources. Two nonprofit groups that offer nonpartisan guidance in telemedicine are the Center for Connected Health Policy and the Regional Telehealth Resource Centers.

Dr. Griffith is assistant professor of medicine and medical director, Ambulatory Telehealth Services, Vanderbilt University Medical Center, in Nashville, Tenn. This article is part of a series based on presentations from the annual meeting of the Endocrine Society in March 2019. Dr. Griffith has no disclosures. Write to her at [email protected].

There is a national epidemic of physician burnout, and endocrinologists are not immune to it, with 47% reporting significant burnout in a recent survey.¹ As the incidence of physician burnout increases, so does the overall cost to the health system, both in quality of care and financially, and findings from a recent study suggested that patients are becoming aware of burnout among providers and are concerned about its impact on the quality of the care that they are receiving.²

Burnout can be described as a form of extreme work-related stress manifesting as physical and/or emotional exhaustion that can generate a range of psychological ripple effects, such as depression, mood and anxiety disorders, a crippling sense of worthlessness, and a loss of sense of self. Anyone can be affected by burnout, but there seems to be a greater prevalence among women (50% vs 30% for men); younger doctors, especially residents; and providers of color.^3,4

The fallout from burnout affects both our personal and professional lives. In our personal lives, it can translate into broken or strained relationships, alcohol and substance abuse, depression and mood or anxiety disorders, financial difficulties, and suicide (14% have reported thoughts of suicide; 1% have committed suicide). Juggling work and family can be overwhelming, and additional strains, such as caring for a parent or a sick family member, having a child, going through a divorce or a family bereavement, dealing with student debt, and pressure to achieve, can be cumulatively devastating for a hardworking provider.⁵

In the practice, we see burnout translate into an increase in the number of medical errors, diminished quality of care, lower patient satisfaction with care, decreased productivity and professional effort, dissatisfaction among staff, and an increase in physician turnover.⁶ Workplace-specific factors that can contribute to burnout include daily use of health information technology, especially the EHR; workplace inequities; pressures to keep abreast with changes in the specialty; and time management challenges and constraints that go along with the continual pressure to deliver better quality care, for less money, in less time.⁷

Our group wanted to devise innovative, practice-based strategies that would help our colleagues address the burnout crisis. We asked ourselves how – through new, innovative models of care – we could rediscover the joy in our work, and what the steppingstones of “meaningful work” would be. It seemed to us that working as a team and revisiting the care we deliver might be good starting points, and that, if we drilled down further, common themes to address burnout and find joy in work revolve around choice, camaraderie, equity, and cocreating solutions.

Evidence suggests that physicians who spend at least 20% of their professional effort focused on work they find most meaningful have a notably lower risk for burnout.⁸ Each 1% reduction below this threshold increases the risk of burnout, and there is a ceiling effect to the benefit at 20% – for example, spending 50% of your time in the most meaningful area is associated with similar rates of burnout as spending 20% on it.

So how do we to get to that meaningful threshold of 20%? You can begin with identifying your passion, making the business case, speaking to your boss, getting your colleagues’ buy-in, and even looking for grants and other funding if needed. We came up with five ways you might bring more joy to your work by adopting innovative models of diabetes care: the first – implementing a direct-to-patient telemedicine program – has been written by Michelle Griffith, MD, and is featured here. In coming articles, we will take a look at tackling the impediments of clinical inertia, coordinating care through use of a transfer summary, shifting to team-based care, how to use  e-consultations to connect with primary care providers, and devising a business case for these and other innovations.

References

1. Kane L. National Physician Burnout, Depression & Suicide Report 2019. Medscape. Published online Jan 16, 2019.

2. American Society of Health-System Pharmacists. Press release. 2019 Jun 17.

3. Oakes K. Female family physicians come up short in burnout gender divide. Family Practice News. Published online November 27, 2017.

4. Dyrbye L. JAMA Network Open. 2019 Jul 26. doi: 10.1001/jamanetworkopen.2019.7457.

5. Yank V et al. JAMA Intern Med. 2019 Jan 28. doi: 10.1001/jamainternmed.2018.6411.

6 . Panagioti M et al. JAMA Intern Med. 2018;178(10):1317-31.

