Clinician Reviews

In a new scientific statement, the American Heart Association highlighted the need to assess Asian American subgroups individually to get a more accurate picture of their risk for diabetes and heart disease.

Asian Americans have significant differences in genetics, socioeconomic factors, culture, diet, lifestyle, and acculturation levels based on the Asian region of their ancestry that likely have unique effects on their risk for type 2 diabetes and heart disease, the statement noted.

“Examining Asian subgroups separately is crucial to better understand the distinctions among them, how these differences translate into their risk of type 2 diabetes and atherosclerotic disease, and how health care professionals may provide care and support in a culturally appropriate manner,” writing group chair Tak W. Kwan, MD, chief of cardiology, Lenox Health Greenwich Village, and clinical professor of medicine, Northwell Health, New York City, said in a news release.

The statement was published online in the journal Circulation.
 

Impact on health outcomes

Asian American subgroups are broadly categorized by the geographic region of Asian descent and include South Asia (India, Pakistan, Sri Lanka, Bangladesh, Nepal, or Bhutan); East Asia (Japan, China, or Korea); Southeast Asia (Philippines, Vietnam, Thailand, Cambodia, Laos, Indonesia, Malaysia, Singapore, Hmong); and Native Hawaiian/Pacific Islander (Hawaii, Guam, Samoa, or other Pacific islands).

Asian Americans make up the fastest growing racial and ethnic group in the United States. Together, type 2 diabetes (T2D) and atherosclerotic cardiovascular disease (ASCVD) are the leading causes of illness and death among Asian American adults.

Yet, there is significant variability in prevalence and risk factors within the different subgroups, the writing group pointed out.

For example, based on available data, rates of coronary artery disease (CAD) among Asian Americans indicate an overall prevalence of 8% in men and about 3% in women.

However, available data for subgroups suggest higher CAD rates among Asian Indian Americans (13% for men and 4.4% for women) and Filipino Americans (about 9% and 4%, respectively).

Available data on T2D among Asian American subgroups also show varied prevalence and risk.

A study from California found overall, Asian American adults had higher rates of T2D (range of 15.6%-34.5%) compared with non-Hispanic White adults (12.8%). Among Chinese Americans, the rate was 15.8%. Among Korean and Japanese Americans, rates were about 18% and among Americans with Filipino ancestry, the rate was nearly 32%.

Yet most studies to date aggregate Asian Americans in a single group and do not examine the subgroups individually, which is a challenge to providing evidence-based recommendations, the writing group said.

“Particular attention should focus on the T2D and ASCVD risk differences among the different Asian American subgroups because they may affect the precision in clinical and health outcomes,” the group suggested.

“Culturally specific recommendations and interventions across the different Asian American subgroups related to T2D and ASCVD will help improve primary and secondary prevention and health outcomes in this population,” they added.

The writing group noted that existing CVD risk calculators, which are based on data validated in non-Hispanic Black adults and non-Hispanic White adults and less extensively studied in Asian Americans, may underestimate the risk of T2D and heart disease in South Asian adults, those of lower socioeconomic status, or those with chronic inflammatory diseases.

On the other hand, these tools may overestimate CVD risk among East Asians, those with higher socioeconomic status or those who are already participating in preventive healthcare services.

Advances in epidemiology and data analysis and the availability of larger, representative cohorts will allow for refinement of pooled cohort equations to better gauge ASCVD risk in Asian American subgroups, the group said.
 

Filling in the gaps

The writing group outlined several key areas to consider for strengthening the data about Asian American adults. Chief among them is the need to include disaggregated data on Asian American subgroups in clinical trials and government-sponsored studies.

Another is to standardize ways of collecting ethnic and subgroup data for Asian Americans for national health systems, surveys, and registries. National surveillance surveys should consider oversampling Asian Americans to increase representation for the various subgroups, the writing group suggested.

“All of us – health care professionals, policymakers, community leaders and patients – must advocate for more health research funding for Asian Americans and demand inclusion of Asian American subgroup information in clinical trials and government-sponsored research,” Dr. Kwan said.

“Having a platform to share and disseminate data on Asian Americans for the scientific and research community would also be an asset for the health care professionals who care for this population,” Dr. Kwan added.

The new scientific statement is a follow-up to a 2010 AHA “call to action” to seek data on health disparities among Asian American subgroups and a 2018 scientific statement addressing CVD risk in South Asians (Asian Indian, Pakistani, Sri Lankan, Bangladeshi, Nepali, or Bhutanese).

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Epidemiology and Prevention; the Council on Lifestyle and Cardiometabolic Health; the Council on Arteriosclerosis, Thrombosis and Vascular Biology; the Council on Clinical Cardiology; the Council on Cardiovascular and Stroke Nursing; and the Council on Genomic and Precision Medicine.
 

A version of this article first appeared on Medscape.com.

In a new scientific statement, the American Heart Association highlighted the need to assess Asian American subgroups individually to get a more accurate picture of their risk for diabetes and heart disease.

Asian Americans have significant differences in genetics, socioeconomic factors, culture, diet, lifestyle, and acculturation levels based on the Asian region of their ancestry that likely have unique effects on their risk for type 2 diabetes and heart disease, the statement noted.

“Examining Asian subgroups separately is crucial to better understand the distinctions among them, how these differences translate into their risk of type 2 diabetes and atherosclerotic disease, and how health care professionals may provide care and support in a culturally appropriate manner,” writing group chair Tak W. Kwan, MD, chief of cardiology, Lenox Health Greenwich Village, and clinical professor of medicine, Northwell Health, New York City, said in a news release.

The statement was published online in the journal Circulation.
 

Impact on health outcomes

Asian American subgroups are broadly categorized by the geographic region of Asian descent and include South Asia (India, Pakistan, Sri Lanka, Bangladesh, Nepal, or Bhutan); East Asia (Japan, China, or Korea); Southeast Asia (Philippines, Vietnam, Thailand, Cambodia, Laos, Indonesia, Malaysia, Singapore, Hmong); and Native Hawaiian/Pacific Islander (Hawaii, Guam, Samoa, or other Pacific islands).

Asian Americans make up the fastest growing racial and ethnic group in the United States. Together, type 2 diabetes (T2D) and atherosclerotic cardiovascular disease (ASCVD) are the leading causes of illness and death among Asian American adults.

Yet, there is significant variability in prevalence and risk factors within the different subgroups, the writing group pointed out.

For example, based on available data, rates of coronary artery disease (CAD) among Asian Americans indicate an overall prevalence of 8% in men and about 3% in women.

However, available data for subgroups suggest higher CAD rates among Asian Indian Americans (13% for men and 4.4% for women) and Filipino Americans (about 9% and 4%, respectively).

Available data on T2D among Asian American subgroups also show varied prevalence and risk.

A study from California found overall, Asian American adults had higher rates of T2D (range of 15.6%-34.5%) compared with non-Hispanic White adults (12.8%). Among Chinese Americans, the rate was 15.8%. Among Korean and Japanese Americans, rates were about 18% and among Americans with Filipino ancestry, the rate was nearly 32%.

Yet most studies to date aggregate Asian Americans in a single group and do not examine the subgroups individually, which is a challenge to providing evidence-based recommendations, the writing group said.

“Particular attention should focus on the T2D and ASCVD risk differences among the different Asian American subgroups because they may affect the precision in clinical and health outcomes,” the group suggested.

“Culturally specific recommendations and interventions across the different Asian American subgroups related to T2D and ASCVD will help improve primary and secondary prevention and health outcomes in this population,” they added.

The writing group noted that existing CVD risk calculators, which are based on data validated in non-Hispanic Black adults and non-Hispanic White adults and less extensively studied in Asian Americans, may underestimate the risk of T2D and heart disease in South Asian adults, those of lower socioeconomic status, or those with chronic inflammatory diseases.

On the other hand, these tools may overestimate CVD risk among East Asians, those with higher socioeconomic status or those who are already participating in preventive healthcare services.

Advances in epidemiology and data analysis and the availability of larger, representative cohorts will allow for refinement of pooled cohort equations to better gauge ASCVD risk in Asian American subgroups, the group said.
 

Filling in the gaps

The writing group outlined several key areas to consider for strengthening the data about Asian American adults. Chief among them is the need to include disaggregated data on Asian American subgroups in clinical trials and government-sponsored studies.

Another is to standardize ways of collecting ethnic and subgroup data for Asian Americans for national health systems, surveys, and registries. National surveillance surveys should consider oversampling Asian Americans to increase representation for the various subgroups, the writing group suggested.

“All of us – health care professionals, policymakers, community leaders and patients – must advocate for more health research funding for Asian Americans and demand inclusion of Asian American subgroup information in clinical trials and government-sponsored research,” Dr. Kwan said.

“Having a platform to share and disseminate data on Asian Americans for the scientific and research community would also be an asset for the health care professionals who care for this population,” Dr. Kwan added.

The new scientific statement is a follow-up to a 2010 AHA “call to action” to seek data on health disparities among Asian American subgroups and a 2018 scientific statement addressing CVD risk in South Asians (Asian Indian, Pakistani, Sri Lankan, Bangladeshi, Nepali, or Bhutanese).

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Epidemiology and Prevention; the Council on Lifestyle and Cardiometabolic Health; the Council on Arteriosclerosis, Thrombosis and Vascular Biology; the Council on Clinical Cardiology; the Council on Cardiovascular and Stroke Nursing; and the Council on Genomic and Precision Medicine.
 

A version of this article first appeared on Medscape.com.

In a new scientific statement, the American Heart Association highlighted the need to assess Asian American subgroups individually to get a more accurate picture of their risk for diabetes and heart disease.

Asian Americans have significant differences in genetics, socioeconomic factors, culture, diet, lifestyle, and acculturation levels based on the Asian region of their ancestry that likely have unique effects on their risk for type 2 diabetes and heart disease, the statement noted.

“Examining Asian subgroups separately is crucial to better understand the distinctions among them, how these differences translate into their risk of type 2 diabetes and atherosclerotic disease, and how health care professionals may provide care and support in a culturally appropriate manner,” writing group chair Tak W. Kwan, MD, chief of cardiology, Lenox Health Greenwich Village, and clinical professor of medicine, Northwell Health, New York City, said in a news release.

The statement was published online in the journal Circulation.
 

Impact on health outcomes

Asian American subgroups are broadly categorized by the geographic region of Asian descent and include South Asia (India, Pakistan, Sri Lanka, Bangladesh, Nepal, or Bhutan); East Asia (Japan, China, or Korea); Southeast Asia (Philippines, Vietnam, Thailand, Cambodia, Laos, Indonesia, Malaysia, Singapore, Hmong); and Native Hawaiian/Pacific Islander (Hawaii, Guam, Samoa, or other Pacific islands).

Asian Americans make up the fastest growing racial and ethnic group in the United States. Together, type 2 diabetes (T2D) and atherosclerotic cardiovascular disease (ASCVD) are the leading causes of illness and death among Asian American adults.

Yet, there is significant variability in prevalence and risk factors within the different subgroups, the writing group pointed out.

For example, based on available data, rates of coronary artery disease (CAD) among Asian Americans indicate an overall prevalence of 8% in men and about 3% in women.

However, available data for subgroups suggest higher CAD rates among Asian Indian Americans (13% for men and 4.4% for women) and Filipino Americans (about 9% and 4%, respectively).

Available data on T2D among Asian American subgroups also show varied prevalence and risk.

A study from California found overall, Asian American adults had higher rates of T2D (range of 15.6%-34.5%) compared with non-Hispanic White adults (12.8%). Among Chinese Americans, the rate was 15.8%. Among Korean and Japanese Americans, rates were about 18% and among Americans with Filipino ancestry, the rate was nearly 32%.

Yet most studies to date aggregate Asian Americans in a single group and do not examine the subgroups individually, which is a challenge to providing evidence-based recommendations, the writing group said.

“Particular attention should focus on the T2D and ASCVD risk differences among the different Asian American subgroups because they may affect the precision in clinical and health outcomes,” the group suggested.

“Culturally specific recommendations and interventions across the different Asian American subgroups related to T2D and ASCVD will help improve primary and secondary prevention and health outcomes in this population,” they added.

The writing group noted that existing CVD risk calculators, which are based on data validated in non-Hispanic Black adults and non-Hispanic White adults and less extensively studied in Asian Americans, may underestimate the risk of T2D and heart disease in South Asian adults, those of lower socioeconomic status, or those with chronic inflammatory diseases.

On the other hand, these tools may overestimate CVD risk among East Asians, those with higher socioeconomic status or those who are already participating in preventive healthcare services.

Advances in epidemiology and data analysis and the availability of larger, representative cohorts will allow for refinement of pooled cohort equations to better gauge ASCVD risk in Asian American subgroups, the group said.
 

Filling in the gaps

The writing group outlined several key areas to consider for strengthening the data about Asian American adults. Chief among them is the need to include disaggregated data on Asian American subgroups in clinical trials and government-sponsored studies.

Another is to standardize ways of collecting ethnic and subgroup data for Asian Americans for national health systems, surveys, and registries. National surveillance surveys should consider oversampling Asian Americans to increase representation for the various subgroups, the writing group suggested.

“All of us – health care professionals, policymakers, community leaders and patients – must advocate for more health research funding for Asian Americans and demand inclusion of Asian American subgroup information in clinical trials and government-sponsored research,” Dr. Kwan said.

“Having a platform to share and disseminate data on Asian Americans for the scientific and research community would also be an asset for the health care professionals who care for this population,” Dr. Kwan added.

The new scientific statement is a follow-up to a 2010 AHA “call to action” to seek data on health disparities among Asian American subgroups and a 2018 scientific statement addressing CVD risk in South Asians (Asian Indian, Pakistani, Sri Lankan, Bangladeshi, Nepali, or Bhutanese).

This scientific statement was prepared by the volunteer writing group on behalf of the AHA Council on Epidemiology and Prevention; the Council on Lifestyle and Cardiometabolic Health; the Council on Arteriosclerosis, Thrombosis and Vascular Biology; the Council on Clinical Cardiology; the Council on Cardiovascular and Stroke Nursing; and the Council on Genomic and Precision Medicine.
 

A version of this article first appeared on Medscape.com.

An 85-year-old woman is brought to the emergency department after a syncopal episode. Her caregivers report a similar episode 2 weeks ago, but she recovered so quickly they did not seek evaluation for her.

Medications: Omeprazole 20 mg, pravastatin 40 mg, citalopram 10 mg, albuterol, donepezil 10 mg, isosorbide mononitrate 60 mg, and calcium. On exam, blood pressure is 100/60 mm Hg, pulse 55. ECG indicates bradycardia with normal intervals. What drug most likely caused her syncope?

A. Citalopram

B. Pravastatin

C. Donepezil

D. Isosorbide

E. Calcium

This woman’s syncope is likely caused by donepezil. Citalopram can lengthen the QT interval, especially in elderly patients, but the normal intervals on ECG eliminate this possibility. Donepezil can cause bradycardia, which can contribute to syncope.

Hernandez and colleagues evaluated a cohort of veterans with dementia over an 8-year period.¹ They found that there was a 1.4-fold increased risk of bradycardia in patients with dementia treated with an acetylcholine inhibitor (compared with that in patients who were not taking these medications) and that there was a dose-dependent increase in risk for patients on donepezil.

Park-Wyllie et al. found in a study of 1.4 million older adults a greater than twofold risk of hospitalization for bradycardia in patients treated with a cholinesterase inhibitor.² Gill and colleagues performed a population-based cohort study of 19,803 elderly patients with dementia who were prescribed cholinesterase inhibitors, and compared them to age-matched controls.³ They found increased hospital visits for syncope in people receiving cholinesterase inhibitors (hazard ratio, 1.76; 95% confidence interval, 1.57-1.98). Other syncope-related events were also more common in people receiving cholinesterase inhibitors, compared with controls: hospital visits for bradycardia (HR, 1.69; 95% CI, 1.32-2.15), permanent pacemaker insertion (HR, 1.49; 95% CI, 1.12-2.00), and hip fracture (HR, 1.18; (95% CI, 1.04-1.34).

Nausea, vomiting, and weight loss are much more common than the rarer side effects of bradycardia and syncope. The frequency of gastroenterological side effects is up to 25%. Cholinesterase inhibitors have modest effects on cognitive function with a high number needed to treat (NNT) of 10, and an NNT as high as 100 for global function. The number needed to harm (NNH) is 4, when gastrointestinal symptoms are added in.⁴ Another important, problematic side effect of cholinesterase inhibitors is urinary incontinence. This often leads to patients receiving medications, to combat this side effect, that may worsen cognitive function.

