MDedge Endocrinology

Drinking two to three daily cups of – ground, instant, or decaffeinated – is associated with significant reductions in new cardiovascular disease (CVD) and mortality risk, compared with avoiding coffee, a new analysis of the prospective UK Biobank suggests.

Ground and instant coffee, but not decaffeinated coffee, also was associated with reduced risk of new-onset arrhythmia, including atrial fibrillation.

Visual_Intermezzo/iStock/Getty Images Plus

“Our study is the first to look at differences in coffee subtypes to tease out important differences which may explain some of the mechanisms through which coffee works,” Peter M. Kistler, MD, of the Alfred Hospital and Baker Heart and Diabetes Institute, Melbourne, Australia, told this news organization.

“Daily coffee intake should not be discouraged by physicians but rather considered part of a healthy diet,” Dr. Kistler said.

“This study supports that coffee is safe and even potentially beneficial, which is consistent with most of the prior evidence,” Carl “Chip” Lavie, MD, who wasn’t involved in the study, told this news organization.

“We do not prescribe coffee to patients, but for the majority who like coffee, they can be encouraged it is fine to take a few cups daily,” said Dr. Lavie, with the Ochsner Heart and Vascular Institute in New Orleans.

The study was published online in the European Journal of Preventive Cardiology.

 

Clear cardiovascular benefits

A total of 449,563 UK Biobank participants (median age 58 years; 55% women), who were free of arrhythmias or other CVD at baseline, reported in questionnaires their level of daily coffee intake and preferred type of coffee.

During more than 12.5 years of follow-up, 27,809 participants (6.2%) died.

Drinking one to five cups per day of ground or instant coffee (but not decaffeinated coffee) was associated with a significant reduction in incident arrhythmia. The lowest risk was with four to five cups per day for ground coffee (hazard ratio [HR] 0.83; 95% confidence interval [CI], 0.76-0.91; P < .0001) and two to three cups per day for instant coffee (HR, 0.88; 95% CI, 0.85-0.92; P < .0001).

Habitual coffee drinking of up to five cups perday was also associated with significant reductions in the risk of incident CVD, when compared with nondrinkers.

Significant reductions in the risk of incident coronary heart disease (CHD) were associated with habitual coffee intake of up to five cups per day, with the lowest risk for CHD observed in those who consumed two to three cups per day (HR 0.89; 95% CI, 0.86-0.91; P < .0001).

Coffee consumption at all levels was linked to significant reduction in the risk of congestive cardiac failure (CCF) and ischemic stroke. The lowest risks were observed in those who consumed two to three cups per day, with HR, 0.83 (95% CI, 0.79-0.87; P < .0001) for CCF and HR, 0.84 (95% CI, 0.78-0.90; P < .0001) for ischemic stroke.

Death from any cause was significantly reduced for all coffee subtypes, with the greatest risk reduction seen with two to three cups per day for decaffeinated (HR, 0.86; 95% CI, 0.81-0.91; P < .0001); ground (HR, 0.73; 95% CI, 0.69-0.78; P < .0001); and instant coffee (HR, 0.89; 95% CI, 0.86-0.93; P < .0001).

“Coffee consumption is associated with cardiovascular benefits and should not empirically be discontinued in those with underlying heart rhythm disorders or cardiovascular disease,” Dr. Kistler told this news organization.

Plausible mechanisms

There are a number of proposed mechanisms to explain the benefits of coffee on CVD.

“Caffeine has antiarrhythmic properties through adenosine A1 and A2A receptor inhibition, hence the difference in effects of decaf vs. full-strength coffee on heart rhythm disorders,” Dr. Kistler explained.

Coffee has vasodilatory effects and coffee also contains antioxidant polyphenols, which reduce oxidative stress and modulate metabolism.

“The explanation for improved survival with habitual coffee consumption remains unclear,” Dr. Kistler said.

“Putative mechanisms include improved endothelial function, circulating antioxidants, improved insulin sensitivity, and reduced inflammation. Another potential mechanism includes the beneficial effects of coffee on metabolic syndrome,” he said.

“Caffeine has a role in weight loss through inhibition of gut fatty acid absorption and increase in basal metabolic rate. Furthermore, coffee has been associated with a significantly lower incidence of type 2 diabetes mellitus,” Dr. Kistler added.
 

Direction of relationship unclear

Charlotte Mills, PhD, University of Reading, England, said this study “adds to the body of evidence from observational trials associating moderate coffee consumption with cardioprotection, which looks promising.”

However, with the observational design, it’s unclear “which direction the relationship goes – for example, does coffee make you healthy or do inherently healthier people consume coffee? Randomized controlled trials are needed to fully understand the relationship between coffee and health before recommendations can be made,” Dr. Mills told the UK nonprofit Science Media Centre.

Annette Creedon, PhD, nutrition scientist with the British Nutrition Foundation, said it’s possible that respondents over- or underestimated the amount of coffee that they were consuming at the start of the study when they self-reported their intake.

“It is therefore difficult to determine whether the outcomes can be directly associated with the behaviors in coffee consumption reported at the start of the study,” she told the Science Media Centre.

The study had no funding. Dr. Kistler has received funding from Abbott Medical for consultancy and speaking engagements and fellowship support from Biosense Webster. Dr. Lavie has no relevant disclosures. Dr. Mills has worked in collaboration with Nestle on research relating to coffee and health funded by UKRI. Dr. Creedon has reported no relevant financial relationships.

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

Drinking two to three daily cups of – ground, instant, or decaffeinated – is associated with significant reductions in new cardiovascular disease (CVD) and mortality risk, compared with avoiding coffee, a new analysis of the prospective UK Biobank suggests.

Ground and instant coffee, but not decaffeinated coffee, also was associated with reduced risk of new-onset arrhythmia, including atrial fibrillation.

Visual_Intermezzo/iStock/Getty Images Plus

“Our study is the first to look at differences in coffee subtypes to tease out important differences which may explain some of the mechanisms through which coffee works,” Peter M. Kistler, MD, of the Alfred Hospital and Baker Heart and Diabetes Institute, Melbourne, Australia, told this news organization.

“Daily coffee intake should not be discouraged by physicians but rather considered part of a healthy diet,” Dr. Kistler said.

“This study supports that coffee is safe and even potentially beneficial, which is consistent with most of the prior evidence,” Carl “Chip” Lavie, MD, who wasn’t involved in the study, told this news organization.

“We do not prescribe coffee to patients, but for the majority who like coffee, they can be encouraged it is fine to take a few cups daily,” said Dr. Lavie, with the Ochsner Heart and Vascular Institute in New Orleans.

The study was published online in the European Journal of Preventive Cardiology.

 

Clear cardiovascular benefits

A total of 449,563 UK Biobank participants (median age 58 years; 55% women), who were free of arrhythmias or other CVD at baseline, reported in questionnaires their level of daily coffee intake and preferred type of coffee.

During more than 12.5 years of follow-up, 27,809 participants (6.2%) died.

Drinking one to five cups per day of ground or instant coffee (but not decaffeinated coffee) was associated with a significant reduction in incident arrhythmia. The lowest risk was with four to five cups per day for ground coffee (hazard ratio [HR] 0.83; 95% confidence interval [CI], 0.76-0.91; P < .0001) and two to three cups per day for instant coffee (HR, 0.88; 95% CI, 0.85-0.92; P < .0001).

Habitual coffee drinking of up to five cups perday was also associated with significant reductions in the risk of incident CVD, when compared with nondrinkers.

Significant reductions in the risk of incident coronary heart disease (CHD) were associated with habitual coffee intake of up to five cups per day, with the lowest risk for CHD observed in those who consumed two to three cups per day (HR 0.89; 95% CI, 0.86-0.91; P < .0001).

Coffee consumption at all levels was linked to significant reduction in the risk of congestive cardiac failure (CCF) and ischemic stroke. The lowest risks were observed in those who consumed two to three cups per day, with HR, 0.83 (95% CI, 0.79-0.87; P < .0001) for CCF and HR, 0.84 (95% CI, 0.78-0.90; P < .0001) for ischemic stroke.

Death from any cause was significantly reduced for all coffee subtypes, with the greatest risk reduction seen with two to three cups per day for decaffeinated (HR, 0.86; 95% CI, 0.81-0.91; P < .0001); ground (HR, 0.73; 95% CI, 0.69-0.78; P < .0001); and instant coffee (HR, 0.89; 95% CI, 0.86-0.93; P < .0001).

“Coffee consumption is associated with cardiovascular benefits and should not empirically be discontinued in those with underlying heart rhythm disorders or cardiovascular disease,” Dr. Kistler told this news organization.

Plausible mechanisms

There are a number of proposed mechanisms to explain the benefits of coffee on CVD.

“Caffeine has antiarrhythmic properties through adenosine A1 and A2A receptor inhibition, hence the difference in effects of decaf vs. full-strength coffee on heart rhythm disorders,” Dr. Kistler explained.

Coffee has vasodilatory effects and coffee also contains antioxidant polyphenols, which reduce oxidative stress and modulate metabolism.

“The explanation for improved survival with habitual coffee consumption remains unclear,” Dr. Kistler said.

“Putative mechanisms include improved endothelial function, circulating antioxidants, improved insulin sensitivity, and reduced inflammation. Another potential mechanism includes the beneficial effects of coffee on metabolic syndrome,” he said.

“Caffeine has a role in weight loss through inhibition of gut fatty acid absorption and increase in basal metabolic rate. Furthermore, coffee has been associated with a significantly lower incidence of type 2 diabetes mellitus,” Dr. Kistler added.
 

Direction of relationship unclear

Charlotte Mills, PhD, University of Reading, England, said this study “adds to the body of evidence from observational trials associating moderate coffee consumption with cardioprotection, which looks promising.”

However, with the observational design, it’s unclear “which direction the relationship goes – for example, does coffee make you healthy or do inherently healthier people consume coffee? Randomized controlled trials are needed to fully understand the relationship between coffee and health before recommendations can be made,” Dr. Mills told the UK nonprofit Science Media Centre.

Annette Creedon, PhD, nutrition scientist with the British Nutrition Foundation, said it’s possible that respondents over- or underestimated the amount of coffee that they were consuming at the start of the study when they self-reported their intake.

“It is therefore difficult to determine whether the outcomes can be directly associated with the behaviors in coffee consumption reported at the start of the study,” she told the Science Media Centre.

The study had no funding. Dr. Kistler has received funding from Abbott Medical for consultancy and speaking engagements and fellowship support from Biosense Webster. Dr. Lavie has no relevant disclosures. Dr. Mills has worked in collaboration with Nestle on research relating to coffee and health funded by UKRI. Dr. Creedon has reported no relevant financial relationships.

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

Drinking two to three daily cups of – ground, instant, or decaffeinated – is associated with significant reductions in new cardiovascular disease (CVD) and mortality risk, compared with avoiding coffee, a new analysis of the prospective UK Biobank suggests.

Ground and instant coffee, but not decaffeinated coffee, also was associated with reduced risk of new-onset arrhythmia, including atrial fibrillation.

Visual_Intermezzo/iStock/Getty Images Plus

“Our study is the first to look at differences in coffee subtypes to tease out important differences which may explain some of the mechanisms through which coffee works,” Peter M. Kistler, MD, of the Alfred Hospital and Baker Heart and Diabetes Institute, Melbourne, Australia, told this news organization.

“Daily coffee intake should not be discouraged by physicians but rather considered part of a healthy diet,” Dr. Kistler said.

“This study supports that coffee is safe and even potentially beneficial, which is consistent with most of the prior evidence,” Carl “Chip” Lavie, MD, who wasn’t involved in the study, told this news organization.

“We do not prescribe coffee to patients, but for the majority who like coffee, they can be encouraged it is fine to take a few cups daily,” said Dr. Lavie, with the Ochsner Heart and Vascular Institute in New Orleans.

The study was published online in the European Journal of Preventive Cardiology.

 

Clear cardiovascular benefits

A total of 449,563 UK Biobank participants (median age 58 years; 55% women), who were free of arrhythmias or other CVD at baseline, reported in questionnaires their level of daily coffee intake and preferred type of coffee.

During more than 12.5 years of follow-up, 27,809 participants (6.2%) died.

Drinking one to five cups per day of ground or instant coffee (but not decaffeinated coffee) was associated with a significant reduction in incident arrhythmia. The lowest risk was with four to five cups per day for ground coffee (hazard ratio [HR] 0.83; 95% confidence interval [CI], 0.76-0.91; P < .0001) and two to three cups per day for instant coffee (HR, 0.88; 95% CI, 0.85-0.92; P < .0001).

Habitual coffee drinking of up to five cups perday was also associated with significant reductions in the risk of incident CVD, when compared with nondrinkers.

Significant reductions in the risk of incident coronary heart disease (CHD) were associated with habitual coffee intake of up to five cups per day, with the lowest risk for CHD observed in those who consumed two to three cups per day (HR 0.89; 95% CI, 0.86-0.91; P < .0001).

Coffee consumption at all levels was linked to significant reduction in the risk of congestive cardiac failure (CCF) and ischemic stroke. The lowest risks were observed in those who consumed two to three cups per day, with HR, 0.83 (95% CI, 0.79-0.87; P < .0001) for CCF and HR, 0.84 (95% CI, 0.78-0.90; P < .0001) for ischemic stroke.

Death from any cause was significantly reduced for all coffee subtypes, with the greatest risk reduction seen with two to three cups per day for decaffeinated (HR, 0.86; 95% CI, 0.81-0.91; P < .0001); ground (HR, 0.73; 95% CI, 0.69-0.78; P < .0001); and instant coffee (HR, 0.89; 95% CI, 0.86-0.93; P < .0001).

“Coffee consumption is associated with cardiovascular benefits and should not empirically be discontinued in those with underlying heart rhythm disorders or cardiovascular disease,” Dr. Kistler told this news organization.

Plausible mechanisms

There are a number of proposed mechanisms to explain the benefits of coffee on CVD.

“Caffeine has antiarrhythmic properties through adenosine A1 and A2A receptor inhibition, hence the difference in effects of decaf vs. full-strength coffee on heart rhythm disorders,” Dr. Kistler explained.

Coffee has vasodilatory effects and coffee also contains antioxidant polyphenols, which reduce oxidative stress and modulate metabolism.

“The explanation for improved survival with habitual coffee consumption remains unclear,” Dr. Kistler said.

“Putative mechanisms include improved endothelial function, circulating antioxidants, improved insulin sensitivity, and reduced inflammation. Another potential mechanism includes the beneficial effects of coffee on metabolic syndrome,” he said.

“Caffeine has a role in weight loss through inhibition of gut fatty acid absorption and increase in basal metabolic rate. Furthermore, coffee has been associated with a significantly lower incidence of type 2 diabetes mellitus,” Dr. Kistler added.
 

Direction of relationship unclear

Charlotte Mills, PhD, University of Reading, England, said this study “adds to the body of evidence from observational trials associating moderate coffee consumption with cardioprotection, which looks promising.”

However, with the observational design, it’s unclear “which direction the relationship goes – for example, does coffee make you healthy or do inherently healthier people consume coffee? Randomized controlled trials are needed to fully understand the relationship between coffee and health before recommendations can be made,” Dr. Mills told the UK nonprofit Science Media Centre.