7. Gardner R et al. J Am Med Inform Assoc. doi: 10.1093/jamia/ocy145.

8. Shanafelt T et al. Am J Med Qual. 2017;32(5):563-5.

Dr. Gabbay is chief medical officer at Joslin Diabetes Center and an associate professor of medicine at Harvard Medical School, both in Boston. This is the introduction to a series of articles based on presentations from the annual meeting of the Endocrine Society in March 2019. Dr. Gabbay reports being an adviser to Lark, Onduo, and HealthReveal. Write to him at [email protected].

There is a national epidemic of physician burnout, and endocrinologists are not immune to it, with 47% reporting significant burnout in a recent survey.¹ As the incidence of physician burnout increases, so does the overall cost to the health system, both in quality of care and financially, and findings from a recent study suggested that patients are becoming aware of burnout among providers and are concerned about its impact on the quality of the care that they are receiving.²

Burnout can be described as a form of extreme work-related stress manifesting as physical and/or emotional exhaustion that can generate a range of psychological ripple effects, such as depression, mood and anxiety disorders, a crippling sense of worthlessness, and a loss of sense of self. Anyone can be affected by burnout, but there seems to be a greater prevalence among women (50% vs 30% for men); younger doctors, especially residents; and providers of color.^3,4

The fallout from burnout affects both our personal and professional lives. In our personal lives, it can translate into broken or strained relationships, alcohol and substance abuse, depression and mood or anxiety disorders, financial difficulties, and suicide (14% have reported thoughts of suicide; 1% have committed suicide). Juggling work and family can be overwhelming, and additional strains, such as caring for a parent or a sick family member, having a child, going through a divorce or a family bereavement, dealing with student debt, and pressure to achieve, can be cumulatively devastating for a hardworking provider.⁵

In the practice, we see burnout translate into an increase in the number of medical errors, diminished quality of care, lower patient satisfaction with care, decreased productivity and professional effort, dissatisfaction among staff, and an increase in physician turnover.⁶ Workplace-specific factors that can contribute to burnout include daily use of health information technology, especially the EHR; workplace inequities; pressures to keep abreast with changes in the specialty; and time management challenges and constraints that go along with the continual pressure to deliver better quality care, for less money, in less time.⁷

Our group wanted to devise innovative, practice-based strategies that would help our colleagues address the burnout crisis. We asked ourselves how – through new, innovative models of care – we could rediscover the joy in our work, and what the steppingstones of “meaningful work” would be. It seemed to us that working as a team and revisiting the care we deliver might be good starting points, and that, if we drilled down further, common themes to address burnout and find joy in work revolve around choice, camaraderie, equity, and cocreating solutions.

Evidence suggests that physicians who spend at least 20% of their professional effort focused on work they find most meaningful have a notably lower risk for burnout.⁸ Each 1% reduction below this threshold increases the risk of burnout, and there is a ceiling effect to the benefit at 20% – for example, spending 50% of your time in the most meaningful area is associated with similar rates of burnout as spending 20% on it.

So how do we to get to that meaningful threshold of 20%? You can begin with identifying your passion, making the business case, speaking to your boss, getting your colleagues’ buy-in, and even looking for grants and other funding if needed. We came up with five ways you might bring more joy to your work by adopting innovative models of diabetes care: the first – implementing a direct-to-patient telemedicine program – has been written by Michelle Griffith, MD, and is featured here. In coming articles, we will take a look at tackling the impediments of clinical inertia, coordinating care through use of a transfer summary, shifting to team-based care, how to use  e-consultations to connect with primary care providers, and devising a business case for these and other innovations.

References

1. Kane L. National Physician Burnout, Depression & Suicide Report 2019. Medscape. Published online Jan 16, 2019.

2. American Society of Health-System Pharmacists. Press release. 2019 Jun 17.

3. Oakes K. Female family physicians come up short in burnout gender divide. Family Practice News. Published online November 27, 2017.

4. Dyrbye L. JAMA Network Open. 2019 Jul 26. doi: 10.1001/jamanetworkopen.2019.7457.

5. Yank V et al. JAMA Intern Med. 2019 Jan 28. doi: 10.1001/jamainternmed.2018.6411.

6 . Panagioti M et al. JAMA Intern Med. 2018;178(10):1317-31.