Another commonly used medication that scares me in certain circumstances is trimethoprim-sulfamethoxazole. My main concern is when it is used in patients who are elderly, have chronic kidney disease, or are taking other medications that can cause hyperkalemia (ACEIs, ARBs, potassium-sparing diuretics including spironolactone). Hyperkalemia is a real concern in these patient populations. Trimethoprim reduces renal potassium excretion through the competitive inhibition of sodium channels in the distal nephron, in a manner similar to the potassium-sparing diuretic amiloride. Hospitalizations for hyperkalemia are more common in patients who take ACEIs and ARBs and are prescribed trimethoprim-sulfamethoxazole, compared with other antibiotics.⁵

Sudden cardiac death is also more common in patients who are taking ACEIs or ARBs and receive trimethoprim-sulfamethoxazole.⁶ Trimethoprim-sulfamethoxazole also has a powerful interaction with warfarin, both displacing warfarin from albumin and inhibiting its metabolism. It raises the INR (international normalized ratio) in warfarin-treated patients much greater than do other antibiotics.⁷
 

Pearls

• Think carefully about the use of cholinesterase inhibitors because of the unfavorable NNH vs. NNT.
• Use caution prescribing trimethoprim for patients who are elderly, especially if they are on an ACEI, an ARB, or spironolactone, and in patients with chronic kidney disease.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

References

1. Hernandez RK et al. J Am Geriatr Soc. 2009;57:1997-2003.

2. Park-Wyllie LY et al. PLoS Med. 2009;6:e1000157.

3. Gill SS et al. Arch Intern Med 2009;169:867-73.

4. Peters KR. J Am Geriatr Soc. 2013 Jul;61(7):1170-4.

5. Antoniou TN et al. Arch Intern Med. 2010;170(12):1045-9.

6. Fralick M et al. BMJ. 2014 Oct 30;349:g6196.

7. Glasheen JJ et al. J Gen Intern Med. 2005 Jul;20(7):653-6.

An 85-year-old woman is brought to the emergency department after a syncopal episode. Her caregivers report a similar episode 2 weeks ago, but she recovered so quickly they did not seek evaluation for her.

Medications: Omeprazole 20 mg, pravastatin 40 mg, citalopram 10 mg, albuterol, donepezil 10 mg, isosorbide mononitrate 60 mg, and calcium. On exam, blood pressure is 100/60 mm Hg, pulse 55. ECG indicates bradycardia with normal intervals. What drug most likely caused her syncope?

A. Citalopram

B. Pravastatin

C. Donepezil

D. Isosorbide

E. Calcium

This woman’s syncope is likely caused by donepezil. Citalopram can lengthen the QT interval, especially in elderly patients, but the normal intervals on ECG eliminate this possibility. Donepezil can cause bradycardia, which can contribute to syncope.

Hernandez and colleagues evaluated a cohort of veterans with dementia over an 8-year period.¹ They found that there was a 1.4-fold increased risk of bradycardia in patients with dementia treated with an acetylcholine inhibitor (compared with that in patients who were not taking these medications) and that there was a dose-dependent increase in risk for patients on donepezil.

Park-Wyllie et al. found in a study of 1.4 million older adults a greater than twofold risk of hospitalization for bradycardia in patients treated with a cholinesterase inhibitor.² Gill and colleagues performed a population-based cohort study of 19,803 elderly patients with dementia who were prescribed cholinesterase inhibitors, and compared them to age-matched controls.³ They found increased hospital visits for syncope in people receiving cholinesterase inhibitors (hazard ratio, 1.76; 95% confidence interval, 1.57-1.98). Other syncope-related events were also more common in people receiving cholinesterase inhibitors, compared with controls: hospital visits for bradycardia (HR, 1.69; 95% CI, 1.32-2.15), permanent pacemaker insertion (HR, 1.49; 95% CI, 1.12-2.00), and hip fracture (HR, 1.18; (95% CI, 1.04-1.34).

Nausea, vomiting, and weight loss are much more common than the rarer side effects of bradycardia and syncope. The frequency of gastroenterological side effects is up to 25%. Cholinesterase inhibitors have modest effects on cognitive function with a high number needed to treat (NNT) of 10, and an NNT as high as 100 for global function. The number needed to harm (NNH) is 4, when gastrointestinal symptoms are added in.⁴ Another important, problematic side effect of cholinesterase inhibitors is urinary incontinence. This often leads to patients receiving medications, to combat this side effect, that may worsen cognitive function.

Another commonly used medication that scares me in certain circumstances is trimethoprim-sulfamethoxazole. My main concern is when it is used in patients who are elderly, have chronic kidney disease, or are taking other medications that can cause hyperkalemia (ACEIs, ARBs, potassium-sparing diuretics including spironolactone). Hyperkalemia is a real concern in these patient populations. Trimethoprim reduces renal potassium excretion through the competitive inhibition of sodium channels in the distal nephron, in a manner similar to the potassium-sparing diuretic amiloride. Hospitalizations for hyperkalemia are more common in patients who take ACEIs and ARBs and are prescribed trimethoprim-sulfamethoxazole, compared with other antibiotics.⁵

Sudden cardiac death is also more common in patients who are taking ACEIs or ARBs and receive trimethoprim-sulfamethoxazole.⁶ Trimethoprim-sulfamethoxazole also has a powerful interaction with warfarin, both displacing warfarin from albumin and inhibiting its metabolism. It raises the INR (international normalized ratio) in warfarin-treated patients much greater than do other antibiotics.⁷
 

Pearls

• Think carefully about the use of cholinesterase inhibitors because of the unfavorable NNH vs. NNT.
• Use caution prescribing trimethoprim for patients who are elderly, especially if they are on an ACEI, an ARB, or spironolactone, and in patients with chronic kidney disease.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

References

1. Hernandez RK et al. J Am Geriatr Soc. 2009;57:1997-2003.

2. Park-Wyllie LY et al. PLoS Med. 2009;6:e1000157.

3. Gill SS et al. Arch Intern Med 2009;169:867-73.

4. Peters KR. J Am Geriatr Soc. 2013 Jul;61(7):1170-4.

5. Antoniou TN et al. Arch Intern Med. 2010;170(12):1045-9.

6. Fralick M et al. BMJ. 2014 Oct 30;349:g6196.

7. Glasheen JJ et al. J Gen Intern Med. 2005 Jul;20(7):653-6.

An 85-year-old woman is brought to the emergency department after a syncopal episode. Her caregivers report a similar episode 2 weeks ago, but she recovered so quickly they did not seek evaluation for her.

Medications: Omeprazole 20 mg, pravastatin 40 mg, citalopram 10 mg, albuterol, donepezil 10 mg, isosorbide mononitrate 60 mg, and calcium. On exam, blood pressure is 100/60 mm Hg, pulse 55. ECG indicates bradycardia with normal intervals. What drug most likely caused her syncope?

A. Citalopram

B. Pravastatin

C. Donepezil

D. Isosorbide

E. Calcium

This woman’s syncope is likely caused by donepezil. Citalopram can lengthen the QT interval, especially in elderly patients, but the normal intervals on ECG eliminate this possibility. Donepezil can cause bradycardia, which can contribute to syncope.

Hernandez and colleagues evaluated a cohort of veterans with dementia over an 8-year period.¹ They found that there was a 1.4-fold increased risk of bradycardia in patients with dementia treated with an acetylcholine inhibitor (compared with that in patients who were not taking these medications) and that there was a dose-dependent increase in risk for patients on donepezil.

Park-Wyllie et al. found in a study of 1.4 million older adults a greater than twofold risk of hospitalization for bradycardia in patients treated with a cholinesterase inhibitor.² Gill and colleagues performed a population-based cohort study of 19,803 elderly patients with dementia who were prescribed cholinesterase inhibitors, and compared them to age-matched controls.³ They found increased hospital visits for syncope in people receiving cholinesterase inhibitors (hazard ratio, 1.76; 95% confidence interval, 1.57-1.98). Other syncope-related events were also more common in people receiving cholinesterase inhibitors, compared with controls: hospital visits for bradycardia (HR, 1.69; 95% CI, 1.32-2.15), permanent pacemaker insertion (HR, 1.49; 95% CI, 1.12-2.00), and hip fracture (HR, 1.18; (95% CI, 1.04-1.34).

Nausea, vomiting, and weight loss are much more common than the rarer side effects of bradycardia and syncope. The frequency of gastroenterological side effects is up to 25%. Cholinesterase inhibitors have modest effects on cognitive function with a high number needed to treat (NNT) of 10, and an NNT as high as 100 for global function. The number needed to harm (NNH) is 4, when gastrointestinal symptoms are added in.⁴ Another important, problematic side effect of cholinesterase inhibitors is urinary incontinence. This often leads to patients receiving medications, to combat this side effect, that may worsen cognitive function.

Another commonly used medication that scares me in certain circumstances is trimethoprim-sulfamethoxazole. My main concern is when it is used in patients who are elderly, have chronic kidney disease, or are taking other medications that can cause hyperkalemia (ACEIs, ARBs, potassium-sparing diuretics including spironolactone). Hyperkalemia is a real concern in these patient populations. Trimethoprim reduces renal potassium excretion through the competitive inhibition of sodium channels in the distal nephron, in a manner similar to the potassium-sparing diuretic amiloride. Hospitalizations for hyperkalemia are more common in patients who take ACEIs and ARBs and are prescribed trimethoprim-sulfamethoxazole, compared with other antibiotics.⁵

Sudden cardiac death is also more common in patients who are taking ACEIs or ARBs and receive trimethoprim-sulfamethoxazole.⁶ Trimethoprim-sulfamethoxazole also has a powerful interaction with warfarin, both displacing warfarin from albumin and inhibiting its metabolism. It raises the INR (international normalized ratio) in warfarin-treated patients much greater than do other antibiotics.⁷
 

Pearls

• Think carefully about the use of cholinesterase inhibitors because of the unfavorable NNH vs. NNT.
• Use caution prescribing trimethoprim for patients who are elderly, especially if they are on an ACEI, an ARB, or spironolactone, and in patients with chronic kidney disease.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

References

1. Hernandez RK et al. J Am Geriatr Soc. 2009;57:1997-2003.

2. Park-Wyllie LY et al. PLoS Med. 2009;6:e1000157.

3. Gill SS et al. Arch Intern Med 2009;169:867-73.

4. Peters KR. J Am Geriatr Soc. 2013 Jul;61(7):1170-4.

5. Antoniou TN et al. Arch Intern Med. 2010;170(12):1045-9.

6. Fralick M et al. BMJ. 2014 Oct 30;349:g6196.

7. Glasheen JJ et al. J Gen Intern Med. 2005 Jul;20(7):653-6.

SEATTLE – The latest American Association of Clinical Endocrinology type 2 diabetes management algorithm uses graphics to focus on individualized care while adding newly compiled information about medication access and affordability, vaccinations, and weight loss drugs.

The clinical guidance document was presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology and simultaneously published in Endocrine Practice.

Using text and colorful graphics, the document summarizes information from last year’s update and other recent AACE documents, including those addressing dyslipidemia and use of diabetes technology.

“The algorithm takes from the larger clinical practice guideline and distills down those management principles in a much more digestible way, and a way that can be used every day in the clinic,” lead author Susan L. Samson, MD, PhD, chair of endocrinology, diabetes & metabolism at the Mayo Clinic Florida, Jacksonville, said in an interview.

Asked to comment, Anne L. Peters, MD, professor of clinical medicine at the University of Southern California, Los Angeles, said: “I like their simple graphics. For the Department of Health Services in Los Angeles County, we have been painstakingly trying to create our own flow diagrams. ... These will help.”
 

Eleven separate algorithms with text and graphics

Included are 11 visual management algorithms, with accompanying text for each one. The first lists 10 overall management principles, including “lifestyle modification underlies all therapy,” “maintain or achieve optimal weight,” “choice of therapy includes ease of use and access,” “individualize all glucose targets,” “avoid hypoglycemia,” and “comorbidities must be managed for comprehensive care.”

Three more algorithms cover the diabetes-adjacent topics of adiposity-based chronic disease, prediabetes, dyslipidemia, and hypertension.

Four separate graphics address glucose-lowering. Two are “complications-centric” and “glucose-centric” algorithms, another covers insulin initiation and titration, and a table summarizes the benefits and risks of currently available glucose-lowering medications, as well as cost.

Splitting the glucose-lowering algorithms into “complications-centric” and “glucose-centric” graphics is new, Dr. Samson said. “The complications one comes first, deliberately. You need to think about: Does my patient have a history of or high risk for cardiovascular disease, heart failure, stroke, or diabetic kidney disease? And, you want to prioritize those medications that have evidence to improve outcomes with those different diabetes complications versus a one-size-fits-all approach.”

And for patients without those complications, the glucose-centric algorithm considers obesity, hypoglycemia risk, and access/cost issues. “So, overall the diabetes medication algorithm has been split in order to emphasize that personalized approach to decision-making,” Dr. Samson explained.

Also new is a table listing the benefits and risks of weight-loss medications, and another covering immunization guidance for people with diabetes based on recommendations from the U.S. Centers for Disease Control and Prevention. “Coming out of the pandemic, we’re thinking about how can we protect our patients from infectious disease and all the comorbidities. In some cases, people with diabetes can have a much higher risk for adverse events,” Dr. Samson noted.

Regarding the weight-loss medications table, she pointed out that the task force couldn’t include the blockbuster twincretin tirzepatide because it’s not yet approved for weight loss by the U.S. Food and Drug Administration. However, it is included in the glucose-lowering drug table with weight loss listed among its benefits.

“We want this to be a living document that should be updated in a timely fashion, and so, as these new indications are approved and we see more evidence supporting their different uses, this should be updated in a really timely fashion to reflect that,” Dr. Samson said.

The end of the document includes a full page of each graphic, meant for wall posting.

Dr. Peters noted that for the most part, the AACE guidelines and algorithm align with joint guidance by the American Diabetes Association and European Association for the Study of Diabetes.

“For many years there seemed to be big differences between the AACE and ADA guidelines for the management of type 2 diabetes. Although small differences still exist ... the ADA and AACE guidelines have become quite similar,” she said.

Dr. Peters also praised the AACE algorithm for providing “a pathway for people who have issues with access and cost.”

“I am incredibly proud that in the County of Los Angeles you can get a [glucagon-like peptide-1 receptor agonist] and/or a [sodium-glucose cotransporter-2 inhibitor] even with the most restricted MediCal insurance if indications are met. But there remain many people in many places where access and cost limit options, and I am grateful that AACE includes this in their algorithms,” she said.

Dr. Samson has reported receiving research support to the Mayo Clinic from Corcept, serving on a steering committee and being a national or overall principal investigator for Chiasma and Novartis, and being a committee chair for the American Board of Internal Medicine. Dr. Peters has reported relationships with Blue Circle Health, Vertex, and Abbott Diabetes Care, receiving research grants from Abbott Diabetes Care and Insulet, and holding stock options in Teladoc and Omada Health.

A version of this article originally appeared on Medscape.com.

SEATTLE – The latest American Association of Clinical Endocrinology type 2 diabetes management algorithm uses graphics to focus on individualized care while adding newly compiled information about medication access and affordability, vaccinations, and weight loss drugs.

The clinical guidance document was presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology and simultaneously published in Endocrine Practice.

Using text and colorful graphics, the document summarizes information from last year’s update and other recent AACE documents, including those addressing dyslipidemia and use of diabetes technology.

“The algorithm takes from the larger clinical practice guideline and distills down those management principles in a much more digestible way, and a way that can be used every day in the clinic,” lead author Susan L. Samson, MD, PhD, chair of endocrinology, diabetes & metabolism at the Mayo Clinic Florida, Jacksonville, said in an interview.

Asked to comment, Anne L. Peters, MD, professor of clinical medicine at the University of Southern California, Los Angeles, said: “I like their simple graphics. For the Department of Health Services in Los Angeles County, we have been painstakingly trying to create our own flow diagrams. ... These will help.”
 

Eleven separate algorithms with text and graphics

Included are 11 visual management algorithms, with accompanying text for each one. The first lists 10 overall management principles, including “lifestyle modification underlies all therapy,” “maintain or achieve optimal weight,” “choice of therapy includes ease of use and access,” “individualize all glucose targets,” “avoid hypoglycemia,” and “comorbidities must be managed for comprehensive care.”