Annette Creedon, PhD, nutrition scientist with the British Nutrition Foundation, said it’s possible that respondents over- or underestimated the amount of coffee that they were consuming at the start of the study when they self-reported their intake.

“It is therefore difficult to determine whether the outcomes can be directly associated with the behaviors in coffee consumption reported at the start of the study,” she told the Science Media Centre.

The study had no funding. Dr. Kistler has received funding from Abbott Medical for consultancy and speaking engagements and fellowship support from Biosense Webster. Dr. Lavie has no relevant disclosures. Dr. Mills has worked in collaboration with Nestle on research relating to coffee and health funded by UKRI. Dr. Creedon has reported no relevant financial relationships.

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

Apremilast may have an overall benefit for patients with cardiometabolic disease and psoriasis, new results from a nonrandomized clinical trial suggest.

The trial, led by Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology and vice chair of clinical research in dermatology at the University of Pennsylvania, Philadelphia, found that apremilast (Otezla) has a neutral effect on aortic vascular inflammation in patients with moderate to severe psoriasis.

It also had variable, but generally favorable, associations with 68 cardiometabolic biomarkers tested and associations with reductions in both visceral and subcutaneous fat. Findings of the study were published online in JAMA Dermatology.

Fat reductions maintained at 1-year mark

The researchers found a 5%-6% reduction in subcutaneous and visceral fat at week 16 of the study that was maintained at the 1-year mark. “The fact that it was rock stable a year later is pretty encouraging,” Dr. Gelfand told this news organization.

Courtesy Dr. Joel M. Gelfand

As for effects on vascular inflammation, Dr. Gelfand said, “The good news is we didn’t find any adverse effects on aortic vascular inflammation, but we didn’t find any beneficial effects either. That was a little disappointing.

“The most surprising thing was really the effects on visceral adiposity,” he added. “I’m not aware of any other drug having demonstrated that effect.”

Michael S. Garshick, MD, a cardiologist with NYU Langone Health in New York, who was not involved with the trial, told this news organization that despite seemingly good epidemiologic evidence in observational studies that by treating psoriasis surrogates of cardiovascular risk can be reduced, this trial, like others before it, failed to reduce aortic vascular inflammation.

Courtesy NYU Langone

Seventy patients enrolled

In total, 70 patients with moderate to severe psoriasis were enrolled, 60 completed week 16, and 39 completed week 52 of the single-arm, open-label trial conducted between April 2017 and August 2021 at seven dermatology sites in the United States.

Participants took 30 mg of apremilast, an oral phosphodiesterase-4 (PDE-4) inhibitor approved for treating psoriasis and psoriatic arthritis, twice daily. Participants’ average age was 47.5 years; most were male (77.1%) and White (82.9%); almost 6% were Black. Average body mass index was 30 kg/m². Patients could not have received biologics within 90 days of study baseline (or 180 days for ustekinumab [Stelara]).

There was no change in aortic vascular inflammation at week 16 (target to background ratio, −0.02; 95% confidence interval [CI], −0.08 to 0.05; P = .61) or week 52 (target to background ratio, −0.07; 95% CI, −0.15 to 0.01; P = .09) compared with baseline.

“At week 16, there were reductions in levels of interleukin-1b, fetuin A, valine, leucine, and isoleucine,” the authors wrote, adding that at week 52, compared with baseline, “there were reductions in levels of ferritin, cholesterol efflux capacity, beta-hydroxybutyrate, acetone, and ketone bodies, and an increase in levels of apolipoprotein A-1.”

This study highlights the importance of screening, Dr. Garshick said.

He and Dr. Gelfand said people with psoriatic disease tend to be vastly underscreened for cardiovascular risk factors.

Dr. Gelfand said, “If we did what we knew worked – meaning we screened them for diabetes, we screen their cholesterol, we check their blood pressure, and we adequately treated those traditional cardiovascular risk factors, we probably could narrow the gap quite a bit” in terms of the lower life expectancy people face when they have more significant psoriasis.

Celgene was the initial funding sponsor; sponsorship was then transferred to Amgen. The authors designed, executed, analyzed, and reported the study. Celgene provided nonbinding input into study design, and Amgen provided nonbinding input into the reporting of results. Dr. Gelfand reported numerous disclosures with various pharmaceutical companies and organizations. Dr. Garshick reported no relevant financial relationships.

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

Apremilast may have an overall benefit for patients with cardiometabolic disease and psoriasis, new results from a nonrandomized clinical trial suggest.

The trial, led by Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology and vice chair of clinical research in dermatology at the University of Pennsylvania, Philadelphia, found that apremilast (Otezla) has a neutral effect on aortic vascular inflammation in patients with moderate to severe psoriasis.

It also had variable, but generally favorable, associations with 68 cardiometabolic biomarkers tested and associations with reductions in both visceral and subcutaneous fat. Findings of the study were published online in JAMA Dermatology.

Fat reductions maintained at 1-year mark

The researchers found a 5%-6% reduction in subcutaneous and visceral fat at week 16 of the study that was maintained at the 1-year mark. “The fact that it was rock stable a year later is pretty encouraging,” Dr. Gelfand told this news organization.

Courtesy Dr. Joel M. Gelfand

As for effects on vascular inflammation, Dr. Gelfand said, “The good news is we didn’t find any adverse effects on aortic vascular inflammation, but we didn’t find any beneficial effects either. That was a little disappointing.

“The most surprising thing was really the effects on visceral adiposity,” he added. “I’m not aware of any other drug having demonstrated that effect.”

Michael S. Garshick, MD, a cardiologist with NYU Langone Health in New York, who was not involved with the trial, told this news organization that despite seemingly good epidemiologic evidence in observational studies that by treating psoriasis surrogates of cardiovascular risk can be reduced, this trial, like others before it, failed to reduce aortic vascular inflammation.

Courtesy NYU Langone

Seventy patients enrolled

In total, 70 patients with moderate to severe psoriasis were enrolled, 60 completed week 16, and 39 completed week 52 of the single-arm, open-label trial conducted between April 2017 and August 2021 at seven dermatology sites in the United States.

Participants took 30 mg of apremilast, an oral phosphodiesterase-4 (PDE-4) inhibitor approved for treating psoriasis and psoriatic arthritis, twice daily. Participants’ average age was 47.5 years; most were male (77.1%) and White (82.9%); almost 6% were Black. Average body mass index was 30 kg/m². Patients could not have received biologics within 90 days of study baseline (or 180 days for ustekinumab [Stelara]).

There was no change in aortic vascular inflammation at week 16 (target to background ratio, −0.02; 95% confidence interval [CI], −0.08 to 0.05; P = .61) or week 52 (target to background ratio, −0.07; 95% CI, −0.15 to 0.01; P = .09) compared with baseline.

“At week 16, there were reductions in levels of interleukin-1b, fetuin A, valine, leucine, and isoleucine,” the authors wrote, adding that at week 52, compared with baseline, “there were reductions in levels of ferritin, cholesterol efflux capacity, beta-hydroxybutyrate, acetone, and ketone bodies, and an increase in levels of apolipoprotein A-1.”

This study highlights the importance of screening, Dr. Garshick said.

He and Dr. Gelfand said people with psoriatic disease tend to be vastly underscreened for cardiovascular risk factors.

Dr. Gelfand said, “If we did what we knew worked – meaning we screened them for diabetes, we screen their cholesterol, we check their blood pressure, and we adequately treated those traditional cardiovascular risk factors, we probably could narrow the gap quite a bit” in terms of the lower life expectancy people face when they have more significant psoriasis.

Celgene was the initial funding sponsor; sponsorship was then transferred to Amgen. The authors designed, executed, analyzed, and reported the study. Celgene provided nonbinding input into study design, and Amgen provided nonbinding input into the reporting of results. Dr. Gelfand reported numerous disclosures with various pharmaceutical companies and organizations. Dr. Garshick reported no relevant financial relationships.

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

Apremilast may have an overall benefit for patients with cardiometabolic disease and psoriasis, new results from a nonrandomized clinical trial suggest.

The trial, led by Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology and vice chair of clinical research in dermatology at the University of Pennsylvania, Philadelphia, found that apremilast (Otezla) has a neutral effect on aortic vascular inflammation in patients with moderate to severe psoriasis.

It also had variable, but generally favorable, associations with 68 cardiometabolic biomarkers tested and associations with reductions in both visceral and subcutaneous fat. Findings of the study were published online in JAMA Dermatology.

Fat reductions maintained at 1-year mark

The researchers found a 5%-6% reduction in subcutaneous and visceral fat at week 16 of the study that was maintained at the 1-year mark. “The fact that it was rock stable a year later is pretty encouraging,” Dr. Gelfand told this news organization.

Courtesy Dr. Joel M. Gelfand

As for effects on vascular inflammation, Dr. Gelfand said, “The good news is we didn’t find any adverse effects on aortic vascular inflammation, but we didn’t find any beneficial effects either. That was a little disappointing.

“The most surprising thing was really the effects on visceral adiposity,” he added. “I’m not aware of any other drug having demonstrated that effect.”

Michael S. Garshick, MD, a cardiologist with NYU Langone Health in New York, who was not involved with the trial, told this news organization that despite seemingly good epidemiologic evidence in observational studies that by treating psoriasis surrogates of cardiovascular risk can be reduced, this trial, like others before it, failed to reduce aortic vascular inflammation.

Courtesy NYU Langone

Seventy patients enrolled

In total, 70 patients with moderate to severe psoriasis were enrolled, 60 completed week 16, and 39 completed week 52 of the single-arm, open-label trial conducted between April 2017 and August 2021 at seven dermatology sites in the United States.

Participants took 30 mg of apremilast, an oral phosphodiesterase-4 (PDE-4) inhibitor approved for treating psoriasis and psoriatic arthritis, twice daily. Participants’ average age was 47.5 years; most were male (77.1%) and White (82.9%); almost 6% were Black. Average body mass index was 30 kg/m². Patients could not have received biologics within 90 days of study baseline (or 180 days for ustekinumab [Stelara]).

There was no change in aortic vascular inflammation at week 16 (target to background ratio, −0.02; 95% confidence interval [CI], −0.08 to 0.05; P = .61) or week 52 (target to background ratio, −0.07; 95% CI, −0.15 to 0.01; P = .09) compared with baseline.

“At week 16, there were reductions in levels of interleukin-1b, fetuin A, valine, leucine, and isoleucine,” the authors wrote, adding that at week 52, compared with baseline, “there were reductions in levels of ferritin, cholesterol efflux capacity, beta-hydroxybutyrate, acetone, and ketone bodies, and an increase in levels of apolipoprotein A-1.”

This study highlights the importance of screening, Dr. Garshick said.

He and Dr. Gelfand said people with psoriatic disease tend to be vastly underscreened for cardiovascular risk factors.

Dr. Gelfand said, “If we did what we knew worked – meaning we screened them for diabetes, we screen their cholesterol, we check their blood pressure, and we adequately treated those traditional cardiovascular risk factors, we probably could narrow the gap quite a bit” in terms of the lower life expectancy people face when they have more significant psoriasis.

Celgene was the initial funding sponsor; sponsorship was then transferred to Amgen. The authors designed, executed, analyzed, and reported the study. Celgene provided nonbinding input into study design, and Amgen provided nonbinding input into the reporting of results. Dr. Gelfand reported numerous disclosures with various pharmaceutical companies and organizations. Dr. Garshick reported no relevant financial relationships.

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

STOCKHOLM – The number of people living with type 1 diabetes worldwide is expected to double by 2040, with most new cases among adults living in low- and middle-income countries, new modeling data suggest.

The forecast, developed from available data collected in the newly established open-source Type 1 Diabetes Index, provides estimates for type 1 diabetes prevalence, incidence, associated mortality, and life expectancy for 201 countries for 2021.

The model also projects estimates for prevalent cases in 2040. It is the first type 1 diabetes dataset to account for the lack of prevalence because of premature mortality, particularly in low- and middle-income countries.

“The worldwide prevalence of type 1 diabetes is substantial and growing. Improved surveillance – particularly in adults who make up most of the population living with type 1 diabetes – is essential to enable improvements to care and outcomes. There is an opportunity to save millions of lives in the coming decades by raising the standard of care (including ensuring universal access to insulin and other essential supplies) and increasing awareness of the signs and symptoms of type 1 diabetes to enable a 100% rate of diagnosis in all countries,” the authors write.

“This work spells out the need for early diagnosis of type 1 diabetes and timely access to quality care,” said Chantal Mathieu, MD, at the European Association for the Study of Diabetes annual meeting.
 

One in five deaths from type 1 diabetes in under 25s

The new findings were published in Lancet Diabetes & Endocrinology by Gabriel A. Gregory, MD, of Life for a Child Program, New South Wales, Australia, and colleagues. The T1D Index Project database was published Sept. 21, 2022.

According to the model, about 8.4 million people were living with type 1 diabetes in 2021, with one-fifth from low- and middle-income countries. An additional 3.7 million died prematurely and would have been added to that count had they lived. One in five of all deaths caused by type 1 diabetes in 2021 is estimated to have occurred in people younger than age 25 years because of nondiagnosis.

“It is unacceptable that, in 2022, some 35,000 people worldwide are dying undiagnosed within a year of onset of symptoms. There also continues to be a huge disparity in life expectancy for people with type 1 diabetes, hitting those in the poorest countries hardest,” noted Dr. Mathieu, who is senior vice-president of EASD and an endocrinologist based at KU Leuven, Belgium.

By 2040, the model predicts that between 13.5 million and 17.4 million people will be living with the condition, with the largest relative increase from 2021 in low-income and lower-middle-income countries. The majority of incident and prevalent cases of type 1 diabetes are in adults, with an estimated 62% of 510,000 new diagnoses worldwide in 2021 occurring in people aged 20 years and older.
 

Type 1 diabetes is not predominantly a disease of childhood

Dr. Mathieu also noted that the data dispute the long-held view of type 1 diabetes as a predominantly pediatric condition. Indeed, worldwide, the median age for a person living with type 1 diabetes is 37 years.

“While type 1 diabetes is often referred to as ‘child-onset’ diabetes, this important study shows that only around one in five living with the condition are aged 20 years or younger, two-thirds are aged 20-64 years, and a further one in five are aged 65 years or older.”

“This condition does not stop at age 18 years – the children become adults, and the adults become elderly. All countries must examine and strengthen their diagnosis and care pathways for people of all ages living with type 1 diabetes,” Dr. Mathieu emphasized.

And in an accompanying editorial, Serena Jingchuan Guo, MD, PhD, and Hui Shao, MD, PhD, point out that most studies that estimate diabetes burden have focused on type 2 diabetes, noting, “type 1 diabetes faces the challenges of misdiagnosis, underdiagnosis, high risk of complications, and premature mortality.”

The insulin affordability issue is central, point out Dr. Guo and Dr. Shao of the Center for Drug Evaluation and Safety, department of pharmaceutical evaluation and policy, University of Florida College of Pharmacy, Gainesville.