7. Gardner R et al. J Am Med Inform Assoc. doi: 10.1093/jamia/ocy145.

8. Shanafelt T et al. Am J Med Qual. 2017;32(5):563-5.

Dr. Gabbay is chief medical officer at Joslin Diabetes Center and an associate professor of medicine at Harvard Medical School, both in Boston. This is the introduction to a series of articles based on presentations from the annual meeting of the Endocrine Society in March 2019. Dr. Gabbay reports being an adviser to Lark, Onduo, and HealthReveal. Write to him at [email protected].

There is a national epidemic of physician burnout, and endocrinologists are not immune to it, with 47% reporting significant burnout in a recent survey.¹ As the incidence of physician burnout increases, so does the overall cost to the health system, both in quality of care and financially, and findings from a recent study suggested that patients are becoming aware of burnout among providers and are concerned about its impact on the quality of the care that they are receiving.²

Burnout can be described as a form of extreme work-related stress manifesting as physical and/or emotional exhaustion that can generate a range of psychological ripple effects, such as depression, mood and anxiety disorders, a crippling sense of worthlessness, and a loss of sense of self. Anyone can be affected by burnout, but there seems to be a greater prevalence among women (50% vs 30% for men); younger doctors, especially residents; and providers of color.^3,4

The fallout from burnout affects both our personal and professional lives. In our personal lives, it can translate into broken or strained relationships, alcohol and substance abuse, depression and mood or anxiety disorders, financial difficulties, and suicide (14% have reported thoughts of suicide; 1% have committed suicide). Juggling work and family can be overwhelming, and additional strains, such as caring for a parent or a sick family member, having a child, going through a divorce or a family bereavement, dealing with student debt, and pressure to achieve, can be cumulatively devastating for a hardworking provider.⁵

In the practice, we see burnout translate into an increase in the number of medical errors, diminished quality of care, lower patient satisfaction with care, decreased productivity and professional effort, dissatisfaction among staff, and an increase in physician turnover.⁶ Workplace-specific factors that can contribute to burnout include daily use of health information technology, especially the EHR; workplace inequities; pressures to keep abreast with changes in the specialty; and time management challenges and constraints that go along with the continual pressure to deliver better quality care, for less money, in less time.⁷

Our group wanted to devise innovative, practice-based strategies that would help our colleagues address the burnout crisis. We asked ourselves how – through new, innovative models of care – we could rediscover the joy in our work, and what the steppingstones of “meaningful work” would be. It seemed to us that working as a team and revisiting the care we deliver might be good starting points, and that, if we drilled down further, common themes to address burnout and find joy in work revolve around choice, camaraderie, equity, and cocreating solutions.

Evidence suggests that physicians who spend at least 20% of their professional effort focused on work they find most meaningful have a notably lower risk for burnout.⁸ Each 1% reduction below this threshold increases the risk of burnout, and there is a ceiling effect to the benefit at 20% – for example, spending 50% of your time in the most meaningful area is associated with similar rates of burnout as spending 20% on it.

So how do we to get to that meaningful threshold of 20%? You can begin with identifying your passion, making the business case, speaking to your boss, getting your colleagues’ buy-in, and even looking for grants and other funding if needed. We came up with five ways you might bring more joy to your work by adopting innovative models of diabetes care: the first – implementing a direct-to-patient telemedicine program – has been written by Michelle Griffith, MD, and is featured here. In coming articles, we will take a look at tackling the impediments of clinical inertia, coordinating care through use of a transfer summary, shifting to team-based care, how to use  e-consultations to connect with primary care providers, and devising a business case for these and other innovations.

References

1. Kane L. National Physician Burnout, Depression & Suicide Report 2019. Medscape. Published online Jan 16, 2019.

2. American Society of Health-System Pharmacists. Press release. 2019 Jun 17.

3. Oakes K. Female family physicians come up short in burnout gender divide. Family Practice News. Published online November 27, 2017.

4. Dyrbye L. JAMA Network Open. 2019 Jul 26. doi: 10.1001/jamanetworkopen.2019.7457.

5. Yank V et al. JAMA Intern Med. 2019 Jan 28. doi: 10.1001/jamainternmed.2018.6411.

6 . Panagioti M et al. JAMA Intern Med. 2018;178(10):1317-31.