Three more algorithms cover the diabetes-adjacent topics of adiposity-based chronic disease, prediabetes, dyslipidemia, and hypertension.

Four separate graphics address glucose-lowering. Two are “complications-centric” and “glucose-centric” algorithms, another covers insulin initiation and titration, and a table summarizes the benefits and risks of currently available glucose-lowering medications, as well as cost.

Splitting the glucose-lowering algorithms into “complications-centric” and “glucose-centric” graphics is new, Dr. Samson said. “The complications one comes first, deliberately. You need to think about: Does my patient have a history of or high risk for cardiovascular disease, heart failure, stroke, or diabetic kidney disease? And, you want to prioritize those medications that have evidence to improve outcomes with those different diabetes complications versus a one-size-fits-all approach.”

And for patients without those complications, the glucose-centric algorithm considers obesity, hypoglycemia risk, and access/cost issues. “So, overall the diabetes medication algorithm has been split in order to emphasize that personalized approach to decision-making,” Dr. Samson explained.

Also new is a table listing the benefits and risks of weight-loss medications, and another covering immunization guidance for people with diabetes based on recommendations from the U.S. Centers for Disease Control and Prevention. “Coming out of the pandemic, we’re thinking about how can we protect our patients from infectious disease and all the comorbidities. In some cases, people with diabetes can have a much higher risk for adverse events,” Dr. Samson noted.

Regarding the weight-loss medications table, she pointed out that the task force couldn’t include the blockbuster twincretin tirzepatide because it’s not yet approved for weight loss by the U.S. Food and Drug Administration. However, it is included in the glucose-lowering drug table with weight loss listed among its benefits.

“We want this to be a living document that should be updated in a timely fashion, and so, as these new indications are approved and we see more evidence supporting their different uses, this should be updated in a really timely fashion to reflect that,” Dr. Samson said.

The end of the document includes a full page of each graphic, meant for wall posting.

Dr. Peters noted that for the most part, the AACE guidelines and algorithm align with joint guidance by the American Diabetes Association and European Association for the Study of Diabetes.

“For many years there seemed to be big differences between the AACE and ADA guidelines for the management of type 2 diabetes. Although small differences still exist ... the ADA and AACE guidelines have become quite similar,” she said.

Dr. Peters also praised the AACE algorithm for providing “a pathway for people who have issues with access and cost.”

“I am incredibly proud that in the County of Los Angeles you can get a [glucagon-like peptide-1 receptor agonist] and/or a [sodium-glucose cotransporter-2 inhibitor] even with the most restricted MediCal insurance if indications are met. But there remain many people in many places where access and cost limit options, and I am grateful that AACE includes this in their algorithms,” she said.

Dr. Samson has reported receiving research support to the Mayo Clinic from Corcept, serving on a steering committee and being a national or overall principal investigator for Chiasma and Novartis, and being a committee chair for the American Board of Internal Medicine. Dr. Peters has reported relationships with Blue Circle Health, Vertex, and Abbott Diabetes Care, receiving research grants from Abbott Diabetes Care and Insulet, and holding stock options in Teladoc and Omada Health.

A version of this article originally appeared on Medscape.com.

SEATTLE – The latest American Association of Clinical Endocrinology type 2 diabetes management algorithm uses graphics to focus on individualized care while adding newly compiled information about medication access and affordability, vaccinations, and weight loss drugs.

The clinical guidance document was presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology and simultaneously published in Endocrine Practice.

Using text and colorful graphics, the document summarizes information from last year’s update and other recent AACE documents, including those addressing dyslipidemia and use of diabetes technology.

“The algorithm takes from the larger clinical practice guideline and distills down those management principles in a much more digestible way, and a way that can be used every day in the clinic,” lead author Susan L. Samson, MD, PhD, chair of endocrinology, diabetes & metabolism at the Mayo Clinic Florida, Jacksonville, said in an interview.

Asked to comment, Anne L. Peters, MD, professor of clinical medicine at the University of Southern California, Los Angeles, said: “I like their simple graphics. For the Department of Health Services in Los Angeles County, we have been painstakingly trying to create our own flow diagrams. ... These will help.”
 

Eleven separate algorithms with text and graphics

Included are 11 visual management algorithms, with accompanying text for each one. The first lists 10 overall management principles, including “lifestyle modification underlies all therapy,” “maintain or achieve optimal weight,” “choice of therapy includes ease of use and access,” “individualize all glucose targets,” “avoid hypoglycemia,” and “comorbidities must be managed for comprehensive care.”

Three more algorithms cover the diabetes-adjacent topics of adiposity-based chronic disease, prediabetes, dyslipidemia, and hypertension.

Four separate graphics address glucose-lowering. Two are “complications-centric” and “glucose-centric” algorithms, another covers insulin initiation and titration, and a table summarizes the benefits and risks of currently available glucose-lowering medications, as well as cost.

Splitting the glucose-lowering algorithms into “complications-centric” and “glucose-centric” graphics is new, Dr. Samson said. “The complications one comes first, deliberately. You need to think about: Does my patient have a history of or high risk for cardiovascular disease, heart failure, stroke, or diabetic kidney disease? And, you want to prioritize those medications that have evidence to improve outcomes with those different diabetes complications versus a one-size-fits-all approach.”

And for patients without those complications, the glucose-centric algorithm considers obesity, hypoglycemia risk, and access/cost issues. “So, overall the diabetes medication algorithm has been split in order to emphasize that personalized approach to decision-making,” Dr. Samson explained.

Also new is a table listing the benefits and risks of weight-loss medications, and another covering immunization guidance for people with diabetes based on recommendations from the U.S. Centers for Disease Control and Prevention. “Coming out of the pandemic, we’re thinking about how can we protect our patients from infectious disease and all the comorbidities. In some cases, people with diabetes can have a much higher risk for adverse events,” Dr. Samson noted.

Regarding the weight-loss medications table, she pointed out that the task force couldn’t include the blockbuster twincretin tirzepatide because it’s not yet approved for weight loss by the U.S. Food and Drug Administration. However, it is included in the glucose-lowering drug table with weight loss listed among its benefits.

“We want this to be a living document that should be updated in a timely fashion, and so, as these new indications are approved and we see more evidence supporting their different uses, this should be updated in a really timely fashion to reflect that,” Dr. Samson said.

The end of the document includes a full page of each graphic, meant for wall posting.

Dr. Peters noted that for the most part, the AACE guidelines and algorithm align with joint guidance by the American Diabetes Association and European Association for the Study of Diabetes.

“For many years there seemed to be big differences between the AACE and ADA guidelines for the management of type 2 diabetes. Although small differences still exist ... the ADA and AACE guidelines have become quite similar,” she said.

Dr. Peters also praised the AACE algorithm for providing “a pathway for people who have issues with access and cost.”

“I am incredibly proud that in the County of Los Angeles you can get a [glucagon-like peptide-1 receptor agonist] and/or a [sodium-glucose cotransporter-2 inhibitor] even with the most restricted MediCal insurance if indications are met. But there remain many people in many places where access and cost limit options, and I am grateful that AACE includes this in their algorithms,” she said.

Dr. Samson has reported receiving research support to the Mayo Clinic from Corcept, serving on a steering committee and being a national or overall principal investigator for Chiasma and Novartis, and being a committee chair for the American Board of Internal Medicine. Dr. Peters has reported relationships with Blue Circle Health, Vertex, and Abbott Diabetes Care, receiving research grants from Abbott Diabetes Care and Insulet, and holding stock options in Teladoc and Omada Health.

A version of this article originally appeared on Medscape.com.

SEATTLE – The American Association of Clinical Endocrinology (AACE) has released a new consensus statement aimed at helping clinicians reduce stigma and bias around obesity.

Highlights from the statement, entitled “Addressing stigma and bias in the diagnosis and management of patients with obesity/adiposity-based chronic disease and assessing bias and stigmatization as determinants of disease severity,” were presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology. It will be published later this year in Endocrine Practice.

The document reiterates AACE’s previous proposal to use the term “adiposity-based chronic disease (ABCD)” to refer to the spectrum of complications of obesity beyond weight. AACE has incorporated weight bias, stigmatization, psychological health, and social determinants of health into disease staging based on the degree to which these factors impair quality of life and could negatively affect treatment. Another change is the use of a scale from 1 to 3 for ABCD staging, in contrast to the previous scale from 0 to 3, as follows.

Stage 1 (previously 0): No known physical ABCD complications (for example, cardiovascular, biomechanical) but with increased risk that might be reduced by weight loss, and/or internalized weight bias and stigmatization, psychological conditions, and social determinants of health that don’t have immediate adverse health effects but may require individualized care.

Stage 2 (previously 1): One or more mild-moderate ABCD complications plus increased risk of other complications and/or bias/stigma/social determinants that adversely affect quality of life or could impair ABCD treatment.

Stage 3 (previously 2): At least one severe ABCD complication plus increased risk for others, and/or bias/stigma/social determinants with pronounced adverse effects on quality of life or that interfere with weight loss treatment plans or render them harmful.

To accomplish this staging, clinicians are advised to use validated questionnaires to screen patients for the presence and degree of self-stigmatization and internalized weight bias and to refer patients to mental health professionals for related psychological issues. The document also advises clinicians to implement practice policies such as implicit bias training and obesity education for their staff.  

“I really hope that this document will increase awareness of the vicious cycle of weight bias, stigma, and internalized weight bias for patients with obesity, both on an individual basis and a bigger chronic care model basis ... By utilizing these concepts in the document, we hope to at least take steps towards reducing the stigma and internalized weight bias and slowing down or reversing that vicious cycle to better care for people with a focus on their health ... It’s not just about a person’s weight,” Karl Nadolsky, DO, the statement’s co-lead author, said.

The new statement builds on previous AACE efforts, including the 2014 publication entitled, “Advanced framework for a new diagnosis of obesity as a chronic disease,” the 2016 management guidelines, and the 2016 position statement, which introduced the ABCD term. All are meant to advance the concept of obesity or ABCD as a medical condition, rather than a cosmetic problem or lifestyle choice.

Now, AACE is explicitly calling attention to the integral role of internal and external weight bias and stigma as both drivers and complications of the condition. The AACE writing panel adopted some of the concepts from a 2020 international consensus statement focusing on obesity stigma, Dr. Nadolsky said.

“We need to focus on health, the biopsychosocial mode. We have to think about the person as a whole. The disease of obesity is really a quintessential disease state that needs a very good holistic approach,” he said.

Asked to comment, Yoni Freedhoff, MD, associate professor, department of family medicine, University of Ottawa, and Medical Director of the Bariatric Medical Institute, said: “I do think staging/categorization are important in the context of bias and stigma and also to combat the notion that the goal is simple medicalization ... It’s good to see the consideration of internalized weight bias as part of an effort to understand the impact of obesity on an individual.”

However, Dr. Freedhoff said he would have preferred that the implicit and internalized bias concepts had been incorporated into the 2009 Edmonton Obesity Staging System, which he believes is easier to use than the AACE staging system.

Dr. Freedhoff also disagrees that it was necessary to remove “0” from the staging (still present in the Edmonton system), done by AACE out of concern that people might mistakenly think it implies zero risk. “It just means no current objective or subjective impact of weight on health or quality of life,” he said.

But, Dr. Nadolsky noted that data on people with “metabolically healthy obesity” suggest that “they might have zero complications but they’re still at high risk, from cancer to stigma and bias, which are a cause of and consequence of obesity and should be part of the ABCD staging system.”

Indeed, Dr. Freedhoff noted, “Obesity confers risk. Just like hypertension. And just like with hypertension, risk is not a guarantee of problems. But we still discuss treatment and people can be symptom- or problem-free when we start it. It can also be ‘borderline’ or mild. But no one gets upset about the idea of treating a known risk factor, or diagnosing a known risk factor, when minor, and when it’s not had any impact on a person’s health. That we don’t do same with obesity is consequent to bias.”

In addition to influencing health care providers and health care systems, the statement also concludes: “Society, including payers and policymakers, should support policies, education, research, and access to care to limit bias and stigma faced by individuals with obesity/ABCD.”

Dr. Nadolsky has reported no relevant financial relationships. Dr. Freedhoff has reported working with the Bariatric Medical Institute and Constant Health, which has received a research grant from Novo Nordisk.

A version of this article originally appeared on Medscape.com.

SEATTLE – The American Association of Clinical Endocrinology (AACE) has released a new consensus statement aimed at helping clinicians reduce stigma and bias around obesity.

Highlights from the statement, entitled “Addressing stigma and bias in the diagnosis and management of patients with obesity/adiposity-based chronic disease and assessing bias and stigmatization as determinants of disease severity,” were presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology. It will be published later this year in Endocrine Practice.

The document reiterates AACE’s previous proposal to use the term “adiposity-based chronic disease (ABCD)” to refer to the spectrum of complications of obesity beyond weight. AACE has incorporated weight bias, stigmatization, psychological health, and social determinants of health into disease staging based on the degree to which these factors impair quality of life and could negatively affect treatment. Another change is the use of a scale from 1 to 3 for ABCD staging, in contrast to the previous scale from 0 to 3, as follows.

Stage 1 (previously 0): No known physical ABCD complications (for example, cardiovascular, biomechanical) but with increased risk that might be reduced by weight loss, and/or internalized weight bias and stigmatization, psychological conditions, and social determinants of health that don’t have immediate adverse health effects but may require individualized care.

Stage 2 (previously 1): One or more mild-moderate ABCD complications plus increased risk of other complications and/or bias/stigma/social determinants that adversely affect quality of life or could impair ABCD treatment.

Stage 3 (previously 2): At least one severe ABCD complication plus increased risk for others, and/or bias/stigma/social determinants with pronounced adverse effects on quality of life or that interfere with weight loss treatment plans or render them harmful.

To accomplish this staging, clinicians are advised to use validated questionnaires to screen patients for the presence and degree of self-stigmatization and internalized weight bias and to refer patients to mental health professionals for related psychological issues. The document also advises clinicians to implement practice policies such as implicit bias training and obesity education for their staff.  

“I really hope that this document will increase awareness of the vicious cycle of weight bias, stigma, and internalized weight bias for patients with obesity, both on an individual basis and a bigger chronic care model basis ... By utilizing these concepts in the document, we hope to at least take steps towards reducing the stigma and internalized weight bias and slowing down or reversing that vicious cycle to better care for people with a focus on their health ... It’s not just about a person’s weight,” Karl Nadolsky, DO, the statement’s co-lead author, said.

The new statement builds on previous AACE efforts, including the 2014 publication entitled, “Advanced framework for a new diagnosis of obesity as a chronic disease,” the 2016 management guidelines, and the 2016 position statement, which introduced the ABCD term. All are meant to advance the concept of obesity or ABCD as a medical condition, rather than a cosmetic problem or lifestyle choice.

Now, AACE is explicitly calling attention to the integral role of internal and external weight bias and stigma as both drivers and complications of the condition. The AACE writing panel adopted some of the concepts from a 2020 international consensus statement focusing on obesity stigma, Dr. Nadolsky said.

“We need to focus on health, the biopsychosocial mode. We have to think about the person as a whole. The disease of obesity is really a quintessential disease state that needs a very good holistic approach,” he said.

Asked to comment, Yoni Freedhoff, MD, associate professor, department of family medicine, University of Ottawa, and Medical Director of the Bariatric Medical Institute, said: “I do think staging/categorization are important in the context of bias and stigma and also to combat the notion that the goal is simple medicalization ... It’s good to see the consideration of internalized weight bias as part of an effort to understand the impact of obesity on an individual.”

However, Dr. Freedhoff said he would have preferred that the implicit and internalized bias concepts had been incorporated into the 2009 Edmonton Obesity Staging System, which he believes is easier to use than the AACE staging system.

Dr. Freedhoff also disagrees that it was necessary to remove “0” from the staging (still present in the Edmonton system), done by AACE out of concern that people might mistakenly think it implies zero risk. “It just means no current objective or subjective impact of weight on health or quality of life,” he said.

But, Dr. Nadolsky noted that data on people with “metabolically healthy obesity” suggest that “they might have zero complications but they’re still at high risk, from cancer to stigma and bias, which are a cause of and consequence of obesity and should be part of the ABCD staging system.”

Indeed, Dr. Freedhoff noted, “Obesity confers risk. Just like hypertension. And just like with hypertension, risk is not a guarantee of problems. But we still discuss treatment and people can be symptom- or problem-free when we start it. It can also be ‘borderline’ or mild. But no one gets upset about the idea of treating a known risk factor, or diagnosing a known risk factor, when minor, and when it’s not had any impact on a person’s health. That we don’t do same with obesity is consequent to bias.”