“Countries need to strengthen the price regulation and reimbursement policy for insulin while building subsidy programs to ensure insulin access and to cope with the growing demand for insulin. Meanwhile, optimizing the insulin supply chain between manufacturers and patients while seeking alternative treatment options (for example, biosimilar products) will also improve the current situation,” they conclude.   

The study was funded by JDRF, of which four coauthors are employees. The editorialists have reported no relevant financial relationships.

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

STOCKHOLM – The number of people living with type 1 diabetes worldwide is expected to double by 2040, with most new cases among adults living in low- and middle-income countries, new modeling data suggest.

The forecast, developed from available data collected in the newly established open-source Type 1 Diabetes Index, provides estimates for type 1 diabetes prevalence, incidence, associated mortality, and life expectancy for 201 countries for 2021.

The model also projects estimates for prevalent cases in 2040. It is the first type 1 diabetes dataset to account for the lack of prevalence because of premature mortality, particularly in low- and middle-income countries.

“The worldwide prevalence of type 1 diabetes is substantial and growing. Improved surveillance – particularly in adults who make up most of the population living with type 1 diabetes – is essential to enable improvements to care and outcomes. There is an opportunity to save millions of lives in the coming decades by raising the standard of care (including ensuring universal access to insulin and other essential supplies) and increasing awareness of the signs and symptoms of type 1 diabetes to enable a 100% rate of diagnosis in all countries,” the authors write.

“This work spells out the need for early diagnosis of type 1 diabetes and timely access to quality care,” said Chantal Mathieu, MD, at the European Association for the Study of Diabetes annual meeting.
 

One in five deaths from type 1 diabetes in under 25s

The new findings were published in Lancet Diabetes & Endocrinology by Gabriel A. Gregory, MD, of Life for a Child Program, New South Wales, Australia, and colleagues. The T1D Index Project database was published Sept. 21, 2022.

According to the model, about 8.4 million people were living with type 1 diabetes in 2021, with one-fifth from low- and middle-income countries. An additional 3.7 million died prematurely and would have been added to that count had they lived. One in five of all deaths caused by type 1 diabetes in 2021 is estimated to have occurred in people younger than age 25 years because of nondiagnosis.

“It is unacceptable that, in 2022, some 35,000 people worldwide are dying undiagnosed within a year of onset of symptoms. There also continues to be a huge disparity in life expectancy for people with type 1 diabetes, hitting those in the poorest countries hardest,” noted Dr. Mathieu, who is senior vice-president of EASD and an endocrinologist based at KU Leuven, Belgium.

By 2040, the model predicts that between 13.5 million and 17.4 million people will be living with the condition, with the largest relative increase from 2021 in low-income and lower-middle-income countries. The majority of incident and prevalent cases of type 1 diabetes are in adults, with an estimated 62% of 510,000 new diagnoses worldwide in 2021 occurring in people aged 20 years and older.
 

Type 1 diabetes is not predominantly a disease of childhood

Dr. Mathieu also noted that the data dispute the long-held view of type 1 diabetes as a predominantly pediatric condition. Indeed, worldwide, the median age for a person living with type 1 diabetes is 37 years.

“While type 1 diabetes is often referred to as ‘child-onset’ diabetes, this important study shows that only around one in five living with the condition are aged 20 years or younger, two-thirds are aged 20-64 years, and a further one in five are aged 65 years or older.”

“This condition does not stop at age 18 years – the children become adults, and the adults become elderly. All countries must examine and strengthen their diagnosis and care pathways for people of all ages living with type 1 diabetes,” Dr. Mathieu emphasized.

And in an accompanying editorial, Serena Jingchuan Guo, MD, PhD, and Hui Shao, MD, PhD, point out that most studies that estimate diabetes burden have focused on type 2 diabetes, noting, “type 1 diabetes faces the challenges of misdiagnosis, underdiagnosis, high risk of complications, and premature mortality.”

The insulin affordability issue is central, point out Dr. Guo and Dr. Shao of the Center for Drug Evaluation and Safety, department of pharmaceutical evaluation and policy, University of Florida College of Pharmacy, Gainesville.

“Countries need to strengthen the price regulation and reimbursement policy for insulin while building subsidy programs to ensure insulin access and to cope with the growing demand for insulin. Meanwhile, optimizing the insulin supply chain between manufacturers and patients while seeking alternative treatment options (for example, biosimilar products) will also improve the current situation,” they conclude.   

The study was funded by JDRF, of which four coauthors are employees. The editorialists have reported no relevant financial relationships.

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

STOCKHOLM – The number of people living with type 1 diabetes worldwide is expected to double by 2040, with most new cases among adults living in low- and middle-income countries, new modeling data suggest.

The forecast, developed from available data collected in the newly established open-source Type 1 Diabetes Index, provides estimates for type 1 diabetes prevalence, incidence, associated mortality, and life expectancy for 201 countries for 2021.

The model also projects estimates for prevalent cases in 2040. It is the first type 1 diabetes dataset to account for the lack of prevalence because of premature mortality, particularly in low- and middle-income countries.

“The worldwide prevalence of type 1 diabetes is substantial and growing. Improved surveillance – particularly in adults who make up most of the population living with type 1 diabetes – is essential to enable improvements to care and outcomes. There is an opportunity to save millions of lives in the coming decades by raising the standard of care (including ensuring universal access to insulin and other essential supplies) and increasing awareness of the signs and symptoms of type 1 diabetes to enable a 100% rate of diagnosis in all countries,” the authors write.

“This work spells out the need for early diagnosis of type 1 diabetes and timely access to quality care,” said Chantal Mathieu, MD, at the European Association for the Study of Diabetes annual meeting.
 

One in five deaths from type 1 diabetes in under 25s

The new findings were published in Lancet Diabetes & Endocrinology by Gabriel A. Gregory, MD, of Life for a Child Program, New South Wales, Australia, and colleagues. The T1D Index Project database was published Sept. 21, 2022.

According to the model, about 8.4 million people were living with type 1 diabetes in 2021, with one-fifth from low- and middle-income countries. An additional 3.7 million died prematurely and would have been added to that count had they lived. One in five of all deaths caused by type 1 diabetes in 2021 is estimated to have occurred in people younger than age 25 years because of nondiagnosis.

“It is unacceptable that, in 2022, some 35,000 people worldwide are dying undiagnosed within a year of onset of symptoms. There also continues to be a huge disparity in life expectancy for people with type 1 diabetes, hitting those in the poorest countries hardest,” noted Dr. Mathieu, who is senior vice-president of EASD and an endocrinologist based at KU Leuven, Belgium.

By 2040, the model predicts that between 13.5 million and 17.4 million people will be living with the condition, with the largest relative increase from 2021 in low-income and lower-middle-income countries. The majority of incident and prevalent cases of type 1 diabetes are in adults, with an estimated 62% of 510,000 new diagnoses worldwide in 2021 occurring in people aged 20 years and older.
 

Type 1 diabetes is not predominantly a disease of childhood

Dr. Mathieu also noted that the data dispute the long-held view of type 1 diabetes as a predominantly pediatric condition. Indeed, worldwide, the median age for a person living with type 1 diabetes is 37 years.

“While type 1 diabetes is often referred to as ‘child-onset’ diabetes, this important study shows that only around one in five living with the condition are aged 20 years or younger, two-thirds are aged 20-64 years, and a further one in five are aged 65 years or older.”

“This condition does not stop at age 18 years – the children become adults, and the adults become elderly. All countries must examine and strengthen their diagnosis and care pathways for people of all ages living with type 1 diabetes,” Dr. Mathieu emphasized.

And in an accompanying editorial, Serena Jingchuan Guo, MD, PhD, and Hui Shao, MD, PhD, point out that most studies that estimate diabetes burden have focused on type 2 diabetes, noting, “type 1 diabetes faces the challenges of misdiagnosis, underdiagnosis, high risk of complications, and premature mortality.”

The insulin affordability issue is central, point out Dr. Guo and Dr. Shao of the Center for Drug Evaluation and Safety, department of pharmaceutical evaluation and policy, University of Florida College of Pharmacy, Gainesville.

“Countries need to strengthen the price regulation and reimbursement policy for insulin while building subsidy programs to ensure insulin access and to cope with the growing demand for insulin. Meanwhile, optimizing the insulin supply chain between manufacturers and patients while seeking alternative treatment options (for example, biosimilar products) will also improve the current situation,” they conclude.   

The study was funded by JDRF, of which four coauthors are employees. The editorialists have reported no relevant financial relationships.

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

BOSTON – Despite a promising start, extended follow-up from the SUGAR trial found that the Cre8 EVO drug-eluting stent could not maintain superiority over the Resolute Onyx DES at 2 years in patients with diabetes undergoing revascularization for coronary artery disease.

The Cre8 EVO stent (Alvimedica) is not available in the United States but, as previously reported, caused a stir last year after demonstrating a 35% relative risk reduction in the primary endpoint of target lesion failure (TLF) at 1 year in a prespecified superiority analysis.

At 2 years, however, the TLF rate was 10.4% with the polymer-free Cre8 EVO amphilimus-eluting stent and 12.1% with the durable polymer Resolute Onyx (Medtronic) zotarolimus-eluting stent, which did not achieve superiority (hazard ratio, 0.84; 95% confidence interval, 0.60-1.19).

Rates were numerically lower with the Cre8 EVO stent for the endpoint’s individual components of cardiac death (3.1% vs. 3.4%), target vessel MI (6.6% vs. 7.6%), and target lesion revascularization (4.3% vs. 4.6%).

Results were also similar between the Cre8 EVO and Resolute Onyx stents for all-cause mortality (7.1% vs. 6.8%), any MI (9.0% vs. 9.2%), target vessel revascularization (5.5% vs. 5.1%), all new revascularizations (7.6% vs. 9.4%), definite stent thrombosis (1.0% vs. 1.2%), and major adverse cardiac events (18.3% vs. 20.8%), Pablo Salinas, MD, PhD, of Hospital Clinico San Carlos, Madrid, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

He noted that all-cause mortality was 7% in just 2 years in the diabetic cohort, or twice the number of cardiac deaths. “In other words, these patients had the same chance of dying from cardiac causes and noncardiac causes, so we need a more comprehensive approach to the disease. Also, if you look at all new revascularizations, roughly 50% were off target, so there is disease progression at 2 years in this population.”

Among the 586 Cre8 EVO and 589 Resolute Onyx patients who underwent percutaneous coronary intervention (PCI), roughly half had multivessel coronary artery disease, 83% had hypertension, 81% had dyslipidemia, and 21% were current smokers. Nearly all patients had diabetes type 2 for an average of 10.6 years for Cre8 EVO and 11.4 years for Resolute Onyx, with hemoglobin A1c levels of 7.4% and 7.5%, respectively.

Although there is “insufficient evidence” the Cre8 EVO stent is superior to the Resolute Onyx stent with regard to TLF, Dr. Salinas concluded extended follow-up until 5 years is warranted.

During a discussion of the results, Dr. Salinas said he expects the 5-year results will “probably go parallel” but that it’s worth following this very valuable cohort. “There are not so many trials with 1,000 diabetic patients. We always speak about how complex they are, the results are bad, but we don’t use the diabetic population in trials,” he said at the meeting sponsored by the Cardiovascular Research Foundation.

Asked during a TCT press conference what could have caused the catch-up in TLF at 2 years, Dr. Salinas said there were only 25 primary events from years 1 to 2, driven primarily by periprocedural MI, but that the timing of restenosis was different. Events accrued “drop by drop” with the Cre8 EVO, whereas with the Resolute Onyx there was a “bump in restenosis” after 6 months “but then it is very nice to see it is flat, which means that durable polymers are also safe because we have not seen late events.”

Press conference discussant Carlo Di Mario, MD, from Careggi University Hospital, Florence, Italy, who was not involved in the study, said the reversal of superiority for the Cre8 EVO might be a “bitter note” for the investigators but “maybe it is not bitter for us because overall, the percentage of figures are so low that it’s very difficult to find a difference” between the two stents.

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

BOSTON – Despite a promising start, extended follow-up from the SUGAR trial found that the Cre8 EVO drug-eluting stent could not maintain superiority over the Resolute Onyx DES at 2 years in patients with diabetes undergoing revascularization for coronary artery disease.

The Cre8 EVO stent (Alvimedica) is not available in the United States but, as previously reported, caused a stir last year after demonstrating a 35% relative risk reduction in the primary endpoint of target lesion failure (TLF) at 1 year in a prespecified superiority analysis.

At 2 years, however, the TLF rate was 10.4% with the polymer-free Cre8 EVO amphilimus-eluting stent and 12.1% with the durable polymer Resolute Onyx (Medtronic) zotarolimus-eluting stent, which did not achieve superiority (hazard ratio, 0.84; 95% confidence interval, 0.60-1.19).

Rates were numerically lower with the Cre8 EVO stent for the endpoint’s individual components of cardiac death (3.1% vs. 3.4%), target vessel MI (6.6% vs. 7.6%), and target lesion revascularization (4.3% vs. 4.6%).

Results were also similar between the Cre8 EVO and Resolute Onyx stents for all-cause mortality (7.1% vs. 6.8%), any MI (9.0% vs. 9.2%), target vessel revascularization (5.5% vs. 5.1%), all new revascularizations (7.6% vs. 9.4%), definite stent thrombosis (1.0% vs. 1.2%), and major adverse cardiac events (18.3% vs. 20.8%), Pablo Salinas, MD, PhD, of Hospital Clinico San Carlos, Madrid, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

He noted that all-cause mortality was 7% in just 2 years in the diabetic cohort, or twice the number of cardiac deaths. “In other words, these patients had the same chance of dying from cardiac causes and noncardiac causes, so we need a more comprehensive approach to the disease. Also, if you look at all new revascularizations, roughly 50% were off target, so there is disease progression at 2 years in this population.”

Among the 586 Cre8 EVO and 589 Resolute Onyx patients who underwent percutaneous coronary intervention (PCI), roughly half had multivessel coronary artery disease, 83% had hypertension, 81% had dyslipidemia, and 21% were current smokers. Nearly all patients had diabetes type 2 for an average of 10.6 years for Cre8 EVO and 11.4 years for Resolute Onyx, with hemoglobin A1c levels of 7.4% and 7.5%, respectively.

Although there is “insufficient evidence” the Cre8 EVO stent is superior to the Resolute Onyx stent with regard to TLF, Dr. Salinas concluded extended follow-up until 5 years is warranted.

During a discussion of the results, Dr. Salinas said he expects the 5-year results will “probably go parallel” but that it’s worth following this very valuable cohort. “There are not so many trials with 1,000 diabetic patients. We always speak about how complex they are, the results are bad, but we don’t use the diabetic population in trials,” he said at the meeting sponsored by the Cardiovascular Research Foundation.

Asked during a TCT press conference what could have caused the catch-up in TLF at 2 years, Dr. Salinas said there were only 25 primary events from years 1 to 2, driven primarily by periprocedural MI, but that the timing of restenosis was different. Events accrued “drop by drop” with the Cre8 EVO, whereas with the Resolute Onyx there was a “bump in restenosis” after 6 months “but then it is very nice to see it is flat, which means that durable polymers are also safe because we have not seen late events.”