7. Gardner R et al. J Am Med Inform Assoc. doi: 10.1093/jamia/ocy145.

8. Shanafelt T et al. Am J Med Qual. 2017;32(5):563-5.

Dr. Gabbay is chief medical officer at Joslin Diabetes Center and an associate professor of medicine at Harvard Medical School, both in Boston. This is the introduction to a series of articles based on presentations from the annual meeting of the Endocrine Society in March 2019. Dr. Gabbay reports being an adviser to Lark, Onduo, and HealthReveal. Write to him at [email protected].

The fracture risk assessment tool FRAX may underestimate fracture risk in women with diabetes when bone mineral density is included, according to data from 566 women aged 40-90 years.

©wildpixel/Thinkstock

In a study published in Bone Reports, Lelia L.F. de Abreu, MD, of Deakin University, Geelong, Australia, and colleagues investigated the accuracy of FRAX scores and the role of impaired fasting glucose (IFG) and bone mineral density (BMD) on fracture risk by comparing FRAX scores for 252 normoglycemic women, 247 women with IFG, and 67 women with diabetes.

When BMD was not included, women with diabetes had a higher median FRAX score for major osteoporotic fractures of the hip, clinical spine, forearm, and wrist than women without diabetes or women with IFG (7.1, 4.3, and 5.1, respectively). In the diabetes group, 11 major osteoporotic fractures were observed versus 5 predicted by FRAX. In the normoglycemic group, 28 fractures were observed versus 15 predicted, and in the IFG group 31 fractures were observed versus 16 predicted.

When BMD was included, major osteoporotic fractures and hip fractures also were underestimated in the diabetes group (11 observed vs. 4 observed; 6 observed vs. 1 predicted, respectively), but the difference in observed versus predicted fractures trended toward statistical significance but was not significant (P = .055; P = .52, respectively). FRAX with BMD increased the underestimation of major osteoporotic fractures in the normoglycemic and IFG groups (28 observed vs. 13 predicted; 31 observed vs. 13 predicted).

The study findings were limited by several factors including the inability to determine the impact of specific types of diabetes on fracture risk, lack of data on the duration of diabetes in study participants, the use of self-reports, and a relatively small and homogeneous sample size, the researchers noted.

However, the results support data from previous studies showing an increased fracture risk in diabetes patients regardless of BMD, and suggest that FRAX may be unreliable as a predictor of fractures in the diabetes population, they concluded.

The study was supported in part by the Victorian Health Promotion Foundation, National Health and Medical Research Council Australia, and the Geelong Region Medical Research Foundation. Two researchers were supported by university postgraduate rewards and one researcher was supported by a university postdoctoral research fellowship. The remaining coauthors reported no relevant financial conflicts.

SOURCE: de Abreu LLF et al. Bone Reports. 2019 Aug 13. doi: 10.1016/j.bonr.2019.100223.

The fracture risk assessment tool FRAX may underestimate fracture risk in women with diabetes when bone mineral density is included, according to data from 566 women aged 40-90 years.

©wildpixel/Thinkstock

In a study published in Bone Reports, Lelia L.F. de Abreu, MD, of Deakin University, Geelong, Australia, and colleagues investigated the accuracy of FRAX scores and the role of impaired fasting glucose (IFG) and bone mineral density (BMD) on fracture risk by comparing FRAX scores for 252 normoglycemic women, 247 women with IFG, and 67 women with diabetes.

When BMD was not included, women with diabetes had a higher median FRAX score for major osteoporotic fractures of the hip, clinical spine, forearm, and wrist than women without diabetes or women with IFG (7.1, 4.3, and 5.1, respectively). In the diabetes group, 11 major osteoporotic fractures were observed versus 5 predicted by FRAX. In the normoglycemic group, 28 fractures were observed versus 15 predicted, and in the IFG group 31 fractures were observed versus 16 predicted.

When BMD was included, major osteoporotic fractures and hip fractures also were underestimated in the diabetes group (11 observed vs. 4 observed; 6 observed vs. 1 predicted, respectively), but the difference in observed versus predicted fractures trended toward statistical significance but was not significant (P = .055; P = .52, respectively). FRAX with BMD increased the underestimation of major osteoporotic fractures in the normoglycemic and IFG groups (28 observed vs. 13 predicted; 31 observed vs. 13 predicted).

The study findings were limited by several factors including the inability to determine the impact of specific types of diabetes on fracture risk, lack of data on the duration of diabetes in study participants, the use of self-reports, and a relatively small and homogeneous sample size, the researchers noted.