In addition to influencing health care providers and health care systems, the statement also concludes: “Society, including payers and policymakers, should support policies, education, research, and access to care to limit bias and stigma faced by individuals with obesity/ABCD.”

Dr. Nadolsky has reported no relevant financial relationships. Dr. Freedhoff has reported working with the Bariatric Medical Institute and Constant Health, which has received a research grant from Novo Nordisk.

A version of this article originally appeared on Medscape.com.

SEATTLE – The American Association of Clinical Endocrinology (AACE) has released a new consensus statement aimed at helping clinicians reduce stigma and bias around obesity.

Highlights from the statement, entitled “Addressing stigma and bias in the diagnosis and management of patients with obesity/adiposity-based chronic disease and assessing bias and stigmatization as determinants of disease severity,” were presented at the annual scientific & clinical congress of the American Association of Clinical Endocrinology. It will be published later this year in Endocrine Practice.

The document reiterates AACE’s previous proposal to use the term “adiposity-based chronic disease (ABCD)” to refer to the spectrum of complications of obesity beyond weight. AACE has incorporated weight bias, stigmatization, psychological health, and social determinants of health into disease staging based on the degree to which these factors impair quality of life and could negatively affect treatment. Another change is the use of a scale from 1 to 3 for ABCD staging, in contrast to the previous scale from 0 to 3, as follows.

Stage 1 (previously 0): No known physical ABCD complications (for example, cardiovascular, biomechanical) but with increased risk that might be reduced by weight loss, and/or internalized weight bias and stigmatization, psychological conditions, and social determinants of health that don’t have immediate adverse health effects but may require individualized care.

Stage 2 (previously 1): One or more mild-moderate ABCD complications plus increased risk of other complications and/or bias/stigma/social determinants that adversely affect quality of life or could impair ABCD treatment.

Stage 3 (previously 2): At least one severe ABCD complication plus increased risk for others, and/or bias/stigma/social determinants with pronounced adverse effects on quality of life or that interfere with weight loss treatment plans or render them harmful.

To accomplish this staging, clinicians are advised to use validated questionnaires to screen patients for the presence and degree of self-stigmatization and internalized weight bias and to refer patients to mental health professionals for related psychological issues. The document also advises clinicians to implement practice policies such as implicit bias training and obesity education for their staff.  

“I really hope that this document will increase awareness of the vicious cycle of weight bias, stigma, and internalized weight bias for patients with obesity, both on an individual basis and a bigger chronic care model basis ... By utilizing these concepts in the document, we hope to at least take steps towards reducing the stigma and internalized weight bias and slowing down or reversing that vicious cycle to better care for people with a focus on their health ... It’s not just about a person’s weight,” Karl Nadolsky, DO, the statement’s co-lead author, said.

The new statement builds on previous AACE efforts, including the 2014 publication entitled, “Advanced framework for a new diagnosis of obesity as a chronic disease,” the 2016 management guidelines, and the 2016 position statement, which introduced the ABCD term. All are meant to advance the concept of obesity or ABCD as a medical condition, rather than a cosmetic problem or lifestyle choice.

Now, AACE is explicitly calling attention to the integral role of internal and external weight bias and stigma as both drivers and complications of the condition. The AACE writing panel adopted some of the concepts from a 2020 international consensus statement focusing on obesity stigma, Dr. Nadolsky said.

“We need to focus on health, the biopsychosocial mode. We have to think about the person as a whole. The disease of obesity is really a quintessential disease state that needs a very good holistic approach,” he said.

Asked to comment, Yoni Freedhoff, MD, associate professor, department of family medicine, University of Ottawa, and Medical Director of the Bariatric Medical Institute, said: “I do think staging/categorization are important in the context of bias and stigma and also to combat the notion that the goal is simple medicalization ... It’s good to see the consideration of internalized weight bias as part of an effort to understand the impact of obesity on an individual.”

However, Dr. Freedhoff said he would have preferred that the implicit and internalized bias concepts had been incorporated into the 2009 Edmonton Obesity Staging System, which he believes is easier to use than the AACE staging system.

Dr. Freedhoff also disagrees that it was necessary to remove “0” from the staging (still present in the Edmonton system), done by AACE out of concern that people might mistakenly think it implies zero risk. “It just means no current objective or subjective impact of weight on health or quality of life,” he said.

But, Dr. Nadolsky noted that data on people with “metabolically healthy obesity” suggest that “they might have zero complications but they’re still at high risk, from cancer to stigma and bias, which are a cause of and consequence of obesity and should be part of the ABCD staging system.”

Indeed, Dr. Freedhoff noted, “Obesity confers risk. Just like hypertension. And just like with hypertension, risk is not a guarantee of problems. But we still discuss treatment and people can be symptom- or problem-free when we start it. It can also be ‘borderline’ or mild. But no one gets upset about the idea of treating a known risk factor, or diagnosing a known risk factor, when minor, and when it’s not had any impact on a person’s health. That we don’t do same with obesity is consequent to bias.”

In addition to influencing health care providers and health care systems, the statement also concludes: “Society, including payers and policymakers, should support policies, education, research, and access to care to limit bias and stigma faced by individuals with obesity/ABCD.”

Dr. Nadolsky has reported no relevant financial relationships. Dr. Freedhoff has reported working with the Bariatric Medical Institute and Constant Health, which has received a research grant from Novo Nordisk.

A version of this article originally appeared on Medscape.com.

Diabetes devices represent a major advancement in the management of diabetes, but they can cause skin reactions that affect patient adherence and quality of life, Jennifer K. Chen, MD, said in a presentation at the annual meeting of the American Contact Dermatitis Society.

Advanced technologies used for the management of diabetes fall into three main categories, said Dr. Chen, of the department of dermatology, Stanford University, Redwood City, Calif. Continuous glucose monitoring (CGM) devices, which are worn on the body, collect glucose measurements. Continuous subcutaneous insulin infusion (CSII) devices are attached to the body via an infusion set and are now available as tubing-free patch pumps that are attached directly to the skin via a catheter. Glucose-responsive insulin delivery systems combine the sensing and delivery features of the other two types of devices.

Dr. Chen

Once thought to be rare, reports of skin complications related to diabetes devices have been increasing in recent years, she said. Some reports suggest that at any given time, skin complications may affect as many as one quarter to one half of patients who use these devices, “so this is an important issue,” she emphasized. “Skin reactions are a major factor in device discontinuation, so we as clinicians need to be really proactive about treating these reactions.”

Risk factors for skin complications related to diabetes devices include sensitization to the adhesive used with the devices, as well as prolonged exposure to the device, Dr. Chen said. Younger age also appears to be a risk factor, as is a compromised skin barrier in the area where the device is used.

Unfortunately, obtaining details on the specific adhesives and the raw materials used in these devices, so as to customize patch testing, remains a challenge, she said. “Patch testing initially was often negative to commercially available allergens, even while patients were testing positive to pieces of device adhesive,” she noted.
 

Consider isobornyl acrylate

An article published in 2017 in Contact Dermatitis was “a major breakthrough” in that it identified isobornyl acrylate (IBOA) as an allergen in connection with the Freestyle Libre, a CGM device that was relatively new at the time. The finding was serendipitous, Dr. Chen said. A patient being treated for suspected allergic contact dermatitis in connection with use of a Freestyle Libre device was tested for IBOA accidentally, after the nurse administering the patch test thought that this was part of the standard acrylate series, she explained.

Subsequently, researchers identified 15 patients who had experienced reactions to the Freestyle Libre; 12 of 13 patients who were patch tested for IBOA tested positive. IBOA was found throughout the device, particularly where the top and bottom plastic components were connected, Dr. Chen said. This suggested that the IBOA was in the device housing and had diffused into the adhesive that attached the device to the skin.

An article published in 2018 in the Journal of Diabetes Science described three patients who developed severe allergic contact dermatitis from IBOA while using a CGM device, Dr. Chen said. The investigators confirmed that there were no reactions to the adhesive itself, again suggesting that IBOA had diffused into the adhesive from other parts of the device.

Although the authors were bound by a confidentiality agreement regarding the individual adhesive components, “the authors noted most of the acrylates in the adhesive were not present in commercially available acrylate series for patch testing,” she said.

IBOA, the ACDS’ Allergen of the Year in 2020, is common in sealants, glues, and adhesives, Dr. Chen said. Although IBOA had been reported infrequently as an allergen, it has now been identified as a “potential culprit” behind skin reactions in many diabetes devices, including CSII and CGM devices, she added.

In addition, N,N-dimethylacrylamide (DMAA) is an allergen that has been identified in several diabetes devices and often occurs with IBOA in medical-grade UV-cured adhesives, Dr. Chen noted. Other allergens identified in diabetes devices include colophony, which is present in many adhesives, as well as other acrylates and epoxy resin.

Diabetes devices are constantly evolving. IBOA is no longer found in Freestyle Libre devices. It is important that clinicians stay up to date with the medical literature and advocate for partnership with device manufacturers, she emphasized.
 

Patch testing

When diabetes devices are suspected as the source of allergic contact dermatitis, a minimum of a baseline series that contains colophony at a concentration of 20% in petrolatum should be carried out, Dr. Chen said. Commercialized patch test trays, which include plastics, glues, acrylates, epoxy resins/isocyanates, and colophony derivatives, should be ideal. “Personal-care products should be included if they are potentially relevant,” she added.

Dr. Chen shared tables published in Contact Dermatitis in 2021 with examples of screening test series. She said to consider including screening for other allergens more recently discovered in diabetes devices, including 2,2’-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate (MBPA) 1.5% pet; dipropylene glycol diacrylate (DPGDA) 0.1% pet; and butylated hydroxytoluene (BHT) 2% pet.

Testing for monomethyl ether of hydroquinone should also be considered; this may be included in the test preparations for IBOA and DMAA.
 

Management strategies

For patients who experience skin reactions to their diabetes devices, consideration may given to relocating the device to another area of skin or changing sensors more frequently, according to Dr. Chen.

For some patients, the reaction can be managed with corticosteroid cream, ointment, solution, or nasal spray. Topical antibiotics or topical antihistamines can be helpful, as can barrier dressings, solutions, or sprays, she said. The best solution is to change to a device that does not have the culprit allergen, “but that is difficult, since we don’t know what is in these devices,” she added. Good alternatives include the Eversense CGM device or devices that have been demonstrated not to contain IBOA, such as the Freestyle Libre 2 or the newer version of the Omnipod, an insulin delivery system

Looking ahead, Dr. Chen said that “mandatory labeling is needed, as devices with the same name may have different compositions, depending on the date of manufacture.” Allergens relevant to people with diabetes are constantly evolving, and many are still unidentified, so clinicians and manufacturers need to work together to identify the culprit allergens and their sources, she said.

Dr. Chen has served as principal investigator or subinvestigator for Amgen, AbbVie, and Sanofi Regeneron and as a consultant for Purity Brands.
 

A version of this article first appeared on Medscape.com.

Diabetes devices represent a major advancement in the management of diabetes, but they can cause skin reactions that affect patient adherence and quality of life, Jennifer K. Chen, MD, said in a presentation at the annual meeting of the American Contact Dermatitis Society.

Advanced technologies used for the management of diabetes fall into three main categories, said Dr. Chen, of the department of dermatology, Stanford University, Redwood City, Calif. Continuous glucose monitoring (CGM) devices, which are worn on the body, collect glucose measurements. Continuous subcutaneous insulin infusion (CSII) devices are attached to the body via an infusion set and are now available as tubing-free patch pumps that are attached directly to the skin via a catheter. Glucose-responsive insulin delivery systems combine the sensing and delivery features of the other two types of devices.

Dr. Chen

Once thought to be rare, reports of skin complications related to diabetes devices have been increasing in recent years, she said. Some reports suggest that at any given time, skin complications may affect as many as one quarter to one half of patients who use these devices, “so this is an important issue,” she emphasized. “Skin reactions are a major factor in device discontinuation, so we as clinicians need to be really proactive about treating these reactions.”

Risk factors for skin complications related to diabetes devices include sensitization to the adhesive used with the devices, as well as prolonged exposure to the device, Dr. Chen said. Younger age also appears to be a risk factor, as is a compromised skin barrier in the area where the device is used.

Unfortunately, obtaining details on the specific adhesives and the raw materials used in these devices, so as to customize patch testing, remains a challenge, she said. “Patch testing initially was often negative to commercially available allergens, even while patients were testing positive to pieces of device adhesive,” she noted.
 

Consider isobornyl acrylate

An article published in 2017 in Contact Dermatitis was “a major breakthrough” in that it identified isobornyl acrylate (IBOA) as an allergen in connection with the Freestyle Libre, a CGM device that was relatively new at the time. The finding was serendipitous, Dr. Chen said. A patient being treated for suspected allergic contact dermatitis in connection with use of a Freestyle Libre device was tested for IBOA accidentally, after the nurse administering the patch test thought that this was part of the standard acrylate series, she explained.

Subsequently, researchers identified 15 patients who had experienced reactions to the Freestyle Libre; 12 of 13 patients who were patch tested for IBOA tested positive. IBOA was found throughout the device, particularly where the top and bottom plastic components were connected, Dr. Chen said. This suggested that the IBOA was in the device housing and had diffused into the adhesive that attached the device to the skin.

An article published in 2018 in the Journal of Diabetes Science described three patients who developed severe allergic contact dermatitis from IBOA while using a CGM device, Dr. Chen said. The investigators confirmed that there were no reactions to the adhesive itself, again suggesting that IBOA had diffused into the adhesive from other parts of the device.

Although the authors were bound by a confidentiality agreement regarding the individual adhesive components, “the authors noted most of the acrylates in the adhesive were not present in commercially available acrylate series for patch testing,” she said.

IBOA, the ACDS’ Allergen of the Year in 2020, is common in sealants, glues, and adhesives, Dr. Chen said. Although IBOA had been reported infrequently as an allergen, it has now been identified as a “potential culprit” behind skin reactions in many diabetes devices, including CSII and CGM devices, she added.

In addition, N,N-dimethylacrylamide (DMAA) is an allergen that has been identified in several diabetes devices and often occurs with IBOA in medical-grade UV-cured adhesives, Dr. Chen noted. Other allergens identified in diabetes devices include colophony, which is present in many adhesives, as well as other acrylates and epoxy resin.

Diabetes devices are constantly evolving. IBOA is no longer found in Freestyle Libre devices. It is important that clinicians stay up to date with the medical literature and advocate for partnership with device manufacturers, she emphasized.
 

Patch testing

When diabetes devices are suspected as the source of allergic contact dermatitis, a minimum of a baseline series that contains colophony at a concentration of 20% in petrolatum should be carried out, Dr. Chen said. Commercialized patch test trays, which include plastics, glues, acrylates, epoxy resins/isocyanates, and colophony derivatives, should be ideal. “Personal-care products should be included if they are potentially relevant,” she added.

Dr. Chen shared tables published in Contact Dermatitis in 2021 with examples of screening test series. She said to consider including screening for other allergens more recently discovered in diabetes devices, including 2,2’-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate (MBPA) 1.5% pet; dipropylene glycol diacrylate (DPGDA) 0.1% pet; and butylated hydroxytoluene (BHT) 2% pet.

Testing for monomethyl ether of hydroquinone should also be considered; this may be included in the test preparations for IBOA and DMAA.
 

Management strategies

For patients who experience skin reactions to their diabetes devices, consideration may given to relocating the device to another area of skin or changing sensors more frequently, according to Dr. Chen.

For some patients, the reaction can be managed with corticosteroid cream, ointment, solution, or nasal spray. Topical antibiotics or topical antihistamines can be helpful, as can barrier dressings, solutions, or sprays, she said. The best solution is to change to a device that does not have the culprit allergen, “but that is difficult, since we don’t know what is in these devices,” she added. Good alternatives include the Eversense CGM device or devices that have been demonstrated not to contain IBOA, such as the Freestyle Libre 2 or the newer version of the Omnipod, an insulin delivery system

Looking ahead, Dr. Chen said that “mandatory labeling is needed, as devices with the same name may have different compositions, depending on the date of manufacture.” Allergens relevant to people with diabetes are constantly evolving, and many are still unidentified, so clinicians and manufacturers need to work together to identify the culprit allergens and their sources, she said.

Dr. Chen has served as principal investigator or subinvestigator for Amgen, AbbVie, and Sanofi Regeneron and as a consultant for Purity Brands.
 