Press conference discussant Carlo Di Mario, MD, from Careggi University Hospital, Florence, Italy, who was not involved in the study, said the reversal of superiority for the Cre8 EVO might be a “bitter note” for the investigators but “maybe it is not bitter for us because overall, the percentage of figures are so low that it’s very difficult to find a difference” between the two stents.

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

BOSTON – Despite a promising start, extended follow-up from the SUGAR trial found that the Cre8 EVO drug-eluting stent could not maintain superiority over the Resolute Onyx DES at 2 years in patients with diabetes undergoing revascularization for coronary artery disease.

The Cre8 EVO stent (Alvimedica) is not available in the United States but, as previously reported, caused a stir last year after demonstrating a 35% relative risk reduction in the primary endpoint of target lesion failure (TLF) at 1 year in a prespecified superiority analysis.

At 2 years, however, the TLF rate was 10.4% with the polymer-free Cre8 EVO amphilimus-eluting stent and 12.1% with the durable polymer Resolute Onyx (Medtronic) zotarolimus-eluting stent, which did not achieve superiority (hazard ratio, 0.84; 95% confidence interval, 0.60-1.19).

Rates were numerically lower with the Cre8 EVO stent for the endpoint’s individual components of cardiac death (3.1% vs. 3.4%), target vessel MI (6.6% vs. 7.6%), and target lesion revascularization (4.3% vs. 4.6%).

Results were also similar between the Cre8 EVO and Resolute Onyx stents for all-cause mortality (7.1% vs. 6.8%), any MI (9.0% vs. 9.2%), target vessel revascularization (5.5% vs. 5.1%), all new revascularizations (7.6% vs. 9.4%), definite stent thrombosis (1.0% vs. 1.2%), and major adverse cardiac events (18.3% vs. 20.8%), Pablo Salinas, MD, PhD, of Hospital Clinico San Carlos, Madrid, reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

He noted that all-cause mortality was 7% in just 2 years in the diabetic cohort, or twice the number of cardiac deaths. “In other words, these patients had the same chance of dying from cardiac causes and noncardiac causes, so we need a more comprehensive approach to the disease. Also, if you look at all new revascularizations, roughly 50% were off target, so there is disease progression at 2 years in this population.”

Among the 586 Cre8 EVO and 589 Resolute Onyx patients who underwent percutaneous coronary intervention (PCI), roughly half had multivessel coronary artery disease, 83% had hypertension, 81% had dyslipidemia, and 21% were current smokers. Nearly all patients had diabetes type 2 for an average of 10.6 years for Cre8 EVO and 11.4 years for Resolute Onyx, with hemoglobin A1c levels of 7.4% and 7.5%, respectively.

Although there is “insufficient evidence” the Cre8 EVO stent is superior to the Resolute Onyx stent with regard to TLF, Dr. Salinas concluded extended follow-up until 5 years is warranted.

During a discussion of the results, Dr. Salinas said he expects the 5-year results will “probably go parallel” but that it’s worth following this very valuable cohort. “There are not so many trials with 1,000 diabetic patients. We always speak about how complex they are, the results are bad, but we don’t use the diabetic population in trials,” he said at the meeting sponsored by the Cardiovascular Research Foundation.

Asked during a TCT press conference what could have caused the catch-up in TLF at 2 years, Dr. Salinas said there were only 25 primary events from years 1 to 2, driven primarily by periprocedural MI, but that the timing of restenosis was different. Events accrued “drop by drop” with the Cre8 EVO, whereas with the Resolute Onyx there was a “bump in restenosis” after 6 months “but then it is very nice to see it is flat, which means that durable polymers are also safe because we have not seen late events.”

Press conference discussant Carlo Di Mario, MD, from Careggi University Hospital, Florence, Italy, who was not involved in the study, said the reversal of superiority for the Cre8 EVO might be a “bitter note” for the investigators but “maybe it is not bitter for us because overall, the percentage of figures are so low that it’s very difficult to find a difference” between the two stents.

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

STOCKHOLM – Weight loss should be a co–primary management goal for type 2 diabetes in adults, according to a new comprehensive joint consensus report from the European Association for the Study of Diabetes and the American Diabetes Association.

And while metformin is still recommended as first-line therapy for patients with type 2 diabetes with no other comorbidities, the statement expands the indications for use of other agents or combinations of agents as initial therapy for subgroups of patients, as part of individualized and patient-centered decision-making.

Last updated in 2019, the new “Management of Hyperglycemia in Type 2 Diabetes” statement also places increased emphasis on social determinants of health, incorporates recent clinical trial data for cardiovascular and kidney outcomes for sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagonlike peptide–1 (GLP-1) agonists to broaden recommendations for cardiorenal protection, and discusses health behaviors such as sleep and sitting. It also targets a wider audience than in the past by addressing health system organization to optimize delivery of diabetes care.

The new statement was presented during a 90-minute session at the annual meeting of the EASD, with 12 of its 14 European and American authors as presenters. The document was simultaneously published in Diabetologia and Diabetes Care.

During the discussion, panel member Jennifer Brigitte Green, MD, commented: “Many of these recommendations are not new. They’re modest revisions of recommendations that have been in place for years, but we know that actual implementation rates of use of these drugs in patients with established comorbidities are very low.”

“I think it’s time for communities, health care systems, etc, to actually introduce these as expectations of care... to assess quality because unless it’s considered formally to be a requirement of care I just don’t think we’re going to move that needle very much,” added Dr. Green, who is professor of medicine at Duke University, Durham, N.C.

Vanita R. Aroda, MD, of the division of endocrinology, diabetes, and hypertension at Brigham and Women’s Hospital, Boston, commented: “In the past, sometimes these recommendations created fodder for debate, but I don’t think this one will. It’s just really solidly evidence based, with the rationales presented throughout, including the figures. I think just having very clear evidence-based directions should support their dissemination and use.”
 

Weight management plays a prominent role in treatment

In an interview, writing panel cochair John B. Buse, MD, PhD, said: “We are saying that the four major components of type 2 diabetes care are glycemic management, cardiovascular risk management, weight management, and prevention of end-organ damage, particularly with regard to cardiorenal risk.”

“The weight management piece is much more explicit now,” said Dr. Buse, director of the Diabetes Center at the University of North Carolina at Chapel Hill.

He noted that recent evidence from the intensive lifestyle trial DiRECT, conducted in the United Kingdom, the bariatric surgery literature, and the emergence of potent weight-loss drugs have meant that “achieving 10%-15% body weight loss is now possible.

“So, aiming for remission is something that might be attractive to patients and providers. This could be based on weight management, with the [chosen] method based on shared decision-making.”

According to the new report: “Weight loss of 5%-10% confers metabolic improvement; weight loss of 10%-15% or more can have a disease-modifying effect and lead to remission of diabetes, defined as normal blood glucose levels for 3 months or more in the absence of pharmacological therapy in a 2021 consensus report.”

“Weight loss may exert benefits that extend beyond glycemic management to improve risk factors for cardiometabolic disease and quality of life,” it adds.
 

Individualization featured throughout

The report’s sections cover principles of care, including the importance of diabetes self-management education and support and avoidance of therapeutic inertia. Detailed guidance addresses therapeutic options including lifestyle, weight management, and pharmacotherapy for treating type 2 diabetes.

Another entire section is devoted to personalizing treatment approaches based on individual characteristics, including new evidence from cardiorenal outcomes studies for SGLT2 inhibitors and GLP-1 agonists that have come out since the last consensus report.

The document advises: “Consider initial combination therapy with glucose-lowering agents, especially in those with high [hemoglobin] A1c at diagnosis (that is, > 70 mmol/mol [> 8.5%]), in younger people with type 2 diabetes (regardless of A1c), and in those in whom a stepwise approach would delay access to agents that provide cardiorenal protection beyond their glucose-lowering effects.”
 

Designed to be used and user-friendly

Under the “Putting it all together: strategies for implementation” section, several lists of “practical tips for clinicians” are provided for many of the topics covered.

A series of colorful infographics are included as well, addressing the “decision cycle for person-centered glycemic management in type 2 diabetes,” including a chart summarizing characteristics of available glucose-lowering medications, including cardiorenal protection.

Also mentioned is the importance of 24-hour physical behaviors (including sleep, sitting, and sweating) and the impact on cardiometabolic health, use of a “holistic person-centered approach” to type 2 diabetes management, and an algorithm on insulin use.

Dr. Buse has financial ties to numerous drug and device companies. Dr. Green is a consultant for AstraZeneca, Pfizer, Boehringer Ingelheim/Lilly, Bayer, Sanofi, Anji, Vertex/ICON, and Valo. Dr. Aroda has served as a consultant for Applied Therapeutics, Duke, Fractyl, Novo Nordisk, Pfizer, and Sanofi.

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

STOCKHOLM – Weight loss should be a co–primary management goal for type 2 diabetes in adults, according to a new comprehensive joint consensus report from the European Association for the Study of Diabetes and the American Diabetes Association.

And while metformin is still recommended as first-line therapy for patients with type 2 diabetes with no other comorbidities, the statement expands the indications for use of other agents or combinations of agents as initial therapy for subgroups of patients, as part of individualized and patient-centered decision-making.

Last updated in 2019, the new “Management of Hyperglycemia in Type 2 Diabetes” statement also places increased emphasis on social determinants of health, incorporates recent clinical trial data for cardiovascular and kidney outcomes for sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagonlike peptide–1 (GLP-1) agonists to broaden recommendations for cardiorenal protection, and discusses health behaviors such as sleep and sitting. It also targets a wider audience than in the past by addressing health system organization to optimize delivery of diabetes care.

The new statement was presented during a 90-minute session at the annual meeting of the EASD, with 12 of its 14 European and American authors as presenters. The document was simultaneously published in Diabetologia and Diabetes Care.

During the discussion, panel member Jennifer Brigitte Green, MD, commented: “Many of these recommendations are not new. They’re modest revisions of recommendations that have been in place for years, but we know that actual implementation rates of use of these drugs in patients with established comorbidities are very low.”

“I think it’s time for communities, health care systems, etc, to actually introduce these as expectations of care... to assess quality because unless it’s considered formally to be a requirement of care I just don’t think we’re going to move that needle very much,” added Dr. Green, who is professor of medicine at Duke University, Durham, N.C.

Vanita R. Aroda, MD, of the division of endocrinology, diabetes, and hypertension at Brigham and Women’s Hospital, Boston, commented: “In the past, sometimes these recommendations created fodder for debate, but I don’t think this one will. It’s just really solidly evidence based, with the rationales presented throughout, including the figures. I think just having very clear evidence-based directions should support their dissemination and use.”
 

Weight management plays a prominent role in treatment

In an interview, writing panel cochair John B. Buse, MD, PhD, said: “We are saying that the four major components of type 2 diabetes care are glycemic management, cardiovascular risk management, weight management, and prevention of end-organ damage, particularly with regard to cardiorenal risk.”

“The weight management piece is much more explicit now,” said Dr. Buse, director of the Diabetes Center at the University of North Carolina at Chapel Hill.

He noted that recent evidence from the intensive lifestyle trial DiRECT, conducted in the United Kingdom, the bariatric surgery literature, and the emergence of potent weight-loss drugs have meant that “achieving 10%-15% body weight loss is now possible.

“So, aiming for remission is something that might be attractive to patients and providers. This could be based on weight management, with the [chosen] method based on shared decision-making.”

According to the new report: “Weight loss of 5%-10% confers metabolic improvement; weight loss of 10%-15% or more can have a disease-modifying effect and lead to remission of diabetes, defined as normal blood glucose levels for 3 months or more in the absence of pharmacological therapy in a 2021 consensus report.”

“Weight loss may exert benefits that extend beyond glycemic management to improve risk factors for cardiometabolic disease and quality of life,” it adds.
 

Individualization featured throughout

The report’s sections cover principles of care, including the importance of diabetes self-management education and support and avoidance of therapeutic inertia. Detailed guidance addresses therapeutic options including lifestyle, weight management, and pharmacotherapy for treating type 2 diabetes.

Another entire section is devoted to personalizing treatment approaches based on individual characteristics, including new evidence from cardiorenal outcomes studies for SGLT2 inhibitors and GLP-1 agonists that have come out since the last consensus report.

The document advises: “Consider initial combination therapy with glucose-lowering agents, especially in those with high [hemoglobin] A1c at diagnosis (that is, > 70 mmol/mol [> 8.5%]), in younger people with type 2 diabetes (regardless of A1c), and in those in whom a stepwise approach would delay access to agents that provide cardiorenal protection beyond their glucose-lowering effects.”
 

Designed to be used and user-friendly

Under the “Putting it all together: strategies for implementation” section, several lists of “practical tips for clinicians” are provided for many of the topics covered.

A series of colorful infographics are included as well, addressing the “decision cycle for person-centered glycemic management in type 2 diabetes,” including a chart summarizing characteristics of available glucose-lowering medications, including cardiorenal protection.

Also mentioned is the importance of 24-hour physical behaviors (including sleep, sitting, and sweating) and the impact on cardiometabolic health, use of a “holistic person-centered approach” to type 2 diabetes management, and an algorithm on insulin use.

Dr. Buse has financial ties to numerous drug and device companies. Dr. Green is a consultant for AstraZeneca, Pfizer, Boehringer Ingelheim/Lilly, Bayer, Sanofi, Anji, Vertex/ICON, and Valo. Dr. Aroda has served as a consultant for Applied Therapeutics, Duke, Fractyl, Novo Nordisk, Pfizer, and Sanofi.

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

STOCKHOLM – Weight loss should be a co–primary management goal for type 2 diabetes in adults, according to a new comprehensive joint consensus report from the European Association for the Study of Diabetes and the American Diabetes Association.

And while metformin is still recommended as first-line therapy for patients with type 2 diabetes with no other comorbidities, the statement expands the indications for use of other agents or combinations of agents as initial therapy for subgroups of patients, as part of individualized and patient-centered decision-making.

Last updated in 2019, the new “Management of Hyperglycemia in Type 2 Diabetes” statement also places increased emphasis on social determinants of health, incorporates recent clinical trial data for cardiovascular and kidney outcomes for sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagonlike peptide–1 (GLP-1) agonists to broaden recommendations for cardiorenal protection, and discusses health behaviors such as sleep and sitting. It also targets a wider audience than in the past by addressing health system organization to optimize delivery of diabetes care.

The new statement was presented during a 90-minute session at the annual meeting of the EASD, with 12 of its 14 European and American authors as presenters. The document was simultaneously published in Diabetologia and Diabetes Care.

During the discussion, panel member Jennifer Brigitte Green, MD, commented: “Many of these recommendations are not new. They’re modest revisions of recommendations that have been in place for years, but we know that actual implementation rates of use of these drugs in patients with established comorbidities are very low.”

“I think it’s time for communities, health care systems, etc, to actually introduce these as expectations of care... to assess quality because unless it’s considered formally to be a requirement of care I just don’t think we’re going to move that needle very much,” added Dr. Green, who is professor of medicine at Duke University, Durham, N.C.