However, the results support data from previous studies showing an increased fracture risk in diabetes patients regardless of BMD, and suggest that FRAX may be unreliable as a predictor of fractures in the diabetes population, they concluded.

The study was supported in part by the Victorian Health Promotion Foundation, National Health and Medical Research Council Australia, and the Geelong Region Medical Research Foundation. Two researchers were supported by university postgraduate rewards and one researcher was supported by a university postdoctoral research fellowship. The remaining coauthors reported no relevant financial conflicts.

SOURCE: de Abreu LLF et al. Bone Reports. 2019 Aug 13. doi: 10.1016/j.bonr.2019.100223.

The fracture risk assessment tool FRAX may underestimate fracture risk in women with diabetes when bone mineral density is included, according to data from 566 women aged 40-90 years.

©wildpixel/Thinkstock

In a study published in Bone Reports, Lelia L.F. de Abreu, MD, of Deakin University, Geelong, Australia, and colleagues investigated the accuracy of FRAX scores and the role of impaired fasting glucose (IFG) and bone mineral density (BMD) on fracture risk by comparing FRAX scores for 252 normoglycemic women, 247 women with IFG, and 67 women with diabetes.

When BMD was not included, women with diabetes had a higher median FRAX score for major osteoporotic fractures of the hip, clinical spine, forearm, and wrist than women without diabetes or women with IFG (7.1, 4.3, and 5.1, respectively). In the diabetes group, 11 major osteoporotic fractures were observed versus 5 predicted by FRAX. In the normoglycemic group, 28 fractures were observed versus 15 predicted, and in the IFG group 31 fractures were observed versus 16 predicted.

When BMD was included, major osteoporotic fractures and hip fractures also were underestimated in the diabetes group (11 observed vs. 4 observed; 6 observed vs. 1 predicted, respectively), but the difference in observed versus predicted fractures trended toward statistical significance but was not significant (P = .055; P = .52, respectively). FRAX with BMD increased the underestimation of major osteoporotic fractures in the normoglycemic and IFG groups (28 observed vs. 13 predicted; 31 observed vs. 13 predicted).

The study findings were limited by several factors including the inability to determine the impact of specific types of diabetes on fracture risk, lack of data on the duration of diabetes in study participants, the use of self-reports, and a relatively small and homogeneous sample size, the researchers noted.

However, the results support data from previous studies showing an increased fracture risk in diabetes patients regardless of BMD, and suggest that FRAX may be unreliable as a predictor of fractures in the diabetes population, they concluded.

The study was supported in part by the Victorian Health Promotion Foundation, National Health and Medical Research Council Australia, and the Geelong Region Medical Research Foundation. Two researchers were supported by university postgraduate rewards and one researcher was supported by a university postdoctoral research fellowship. The remaining coauthors reported no relevant financial conflicts.

SOURCE: de Abreu LLF et al. Bone Reports. 2019 Aug 13. doi: 10.1016/j.bonr.2019.100223.

Veterans with a clinically meaningful reduction in symptoms of PTSD are less likely to develop type 2 diabetes, research from a retrospective study shows.

“We cautiously speculate that normalization of hypothalamic-pituitary-adrenal axis and cortisol levels could be one mechanism behind our results,” wrote Jeffrey F. Scherrer, PhD, and colleagues. “PTSD is associated with inflammation, which may in turn be associated with increased risk for [type 2 diabetes].” The study was published in JAMA Psychiatry.

Using medical record data from the Veterans Health Administration, Dr. Scherrer and colleagues identified 5,916 patients with PTSD who visited a VHA medical center between 2008 and 2012, and scored at least 50 points or higher on the PTSD Checklist (PCL) followed by another PCL score at least 8 months after the previous score. The mean age of patients in the study was 42.1 years, the cohort consisted of 84.3% men, and 66.3% patients were white. PCL score reduction was deemed clinically meaningful if there was a decrease of 20 points or more in the score, reported Dr. Scherrer of the department of family and community medicine at Saint Louis University and colleagues.