A version of this article first appeared on Medscape.com.

Diabetes devices represent a major advancement in the management of diabetes, but they can cause skin reactions that affect patient adherence and quality of life, Jennifer K. Chen, MD, said in a presentation at the annual meeting of the American Contact Dermatitis Society.

Advanced technologies used for the management of diabetes fall into three main categories, said Dr. Chen, of the department of dermatology, Stanford University, Redwood City, Calif. Continuous glucose monitoring (CGM) devices, which are worn on the body, collect glucose measurements. Continuous subcutaneous insulin infusion (CSII) devices are attached to the body via an infusion set and are now available as tubing-free patch pumps that are attached directly to the skin via a catheter. Glucose-responsive insulin delivery systems combine the sensing and delivery features of the other two types of devices.

Dr. Chen

Once thought to be rare, reports of skin complications related to diabetes devices have been increasing in recent years, she said. Some reports suggest that at any given time, skin complications may affect as many as one quarter to one half of patients who use these devices, “so this is an important issue,” she emphasized. “Skin reactions are a major factor in device discontinuation, so we as clinicians need to be really proactive about treating these reactions.”

Risk factors for skin complications related to diabetes devices include sensitization to the adhesive used with the devices, as well as prolonged exposure to the device, Dr. Chen said. Younger age also appears to be a risk factor, as is a compromised skin barrier in the area where the device is used.

Unfortunately, obtaining details on the specific adhesives and the raw materials used in these devices, so as to customize patch testing, remains a challenge, she said. “Patch testing initially was often negative to commercially available allergens, even while patients were testing positive to pieces of device adhesive,” she noted.
 

Consider isobornyl acrylate

An article published in 2017 in Contact Dermatitis was “a major breakthrough” in that it identified isobornyl acrylate (IBOA) as an allergen in connection with the Freestyle Libre, a CGM device that was relatively new at the time. The finding was serendipitous, Dr. Chen said. A patient being treated for suspected allergic contact dermatitis in connection with use of a Freestyle Libre device was tested for IBOA accidentally, after the nurse administering the patch test thought that this was part of the standard acrylate series, she explained.

Subsequently, researchers identified 15 patients who had experienced reactions to the Freestyle Libre; 12 of 13 patients who were patch tested for IBOA tested positive. IBOA was found throughout the device, particularly where the top and bottom plastic components were connected, Dr. Chen said. This suggested that the IBOA was in the device housing and had diffused into the adhesive that attached the device to the skin.

An article published in 2018 in the Journal of Diabetes Science described three patients who developed severe allergic contact dermatitis from IBOA while using a CGM device, Dr. Chen said. The investigators confirmed that there were no reactions to the adhesive itself, again suggesting that IBOA had diffused into the adhesive from other parts of the device.

Although the authors were bound by a confidentiality agreement regarding the individual adhesive components, “the authors noted most of the acrylates in the adhesive were not present in commercially available acrylate series for patch testing,” she said.

IBOA, the ACDS’ Allergen of the Year in 2020, is common in sealants, glues, and adhesives, Dr. Chen said. Although IBOA had been reported infrequently as an allergen, it has now been identified as a “potential culprit” behind skin reactions in many diabetes devices, including CSII and CGM devices, she added.

In addition, N,N-dimethylacrylamide (DMAA) is an allergen that has been identified in several diabetes devices and often occurs with IBOA in medical-grade UV-cured adhesives, Dr. Chen noted. Other allergens identified in diabetes devices include colophony, which is present in many adhesives, as well as other acrylates and epoxy resin.

Diabetes devices are constantly evolving. IBOA is no longer found in Freestyle Libre devices. It is important that clinicians stay up to date with the medical literature and advocate for partnership with device manufacturers, she emphasized.
 

Patch testing

When diabetes devices are suspected as the source of allergic contact dermatitis, a minimum of a baseline series that contains colophony at a concentration of 20% in petrolatum should be carried out, Dr. Chen said. Commercialized patch test trays, which include plastics, glues, acrylates, epoxy resins/isocyanates, and colophony derivatives, should be ideal. “Personal-care products should be included if they are potentially relevant,” she added.

Dr. Chen shared tables published in Contact Dermatitis in 2021 with examples of screening test series. She said to consider including screening for other allergens more recently discovered in diabetes devices, including 2,2’-methylenebis(6-tert-butyl-4-methylphenol) monoacrylate (MBPA) 1.5% pet; dipropylene glycol diacrylate (DPGDA) 0.1% pet; and butylated hydroxytoluene (BHT) 2% pet.

Testing for monomethyl ether of hydroquinone should also be considered; this may be included in the test preparations for IBOA and DMAA.
 

Management strategies

For patients who experience skin reactions to their diabetes devices, consideration may given to relocating the device to another area of skin or changing sensors more frequently, according to Dr. Chen.

For some patients, the reaction can be managed with corticosteroid cream, ointment, solution, or nasal spray. Topical antibiotics or topical antihistamines can be helpful, as can barrier dressings, solutions, or sprays, she said. The best solution is to change to a device that does not have the culprit allergen, “but that is difficult, since we don’t know what is in these devices,” she added. Good alternatives include the Eversense CGM device or devices that have been demonstrated not to contain IBOA, such as the Freestyle Libre 2 or the newer version of the Omnipod, an insulin delivery system

Looking ahead, Dr. Chen said that “mandatory labeling is needed, as devices with the same name may have different compositions, depending on the date of manufacture.” Allergens relevant to people with diabetes are constantly evolving, and many are still unidentified, so clinicians and manufacturers need to work together to identify the culprit allergens and their sources, she said.

Dr. Chen has served as principal investigator or subinvestigator for Amgen, AbbVie, and Sanofi Regeneron and as a consultant for Purity Brands.
 

A version of this article first appeared on Medscape.com.

Consider popular nutritional supplements as a potential source of allergic reactions if the cause of the reaction is otherwise unknown, Alison Ehrlich, MD, said at the annual meeting of the American Contact Dermatitis Society.

Sherri Holdridge

Allergens may be hidden in a range of supplement products, from colorings in vitamin C powders to some vitamins used in hair products and other products.

“In general, our patients do not tell us what supplements they are taking,” said Dr. Ehrlich, a dermatologist who practices in Washington, D.C. Antiaging, sleep, and weight loss/weight control supplements are among the most popular, she said.

Surveys have shown that many patients do not discuss supplement use with their health care providers, in part because they believe their providers would disapprove of supplement use, and patients are not educated about supplements, she said. “This is definitely an area that we should try to learn more about,” she added.

Current regulations regarding dietary supplements stem from the Dietary Supplement Health and Education Act of 1994, which defined dietary supplements as distinct from meals but regulated them as a category of food, not as medications. Dietary supplements can be vitamins, minerals, herbs, and extracts, Dr. Ehrlich said.

“There is not a lot of safety wrapped around how supplements come onto the market,” she explained. “It is not the manufacturer’s responsibility to test these products and make sure they are safe. When they get pulled off the market, it is because safety reports are getting back to the FDA.”

Consequently, a detailed history of supplement use is important, as it may reveal possible allergens as the cause of previously unidentified reactions, she said.

Dr. Ehrlich shared a case involving a patient who claimed to have had a reaction to a “Prevage-like” product that was labeled as a crepe repair cream. Listed among the product’s ingredients was idebenone, a synthetic version of the popular antioxidant known as Coenzyme Q.
 

Be wary of vitamins

Another potential source of allergy is vitamin C supplements, which became especially popular during the pandemic as people sought additional immune system support, Dr. Ehrlich noted. “What kind of vitamin C product our patients are taking is important,” she said. For example, some vitamin C powders contain coloring agents, such as carmine. Some also contain gelatin, which may cause an allergic reaction in individuals with alpha-gal syndrome, she added.

Sally Koch Kubetin/MDedge News

In general, water-soluble vitamins such as vitamins B1 to B9, B12, and C are more likely to cause an immediate reaction, Dr. Ehrlich said. Fat-soluble vitamins, such as vitamins A, D, E, and K, are more likely to cause a delayed reaction of allergic contact dermatitis.

Dr. Ehrlich described some unusual reactions to vitamins that have been reported, including a systemic allergy associated with vitamin B1 (thiamine), burning mouth syndrome associated with vitamin B3 (nicotinate), contact urticaria associated with vitamin B5 (panthenol), systemic allergy and generalized ACD associated with vitamin E (tocopherol), and erythema multiforme–like ACD associated with vitamin K1.

Notably, vitamin B5 has been associated with ACD as an ingredient in hair products, moisturizers, and wound care products, as well as B-complex vitamins and fortified foods, Dr. Ehrlich said.

Herbs and spices can act as allergens as well. Turmeric is a spice that has become a popular supplement ingredient, she said. Turmeric and curcumin (found in turmeric) can be used as a dye for its yellow color as well as a flavoring but has been associated with allergic reactions. Another popular herbal supplement, ginkgo biloba, has been marketed as a product that improves memory and cognition. It is available in pill form and in herbal teas.

“It’s really important to think about what herbal products our patients are taking, and not just in pill form,” Dr. Ehrlich said. “We need to expand our thoughts on what the herbs are in.”
 

Consider food additives as allergens

Food additives, in the form of colorants, preservatives, or flavoring agents, can cause allergic reactions, Dr. Ehrlich noted.

The question of whether food-additive contact sensitivity has a role in the occurrence of atopic dermatitis (AD) in children remains unclear, she said. However, a study published in 2020 found that 62% of children with AD had positive patch test reactions to at least one food-additive allergen, compared with 20% of children without AD. The additives responsible for the most reactions were azorubine (24.4%); formic acid (15.6%); and carmine, cochineal red, and amaranth (13.3% for each).

Common colorant culprits in allergic reactions include carmine, annatto, tartrazine, and spices (such as paprika and saffron), Dr. Ehrlich said. Carmine is used in meat to prevent photo-oxidation and to preserve a red color, and it has other uses as well, she said. Carmine has been associated with ACD, AD flares, and immediate hypersensitivity. Annatto is used in foods, including processed foods, butter, and cheese, to provide a yellow color. It is also found in some lipsticks and has been associated with urticaria and angioedema, she noted.

Food preservatives that have been associated with allergic reactions include butylated hydroxyanisole and sulfites, Dr. Ehrlich said. Sulfites are used to prevent food from turning brown, and it may be present in dried fruit, fruit juice, molasses, pickled foods, vinegar, and wine.

Reports of ACD in response to sodium metabisulfite have been increasing, she noted. Other sulfite reactions may occur with exposure to other products, such as cosmetics, body washes, and swimming pool water, she said.

Awareness of allergens in supplements is important “because the number of our patients taking supplements for different reasons is increasing” and allergens in supplements could account for flares, Dr. Ehrlich said. Clinicians should encourage patients to tell them what supplements they use. Clinicians should review the ingredients in these supplements with their patients to identify potential allergens that may be causing reactions, she advised.

Dr. Ehrlich has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Consider popular nutritional supplements as a potential source of allergic reactions if the cause of the reaction is otherwise unknown, Alison Ehrlich, MD, said at the annual meeting of the American Contact Dermatitis Society.

Sherri Holdridge

Allergens may be hidden in a range of supplement products, from colorings in vitamin C powders to some vitamins used in hair products and other products.

“In general, our patients do not tell us what supplements they are taking,” said Dr. Ehrlich, a dermatologist who practices in Washington, D.C. Antiaging, sleep, and weight loss/weight control supplements are among the most popular, she said.

Surveys have shown that many patients do not discuss supplement use with their health care providers, in part because they believe their providers would disapprove of supplement use, and patients are not educated about supplements, she said. “This is definitely an area that we should try to learn more about,” she added.

Current regulations regarding dietary supplements stem from the Dietary Supplement Health and Education Act of 1994, which defined dietary supplements as distinct from meals but regulated them as a category of food, not as medications. Dietary supplements can be vitamins, minerals, herbs, and extracts, Dr. Ehrlich said.

“There is not a lot of safety wrapped around how supplements come onto the market,” she explained. “It is not the manufacturer’s responsibility to test these products and make sure they are safe. When they get pulled off the market, it is because safety reports are getting back to the FDA.”

Consequently, a detailed history of supplement use is important, as it may reveal possible allergens as the cause of previously unidentified reactions, she said.

Dr. Ehrlich shared a case involving a patient who claimed to have had a reaction to a “Prevage-like” product that was labeled as a crepe repair cream. Listed among the product’s ingredients was idebenone, a synthetic version of the popular antioxidant known as Coenzyme Q.
 

Be wary of vitamins

Another potential source of allergy is vitamin C supplements, which became especially popular during the pandemic as people sought additional immune system support, Dr. Ehrlich noted. “What kind of vitamin C product our patients are taking is important,” she said. For example, some vitamin C powders contain coloring agents, such as carmine. Some also contain gelatin, which may cause an allergic reaction in individuals with alpha-gal syndrome, she added.

Sally Koch Kubetin/MDedge News

In general, water-soluble vitamins such as vitamins B1 to B9, B12, and C are more likely to cause an immediate reaction, Dr. Ehrlich said. Fat-soluble vitamins, such as vitamins A, D, E, and K, are more likely to cause a delayed reaction of allergic contact dermatitis.

Dr. Ehrlich described some unusual reactions to vitamins that have been reported, including a systemic allergy associated with vitamin B1 (thiamine), burning mouth syndrome associated with vitamin B3 (nicotinate), contact urticaria associated with vitamin B5 (panthenol), systemic allergy and generalized ACD associated with vitamin E (tocopherol), and erythema multiforme–like ACD associated with vitamin K1.

Notably, vitamin B5 has been associated with ACD as an ingredient in hair products, moisturizers, and wound care products, as well as B-complex vitamins and fortified foods, Dr. Ehrlich said.

Herbs and spices can act as allergens as well. Turmeric is a spice that has become a popular supplement ingredient, she said. Turmeric and curcumin (found in turmeric) can be used as a dye for its yellow color as well as a flavoring but has been associated with allergic reactions. Another popular herbal supplement, ginkgo biloba, has been marketed as a product that improves memory and cognition. It is available in pill form and in herbal teas.

“It’s really important to think about what herbal products our patients are taking, and not just in pill form,” Dr. Ehrlich said. “We need to expand our thoughts on what the herbs are in.”
 

Consider food additives as allergens

Food additives, in the form of colorants, preservatives, or flavoring agents, can cause allergic reactions, Dr. Ehrlich noted.

The question of whether food-additive contact sensitivity has a role in the occurrence of atopic dermatitis (AD) in children remains unclear, she said. However, a study published in 2020 found that 62% of children with AD had positive patch test reactions to at least one food-additive allergen, compared with 20% of children without AD. The additives responsible for the most reactions were azorubine (24.4%); formic acid (15.6%); and carmine, cochineal red, and amaranth (13.3% for each).

Common colorant culprits in allergic reactions include carmine, annatto, tartrazine, and spices (such as paprika and saffron), Dr. Ehrlich said. Carmine is used in meat to prevent photo-oxidation and to preserve a red color, and it has other uses as well, she said. Carmine has been associated with ACD, AD flares, and immediate hypersensitivity. Annatto is used in foods, including processed foods, butter, and cheese, to provide a yellow color. It is also found in some lipsticks and has been associated with urticaria and angioedema, she noted.

Food preservatives that have been associated with allergic reactions include butylated hydroxyanisole and sulfites, Dr. Ehrlich said. Sulfites are used to prevent food from turning brown, and it may be present in dried fruit, fruit juice, molasses, pickled foods, vinegar, and wine.

Reports of ACD in response to sodium metabisulfite have been increasing, she noted. Other sulfite reactions may occur with exposure to other products, such as cosmetics, body washes, and swimming pool water, she said.

Awareness of allergens in supplements is important “because the number of our patients taking supplements for different reasons is increasing” and allergens in supplements could account for flares, Dr. Ehrlich said. Clinicians should encourage patients to tell them what supplements they use. Clinicians should review the ingredients in these supplements with their patients to identify potential allergens that may be causing reactions, she advised.

Dr. Ehrlich has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Consider popular nutritional supplements as a potential source of allergic reactions if the cause of the reaction is otherwise unknown, Alison Ehrlich, MD, said at the annual meeting of the American Contact Dermatitis Society.

Sherri Holdridge

Allergens may be hidden in a range of supplement products, from colorings in vitamin C powders to some vitamins used in hair products and other products.