Vanita R. Aroda, MD, of the division of endocrinology, diabetes, and hypertension at Brigham and Women’s Hospital, Boston, commented: “In the past, sometimes these recommendations created fodder for debate, but I don’t think this one will. It’s just really solidly evidence based, with the rationales presented throughout, including the figures. I think just having very clear evidence-based directions should support their dissemination and use.”
 

Weight management plays a prominent role in treatment

In an interview, writing panel cochair John B. Buse, MD, PhD, said: “We are saying that the four major components of type 2 diabetes care are glycemic management, cardiovascular risk management, weight management, and prevention of end-organ damage, particularly with regard to cardiorenal risk.”

“The weight management piece is much more explicit now,” said Dr. Buse, director of the Diabetes Center at the University of North Carolina at Chapel Hill.

He noted that recent evidence from the intensive lifestyle trial DiRECT, conducted in the United Kingdom, the bariatric surgery literature, and the emergence of potent weight-loss drugs have meant that “achieving 10%-15% body weight loss is now possible.

“So, aiming for remission is something that might be attractive to patients and providers. This could be based on weight management, with the [chosen] method based on shared decision-making.”

According to the new report: “Weight loss of 5%-10% confers metabolic improvement; weight loss of 10%-15% or more can have a disease-modifying effect and lead to remission of diabetes, defined as normal blood glucose levels for 3 months or more in the absence of pharmacological therapy in a 2021 consensus report.”

“Weight loss may exert benefits that extend beyond glycemic management to improve risk factors for cardiometabolic disease and quality of life,” it adds.
 

Individualization featured throughout

The report’s sections cover principles of care, including the importance of diabetes self-management education and support and avoidance of therapeutic inertia. Detailed guidance addresses therapeutic options including lifestyle, weight management, and pharmacotherapy for treating type 2 diabetes.

Another entire section is devoted to personalizing treatment approaches based on individual characteristics, including new evidence from cardiorenal outcomes studies for SGLT2 inhibitors and GLP-1 agonists that have come out since the last consensus report.

The document advises: “Consider initial combination therapy with glucose-lowering agents, especially in those with high [hemoglobin] A1c at diagnosis (that is, > 70 mmol/mol [> 8.5%]), in younger people with type 2 diabetes (regardless of A1c), and in those in whom a stepwise approach would delay access to agents that provide cardiorenal protection beyond their glucose-lowering effects.”
 

Designed to be used and user-friendly

Under the “Putting it all together: strategies for implementation” section, several lists of “practical tips for clinicians” are provided for many of the topics covered.

A series of colorful infographics are included as well, addressing the “decision cycle for person-centered glycemic management in type 2 diabetes,” including a chart summarizing characteristics of available glucose-lowering medications, including cardiorenal protection.

Also mentioned is the importance of 24-hour physical behaviors (including sleep, sitting, and sweating) and the impact on cardiometabolic health, use of a “holistic person-centered approach” to type 2 diabetes management, and an algorithm on insulin use.

Dr. Buse has financial ties to numerous drug and device companies. Dr. Green is a consultant for AstraZeneca, Pfizer, Boehringer Ingelheim/Lilly, Bayer, Sanofi, Anji, Vertex/ICON, and Valo. Dr. Aroda has served as a consultant for Applied Therapeutics, Duke, Fractyl, Novo Nordisk, Pfizer, and Sanofi.

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

A look at the top cardiovascular disease (CVD) diagnoses in U.S. emergency departments (EDs) suggests that many heart-related emergencies are due to poorly controlled high blood pressure.

In a study of more than 20 million ED visits, about one-third of CVD-related ED visits in the United States were for hypertension-related conditions.

Overall, 13% of ED visits, representing more than 2.7 million individuals, were for essential hypertension.

Nationwide sample

The researchers studied more than 20.6 million ED encounters in adults with a primary CVD diagnosis using data from the Nationwide Emergency Department Sample between 2016 and 2018.

In the sample, 49% were women, and the median age was 67 years. Men had poorer overall baseline cardiometabolic profiles, but women had higher rates of obesity, hypertension, and cerebrovascular disease. The majority had Medicare or Medicaid insurance.

In women, essential hypertension was the most common reason for an ED visit (16%), followed by hypertensive heart or kidney disease (14%) and atrial fibrillation (AF)/flutter (10%).

In men, the top three reasons were hypertensive heart or kidney disease (15%), essential hypertension (11%), and acute myocardial infarction (AMI, 11%).

On presentation, women were significantly more likely to have essential hypertension, hypertensive crisis, AF/flutter, supraventricular tachycardia, pulmonary embolism, or ischemic stroke, while men were more likely to have AMI, or cardiac arrest.

“Previous studies have shown sex differences in patterns of CVD among hospitalized patients,” Dr. Mamas noted. “However, examining CVD encounters in the ED provides a more complete picture of the cardiovascular healthcare needs of men and women, as it captures encounters prior to hospitalization.”

He noted that previous studies of CVD emergency visits are limited to suspected MI visits. “Therefore, this analysis of 15 CVD conditions helps to better understand the full spectrum of acute CVD needs, including sex disparities in hospitalization and risk of death,” Dr. Mamas said.
 

Sex differences in outcomes

The study found that outcomes from the emergency CVD visits were slightly different for men and women.

Overall, women were less likely than were men to die (3.3% vs. 4.3%) or be hospitalized (49.1% vs. 52.3%) after an ED visit for CVD. The difference may be due to women’s generally lower-risk diagnoses, Dr. Mamas said, but there could be an underestimation of deaths in women.

In logistic regression models adjusted for baseline covariates, women with intracranial hemorrhage (ICH) had a higher risk of being admitted to hospital or dying compared with men with ICH.

Men were more likely to die if they presented with hypertensive heart or kidney disease, AF/flutter, AMI or cardiac arrest, the researchers found. 

“We did not track deaths outside of the hospital setting,” Dr. Mamas pointed out. Given past evidence that women are more likely to be inappropriately discharged from the ED, and strong evidence for the systemic undertreatment of women, further study is warranted to track outcomes beyond the ED visit,” he added.

The researchers called for further research into understanding the underlying factors driving the differences in CVD patterns and outcomes between men and women.

Reached for comment, Maryann McLaughlin, MD, a cardiologist at Mount Sinai Hospital, New York, said: “Hypertension is a silent killer” and this study “reiterates that people need to get their blood pressure checked more regularly.

“In the very least, if they do present to the hospital as not feeling well or whatever it is, and they are identified as having high blood pressure, that’s an important opportunity to really teach them about hypertension and have them follow-up with it,” Dr. McLaughlin told this news organization. 

The study was supported by Health Data Research UK. Dr. Keele and Dr. McLaughlin have reported no relevant financial relationships.

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

A look at the top cardiovascular disease (CVD) diagnoses in U.S. emergency departments (EDs) suggests that many heart-related emergencies are due to poorly controlled high blood pressure.

In a study of more than 20 million ED visits, about one-third of CVD-related ED visits in the United States were for hypertension-related conditions.

Overall, 13% of ED visits, representing more than 2.7 million individuals, were for essential hypertension.

Nationwide sample

The researchers studied more than 20.6 million ED encounters in adults with a primary CVD diagnosis using data from the Nationwide Emergency Department Sample between 2016 and 2018.

In the sample, 49% were women, and the median age was 67 years. Men had poorer overall baseline cardiometabolic profiles, but women had higher rates of obesity, hypertension, and cerebrovascular disease. The majority had Medicare or Medicaid insurance.

In women, essential hypertension was the most common reason for an ED visit (16%), followed by hypertensive heart or kidney disease (14%) and atrial fibrillation (AF)/flutter (10%).

In men, the top three reasons were hypertensive heart or kidney disease (15%), essential hypertension (11%), and acute myocardial infarction (AMI, 11%).

On presentation, women were significantly more likely to have essential hypertension, hypertensive crisis, AF/flutter, supraventricular tachycardia, pulmonary embolism, or ischemic stroke, while men were more likely to have AMI, or cardiac arrest.

“Previous studies have shown sex differences in patterns of CVD among hospitalized patients,” Dr. Mamas noted. “However, examining CVD encounters in the ED provides a more complete picture of the cardiovascular healthcare needs of men and women, as it captures encounters prior to hospitalization.”

He noted that previous studies of CVD emergency visits are limited to suspected MI visits. “Therefore, this analysis of 15 CVD conditions helps to better understand the full spectrum of acute CVD needs, including sex disparities in hospitalization and risk of death,” Dr. Mamas said.
 

Sex differences in outcomes

The study found that outcomes from the emergency CVD visits were slightly different for men and women.

Overall, women were less likely than were men to die (3.3% vs. 4.3%) or be hospitalized (49.1% vs. 52.3%) after an ED visit for CVD. The difference may be due to women’s generally lower-risk diagnoses, Dr. Mamas said, but there could be an underestimation of deaths in women.

In logistic regression models adjusted for baseline covariates, women with intracranial hemorrhage (ICH) had a higher risk of being admitted to hospital or dying compared with men with ICH.

Men were more likely to die if they presented with hypertensive heart or kidney disease, AF/flutter, AMI or cardiac arrest, the researchers found. 

“We did not track deaths outside of the hospital setting,” Dr. Mamas pointed out. Given past evidence that women are more likely to be inappropriately discharged from the ED, and strong evidence for the systemic undertreatment of women, further study is warranted to track outcomes beyond the ED visit,” he added.

The researchers called for further research into understanding the underlying factors driving the differences in CVD patterns and outcomes between men and women.

Reached for comment, Maryann McLaughlin, MD, a cardiologist at Mount Sinai Hospital, New York, said: “Hypertension is a silent killer” and this study “reiterates that people need to get their blood pressure checked more regularly.

“In the very least, if they do present to the hospital as not feeling well or whatever it is, and they are identified as having high blood pressure, that’s an important opportunity to really teach them about hypertension and have them follow-up with it,” Dr. McLaughlin told this news organization. 

The study was supported by Health Data Research UK. Dr. Keele and Dr. McLaughlin have reported no relevant financial relationships.

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

A look at the top cardiovascular disease (CVD) diagnoses in U.S. emergency departments (EDs) suggests that many heart-related emergencies are due to poorly controlled high blood pressure.

In a study of more than 20 million ED visits, about one-third of CVD-related ED visits in the United States were for hypertension-related conditions.

Overall, 13% of ED visits, representing more than 2.7 million individuals, were for essential hypertension.

Nationwide sample

The researchers studied more than 20.6 million ED encounters in adults with a primary CVD diagnosis using data from the Nationwide Emergency Department Sample between 2016 and 2018.

In the sample, 49% were women, and the median age was 67 years. Men had poorer overall baseline cardiometabolic profiles, but women had higher rates of obesity, hypertension, and cerebrovascular disease. The majority had Medicare or Medicaid insurance.

In women, essential hypertension was the most common reason for an ED visit (16%), followed by hypertensive heart or kidney disease (14%) and atrial fibrillation (AF)/flutter (10%).

In men, the top three reasons were hypertensive heart or kidney disease (15%), essential hypertension (11%), and acute myocardial infarction (AMI, 11%).

On presentation, women were significantly more likely to have essential hypertension, hypertensive crisis, AF/flutter, supraventricular tachycardia, pulmonary embolism, or ischemic stroke, while men were more likely to have AMI, or cardiac arrest.

“Previous studies have shown sex differences in patterns of CVD among hospitalized patients,” Dr. Mamas noted. “However, examining CVD encounters in the ED provides a more complete picture of the cardiovascular healthcare needs of men and women, as it captures encounters prior to hospitalization.”

He noted that previous studies of CVD emergency visits are limited to suspected MI visits. “Therefore, this analysis of 15 CVD conditions helps to better understand the full spectrum of acute CVD needs, including sex disparities in hospitalization and risk of death,” Dr. Mamas said.
 

Sex differences in outcomes

The study found that outcomes from the emergency CVD visits were slightly different for men and women.

Overall, women were less likely than were men to die (3.3% vs. 4.3%) or be hospitalized (49.1% vs. 52.3%) after an ED visit for CVD. The difference may be due to women’s generally lower-risk diagnoses, Dr. Mamas said, but there could be an underestimation of deaths in women.

In logistic regression models adjusted for baseline covariates, women with intracranial hemorrhage (ICH) had a higher risk of being admitted to hospital or dying compared with men with ICH.

Men were more likely to die if they presented with hypertensive heart or kidney disease, AF/flutter, AMI or cardiac arrest, the researchers found. 

“We did not track deaths outside of the hospital setting,” Dr. Mamas pointed out. Given past evidence that women are more likely to be inappropriately discharged from the ED, and strong evidence for the systemic undertreatment of women, further study is warranted to track outcomes beyond the ED visit,” he added.

The researchers called for further research into understanding the underlying factors driving the differences in CVD patterns and outcomes between men and women.

Reached for comment, Maryann McLaughlin, MD, a cardiologist at Mount Sinai Hospital, New York, said: “Hypertension is a silent killer” and this study “reiterates that people need to get their blood pressure checked more regularly.

“In the very least, if they do present to the hospital as not feeling well or whatever it is, and they are identified as having high blood pressure, that’s an important opportunity to really teach them about hypertension and have them follow-up with it,” Dr. McLaughlin told this news organization. 

The study was supported by Health Data Research UK. Dr. Keele and Dr. McLaughlin have reported no relevant financial relationships.

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

It’s best to have patients on aggressive lipid-lowering therapy before discharge after an acute ST-segment elevation myocardial infarction (STEMI), so why not start it right away – even in the cath lab – using some of the most potent LDL cholesterol–lowering agents available?

That was a main idea behind the randomized, sham-controlled EPIC-STEMI trial, in which STEMI patients were started on a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor immediately before direct percutaneous coronary intervention (PCI) and on top of high-intensity statins.

Those in the trial getting the active agent showed a 22% drop in LDL cholesterol levels by 6 weeks, compared with the control group given a sham injection along with high-intensity statins. They were also more likely to meet LDL cholesterol goals specified in some guidelines, including reduction by at least 50%. And those outcomes were achieved regardless of baseline LDL cholesterol levels or prior statin use.

Adoption of the trial’s early, aggressive LDL cholesterolreduction strategy in practice “has the potential to substantially reduce morbidity and mortality” in such cases “by further reducing LDL beyond statins in a much greater number of high-risk patients than are currently being treated with these agents,” suggested principal investigator Shamir R. Mehta, MD, MSc, when presenting the findings at the Transcatheter Cardiovascular Therapeutics annual meeting, sponsored by the Cardiovascular Research Foundation.

Adherence to secondary prevention measures in patients with acute coronary syndromes (ACS) is much better if they are started before hospital discharge, explained Dr. Mehta, senior scientist with Population Health Research Institute and professor of medicine at McMaster University, Hamilton, Ont. But “as soon as the patient has left the hospital, it is much more difficult to get these therapies on board.”

Routine adoption of such aggressive in-hospital, lipid-lowering therapy for the vast population with ACS would likely mean far fewer deaths and cardiovascular events “across a broader patient population.”

EPIC-STEMI is among the first studies to explore the strategy. “I think that’s the point of the trial that we wanted to make, that we don’t yet have data on this. We’re treading very carefully with PCSK9 inhibitors, and it’s just inching forward in populations. And I think we need a bold trial to see whether or not this changes things.”