Patients who were older (mean 43.6 years vs. mean 41.7 years; P = .02) and those who underwent minimally adequate duration of PTSD psychotherapy (P less than .001) were significantly more likely to have a clinically meaningful decrease in PCL scores. Patients who received antidepressants (P = .004) or antipsychotics (P less than .001) were significantly more likely to have less than clinically meaningful decreases in PCL scores. Factors that put patients at significantly higher risk of developing type 2 diabetes included older age (hazard ratio, 1.05; 95% confidence interval, 1.04-1.07; P less than .001), black race/ethnicity (HR, 1.86; 95% CI, 1.23-2.83; P = .004), hypertension (HR, 3.46; 95% CI, 2.33-5.16), hyperlipidemia (HR, 2.82; 95% CI, 1.91-4.16), and obesity (HR, 3.32; 95% CI, 2.12-5.21) (all P less than .001).

Minimally adequate duration of PTSD psychotherapy and high use of primary care health services also were associated with developing type 2 diabetes.

In a Cox proportional hazards regression model, patients with clinically meaningful decreases in PCL scores had significantly lower risk of developing type 2 diabetes, and those results remained consistent after adjusting for age, calculating the results using weighted data, and factoring in hypertension, obesity, and hyperlipidemia.

“This result was independent of numerous demographics and psychiatric and physical comorbidities,” said Dr. Scherrer and colleagues. “The association was also independent of the number of PTSD psychotherapy sessions used, suggesting that a healthy adherer effect, or a general orientation to improve health, is unlikely to explain our observations.”

Dr. Scherrer and colleagues cited several limitations, such as unmeasured confounding and the difficulty of generalizing the results beyond PTSD patients in a VHA setting. In addition, the researchers were unable to calculate the lifetime effect of reduced PTSD symptoms and incidence of type 2 diabetes.

This study was funded in part by a grant from the National Heart, Lung, and Blood Institute. Four authors reported receiving one or more grants from the National Heart, Lung, and Blood Institute during the study period. Some authors reported receiving other support from Noblis Therapeutics and Saint Louis University both during and outside the study period. The other authors reported no relevant conflicts of interest.

SOURCE: Scherrer JF et al. JAMA Psychiatry. 2019 Aug 21. doi: 10.1001/jamapsychiatry.2019.2096.

Veterans with a clinically meaningful reduction in symptoms of PTSD are less likely to develop type 2 diabetes, research from a retrospective study shows.

“We cautiously speculate that normalization of hypothalamic-pituitary-adrenal axis and cortisol levels could be one mechanism behind our results,” wrote Jeffrey F. Scherrer, PhD, and colleagues. “PTSD is associated with inflammation, which may in turn be associated with increased risk for [type 2 diabetes].” The study was published in JAMA Psychiatry.

Using medical record data from the Veterans Health Administration, Dr. Scherrer and colleagues identified 5,916 patients with PTSD who visited a VHA medical center between 2008 and 2012, and scored at least 50 points or higher on the PTSD Checklist (PCL) followed by another PCL score at least 8 months after the previous score. The mean age of patients in the study was 42.1 years, the cohort consisted of 84.3% men, and 66.3% patients were white. PCL score reduction was deemed clinically meaningful if there was a decrease of 20 points or more in the score, reported Dr. Scherrer of the department of family and community medicine at Saint Louis University and colleagues.

Patients who were older (mean 43.6 years vs. mean 41.7 years; P = .02) and those who underwent minimally adequate duration of PTSD psychotherapy (P less than .001) were significantly more likely to have a clinically meaningful decrease in PCL scores. Patients who received antidepressants (P = .004) or antipsychotics (P less than .001) were significantly more likely to have less than clinically meaningful decreases in PCL scores. Factors that put patients at significantly higher risk of developing type 2 diabetes included older age (hazard ratio, 1.05; 95% confidence interval, 1.04-1.07; P less than .001), black race/ethnicity (HR, 1.86; 95% CI, 1.23-2.83; P = .004), hypertension (HR, 3.46; 95% CI, 2.33-5.16), hyperlipidemia (HR, 2.82; 95% CI, 1.91-4.16), and obesity (HR, 3.32; 95% CI, 2.12-5.21) (all P less than .001).

Minimally adequate duration of PTSD psychotherapy and high use of primary care health services also were associated with developing type 2 diabetes.

In a Cox proportional hazards regression model, patients with clinically meaningful decreases in PCL scores had significantly lower risk of developing type 2 diabetes, and those results remained consistent after adjusting for age, calculating the results using weighted data, and factoring in hypertension, obesity, and hyperlipidemia.