“In general, our patients do not tell us what supplements they are taking,” said Dr. Ehrlich, a dermatologist who practices in Washington, D.C. Antiaging, sleep, and weight loss/weight control supplements are among the most popular, she said.

Surveys have shown that many patients do not discuss supplement use with their health care providers, in part because they believe their providers would disapprove of supplement use, and patients are not educated about supplements, she said. “This is definitely an area that we should try to learn more about,” she added.

Current regulations regarding dietary supplements stem from the Dietary Supplement Health and Education Act of 1994, which defined dietary supplements as distinct from meals but regulated them as a category of food, not as medications. Dietary supplements can be vitamins, minerals, herbs, and extracts, Dr. Ehrlich said.

“There is not a lot of safety wrapped around how supplements come onto the market,” she explained. “It is not the manufacturer’s responsibility to test these products and make sure they are safe. When they get pulled off the market, it is because safety reports are getting back to the FDA.”

Consequently, a detailed history of supplement use is important, as it may reveal possible allergens as the cause of previously unidentified reactions, she said.

Dr. Ehrlich shared a case involving a patient who claimed to have had a reaction to a “Prevage-like” product that was labeled as a crepe repair cream. Listed among the product’s ingredients was idebenone, a synthetic version of the popular antioxidant known as Coenzyme Q.
 

Be wary of vitamins

Another potential source of allergy is vitamin C supplements, which became especially popular during the pandemic as people sought additional immune system support, Dr. Ehrlich noted. “What kind of vitamin C product our patients are taking is important,” she said. For example, some vitamin C powders contain coloring agents, such as carmine. Some also contain gelatin, which may cause an allergic reaction in individuals with alpha-gal syndrome, she added.

Sally Koch Kubetin/MDedge News

In general, water-soluble vitamins such as vitamins B1 to B9, B12, and C are more likely to cause an immediate reaction, Dr. Ehrlich said. Fat-soluble vitamins, such as vitamins A, D, E, and K, are more likely to cause a delayed reaction of allergic contact dermatitis.

Dr. Ehrlich described some unusual reactions to vitamins that have been reported, including a systemic allergy associated with vitamin B1 (thiamine), burning mouth syndrome associated with vitamin B3 (nicotinate), contact urticaria associated with vitamin B5 (panthenol), systemic allergy and generalized ACD associated with vitamin E (tocopherol), and erythema multiforme–like ACD associated with vitamin K1.

Notably, vitamin B5 has been associated with ACD as an ingredient in hair products, moisturizers, and wound care products, as well as B-complex vitamins and fortified foods, Dr. Ehrlich said.

Herbs and spices can act as allergens as well. Turmeric is a spice that has become a popular supplement ingredient, she said. Turmeric and curcumin (found in turmeric) can be used as a dye for its yellow color as well as a flavoring but has been associated with allergic reactions. Another popular herbal supplement, ginkgo biloba, has been marketed as a product that improves memory and cognition. It is available in pill form and in herbal teas.

“It’s really important to think about what herbal products our patients are taking, and not just in pill form,” Dr. Ehrlich said. “We need to expand our thoughts on what the herbs are in.”
 

Consider food additives as allergens

Food additives, in the form of colorants, preservatives, or flavoring agents, can cause allergic reactions, Dr. Ehrlich noted.

The question of whether food-additive contact sensitivity has a role in the occurrence of atopic dermatitis (AD) in children remains unclear, she said. However, a study published in 2020 found that 62% of children with AD had positive patch test reactions to at least one food-additive allergen, compared with 20% of children without AD. The additives responsible for the most reactions were azorubine (24.4%); formic acid (15.6%); and carmine, cochineal red, and amaranth (13.3% for each).

Common colorant culprits in allergic reactions include carmine, annatto, tartrazine, and spices (such as paprika and saffron), Dr. Ehrlich said. Carmine is used in meat to prevent photo-oxidation and to preserve a red color, and it has other uses as well, she said. Carmine has been associated with ACD, AD flares, and immediate hypersensitivity. Annatto is used in foods, including processed foods, butter, and cheese, to provide a yellow color. It is also found in some lipsticks and has been associated with urticaria and angioedema, she noted.

Food preservatives that have been associated with allergic reactions include butylated hydroxyanisole and sulfites, Dr. Ehrlich said. Sulfites are used to prevent food from turning brown, and it may be present in dried fruit, fruit juice, molasses, pickled foods, vinegar, and wine.

Reports of ACD in response to sodium metabisulfite have been increasing, she noted. Other sulfite reactions may occur with exposure to other products, such as cosmetics, body washes, and swimming pool water, she said.

Awareness of allergens in supplements is important “because the number of our patients taking supplements for different reasons is increasing” and allergens in supplements could account for flares, Dr. Ehrlich said. Clinicians should encourage patients to tell them what supplements they use. Clinicians should review the ingredients in these supplements with their patients to identify potential allergens that may be causing reactions, she advised.

Dr. Ehrlich has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

There is wonderful news in the field of hybrid closed-loop pump technology because the Medtronic 780G system was just approved. I can’t tell you how happy this makes me because we’ve all been waiting for this seemingly forever and ever. This isn’t just a small upgrade from the 770G. It’s a quantum leap from the 770G to the 780G. The 780G has newer algorithms, a new sensor, and a longer-lasting infusion set.

USC Westside Center for Diabetes

It’s been used since 2020 in Europe, so we have good data on how well it works. Frankly, I think it works really well. We’ve seen nice improvements in [hemoglobin] A1c, time in range, other glycemic metrics, and patient satisfaction in studies done in Europe.

Now, I’ve never had the system to use in one of my patients. I always say I never know a system until I see it in use in my own patients, but let me tell you what I’ve read.

First, it has something called meal-detection technology with autocorrection boluses every 5 minutes. If this works, it can be a huge win for our patients because the problem my patients have is with mealtime dosing. They often dose late, or they may not dose enough insulin for the carbohydrates. That’s where the issues are.

All these hybrid closed-loop systems, this one included, show that the best improvements in glycemia are overnight. I’m hoping that this one shows some nice improvements in daytime glycemia as well. Stay tuned and I’ll let you know once I’ve been using it.

Next, it has adjustable targets down to 100. This is the lowest target for any hybrid closed-loop system. It has an extended-wear infusion set that lasts for 7 days. This infusion set is already available but works with this new system.

Finally, it has a new sensor. It looks like the old sensors, but it’s the Guardian 4, which requires much fewer finger sticks. Now, I’m not entirely sure about how often one has to do a finger stick. I know one has to do with finger sticking to initiate auto mode, or what they call SmartGuard, but I don’t know whether you ever have to do it again. I know for sure that you have to do it again if you fall out of the automated mode into manual mode. Once you’re in SmartGuard, I believe there are no further finger-stick calibrations required.

If people are already on the 770G system, this is just a software update that is presumably easy to upgrade to the 780G. Now, the physical pieces ... If someone doesn’t already have the Guardian 4 sensor or the extended-wear infusion set, they’ll have to get those. The software update to make the 770G increase to the 780G should just come through the cloud. I don’t know when that’s going to happen.

I do know that preorders for this system, if you want to buy the new physical system, start on May 15. The shipping of the new 780G system should occur in the United States toward the end of this summer.

I’m so excited. I think this is really going to benefit my patients. I can’t wait to start using it and letting patients see how these algorithms work and how they really help patients improve their glucose control.

Anne L. Peters, MD, is a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes programs. She reported conflicts of interest with Abbott Diabetes Care, Becton Dickinson, Boehringer Ingelheim, Eli Lilly, Lexicon Pharmaceuticals, Livongo, Medscape, Merck, Novo Nordisk, Omada Health, OptumHealth, Sanofi, Zafgen, Dexcom, MannKind, and AstraZeneca.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

There is wonderful news in the field of hybrid closed-loop pump technology because the Medtronic 780G system was just approved. I can’t tell you how happy this makes me because we’ve all been waiting for this seemingly forever and ever. This isn’t just a small upgrade from the 770G. It’s a quantum leap from the 770G to the 780G. The 780G has newer algorithms, a new sensor, and a longer-lasting infusion set.

USC Westside Center for Diabetes

It’s been used since 2020 in Europe, so we have good data on how well it works. Frankly, I think it works really well. We’ve seen nice improvements in [hemoglobin] A1c, time in range, other glycemic metrics, and patient satisfaction in studies done in Europe.

Now, I’ve never had the system to use in one of my patients. I always say I never know a system until I see it in use in my own patients, but let me tell you what I’ve read.

First, it has something called meal-detection technology with autocorrection boluses every 5 minutes. If this works, it can be a huge win for our patients because the problem my patients have is with mealtime dosing. They often dose late, or they may not dose enough insulin for the carbohydrates. That’s where the issues are.

All these hybrid closed-loop systems, this one included, show that the best improvements in glycemia are overnight. I’m hoping that this one shows some nice improvements in daytime glycemia as well. Stay tuned and I’ll let you know once I’ve been using it.

Next, it has adjustable targets down to 100. This is the lowest target for any hybrid closed-loop system. It has an extended-wear infusion set that lasts for 7 days. This infusion set is already available but works with this new system.

Finally, it has a new sensor. It looks like the old sensors, but it’s the Guardian 4, which requires much fewer finger sticks. Now, I’m not entirely sure about how often one has to do a finger stick. I know one has to do with finger sticking to initiate auto mode, or what they call SmartGuard, but I don’t know whether you ever have to do it again. I know for sure that you have to do it again if you fall out of the automated mode into manual mode. Once you’re in SmartGuard, I believe there are no further finger-stick calibrations required.

If people are already on the 770G system, this is just a software update that is presumably easy to upgrade to the 780G. Now, the physical pieces ... If someone doesn’t already have the Guardian 4 sensor or the extended-wear infusion set, they’ll have to get those. The software update to make the 770G increase to the 780G should just come through the cloud. I don’t know when that’s going to happen.

I do know that preorders for this system, if you want to buy the new physical system, start on May 15. The shipping of the new 780G system should occur in the United States toward the end of this summer.

I’m so excited. I think this is really going to benefit my patients. I can’t wait to start using it and letting patients see how these algorithms work and how they really help patients improve their glucose control.

Anne L. Peters, MD, is a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes programs. She reported conflicts of interest with Abbott Diabetes Care, Becton Dickinson, Boehringer Ingelheim, Eli Lilly, Lexicon Pharmaceuticals, Livongo, Medscape, Merck, Novo Nordisk, Omada Health, OptumHealth, Sanofi, Zafgen, Dexcom, MannKind, and AstraZeneca.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

There is wonderful news in the field of hybrid closed-loop pump technology because the Medtronic 780G system was just approved. I can’t tell you how happy this makes me because we’ve all been waiting for this seemingly forever and ever. This isn’t just a small upgrade from the 770G. It’s a quantum leap from the 770G to the 780G. The 780G has newer algorithms, a new sensor, and a longer-lasting infusion set.

USC Westside Center for Diabetes

It’s been used since 2020 in Europe, so we have good data on how well it works. Frankly, I think it works really well. We’ve seen nice improvements in [hemoglobin] A1c, time in range, other glycemic metrics, and patient satisfaction in studies done in Europe.

Now, I’ve never had the system to use in one of my patients. I always say I never know a system until I see it in use in my own patients, but let me tell you what I’ve read.

First, it has something called meal-detection technology with autocorrection boluses every 5 minutes. If this works, it can be a huge win for our patients because the problem my patients have is with mealtime dosing. They often dose late, or they may not dose enough insulin for the carbohydrates. That’s where the issues are.

All these hybrid closed-loop systems, this one included, show that the best improvements in glycemia are overnight. I’m hoping that this one shows some nice improvements in daytime glycemia as well. Stay tuned and I’ll let you know once I’ve been using it.

Next, it has adjustable targets down to 100. This is the lowest target for any hybrid closed-loop system. It has an extended-wear infusion set that lasts for 7 days. This infusion set is already available but works with this new system.

Finally, it has a new sensor. It looks like the old sensors, but it’s the Guardian 4, which requires much fewer finger sticks. Now, I’m not entirely sure about how often one has to do a finger stick. I know one has to do with finger sticking to initiate auto mode, or what they call SmartGuard, but I don’t know whether you ever have to do it again. I know for sure that you have to do it again if you fall out of the automated mode into manual mode. Once you’re in SmartGuard, I believe there are no further finger-stick calibrations required.

If people are already on the 770G system, this is just a software update that is presumably easy to upgrade to the 780G. Now, the physical pieces ... If someone doesn’t already have the Guardian 4 sensor or the extended-wear infusion set, they’ll have to get those. The software update to make the 770G increase to the 780G should just come through the cloud. I don’t know when that’s going to happen.

I do know that preorders for this system, if you want to buy the new physical system, start on May 15. The shipping of the new 780G system should occur in the United States toward the end of this summer.

I’m so excited. I think this is really going to benefit my patients. I can’t wait to start using it and letting patients see how these algorithms work and how they really help patients improve their glucose control.

Anne L. Peters, MD, is a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes programs. She reported conflicts of interest with Abbott Diabetes Care, Becton Dickinson, Boehringer Ingelheim, Eli Lilly, Lexicon Pharmaceuticals, Livongo, Medscape, Merck, Novo Nordisk, Omada Health, OptumHealth, Sanofi, Zafgen, Dexcom, MannKind, and AstraZeneca.

A version of this article first appeared on Medscape.com.

Using artificial intelligence to analyze large amounts of information from social media platforms generated some novel insights into public perceptions about statins, results of a new study show.

The study, which used AI to analyze discussions about statins on the social media platform Reddit, corroborated previously documented reasons for statin hesitancy, including adverse effect profiles and general disenfranchisement with health care.

But it also found novel points of discourse, including linking statins to COVID-19 outcomes and the role of cholesterol, statins, and the ketogenic diet.

“We used AI to tell us what is being discussed about statins on social media and to quantify the information in topics that people think are important,” senior study author Fatima Rodriguez, MD, MPH, Stanford (Calif.) University School of Medicine, said in an interview.

“Some of the themes were surprising to us. While we expected discussion on side effects, we were surprised to see so much discussion refuting the idea that increased levels of LDL were detrimental. There were also a large amount of posts on statin use being correlated to COVID outcomes. Our findings show how widespread this misinformation is,” she said.

“As a preventative cardiologist, I spend a lot of my time trying to get patients to take statins, but patients often rely on social media for information, and this can contain a lot of misinformation. People tend to be more honest on online forums than they are in the doctor’s office, so they are probably asking the questions and having discussions on subjects they really care about. So, understanding what is being discussed on social media is very valuable information for us as clinicians.”

The study was published online in JAMA Network Open.

The researchers analyzed all statin-related discussions on Reddit that were dated between Jan. 1, 2009, and July 12, 2022. Statin- and cholesterol-focused communities were identified to create a list of statin-related discussions. An AI pipeline was developed to cluster these discussions into specific topics and overarching thematic groups.

A total of 10,233 unique statin-related discussions and 5,188 unique authors were identified. A total of 100 discussion topics were identified and classified into six overarching thematic groups: (1) ketogenic diets, diabetes, supplements, and statins; (2) statin adverse effects; (3) statin hesitancy; (4) clinical trial appraisals; (5) pharmaceutical industry bias and statins; and (6) red yeast rice and statins.

Several examples of statin-related misinformation were identified, including distrust of the hypothesis that LDL-C has a causal association with heart disease. Discussions included quotes such as, “I think LDL is pretty much irrelevant. Your HDL and triglycerides are far more important.”

Other topics suggested that certain natural supplements would be an acceptable alternative to statins. Quotes included: “Red yeast rice is a statin basically, by the way,” and “statins are basically mycotoxins and deplete you of fat-soluble nutrients, like coQ10, vit D, K, A and E, and in all likelihood through these depletions worsen cardiovascular health.”

The researchers also looked at temporal trends and found that these sorts of discussions have increased over time.

One of the common themes identified was using the ketogenic diet phenomenon as an argument against increased cholesterol levels being bad for health.

Dr. Rodriguez elaborated: “People think the ketogenic diet is healthy as they lose weight on it. And as it can be associated with a small increase in LDL cholesterol, there was a lot of opinion that this meant increasing LDL was a good thing.”

The researchers also conducted a sentiment analysis, which designated topics as positive, negative, or neutral with regard to statins.  

“We found that almost no topic was positive. Everything was either neutral or negative. This is pretty consistent with what we are seeing around hesitancy in clinical practice, but you would think that maybe a few people may have a positive view on statins,” Dr. Rodriguez commented.