The PCSK9 inhibitor alirocumab (Praluent) was used in EPIC-STEMI, which was published in EuroIntervention, with Dr. Mehta as lead author, the same day as his presentation. The drug and its sham injection were given on top of either atorvastatin 40-80 mg or rosuvastatin 40 mg.

Early initiation of statins in patients with acute STEMI has become standard, but there’s good evidence from intracoronary imaging studies suggesting that the addition of PCSK9 inhibitors might promote further stabilization of plaques that could potentially cause recurrent ischemic events.

Treatment with the injectable drugs plus statins led to significant coronary lesion regression in the GLAGOV trial of patients with stable coronary disease. And initiation of PCSK9 inhibitors with high-intensity statins soon after PCI for ACS improved atheroma shrinkage in non–infarct-related arteries over 1 year in the recent, placebo-controlled PACMAN-AMI trial.

Dr. Mehta pointed out that LDL reductions on PCSK9 inhibition, compared with the sham control, weren’t necessarily as impressive as might be expected from the major trials of long-term therapy with the drugs.

“You need longer [therapy] in order to see a difference in LDL levels when you use a PCSK9 inhibitor acutely. This is shown also on measures of infarct size.” There was no difference between treatment groups in infarct size as measured by levels of the MB fraction of creatine kinase, he reported.

“What this is telling us is that the acute use of a PCSK9 inhibitor did not modify the size or the severity of the baseline STEMI event.”

And EPIC-STEMI was too small and never intended to assess clinical outcomes; it was more about feasibility and what degree of LDL cholesterol lowering might be expected.

The trial was needed, Dr. Mehta said, because the PCSK9 inhibitors haven’t been extensively adopted into clinical practice and are not getting to the patients who could most benefit. One of the reasons for that is quite clear to him. “We are missing the high-risk patients because we are not treating them acutely,” Dr. Mehta said in an interview.

The strategy “has not yet been evaluated, and there have been barriers,” he observed. “Cost has been a barrier. Access to the drug has been a barrier. But in terms of the science, in terms of reducing cardiovascular events, this is a strategy that has to be tested.”

Mount Sinai Medical Center

The aggressive, early LDL cholesterol reduction strategy should be evaluated for its effect on long-term outcomes, “especially knowing that in the first 30 days to 6 months post STEMI there’s a tremendous uptick in ischemic events, including recurrent myocardial infarction,” Roxana Mehran, MD, said at a media briefing on EPIC-STEMI held before Dr. Mehta’s formal presentation.

The “fantastic reduction acutely” with a PCSK9 inhibitor on top of statins, “hopefully reducing inflammation” similarly to what’s been observed in past trials, “absolutely warrants” a STEMI clinical outcomes trial, said Dr. Mehran, Icahn School of Medicine at Mount Sinai, New York, who isn’t connected with EPIC-STEMI.

If better post-discharge medication adherence is one of the acute strategy’s goals, it will be important to consider the potential influence of prescribing a periodically injected drug, proposed Eric A. Cohen, MD, Sunnybrook Health Sciences Center, Toronto, at the press conference.

“Keep in mind that STEMI patients typically come to the hospital on zero medications and leave 2 days later on five medications,” Dr. Cohen observed. “I’m curious whether having one of those as a sub-Q injection every 2 weeks, and reducing the pill burden, will help or deter adherence to therapy. I think it’s worth studying.”

The trial originally included 97 patients undergoing PCI for STEMI who were randomly assigned to receive the PCSK9 inhibitor or a sham injection on top of high-intensity statins, without regard to LDL cholesterol levels. Randomization took place after diagnostic angiography but before PCI.

The analysis, however, subsequently excluded 29 patients who could not continue with the study, “mainly because of hospital research clinic closure due to the COVID-19 pandemic,” the published report states.

That left 68 patients who had received at least one dose of PCSK9 inhibitor, alirocumab 150 mg subcutaneously, or the sham injection, and had at least one blood draw for LDL cholesterol response which, Dr. Mehta said, still left adequate statistical power for the LDL cholesterol–based primary endpoint.

By 6 weeks, LDL cholesterol levels had fallen 72.9% in the active-therapy group and by 48.1% in the control group (P < .001). Also, 92.1% and 56.7% of patients, respectively (P = .002), had achieved levels below the 1.4 mmol/L (54 mg/dL) goal in the European guidelines, Dr. Mehta reported.

Levels fell more than 50% compared with baseline in 89.5% of alirocumab patients and 60% (P = .007) of controls, respectively.

There was no significant difference in rates of attaining LDL cholesterol levels below the 70 mg/dL (1.8 mmol/L) threshold specified in U.S. guidelines for very high-risk patients: 94.7% of alirocumab patients and 83.4% of controls (P = .26).
Nor did the groups differ significantly in natriuretic peptide levels, which reflect ventricular remodeling; or in 6-week change in the inflammatory biomarker high-sensitivity C-reactive protein.

An open-label, randomized trial scheduled to launch before the end of 2022 will explore similarly early initiation of a PCSK9 inhibitor, compared with standard lipid management, in an estimated 4,000 patients hospitalized with STEMI or non-STEMI.

The EVOLVE MI trial is looking at the monoclonal antibody evolocumab (Repatha) for its effect on the primary endpoint of myocardial infarction, ischemic stroke, arterial revascularization, or death from any cause over an expected 3-4 years.

EPIC-STEMI was supported in part by Sanofi. Dr. Mehta reported an unrestricted grant from Sanofi to Hamilton Health Sciences for the present study and consulting fees from Amgen, Sanofi, and Novartis. Dr. Cohen disclosed receiving grant support from and holding research contracts with Abbott Vascular; and receiving fees for consulting, honoraria, or serving on a speaker’s bureau for Abbott Vascular, Medtronic, and Baylis. Dr. Mehran disclosed receiving grants or research support from numerous pharmaceutical companies; receiving consultant fee or honoraria or serving on a speaker’s bureau for Novartis, Abbott Vascular, Janssen, Medtronic, Medscape/WebMD, and Cine-Med Research; and holding equity, stock, or stock options with Control Rad, Applied Therapeutics, and Elixir Medical.

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

It’s best to have patients on aggressive lipid-lowering therapy before discharge after an acute ST-segment elevation myocardial infarction (STEMI), so why not start it right away – even in the cath lab – using some of the most potent LDL cholesterol–lowering agents available?

That was a main idea behind the randomized, sham-controlled EPIC-STEMI trial, in which STEMI patients were started on a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor immediately before direct percutaneous coronary intervention (PCI) and on top of high-intensity statins.

Those in the trial getting the active agent showed a 22% drop in LDL cholesterol levels by 6 weeks, compared with the control group given a sham injection along with high-intensity statins. They were also more likely to meet LDL cholesterol goals specified in some guidelines, including reduction by at least 50%. And those outcomes were achieved regardless of baseline LDL cholesterol levels or prior statin use.

Adoption of the trial’s early, aggressive LDL cholesterolreduction strategy in practice “has the potential to substantially reduce morbidity and mortality” in such cases “by further reducing LDL beyond statins in a much greater number of high-risk patients than are currently being treated with these agents,” suggested principal investigator Shamir R. Mehta, MD, MSc, when presenting the findings at the Transcatheter Cardiovascular Therapeutics annual meeting, sponsored by the Cardiovascular Research Foundation.

Adherence to secondary prevention measures in patients with acute coronary syndromes (ACS) is much better if they are started before hospital discharge, explained Dr. Mehta, senior scientist with Population Health Research Institute and professor of medicine at McMaster University, Hamilton, Ont. But “as soon as the patient has left the hospital, it is much more difficult to get these therapies on board.”

Routine adoption of such aggressive in-hospital, lipid-lowering therapy for the vast population with ACS would likely mean far fewer deaths and cardiovascular events “across a broader patient population.”

EPIC-STEMI is among the first studies to explore the strategy. “I think that’s the point of the trial that we wanted to make, that we don’t yet have data on this. We’re treading very carefully with PCSK9 inhibitors, and it’s just inching forward in populations. And I think we need a bold trial to see whether or not this changes things.”

The PCSK9 inhibitor alirocumab (Praluent) was used in EPIC-STEMI, which was published in EuroIntervention, with Dr. Mehta as lead author, the same day as his presentation. The drug and its sham injection were given on top of either atorvastatin 40-80 mg or rosuvastatin 40 mg.

Early initiation of statins in patients with acute STEMI has become standard, but there’s good evidence from intracoronary imaging studies suggesting that the addition of PCSK9 inhibitors might promote further stabilization of plaques that could potentially cause recurrent ischemic events.

Treatment with the injectable drugs plus statins led to significant coronary lesion regression in the GLAGOV trial of patients with stable coronary disease. And initiation of PCSK9 inhibitors with high-intensity statins soon after PCI for ACS improved atheroma shrinkage in non–infarct-related arteries over 1 year in the recent, placebo-controlled PACMAN-AMI trial.

Dr. Mehta pointed out that LDL reductions on PCSK9 inhibition, compared with the sham control, weren’t necessarily as impressive as might be expected from the major trials of long-term therapy with the drugs.

“You need longer [therapy] in order to see a difference in LDL levels when you use a PCSK9 inhibitor acutely. This is shown also on measures of infarct size.” There was no difference between treatment groups in infarct size as measured by levels of the MB fraction of creatine kinase, he reported.

“What this is telling us is that the acute use of a PCSK9 inhibitor did not modify the size or the severity of the baseline STEMI event.”

And EPIC-STEMI was too small and never intended to assess clinical outcomes; it was more about feasibility and what degree of LDL cholesterol lowering might be expected.

The trial was needed, Dr. Mehta said, because the PCSK9 inhibitors haven’t been extensively adopted into clinical practice and are not getting to the patients who could most benefit. One of the reasons for that is quite clear to him. “We are missing the high-risk patients because we are not treating them acutely,” Dr. Mehta said in an interview.

The strategy “has not yet been evaluated, and there have been barriers,” he observed. “Cost has been a barrier. Access to the drug has been a barrier. But in terms of the science, in terms of reducing cardiovascular events, this is a strategy that has to be tested.”

Mount Sinai Medical Center

The aggressive, early LDL cholesterol reduction strategy should be evaluated for its effect on long-term outcomes, “especially knowing that in the first 30 days to 6 months post STEMI there’s a tremendous uptick in ischemic events, including recurrent myocardial infarction,” Roxana Mehran, MD, said at a media briefing on EPIC-STEMI held before Dr. Mehta’s formal presentation.

The “fantastic reduction acutely” with a PCSK9 inhibitor on top of statins, “hopefully reducing inflammation” similarly to what’s been observed in past trials, “absolutely warrants” a STEMI clinical outcomes trial, said Dr. Mehran, Icahn School of Medicine at Mount Sinai, New York, who isn’t connected with EPIC-STEMI.

If better post-discharge medication adherence is one of the acute strategy’s goals, it will be important to consider the potential influence of prescribing a periodically injected drug, proposed Eric A. Cohen, MD, Sunnybrook Health Sciences Center, Toronto, at the press conference.

“Keep in mind that STEMI patients typically come to the hospital on zero medications and leave 2 days later on five medications,” Dr. Cohen observed. “I’m curious whether having one of those as a sub-Q injection every 2 weeks, and reducing the pill burden, will help or deter adherence to therapy. I think it’s worth studying.”

The trial originally included 97 patients undergoing PCI for STEMI who were randomly assigned to receive the PCSK9 inhibitor or a sham injection on top of high-intensity statins, without regard to LDL cholesterol levels. Randomization took place after diagnostic angiography but before PCI.

The analysis, however, subsequently excluded 29 patients who could not continue with the study, “mainly because of hospital research clinic closure due to the COVID-19 pandemic,” the published report states.

That left 68 patients who had received at least one dose of PCSK9 inhibitor, alirocumab 150 mg subcutaneously, or the sham injection, and had at least one blood draw for LDL cholesterol response which, Dr. Mehta said, still left adequate statistical power for the LDL cholesterol–based primary endpoint.

By 6 weeks, LDL cholesterol levels had fallen 72.9% in the active-therapy group and by 48.1% in the control group (P < .001). Also, 92.1% and 56.7% of patients, respectively (P = .002), had achieved levels below the 1.4 mmol/L (54 mg/dL) goal in the European guidelines, Dr. Mehta reported.

Levels fell more than 50% compared with baseline in 89.5% of alirocumab patients and 60% (P = .007) of controls, respectively.

There was no significant difference in rates of attaining LDL cholesterol levels below the 70 mg/dL (1.8 mmol/L) threshold specified in U.S. guidelines for very high-risk patients: 94.7% of alirocumab patients and 83.4% of controls (P = .26).
Nor did the groups differ significantly in natriuretic peptide levels, which reflect ventricular remodeling; or in 6-week change in the inflammatory biomarker high-sensitivity C-reactive protein.

An open-label, randomized trial scheduled to launch before the end of 2022 will explore similarly early initiation of a PCSK9 inhibitor, compared with standard lipid management, in an estimated 4,000 patients hospitalized with STEMI or non-STEMI.

The EVOLVE MI trial is looking at the monoclonal antibody evolocumab (Repatha) for its effect on the primary endpoint of myocardial infarction, ischemic stroke, arterial revascularization, or death from any cause over an expected 3-4 years.

EPIC-STEMI was supported in part by Sanofi. Dr. Mehta reported an unrestricted grant from Sanofi to Hamilton Health Sciences for the present study and consulting fees from Amgen, Sanofi, and Novartis. Dr. Cohen disclosed receiving grant support from and holding research contracts with Abbott Vascular; and receiving fees for consulting, honoraria, or serving on a speaker’s bureau for Abbott Vascular, Medtronic, and Baylis. Dr. Mehran disclosed receiving grants or research support from numerous pharmaceutical companies; receiving consultant fee or honoraria or serving on a speaker’s bureau for Novartis, Abbott Vascular, Janssen, Medtronic, Medscape/WebMD, and Cine-Med Research; and holding equity, stock, or stock options with Control Rad, Applied Therapeutics, and Elixir Medical.

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

It’s best to have patients on aggressive lipid-lowering therapy before discharge after an acute ST-segment elevation myocardial infarction (STEMI), so why not start it right away – even in the cath lab – using some of the most potent LDL cholesterol–lowering agents available?

That was a main idea behind the randomized, sham-controlled EPIC-STEMI trial, in which STEMI patients were started on a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor immediately before direct percutaneous coronary intervention (PCI) and on top of high-intensity statins.

Those in the trial getting the active agent showed a 22% drop in LDL cholesterol levels by 6 weeks, compared with the control group given a sham injection along with high-intensity statins. They were also more likely to meet LDL cholesterol goals specified in some guidelines, including reduction by at least 50%. And those outcomes were achieved regardless of baseline LDL cholesterol levels or prior statin use.

Adoption of the trial’s early, aggressive LDL cholesterolreduction strategy in practice “has the potential to substantially reduce morbidity and mortality” in such cases “by further reducing LDL beyond statins in a much greater number of high-risk patients than are currently being treated with these agents,” suggested principal investigator Shamir R. Mehta, MD, MSc, when presenting the findings at the Transcatheter Cardiovascular Therapeutics annual meeting, sponsored by the Cardiovascular Research Foundation.