“This result was independent of numerous demographics and psychiatric and physical comorbidities,” said Dr. Scherrer and colleagues. “The association was also independent of the number of PTSD psychotherapy sessions used, suggesting that a healthy adherer effect, or a general orientation to improve health, is unlikely to explain our observations.”

Dr. Scherrer and colleagues cited several limitations, such as unmeasured confounding and the difficulty of generalizing the results beyond PTSD patients in a VHA setting. In addition, the researchers were unable to calculate the lifetime effect of reduced PTSD symptoms and incidence of type 2 diabetes.

This study was funded in part by a grant from the National Heart, Lung, and Blood Institute. Four authors reported receiving one or more grants from the National Heart, Lung, and Blood Institute during the study period. Some authors reported receiving other support from Noblis Therapeutics and Saint Louis University both during and outside the study period. The other authors reported no relevant conflicts of interest.

SOURCE: Scherrer JF et al. JAMA Psychiatry. 2019 Aug 21. doi: 10.1001/jamapsychiatry.2019.2096.

Veterans with a clinically meaningful reduction in symptoms of PTSD are less likely to develop type 2 diabetes, research from a retrospective study shows.

“We cautiously speculate that normalization of hypothalamic-pituitary-adrenal axis and cortisol levels could be one mechanism behind our results,” wrote Jeffrey F. Scherrer, PhD, and colleagues. “PTSD is associated with inflammation, which may in turn be associated with increased risk for [type 2 diabetes].” The study was published in JAMA Psychiatry.

Using medical record data from the Veterans Health Administration, Dr. Scherrer and colleagues identified 5,916 patients with PTSD who visited a VHA medical center between 2008 and 2012, and scored at least 50 points or higher on the PTSD Checklist (PCL) followed by another PCL score at least 8 months after the previous score. The mean age of patients in the study was 42.1 years, the cohort consisted of 84.3% men, and 66.3% patients were white. PCL score reduction was deemed clinically meaningful if there was a decrease of 20 points or more in the score, reported Dr. Scherrer of the department of family and community medicine at Saint Louis University and colleagues.

Patients who were older (mean 43.6 years vs. mean 41.7 years; P = .02) and those who underwent minimally adequate duration of PTSD psychotherapy (P less than .001) were significantly more likely to have a clinically meaningful decrease in PCL scores. Patients who received antidepressants (P = .004) or antipsychotics (P less than .001) were significantly more likely to have less than clinically meaningful decreases in PCL scores. Factors that put patients at significantly higher risk of developing type 2 diabetes included older age (hazard ratio, 1.05; 95% confidence interval, 1.04-1.07; P less than .001), black race/ethnicity (HR, 1.86; 95% CI, 1.23-2.83; P = .004), hypertension (HR, 3.46; 95% CI, 2.33-5.16), hyperlipidemia (HR, 2.82; 95% CI, 1.91-4.16), and obesity (HR, 3.32; 95% CI, 2.12-5.21) (all P less than .001).

Minimally adequate duration of PTSD psychotherapy and high use of primary care health services also were associated with developing type 2 diabetes.

In a Cox proportional hazards regression model, patients with clinically meaningful decreases in PCL scores had significantly lower risk of developing type 2 diabetes, and those results remained consistent after adjusting for age, calculating the results using weighted data, and factoring in hypertension, obesity, and hyperlipidemia.

“This result was independent of numerous demographics and psychiatric and physical comorbidities,” said Dr. Scherrer and colleagues. “The association was also independent of the number of PTSD psychotherapy sessions used, suggesting that a healthy adherer effect, or a general orientation to improve health, is unlikely to explain our observations.”

Dr. Scherrer and colleagues cited several limitations, such as unmeasured confounding and the difficulty of generalizing the results beyond PTSD patients in a VHA setting. In addition, the researchers were unable to calculate the lifetime effect of reduced PTSD symptoms and incidence of type 2 diabetes.

This study was funded in part by a grant from the National Heart, Lung, and Blood Institute. Four authors reported receiving one or more grants from the National Heart, Lung, and Blood Institute during the study period. Some authors reported receiving other support from Noblis Therapeutics and Saint Louis University both during and outside the study period. The other authors reported no relevant conflicts of interest.

SOURCE: Scherrer JF et al. JAMA Psychiatry. 2019 Aug 21. doi: 10.1001/jamapsychiatry.2019.2096.