“One of the problems with statins and lowering cholesterol is that it takes a long time to see a benefit, but this misinformation will result in some people not taking their medication,” she added.

Dr. Rodriguez noted that in this study AI is augmenting, not replacing, what clinicians and researchers do. “But it is a valuable tool to scan a large volume of information, and we have shown here it can generate new insights that we may not have thought of. It’s important to know what’s out there so we can try and combat it.” 

She pointed out that patients don’t read the medical literature showing the benefits of statins but rather rely on social media for their information. 

“We need to understand all sorts of patient engagement and use the same tools to combat this misinformation. We have a responsibility to try and stop dangerous and false information from being propagated,” she commented.

“These drugs are clearly not dangerous when used in line with clinical guidelines, and they have been proven to have multiple benefits again and again, but we don’t see those kinds of discussions in the community at all. We as clinicians need to use social media and AI to give out the right information. This could start to combat all the misinformation out there.”

A version of this article first appeared on Medscape.com.

Using artificial intelligence to analyze large amounts of information from social media platforms generated some novel insights into public perceptions about statins, results of a new study show.

The study, which used AI to analyze discussions about statins on the social media platform Reddit, corroborated previously documented reasons for statin hesitancy, including adverse effect profiles and general disenfranchisement with health care.

But it also found novel points of discourse, including linking statins to COVID-19 outcomes and the role of cholesterol, statins, and the ketogenic diet.

“We used AI to tell us what is being discussed about statins on social media and to quantify the information in topics that people think are important,” senior study author Fatima Rodriguez, MD, MPH, Stanford (Calif.) University School of Medicine, said in an interview.

“Some of the themes were surprising to us. While we expected discussion on side effects, we were surprised to see so much discussion refuting the idea that increased levels of LDL were detrimental. There were also a large amount of posts on statin use being correlated to COVID outcomes. Our findings show how widespread this misinformation is,” she said.

“As a preventative cardiologist, I spend a lot of my time trying to get patients to take statins, but patients often rely on social media for information, and this can contain a lot of misinformation. People tend to be more honest on online forums than they are in the doctor’s office, so they are probably asking the questions and having discussions on subjects they really care about. So, understanding what is being discussed on social media is very valuable information for us as clinicians.”

The study was published online in JAMA Network Open.

The researchers analyzed all statin-related discussions on Reddit that were dated between Jan. 1, 2009, and July 12, 2022. Statin- and cholesterol-focused communities were identified to create a list of statin-related discussions. An AI pipeline was developed to cluster these discussions into specific topics and overarching thematic groups.

A total of 10,233 unique statin-related discussions and 5,188 unique authors were identified. A total of 100 discussion topics were identified and classified into six overarching thematic groups: (1) ketogenic diets, diabetes, supplements, and statins; (2) statin adverse effects; (3) statin hesitancy; (4) clinical trial appraisals; (5) pharmaceutical industry bias and statins; and (6) red yeast rice and statins.

Several examples of statin-related misinformation were identified, including distrust of the hypothesis that LDL-C has a causal association with heart disease. Discussions included quotes such as, “I think LDL is pretty much irrelevant. Your HDL and triglycerides are far more important.”

Other topics suggested that certain natural supplements would be an acceptable alternative to statins. Quotes included: “Red yeast rice is a statin basically, by the way,” and “statins are basically mycotoxins and deplete you of fat-soluble nutrients, like coQ10, vit D, K, A and E, and in all likelihood through these depletions worsen cardiovascular health.”

The researchers also looked at temporal trends and found that these sorts of discussions have increased over time.

One of the common themes identified was using the ketogenic diet phenomenon as an argument against increased cholesterol levels being bad for health.

Dr. Rodriguez elaborated: “People think the ketogenic diet is healthy as they lose weight on it. And as it can be associated with a small increase in LDL cholesterol, there was a lot of opinion that this meant increasing LDL was a good thing.”

The researchers also conducted a sentiment analysis, which designated topics as positive, negative, or neutral with regard to statins.  

“We found that almost no topic was positive. Everything was either neutral or negative. This is pretty consistent with what we are seeing around hesitancy in clinical practice, but you would think that maybe a few people may have a positive view on statins,” Dr. Rodriguez commented.

“One of the problems with statins and lowering cholesterol is that it takes a long time to see a benefit, but this misinformation will result in some people not taking their medication,” she added.

Dr. Rodriguez noted that in this study AI is augmenting, not replacing, what clinicians and researchers do. “But it is a valuable tool to scan a large volume of information, and we have shown here it can generate new insights that we may not have thought of. It’s important to know what’s out there so we can try and combat it.” 

She pointed out that patients don’t read the medical literature showing the benefits of statins but rather rely on social media for their information. 

“We need to understand all sorts of patient engagement and use the same tools to combat this misinformation. We have a responsibility to try and stop dangerous and false information from being propagated,” she commented.

“These drugs are clearly not dangerous when used in line with clinical guidelines, and they have been proven to have multiple benefits again and again, but we don’t see those kinds of discussions in the community at all. We as clinicians need to use social media and AI to give out the right information. This could start to combat all the misinformation out there.”

A version of this article first appeared on Medscape.com.

Using artificial intelligence to analyze large amounts of information from social media platforms generated some novel insights into public perceptions about statins, results of a new study show.

The study, which used AI to analyze discussions about statins on the social media platform Reddit, corroborated previously documented reasons for statin hesitancy, including adverse effect profiles and general disenfranchisement with health care.

But it also found novel points of discourse, including linking statins to COVID-19 outcomes and the role of cholesterol, statins, and the ketogenic diet.

“We used AI to tell us what is being discussed about statins on social media and to quantify the information in topics that people think are important,” senior study author Fatima Rodriguez, MD, MPH, Stanford (Calif.) University School of Medicine, said in an interview.

“Some of the themes were surprising to us. While we expected discussion on side effects, we were surprised to see so much discussion refuting the idea that increased levels of LDL were detrimental. There were also a large amount of posts on statin use being correlated to COVID outcomes. Our findings show how widespread this misinformation is,” she said.

“As a preventative cardiologist, I spend a lot of my time trying to get patients to take statins, but patients often rely on social media for information, and this can contain a lot of misinformation. People tend to be more honest on online forums than they are in the doctor’s office, so they are probably asking the questions and having discussions on subjects they really care about. So, understanding what is being discussed on social media is very valuable information for us as clinicians.”

The study was published online in JAMA Network Open.

The researchers analyzed all statin-related discussions on Reddit that were dated between Jan. 1, 2009, and July 12, 2022. Statin- and cholesterol-focused communities were identified to create a list of statin-related discussions. An AI pipeline was developed to cluster these discussions into specific topics and overarching thematic groups.

A total of 10,233 unique statin-related discussions and 5,188 unique authors were identified. A total of 100 discussion topics were identified and classified into six overarching thematic groups: (1) ketogenic diets, diabetes, supplements, and statins; (2) statin adverse effects; (3) statin hesitancy; (4) clinical trial appraisals; (5) pharmaceutical industry bias and statins; and (6) red yeast rice and statins.

Several examples of statin-related misinformation were identified, including distrust of the hypothesis that LDL-C has a causal association with heart disease. Discussions included quotes such as, “I think LDL is pretty much irrelevant. Your HDL and triglycerides are far more important.”

Other topics suggested that certain natural supplements would be an acceptable alternative to statins. Quotes included: “Red yeast rice is a statin basically, by the way,” and “statins are basically mycotoxins and deplete you of fat-soluble nutrients, like coQ10, vit D, K, A and E, and in all likelihood through these depletions worsen cardiovascular health.”

The researchers also looked at temporal trends and found that these sorts of discussions have increased over time.

One of the common themes identified was using the ketogenic diet phenomenon as an argument against increased cholesterol levels being bad for health.

Dr. Rodriguez elaborated: “People think the ketogenic diet is healthy as they lose weight on it. And as it can be associated with a small increase in LDL cholesterol, there was a lot of opinion that this meant increasing LDL was a good thing.”

The researchers also conducted a sentiment analysis, which designated topics as positive, negative, or neutral with regard to statins.  

“We found that almost no topic was positive. Everything was either neutral or negative. This is pretty consistent with what we are seeing around hesitancy in clinical practice, but you would think that maybe a few people may have a positive view on statins,” Dr. Rodriguez commented.

“One of the problems with statins and lowering cholesterol is that it takes a long time to see a benefit, but this misinformation will result in some people not taking their medication,” she added.

Dr. Rodriguez noted that in this study AI is augmenting, not replacing, what clinicians and researchers do. “But it is a valuable tool to scan a large volume of information, and we have shown here it can generate new insights that we may not have thought of. It’s important to know what’s out there so we can try and combat it.” 

She pointed out that patients don’t read the medical literature showing the benefits of statins but rather rely on social media for their information. 

“We need to understand all sorts of patient engagement and use the same tools to combat this misinformation. We have a responsibility to try and stop dangerous and false information from being propagated,” she commented.

“These drugs are clearly not dangerous when used in line with clinical guidelines, and they have been proven to have multiple benefits again and again, but we don’t see those kinds of discussions in the community at all. We as clinicians need to use social media and AI to give out the right information. This could start to combat all the misinformation out there.”

A version of this article first appeared on Medscape.com.

SAN DIEGO – A COVID-19 combination antiviral is the most important new drug primary care physicians have prescribed in recent years – plus it has helped keep many patients out of the hospital, according to a presenter at the annual meeting of the American College of Physicians.

Nirmatrelvir-ritonavir was granted emergency use authorization by the FDA late in 2021 to prevent progression to severe disease when COVID-19 cases and deaths were surging, and the Delta and Omicron variants started to spread.

Gerald Smetana, MD, an internist at Beth Israel Deaconess Medical Center in Boston, discussed nirmatrelvir-ritonavir as an example of how new drugs relevant to primary care can have a profound impact on public health.
 

Understanding the mechanism of action

Nirmatrelvir is the active agent of this combination and inhibits the SARS-CoV-2 main protease (Mpro), which is required for viral replication. In contrast to the SARS-CoV-2 spike protein, Mpro is highly conserved in coronaviruses and rarely acquires mutations. Therefore, unlike monoclonal antibodies targeting the spike protein, nirmatrelvir is active against known Omicron variants and is predicted to remain active against new variants that may emerge. The HIV1 protease inhibitor ritonavir has no activity against SARS-CoV-2. It can help increase the serum concentration of nirmatrelvir by inhibiting its metabolization.

“Although the details are not important for prescribing internists, having a basic understanding of the mechanism of action can help [doctors] better understand for which patients the drugs are indicated,” said Dr. Smetana, also a professor of medicine at Harvard Medical School, Boston. This is particularly important for newly approved drugs with a lot of new information to digest.

“Knowing the mechanisms of action of new drugs can help us predict their efficacy and potential side effects,” said Hubertus Kiefl, MD, an internist at Beth Israel Deaconess Medical Center and a lecturer at Harvard Medical School, during an interview after the session.

Understanding how drugs work also can help clinicians make better decisions, such as avoiding the use of a monoclonal antibody during a surge of a new variant with mutations in surface proteins or carefully managing the use of nirmatrelvir-ritonavir in patients who take certain medications that would cause potentially serious drug-drug interactions, Dr. Kiefl added.

Nirmatrelvir-ritonavir reduces the risk of hospitalization – but only in high-risk patients.

Dr. Smetana presented published data from the EPIC-HR study, a pivotal phase 2-3 clinical trial in 2,246 adult patients with COVID-19, all of whom were unvaccinated. Additionally, all patients had at least one risk factor for progression to severe disease.

When initiated 5 days after symptom onset or earlier, treatment with 300 mg nirmatrelvir plus 100 mg ritonavir twice a day for 5 days led to an 89% relative risk reduction in COVID-19–related hospitalization or death through day 28, compared with placebo.

Subgroup analyses showed that some patients benefited more than others. The highest risk reduction after treatment with nirmatrelvir-ritonavir was observed in patients at least 65 years old.

“It is important to remember that all the patients of this study were unvaccinated and [had] not had prior SARS-CoV-2 infection. This study population isn’t representative of most patients we are seeing today,” said Dr. Smetana.

Unpublished data from a study of standard-risk patients showed a nonsignificant reduction in the risk of hospitalization or death, he said. The study was stopped because of the low rates of hospitalization and death.
 

Effective in real world, but less so than in clinical trials

The fact that the patient cohort in the EPIC-HR trial was different from the patients internists see today makes real-world data critical for determining the usefulness of nirmatrelvir-ritonavir in everyday practice, Dr. Smetana said.

A real-world study from Israel conducted during the first Omicron wave (January to March 2022) showed that treatment with nirmatrelvir alone substantially reduced the relative risk of hospitalization in adults older than 65, with no evidence of benefit in adults aged 40-65. Dr. Smetana highlighted that, unlike the EPIC-HR cohort, most patients in the Israeli study had prior immunity due to vaccination or prior SARS-CoV-2 infection.
 

Many drug-drug interactions, but they can be managed

Nirmatrelvir-ritonavir interacts with many drugs, some of which are commonly used by primary care patients.

To help internists identify drug-drug interactions, Dr. Smetana proposed the use of the Liverpool COVID-19 Drug Interactions Checker, an intuitive tool that can help prescribers identify potential drug-drug interactions, categorize them based on severity, and identify management strategies.

This tool is specific to COVID-19 drugs. The Liverpool group also offers online drug interaction checkers for HIV, hepatitis, and cancer. “We need more tools like this to help improve the safe use of new drugs,” Dr. Smetana said.

To manage drug interactions, according to Dr. Smetana, U.S. treatment guidelines offer the following three options:

• Prescribe an alternative COVID therapy.
• Temporarily withhold concomitant medication if clinically appropriate.
• Adjust the dose of concomitant medication and monitor for adverse effects.

Medication doses that are withheld or modified should be continued through 3 days after completing nirmatrelvir-ritonavir, he added.
 

Important considerations

Commenting on things to consider for patients with COVID-19, Dr. Smetana said that there is a short window after symptom onset when nirmatrelvir-ritonavir can be prescribed, and safety in pregnancy is not known. There is also uncertainty regarding funding of nirmatrelvir-ritonavir prescriptions after the state of emergency is lifted. He reminded attendees that, although nirmatrelvir-ritonavir is the preferred first-line treatment for high-risk patients, another antiviral agent, molnupiravir, is also available and might be more appropriate for some patients.

He also cautioned about prescribing new drugs off label for indications that are not yet FDA-approved. “We are often stewards of limited resources when new drugs first become available but are not yet in sufficient supply to meet demand. Limiting our prescribing to FDA-approved indications helps to ensure equitable access,” he said.

Dr. Smetana and Dr. Kiefl reported no disclosures.

SAN DIEGO – A COVID-19 combination antiviral is the most important new drug primary care physicians have prescribed in recent years – plus it has helped keep many patients out of the hospital, according to a presenter at the annual meeting of the American College of Physicians.

Nirmatrelvir-ritonavir was granted emergency use authorization by the FDA late in 2021 to prevent progression to severe disease when COVID-19 cases and deaths were surging, and the Delta and Omicron variants started to spread.

Gerald Smetana, MD, an internist at Beth Israel Deaconess Medical Center in Boston, discussed nirmatrelvir-ritonavir as an example of how new drugs relevant to primary care can have a profound impact on public health.
 

Understanding the mechanism of action

Nirmatrelvir is the active agent of this combination and inhibits the SARS-CoV-2 main protease (Mpro), which is required for viral replication. In contrast to the SARS-CoV-2 spike protein, Mpro is highly conserved in coronaviruses and rarely acquires mutations. Therefore, unlike monoclonal antibodies targeting the spike protein, nirmatrelvir is active against known Omicron variants and is predicted to remain active against new variants that may emerge. The HIV1 protease inhibitor ritonavir has no activity against SARS-CoV-2. It can help increase the serum concentration of nirmatrelvir by inhibiting its metabolization.

“Although the details are not important for prescribing internists, having a basic understanding of the mechanism of action can help [doctors] better understand for which patients the drugs are indicated,” said Dr. Smetana, also a professor of medicine at Harvard Medical School, Boston. This is particularly important for newly approved drugs with a lot of new information to digest.

“Knowing the mechanisms of action of new drugs can help us predict their efficacy and potential side effects,” said Hubertus Kiefl, MD, an internist at Beth Israel Deaconess Medical Center and a lecturer at Harvard Medical School, during an interview after the session.

Understanding how drugs work also can help clinicians make better decisions, such as avoiding the use of a monoclonal antibody during a surge of a new variant with mutations in surface proteins or carefully managing the use of nirmatrelvir-ritonavir in patients who take certain medications that would cause potentially serious drug-drug interactions, Dr. Kiefl added.