Adherence to secondary prevention measures in patients with acute coronary syndromes (ACS) is much better if they are started before hospital discharge, explained Dr. Mehta, senior scientist with Population Health Research Institute and professor of medicine at McMaster University, Hamilton, Ont. But “as soon as the patient has left the hospital, it is much more difficult to get these therapies on board.”

Routine adoption of such aggressive in-hospital, lipid-lowering therapy for the vast population with ACS would likely mean far fewer deaths and cardiovascular events “across a broader patient population.”

EPIC-STEMI is among the first studies to explore the strategy. “I think that’s the point of the trial that we wanted to make, that we don’t yet have data on this. We’re treading very carefully with PCSK9 inhibitors, and it’s just inching forward in populations. And I think we need a bold trial to see whether or not this changes things.”

The PCSK9 inhibitor alirocumab (Praluent) was used in EPIC-STEMI, which was published in EuroIntervention, with Dr. Mehta as lead author, the same day as his presentation. The drug and its sham injection were given on top of either atorvastatin 40-80 mg or rosuvastatin 40 mg.

Early initiation of statins in patients with acute STEMI has become standard, but there’s good evidence from intracoronary imaging studies suggesting that the addition of PCSK9 inhibitors might promote further stabilization of plaques that could potentially cause recurrent ischemic events.

Treatment with the injectable drugs plus statins led to significant coronary lesion regression in the GLAGOV trial of patients with stable coronary disease. And initiation of PCSK9 inhibitors with high-intensity statins soon after PCI for ACS improved atheroma shrinkage in non–infarct-related arteries over 1 year in the recent, placebo-controlled PACMAN-AMI trial.

Dr. Mehta pointed out that LDL reductions on PCSK9 inhibition, compared with the sham control, weren’t necessarily as impressive as might be expected from the major trials of long-term therapy with the drugs.

“You need longer [therapy] in order to see a difference in LDL levels when you use a PCSK9 inhibitor acutely. This is shown also on measures of infarct size.” There was no difference between treatment groups in infarct size as measured by levels of the MB fraction of creatine kinase, he reported.

“What this is telling us is that the acute use of a PCSK9 inhibitor did not modify the size or the severity of the baseline STEMI event.”

And EPIC-STEMI was too small and never intended to assess clinical outcomes; it was more about feasibility and what degree of LDL cholesterol lowering might be expected.

The trial was needed, Dr. Mehta said, because the PCSK9 inhibitors haven’t been extensively adopted into clinical practice and are not getting to the patients who could most benefit. One of the reasons for that is quite clear to him. “We are missing the high-risk patients because we are not treating them acutely,” Dr. Mehta said in an interview.

The strategy “has not yet been evaluated, and there have been barriers,” he observed. “Cost has been a barrier. Access to the drug has been a barrier. But in terms of the science, in terms of reducing cardiovascular events, this is a strategy that has to be tested.”

Mount Sinai Medical Center

The aggressive, early LDL cholesterol reduction strategy should be evaluated for its effect on long-term outcomes, “especially knowing that in the first 30 days to 6 months post STEMI there’s a tremendous uptick in ischemic events, including recurrent myocardial infarction,” Roxana Mehran, MD, said at a media briefing on EPIC-STEMI held before Dr. Mehta’s formal presentation.

The “fantastic reduction acutely” with a PCSK9 inhibitor on top of statins, “hopefully reducing inflammation” similarly to what’s been observed in past trials, “absolutely warrants” a STEMI clinical outcomes trial, said Dr. Mehran, Icahn School of Medicine at Mount Sinai, New York, who isn’t connected with EPIC-STEMI.

If better post-discharge medication adherence is one of the acute strategy’s goals, it will be important to consider the potential influence of prescribing a periodically injected drug, proposed Eric A. Cohen, MD, Sunnybrook Health Sciences Center, Toronto, at the press conference.

“Keep in mind that STEMI patients typically come to the hospital on zero medications and leave 2 days later on five medications,” Dr. Cohen observed. “I’m curious whether having one of those as a sub-Q injection every 2 weeks, and reducing the pill burden, will help or deter adherence to therapy. I think it’s worth studying.”

The trial originally included 97 patients undergoing PCI for STEMI who were randomly assigned to receive the PCSK9 inhibitor or a sham injection on top of high-intensity statins, without regard to LDL cholesterol levels. Randomization took place after diagnostic angiography but before PCI.

The analysis, however, subsequently excluded 29 patients who could not continue with the study, “mainly because of hospital research clinic closure due to the COVID-19 pandemic,” the published report states.

That left 68 patients who had received at least one dose of PCSK9 inhibitor, alirocumab 150 mg subcutaneously, or the sham injection, and had at least one blood draw for LDL cholesterol response which, Dr. Mehta said, still left adequate statistical power for the LDL cholesterol–based primary endpoint.

By 6 weeks, LDL cholesterol levels had fallen 72.9% in the active-therapy group and by 48.1% in the control group (P < .001). Also, 92.1% and 56.7% of patients, respectively (P = .002), had achieved levels below the 1.4 mmol/L (54 mg/dL) goal in the European guidelines, Dr. Mehta reported.

Levels fell more than 50% compared with baseline in 89.5% of alirocumab patients and 60% (P = .007) of controls, respectively.

There was no significant difference in rates of attaining LDL cholesterol levels below the 70 mg/dL (1.8 mmol/L) threshold specified in U.S. guidelines for very high-risk patients: 94.7% of alirocumab patients and 83.4% of controls (P = .26).
Nor did the groups differ significantly in natriuretic peptide levels, which reflect ventricular remodeling; or in 6-week change in the inflammatory biomarker high-sensitivity C-reactive protein.

An open-label, randomized trial scheduled to launch before the end of 2022 will explore similarly early initiation of a PCSK9 inhibitor, compared with standard lipid management, in an estimated 4,000 patients hospitalized with STEMI or non-STEMI.

The EVOLVE MI trial is looking at the monoclonal antibody evolocumab (Repatha) for its effect on the primary endpoint of myocardial infarction, ischemic stroke, arterial revascularization, or death from any cause over an expected 3-4 years.

EPIC-STEMI was supported in part by Sanofi. Dr. Mehta reported an unrestricted grant from Sanofi to Hamilton Health Sciences for the present study and consulting fees from Amgen, Sanofi, and Novartis. Dr. Cohen disclosed receiving grant support from and holding research contracts with Abbott Vascular; and receiving fees for consulting, honoraria, or serving on a speaker’s bureau for Abbott Vascular, Medtronic, and Baylis. Dr. Mehran disclosed receiving grants or research support from numerous pharmaceutical companies; receiving consultant fee or honoraria or serving on a speaker’s bureau for Novartis, Abbott Vascular, Janssen, Medtronic, Medscape/WebMD, and Cine-Med Research; and holding equity, stock, or stock options with Control Rad, Applied Therapeutics, and Elixir Medical.

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

Adolescents and young adults who undergo “top surgery” for gender dysphoria overwhelmingly report being satisfied with the procedure in the near-term, new research shows.

The results of the prospective cohort study, reported recently in JAMA Pediatrics, suggest that the surgery can help facilitate gender congruence and comfort with body image for transmasculine and nonbinary youth. The authors, from Northwestern University, Chicago, said the findings may “help dispel misconceptions that gender-affirming treatment is experimental and support evidence-based practices of top surgery.”

Sumanas Jordan, MD, PhD, assistant professor of plastic surgery at Northwestern University, Chicago, and a coauthor of the study, said the study was the first prospective, matched cohort analysis showing that chest surgery improves outcomes in this age group.

“We focused our study on chest dysphoria, the distress due to the presence of breasts, and gender congruence, the feeling of alignment between identity and physical characteristics,” Dr. Jordan said. “We will continue to study the effect of surgery in other areas of health, such as physical functioning and quality of life, and follow our patients longer term.”

As many as 9% of adolescents and young adults identify as transgender or nonbinary - a group underrepresented in the pediatric literature, Dr. Jordan’s group said. Chest dysphoria often is associated with psychosocial issues such as depression and anxiety.

“Dysphoria can lead to a range of negative physical and emotional consequences, such as avoidance of exercise and sports, harmful chest-binding practices, functional limitations, and suicidal ideation, said M. Brett Cooper, MD, MEd, assistant professor of pediatrics, and adolescent and young adult medicine, at UT Southwestern Medical Center/Children’s Health, Dallas. “These young people often bind for several hours a day to reduce the presence of their chest.”

The study

The Northwestern team recruited 81 patients with a mean age of 18.6 years whose sex at birth was assigned female. Patients were overwhelmingly White (89%), and the majority (59%) were transgender male, the remaining patients nonbinary.

The population sample included patients aged 13-24 who underwent top surgery from December 2019 to April 2021 and a matched control group of those who did not have surgery.

Outcomes measures were assessed preoperatively and 3 months after surgery.

Thirty-six surgical patients and 34 of those in the control arm completed the outcomes measures. Surgical complications were minimal. Propensity analyses suggested an association between surgery and substantial improvements in scores on the following study endpoints:

• Chest dysphoria measure (–25.58 points, 95% confidence interval [CI], –29.18 to –21.98).
• Transgender congruence scale (7.78 points, 95%: CI, 6.06-9.50)
• Body image scale (–7.20 points, 95% CI, –11.68 to –2.72).

The patients who underwent top surgery reported significant improvements in scores of chest dysphoria, transgender congruence, and body image. The results for patients younger than age 18 paralleled those for older participants in the study.

While the results corroborate other studies showing that gender-affirming therapy improves mental health and quality of life among these young people, the researchers cautioned that some insurers require testosterone therapy for 1 year before their plans will cover the costs of gender-affirming surgery.

This may negatively affect those nonbinary patients who do not undergo hormone therapy,” the researchers wrote. They are currently collecting 1-year follow-up data to determine the long-term effects of top surgery on chest dysphoria, gender congruence, and body image.

As surgical patients progress through adult life, does the risk of regret increase? “We did not address regret in this short-term study,” Dr. Jordan said. “However, previous studies have shown very low levels of regret.”

An accompanying editorial concurred that top surgery is effective and medically necessary in this population of young people.

Calling the study “an important milestone in gender affirmation research,” Kishan M. Thadikonda, MD, and Katherine M. Gast, MD, MS, of the school of medicine and public health at the University of Wisconsin in Madison, said it will be important to follow this young cohort to prove these benefits will endure as patients age.

They cautioned, however, that nonbinary patients represented just 13% of the patient total and only 8% of the surgical cohort. Nonbinary patients are not well understood as a patient population when it comes to gender-affirmation surgery and are often included in studies with transgender patients despite clear differences, they noted.
 

Current setbacks

According to Dr. Cooper, politics is already affecting care in Texas. “Due to the sociopolitical climate in my state in regard to gender-affirming care, I have also seen a few young people have their surgeries either canceled or postponed by their parents,” he said. “This has led to a worsening of mental health in these patients.”

Dr. Cooper stressed the need for more research on the perspective of non-White and socioeconomically disadvantaged youth.

“This study also highlights the disparity between patients who have commercial insurance versus those who are on Medicaid,” he said. “Medicaid plans often do not cover this, so those patients usually have to continue to suffer or pay for this surgery out of their own pocket.”

This study was supported by the Northwestern University Clinical and Translational Sciences Institute, funded in part by the National Institutes of Health. Funding also came from the Plastic Surgery Foundation and American Association of Pediatric Plastic Surgery. Dr. Jordan received grants from the Plastic Surgery Foundation during the study. One coauthor reported consultant fees from CVS Caremark for consulting outside the submitted work, and another reported grants from the National Institutes of Health outside the submitted work. Dr. Cooper disclosed no competing interests relevant to his comments. The editorial commentators disclosed no conflicts of interest.

Adolescents and young adults who undergo “top surgery” for gender dysphoria overwhelmingly report being satisfied with the procedure in the near-term, new research shows.

The results of the prospective cohort study, reported recently in JAMA Pediatrics, suggest that the surgery can help facilitate gender congruence and comfort with body image for transmasculine and nonbinary youth. The authors, from Northwestern University, Chicago, said the findings may “help dispel misconceptions that gender-affirming treatment is experimental and support evidence-based practices of top surgery.”

Sumanas Jordan, MD, PhD, assistant professor of plastic surgery at Northwestern University, Chicago, and a coauthor of the study, said the study was the first prospective, matched cohort analysis showing that chest surgery improves outcomes in this age group.

“We focused our study on chest dysphoria, the distress due to the presence of breasts, and gender congruence, the feeling of alignment between identity and physical characteristics,” Dr. Jordan said. “We will continue to study the effect of surgery in other areas of health, such as physical functioning and quality of life, and follow our patients longer term.”

As many as 9% of adolescents and young adults identify as transgender or nonbinary - a group underrepresented in the pediatric literature, Dr. Jordan’s group said. Chest dysphoria often is associated with psychosocial issues such as depression and anxiety.

“Dysphoria can lead to a range of negative physical and emotional consequences, such as avoidance of exercise and sports, harmful chest-binding practices, functional limitations, and suicidal ideation, said M. Brett Cooper, MD, MEd, assistant professor of pediatrics, and adolescent and young adult medicine, at UT Southwestern Medical Center/Children’s Health, Dallas. “These young people often bind for several hours a day to reduce the presence of their chest.”

The study

The Northwestern team recruited 81 patients with a mean age of 18.6 years whose sex at birth was assigned female. Patients were overwhelmingly White (89%), and the majority (59%) were transgender male, the remaining patients nonbinary.

The population sample included patients aged 13-24 who underwent top surgery from December 2019 to April 2021 and a matched control group of those who did not have surgery.

Outcomes measures were assessed preoperatively and 3 months after surgery.

Thirty-six surgical patients and 34 of those in the control arm completed the outcomes measures. Surgical complications were minimal. Propensity analyses suggested an association between surgery and substantial improvements in scores on the following study endpoints:

• Chest dysphoria measure (–25.58 points, 95% confidence interval [CI], –29.18 to –21.98).
• Transgender congruence scale (7.78 points, 95%: CI, 6.06-9.50)
• Body image scale (–7.20 points, 95% CI, –11.68 to –2.72).

The patients who underwent top surgery reported significant improvements in scores of chest dysphoria, transgender congruence, and body image. The results for patients younger than age 18 paralleled those for older participants in the study.

While the results corroborate other studies showing that gender-affirming therapy improves mental health and quality of life among these young people, the researchers cautioned that some insurers require testosterone therapy for 1 year before their plans will cover the costs of gender-affirming surgery.

This may negatively affect those nonbinary patients who do not undergo hormone therapy,” the researchers wrote. They are currently collecting 1-year follow-up data to determine the long-term effects of top surgery on chest dysphoria, gender congruence, and body image.

As surgical patients progress through adult life, does the risk of regret increase? “We did not address regret in this short-term study,” Dr. Jordan said. “However, previous studies have shown very low levels of regret.”

An accompanying editorial concurred that top surgery is effective and medically necessary in this population of young people.