Nirmatrelvir-ritonavir reduces the risk of hospitalization – but only in high-risk patients.

Dr. Smetana presented published data from the EPIC-HR study, a pivotal phase 2-3 clinical trial in 2,246 adult patients with COVID-19, all of whom were unvaccinated. Additionally, all patients had at least one risk factor for progression to severe disease.

When initiated 5 days after symptom onset or earlier, treatment with 300 mg nirmatrelvir plus 100 mg ritonavir twice a day for 5 days led to an 89% relative risk reduction in COVID-19–related hospitalization or death through day 28, compared with placebo.

Subgroup analyses showed that some patients benefited more than others. The highest risk reduction after treatment with nirmatrelvir-ritonavir was observed in patients at least 65 years old.

“It is important to remember that all the patients of this study were unvaccinated and [had] not had prior SARS-CoV-2 infection. This study population isn’t representative of most patients we are seeing today,” said Dr. Smetana.

Unpublished data from a study of standard-risk patients showed a nonsignificant reduction in the risk of hospitalization or death, he said. The study was stopped because of the low rates of hospitalization and death.
 

Effective in real world, but less so than in clinical trials

The fact that the patient cohort in the EPIC-HR trial was different from the patients internists see today makes real-world data critical for determining the usefulness of nirmatrelvir-ritonavir in everyday practice, Dr. Smetana said.

A real-world study from Israel conducted during the first Omicron wave (January to March 2022) showed that treatment with nirmatrelvir alone substantially reduced the relative risk of hospitalization in adults older than 65, with no evidence of benefit in adults aged 40-65. Dr. Smetana highlighted that, unlike the EPIC-HR cohort, most patients in the Israeli study had prior immunity due to vaccination or prior SARS-CoV-2 infection.
 

Many drug-drug interactions, but they can be managed

Nirmatrelvir-ritonavir interacts with many drugs, some of which are commonly used by primary care patients.

To help internists identify drug-drug interactions, Dr. Smetana proposed the use of the Liverpool COVID-19 Drug Interactions Checker, an intuitive tool that can help prescribers identify potential drug-drug interactions, categorize them based on severity, and identify management strategies.

This tool is specific to COVID-19 drugs. The Liverpool group also offers online drug interaction checkers for HIV, hepatitis, and cancer. “We need more tools like this to help improve the safe use of new drugs,” Dr. Smetana said.

To manage drug interactions, according to Dr. Smetana, U.S. treatment guidelines offer the following three options:

• Prescribe an alternative COVID therapy.
• Temporarily withhold concomitant medication if clinically appropriate.
• Adjust the dose of concomitant medication and monitor for adverse effects.

Medication doses that are withheld or modified should be continued through 3 days after completing nirmatrelvir-ritonavir, he added.
 

Important considerations

Commenting on things to consider for patients with COVID-19, Dr. Smetana said that there is a short window after symptom onset when nirmatrelvir-ritonavir can be prescribed, and safety in pregnancy is not known. There is also uncertainty regarding funding of nirmatrelvir-ritonavir prescriptions after the state of emergency is lifted. He reminded attendees that, although nirmatrelvir-ritonavir is the preferred first-line treatment for high-risk patients, another antiviral agent, molnupiravir, is also available and might be more appropriate for some patients.

He also cautioned about prescribing new drugs off label for indications that are not yet FDA-approved. “We are often stewards of limited resources when new drugs first become available but are not yet in sufficient supply to meet demand. Limiting our prescribing to FDA-approved indications helps to ensure equitable access,” he said.

Dr. Smetana and Dr. Kiefl reported no disclosures.

SAN DIEGO – A COVID-19 combination antiviral is the most important new drug primary care physicians have prescribed in recent years – plus it has helped keep many patients out of the hospital, according to a presenter at the annual meeting of the American College of Physicians.

Nirmatrelvir-ritonavir was granted emergency use authorization by the FDA late in 2021 to prevent progression to severe disease when COVID-19 cases and deaths were surging, and the Delta and Omicron variants started to spread.

Gerald Smetana, MD, an internist at Beth Israel Deaconess Medical Center in Boston, discussed nirmatrelvir-ritonavir as an example of how new drugs relevant to primary care can have a profound impact on public health.
 

Understanding the mechanism of action

Nirmatrelvir is the active agent of this combination and inhibits the SARS-CoV-2 main protease (Mpro), which is required for viral replication. In contrast to the SARS-CoV-2 spike protein, Mpro is highly conserved in coronaviruses and rarely acquires mutations. Therefore, unlike monoclonal antibodies targeting the spike protein, nirmatrelvir is active against known Omicron variants and is predicted to remain active against new variants that may emerge. The HIV1 protease inhibitor ritonavir has no activity against SARS-CoV-2. It can help increase the serum concentration of nirmatrelvir by inhibiting its metabolization.

“Although the details are not important for prescribing internists, having a basic understanding of the mechanism of action can help [doctors] better understand for which patients the drugs are indicated,” said Dr. Smetana, also a professor of medicine at Harvard Medical School, Boston. This is particularly important for newly approved drugs with a lot of new information to digest.

“Knowing the mechanisms of action of new drugs can help us predict their efficacy and potential side effects,” said Hubertus Kiefl, MD, an internist at Beth Israel Deaconess Medical Center and a lecturer at Harvard Medical School, during an interview after the session.

Understanding how drugs work also can help clinicians make better decisions, such as avoiding the use of a monoclonal antibody during a surge of a new variant with mutations in surface proteins or carefully managing the use of nirmatrelvir-ritonavir in patients who take certain medications that would cause potentially serious drug-drug interactions, Dr. Kiefl added.

Nirmatrelvir-ritonavir reduces the risk of hospitalization – but only in high-risk patients.

Dr. Smetana presented published data from the EPIC-HR study, a pivotal phase 2-3 clinical trial in 2,246 adult patients with COVID-19, all of whom were unvaccinated. Additionally, all patients had at least one risk factor for progression to severe disease.

When initiated 5 days after symptom onset or earlier, treatment with 300 mg nirmatrelvir plus 100 mg ritonavir twice a day for 5 days led to an 89% relative risk reduction in COVID-19–related hospitalization or death through day 28, compared with placebo.

Subgroup analyses showed that some patients benefited more than others. The highest risk reduction after treatment with nirmatrelvir-ritonavir was observed in patients at least 65 years old.

“It is important to remember that all the patients of this study were unvaccinated and [had] not had prior SARS-CoV-2 infection. This study population isn’t representative of most patients we are seeing today,” said Dr. Smetana.

Unpublished data from a study of standard-risk patients showed a nonsignificant reduction in the risk of hospitalization or death, he said. The study was stopped because of the low rates of hospitalization and death.
 

Effective in real world, but less so than in clinical trials

The fact that the patient cohort in the EPIC-HR trial was different from the patients internists see today makes real-world data critical for determining the usefulness of nirmatrelvir-ritonavir in everyday practice, Dr. Smetana said.

A real-world study from Israel conducted during the first Omicron wave (January to March 2022) showed that treatment with nirmatrelvir alone substantially reduced the relative risk of hospitalization in adults older than 65, with no evidence of benefit in adults aged 40-65. Dr. Smetana highlighted that, unlike the EPIC-HR cohort, most patients in the Israeli study had prior immunity due to vaccination or prior SARS-CoV-2 infection.
 

Many drug-drug interactions, but they can be managed

Nirmatrelvir-ritonavir interacts with many drugs, some of which are commonly used by primary care patients.

To help internists identify drug-drug interactions, Dr. Smetana proposed the use of the Liverpool COVID-19 Drug Interactions Checker, an intuitive tool that can help prescribers identify potential drug-drug interactions, categorize them based on severity, and identify management strategies.

This tool is specific to COVID-19 drugs. The Liverpool group also offers online drug interaction checkers for HIV, hepatitis, and cancer. “We need more tools like this to help improve the safe use of new drugs,” Dr. Smetana said.

To manage drug interactions, according to Dr. Smetana, U.S. treatment guidelines offer the following three options:

• Prescribe an alternative COVID therapy.
• Temporarily withhold concomitant medication if clinically appropriate.
• Adjust the dose of concomitant medication and monitor for adverse effects.

Medication doses that are withheld or modified should be continued through 3 days after completing nirmatrelvir-ritonavir, he added.
 

Important considerations

Commenting on things to consider for patients with COVID-19, Dr. Smetana said that there is a short window after symptom onset when nirmatrelvir-ritonavir can be prescribed, and safety in pregnancy is not known. There is also uncertainty regarding funding of nirmatrelvir-ritonavir prescriptions after the state of emergency is lifted. He reminded attendees that, although nirmatrelvir-ritonavir is the preferred first-line treatment for high-risk patients, another antiviral agent, molnupiravir, is also available and might be more appropriate for some patients.

He also cautioned about prescribing new drugs off label for indications that are not yet FDA-approved. “We are often stewards of limited resources when new drugs first become available but are not yet in sufficient supply to meet demand. Limiting our prescribing to FDA-approved indications helps to ensure equitable access,” he said.

Dr. Smetana and Dr. Kiefl reported no disclosures.

The Food and Drug Administration has asked the manufacturer of the investigational drug for alopecia areata, deuruxolitinib to stop trials of the 12-mg dose because of the potential for thrombotic events, the company said in a press release on May 2.

The announcement came after a pulmonary embolism occurred with the 12-mg twice-daily dose in one of the long-term open-label extension (OLE) studies, the company, Sun Pharmaceutical Industries, said.

The company stated that the FDA has placed the Investigational New Drug testing for deuruxolitinib on partial clinical hold, and the agency is requiring that study participants who are currently on the 12-mg twice-daily dose in the OLE studies stop taking that dose. The hold covers only the 12-mg dose.
 

No hold on 8-mg dose

“There have been no thrombotic events reported to date for the 8-mg b.i.d. dose and U.S. FDA has not placed the 8-mg b.i.d. dose on hold,” the company said in the statement.

The statement added, “We are taking immediate steps to transition the patients in the OLE studies to the 8-mg b.i.d. dose arm in the ongoing studies.”

The company said that no thromboembolic events were observed in the phase 2 or phase 3 trials and said that it will work closely with the FDA to address its concerns. A formal letter detailing the FDA’s concerns is expected within 30 days.

Deuruxolitinib is an investigational oral selective inhibitor of Janus kinase 1 (JAK1) and JAK2 enzymes.

The FDA has granted deuruxolitinib breakthrough therapy designation for the treatment of adult patients with moderate to severe alopecia areata as well as fast-track designation for the treatment of alopecia areata.

In March, this news organization reported from the annual meeting of the American Academy of Dermatology that, based on phase 3 studies that demonstrate robust hair growth in about one-third of patients, deuruxolitinib has the potential to become the second JAK inhibitor available for the treatment of alopecia areata. If approved, it will join baricitinib (Olumiant), which received FDA approval almost 1 year ago.

Also at the AAD annual meeting, this news organization reported that principal investigator Brett A. King, MD, PhD, associate professor of dermatology, Yale University, New Haven, Conn., in his presentation on the results of THRIVE-AA2, one of the two phase 3 trials of deuruxolitinib, displayed several before-and-after photos and said, “The photos tell the whole story. This is why there is so much excitement about these drugs.” Dr King also was a principal investigator in studies of baricitinib.

With one exception, labeling for baricitinib and other JAK inhibitors with dermatologic indications includes a boxed warning listing serious adverse events including the risk for major adverse cardiac events and thrombosis, including pulmonary embolism, based on the risks in a rheumatoid arthritis study.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has asked the manufacturer of the investigational drug for alopecia areata, deuruxolitinib to stop trials of the 12-mg dose because of the potential for thrombotic events, the company said in a press release on May 2.

The announcement came after a pulmonary embolism occurred with the 12-mg twice-daily dose in one of the long-term open-label extension (OLE) studies, the company, Sun Pharmaceutical Industries, said.

The company stated that the FDA has placed the Investigational New Drug testing for deuruxolitinib on partial clinical hold, and the agency is requiring that study participants who are currently on the 12-mg twice-daily dose in the OLE studies stop taking that dose. The hold covers only the 12-mg dose.
 

No hold on 8-mg dose

“There have been no thrombotic events reported to date for the 8-mg b.i.d. dose and U.S. FDA has not placed the 8-mg b.i.d. dose on hold,” the company said in the statement.

The statement added, “We are taking immediate steps to transition the patients in the OLE studies to the 8-mg b.i.d. dose arm in the ongoing studies.”

The company said that no thromboembolic events were observed in the phase 2 or phase 3 trials and said that it will work closely with the FDA to address its concerns. A formal letter detailing the FDA’s concerns is expected within 30 days.

Deuruxolitinib is an investigational oral selective inhibitor of Janus kinase 1 (JAK1) and JAK2 enzymes.

The FDA has granted deuruxolitinib breakthrough therapy designation for the treatment of adult patients with moderate to severe alopecia areata as well as fast-track designation for the treatment of alopecia areata.

In March, this news organization reported from the annual meeting of the American Academy of Dermatology that, based on phase 3 studies that demonstrate robust hair growth in about one-third of patients, deuruxolitinib has the potential to become the second JAK inhibitor available for the treatment of alopecia areata. If approved, it will join baricitinib (Olumiant), which received FDA approval almost 1 year ago.

Also at the AAD annual meeting, this news organization reported that principal investigator Brett A. King, MD, PhD, associate professor of dermatology, Yale University, New Haven, Conn., in his presentation on the results of THRIVE-AA2, one of the two phase 3 trials of deuruxolitinib, displayed several before-and-after photos and said, “The photos tell the whole story. This is why there is so much excitement about these drugs.” Dr King also was a principal investigator in studies of baricitinib.

With one exception, labeling for baricitinib and other JAK inhibitors with dermatologic indications includes a boxed warning listing serious adverse events including the risk for major adverse cardiac events and thrombosis, including pulmonary embolism, based on the risks in a rheumatoid arthritis study.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has asked the manufacturer of the investigational drug for alopecia areata, deuruxolitinib to stop trials of the 12-mg dose because of the potential for thrombotic events, the company said in a press release on May 2.

The announcement came after a pulmonary embolism occurred with the 12-mg twice-daily dose in one of the long-term open-label extension (OLE) studies, the company, Sun Pharmaceutical Industries, said.

The company stated that the FDA has placed the Investigational New Drug testing for deuruxolitinib on partial clinical hold, and the agency is requiring that study participants who are currently on the 12-mg twice-daily dose in the OLE studies stop taking that dose. The hold covers only the 12-mg dose.
 

No hold on 8-mg dose

“There have been no thrombotic events reported to date for the 8-mg b.i.d. dose and U.S. FDA has not placed the 8-mg b.i.d. dose on hold,” the company said in the statement.

The statement added, “We are taking immediate steps to transition the patients in the OLE studies to the 8-mg b.i.d. dose arm in the ongoing studies.”

The company said that no thromboembolic events were observed in the phase 2 or phase 3 trials and said that it will work closely with the FDA to address its concerns. A formal letter detailing the FDA’s concerns is expected within 30 days.

Deuruxolitinib is an investigational oral selective inhibitor of Janus kinase 1 (JAK1) and JAK2 enzymes.

The FDA has granted deuruxolitinib breakthrough therapy designation for the treatment of adult patients with moderate to severe alopecia areata as well as fast-track designation for the treatment of alopecia areata.

In March, this news organization reported from the annual meeting of the American Academy of Dermatology that, based on phase 3 studies that demonstrate robust hair growth in about one-third of patients, deuruxolitinib has the potential to become the second JAK inhibitor available for the treatment of alopecia areata. If approved, it will join baricitinib (Olumiant), which received FDA approval almost 1 year ago.

Also at the AAD annual meeting, this news organization reported that principal investigator Brett A. King, MD, PhD, associate professor of dermatology, Yale University, New Haven, Conn., in his presentation on the results of THRIVE-AA2, one of the two phase 3 trials of deuruxolitinib, displayed several before-and-after photos and said, “The photos tell the whole story. This is why there is so much excitement about these drugs.” Dr King also was a principal investigator in studies of baricitinib.

With one exception, labeling for baricitinib and other JAK inhibitors with dermatologic indications includes a boxed warning listing serious adverse events including the risk for major adverse cardiac events and thrombosis, including pulmonary embolism, based on the risks in a rheumatoid arthritis study.

A version of this article first appeared on Medscape.com.