Calling the study “an important milestone in gender affirmation research,” Kishan M. Thadikonda, MD, and Katherine M. Gast, MD, MS, of the school of medicine and public health at the University of Wisconsin in Madison, said it will be important to follow this young cohort to prove these benefits will endure as patients age.

They cautioned, however, that nonbinary patients represented just 13% of the patient total and only 8% of the surgical cohort. Nonbinary patients are not well understood as a patient population when it comes to gender-affirmation surgery and are often included in studies with transgender patients despite clear differences, they noted.
 

Current setbacks

According to Dr. Cooper, politics is already affecting care in Texas. “Due to the sociopolitical climate in my state in regard to gender-affirming care, I have also seen a few young people have their surgeries either canceled or postponed by their parents,” he said. “This has led to a worsening of mental health in these patients.”

Dr. Cooper stressed the need for more research on the perspective of non-White and socioeconomically disadvantaged youth.

“This study also highlights the disparity between patients who have commercial insurance versus those who are on Medicaid,” he said. “Medicaid plans often do not cover this, so those patients usually have to continue to suffer or pay for this surgery out of their own pocket.”

This study was supported by the Northwestern University Clinical and Translational Sciences Institute, funded in part by the National Institutes of Health. Funding also came from the Plastic Surgery Foundation and American Association of Pediatric Plastic Surgery. Dr. Jordan received grants from the Plastic Surgery Foundation during the study. One coauthor reported consultant fees from CVS Caremark for consulting outside the submitted work, and another reported grants from the National Institutes of Health outside the submitted work. Dr. Cooper disclosed no competing interests relevant to his comments. The editorial commentators disclosed no conflicts of interest.

Adolescents and young adults who undergo “top surgery” for gender dysphoria overwhelmingly report being satisfied with the procedure in the near-term, new research shows.

The results of the prospective cohort study, reported recently in JAMA Pediatrics, suggest that the surgery can help facilitate gender congruence and comfort with body image for transmasculine and nonbinary youth. The authors, from Northwestern University, Chicago, said the findings may “help dispel misconceptions that gender-affirming treatment is experimental and support evidence-based practices of top surgery.”

Sumanas Jordan, MD, PhD, assistant professor of plastic surgery at Northwestern University, Chicago, and a coauthor of the study, said the study was the first prospective, matched cohort analysis showing that chest surgery improves outcomes in this age group.

“We focused our study on chest dysphoria, the distress due to the presence of breasts, and gender congruence, the feeling of alignment between identity and physical characteristics,” Dr. Jordan said. “We will continue to study the effect of surgery in other areas of health, such as physical functioning and quality of life, and follow our patients longer term.”

As many as 9% of adolescents and young adults identify as transgender or nonbinary - a group underrepresented in the pediatric literature, Dr. Jordan’s group said. Chest dysphoria often is associated with psychosocial issues such as depression and anxiety.

“Dysphoria can lead to a range of negative physical and emotional consequences, such as avoidance of exercise and sports, harmful chest-binding practices, functional limitations, and suicidal ideation, said M. Brett Cooper, MD, MEd, assistant professor of pediatrics, and adolescent and young adult medicine, at UT Southwestern Medical Center/Children’s Health, Dallas. “These young people often bind for several hours a day to reduce the presence of their chest.”

The study

The Northwestern team recruited 81 patients with a mean age of 18.6 years whose sex at birth was assigned female. Patients were overwhelmingly White (89%), and the majority (59%) were transgender male, the remaining patients nonbinary.

The population sample included patients aged 13-24 who underwent top surgery from December 2019 to April 2021 and a matched control group of those who did not have surgery.

Outcomes measures were assessed preoperatively and 3 months after surgery.

Thirty-six surgical patients and 34 of those in the control arm completed the outcomes measures. Surgical complications were minimal. Propensity analyses suggested an association between surgery and substantial improvements in scores on the following study endpoints:

• Chest dysphoria measure (–25.58 points, 95% confidence interval [CI], –29.18 to –21.98).
• Transgender congruence scale (7.78 points, 95%: CI, 6.06-9.50)
• Body image scale (–7.20 points, 95% CI, –11.68 to –2.72).

The patients who underwent top surgery reported significant improvements in scores of chest dysphoria, transgender congruence, and body image. The results for patients younger than age 18 paralleled those for older participants in the study.

While the results corroborate other studies showing that gender-affirming therapy improves mental health and quality of life among these young people, the researchers cautioned that some insurers require testosterone therapy for 1 year before their plans will cover the costs of gender-affirming surgery.

This may negatively affect those nonbinary patients who do not undergo hormone therapy,” the researchers wrote. They are currently collecting 1-year follow-up data to determine the long-term effects of top surgery on chest dysphoria, gender congruence, and body image.

As surgical patients progress through adult life, does the risk of regret increase? “We did not address regret in this short-term study,” Dr. Jordan said. “However, previous studies have shown very low levels of regret.”

An accompanying editorial concurred that top surgery is effective and medically necessary in this population of young people.

Calling the study “an important milestone in gender affirmation research,” Kishan M. Thadikonda, MD, and Katherine M. Gast, MD, MS, of the school of medicine and public health at the University of Wisconsin in Madison, said it will be important to follow this young cohort to prove these benefits will endure as patients age.

They cautioned, however, that nonbinary patients represented just 13% of the patient total and only 8% of the surgical cohort. Nonbinary patients are not well understood as a patient population when it comes to gender-affirmation surgery and are often included in studies with transgender patients despite clear differences, they noted.
 

Current setbacks

According to Dr. Cooper, politics is already affecting care in Texas. “Due to the sociopolitical climate in my state in regard to gender-affirming care, I have also seen a few young people have their surgeries either canceled or postponed by their parents,” he said. “This has led to a worsening of mental health in these patients.”

Dr. Cooper stressed the need for more research on the perspective of non-White and socioeconomically disadvantaged youth.

“This study also highlights the disparity between patients who have commercial insurance versus those who are on Medicaid,” he said. “Medicaid plans often do not cover this, so those patients usually have to continue to suffer or pay for this surgery out of their own pocket.”

This study was supported by the Northwestern University Clinical and Translational Sciences Institute, funded in part by the National Institutes of Health. Funding also came from the Plastic Surgery Foundation and American Association of Pediatric Plastic Surgery. Dr. Jordan received grants from the Plastic Surgery Foundation during the study. One coauthor reported consultant fees from CVS Caremark for consulting outside the submitted work, and another reported grants from the National Institutes of Health outside the submitted work. Dr. Cooper disclosed no competing interests relevant to his comments. The editorial commentators disclosed no conflicts of interest.

Adding community health workers (CHW) to a primary care setting was linked with improved type 2 diabetes management in a safety-net population, new research indicates.

The researchers, led by Robert L. Ferrer, MD, MPH, with the department of family and community medicine at the University of Texas Health Science Center, San Antonio, enrolled 986 people in a Latino, inner-city cohort in primary care in San Antonio. Patients had uncontrolled type 2 diabetes and psychosocial risk factors. The study was published in Annals of Family Medicine.

The primary outcome measured was whether patients progressed through three stages of self-care: outreach (meeting face to face with a community health care worker), stabilization (collaborating with community health care workers to address life circumstances), and a third stage the researchers called “self-care generativity” (being able to manage blood sugar levels at home). The intervention lasted up to 12 weeks and had a 4-year follow-up.

Of participating patients, the researchers reported, 27% remained in outreach, 41% progressed to stabilization, 32% achieved self-care generativity status.

Coauthor Carlos Roberto Jaén, MD, PhD, also from the UT Health Science Center at San Antonio, said in an interview, “I don’t know any other intervention for diabetes that has 32% of participants having this kind of effect 4 years later.”

Dr. Jaén added that the study is unusual in that it had a 4-year follow-up and showed positive effects throughout that period, as most CHW studies have followed patients only up to one year.

The positive results over the 4 years after a short intervention “is a testimony of the power of intervention,” he said.

A1c drops with more progress in the intervention

The secondary outcome was change in hemoglobin A1c and need for urgent care or emergency department or hospital care.

Study participants who worked with a CHW – regardless of which group they were in at the end of the intervention – collectively saw a 2% drop in blood sugar.

Over a similar time period to when the study was conducted, the researchers analyzed 27,000 A1c measurements of patients with type 2 diabetes in a comparator group. For these patients, who did not receive the study intervention but were part of the same practice as those who received the intervention, the researchers observed a reduction in A1c levels of 0.05%.

Among the study participants, for those who remained in outreach, hospital visits were 6% higher than for those who advanced to the level of self-care generativity, but this difference was not statistically significant. Hospital visits were 90% higher for those who achieved stabilization versus those who remained in outreach (P = .014) The average count of emergency department visits was 74% higher for those who achieved stabilization versus those who achieved self-care generativity, and 31% higher in the group remaining at outreach versus those who reached the highest level of self-care.
 

Advantages of community workers

In San Antonio, the authors noted, type 2 diabetes prevalence is high: 15.5% of its 1.6 million residents have been diagnosed with the disease.

The CHWs built trust with patients and helped them set goals, navigate the health system and connect to community resources. They worked with behavioral health clinicians, nurse care managers, and medical assistants toward population management.

“Community health workers’ detailed understanding of patients’ circumstances help to tailor their care rather than apply fixed interventions,” the authors wrote.

Ricardo Correa, MD, director of the endocrinology, diabetes, and metabolism fellowship program in the University of Arizona, Phoenix, who was not involved with the study, said in an interview he was not surprised by the positive results.

He described the difference when CHWs get involved with type 2 diabetes care, particularly in the Latino community.

“They understand the culture, not just the language,” he said. “They have the trust of the community.”

It’s different when a provider not from the community tells a person with type 2 diabetes he or she needs to eat healthier or exercise more, he said.

The CHW can understand, for instance, that the nearest fresh market may be two towns away and open only on Saturdays and the parks are not safe for exercise outside at certain times of the day. Then they can help the patient find a sustainable solution.

“Community workers also won’t be looking at your immigration status,” something important to many in the Latino community, he explained.

Though this study looked at type 2 diabetes management, community health workers are also effective in other areas, he explained, such as increasing COVID-19 vaccinations, also do them being trustworthy and understanding.
 

Other study strengths

The group of people with type 2 diabetes they studied has the highest rates of poverty – “the poorest of the poor” – and the highest rates of diabetes-related amputations in San Antonio, Dr. Jaén said.

The intervention “is more focused on what people want to do, less so on the disease,” he explained. People are asked what goals they want to achieve and how the care team can help.

“It becomes an alliance between the community health worker and the patient,” he continued.

Others interested in implementing a program should know that building that relationship takes time and takes a broad multidisciplinary team working together, he said. “We would not necessarily see these effects in 6 months. You have to use a larger perspective.”

The researchers include with this study under the first-page tab “more online” access to tools, including resources for training, for others who want to implement such a program.

The study authors and Dr. Correa reported no relevant financial relationships.

Adding community health workers (CHW) to a primary care setting was linked with improved type 2 diabetes management in a safety-net population, new research indicates.

The researchers, led by Robert L. Ferrer, MD, MPH, with the department of family and community medicine at the University of Texas Health Science Center, San Antonio, enrolled 986 people in a Latino, inner-city cohort in primary care in San Antonio. Patients had uncontrolled type 2 diabetes and psychosocial risk factors. The study was published in Annals of Family Medicine.

The primary outcome measured was whether patients progressed through three stages of self-care: outreach (meeting face to face with a community health care worker), stabilization (collaborating with community health care workers to address life circumstances), and a third stage the researchers called “self-care generativity” (being able to manage blood sugar levels at home). The intervention lasted up to 12 weeks and had a 4-year follow-up.

Of participating patients, the researchers reported, 27% remained in outreach, 41% progressed to stabilization, 32% achieved self-care generativity status.

Coauthor Carlos Roberto Jaén, MD, PhD, also from the UT Health Science Center at San Antonio, said in an interview, “I don’t know any other intervention for diabetes that has 32% of participants having this kind of effect 4 years later.”

Dr. Jaén added that the study is unusual in that it had a 4-year follow-up and showed positive effects throughout that period, as most CHW studies have followed patients only up to one year.

The positive results over the 4 years after a short intervention “is a testimony of the power of intervention,” he said.

A1c drops with more progress in the intervention

The secondary outcome was change in hemoglobin A1c and need for urgent care or emergency department or hospital care.

Study participants who worked with a CHW – regardless of which group they were in at the end of the intervention – collectively saw a 2% drop in blood sugar.

Over a similar time period to when the study was conducted, the researchers analyzed 27,000 A1c measurements of patients with type 2 diabetes in a comparator group. For these patients, who did not receive the study intervention but were part of the same practice as those who received the intervention, the researchers observed a reduction in A1c levels of 0.05%.

Among the study participants, for those who remained in outreach, hospital visits were 6% higher than for those who advanced to the level of self-care generativity, but this difference was not statistically significant. Hospital visits were 90% higher for those who achieved stabilization versus those who remained in outreach (P = .014) The average count of emergency department visits was 74% higher for those who achieved stabilization versus those who achieved self-care generativity, and 31% higher in the group remaining at outreach versus those who reached the highest level of self-care.
 

Advantages of community workers

In San Antonio, the authors noted, type 2 diabetes prevalence is high: 15.5% of its 1.6 million residents have been diagnosed with the disease.

The CHWs built trust with patients and helped them set goals, navigate the health system and connect to community resources. They worked with behavioral health clinicians, nurse care managers, and medical assistants toward population management.

“Community health workers’ detailed understanding of patients’ circumstances help to tailor their care rather than apply fixed interventions,” the authors wrote.

Ricardo Correa, MD, director of the endocrinology, diabetes, and metabolism fellowship program in the University of Arizona, Phoenix, who was not involved with the study, said in an interview he was not surprised by the positive results.

He described the difference when CHWs get involved with type 2 diabetes care, particularly in the Latino community.

“They understand the culture, not just the language,” he said. “They have the trust of the community.”

It’s different when a provider not from the community tells a person with type 2 diabetes he or she needs to eat healthier or exercise more, he said.

The CHW can understand, for instance, that the nearest fresh market may be two towns away and open only on Saturdays and the parks are not safe for exercise outside at certain times of the day. Then they can help the patient find a sustainable solution.

“Community workers also won’t be looking at your immigration status,” something important to many in the Latino community, he explained.

Though this study looked at type 2 diabetes management, community health workers are also effective in other areas, he explained, such as increasing COVID-19 vaccinations, also do them being trustworthy and understanding.
 

Other study strengths

The group of people with type 2 diabetes they studied has the highest rates of poverty – “the poorest of the poor” – and the highest rates of diabetes-related amputations in San Antonio, Dr. Jaén said.

The intervention “is more focused on what people want to do, less so on the disease,” he explained. People are asked what goals they want to achieve and how the care team can help.

“It becomes an alliance between the community health worker and the patient,” he continued.

Others interested in implementing a program should know that building that relationship takes time and takes a broad multidisciplinary team working together, he said. “We would not necessarily see these effects in 6 months. You have to use a larger perspective.”

The researchers include with this study under the first-page tab “more online” access to tools, including resources for training, for others who want to implement such a program.

The study authors and Dr. Correa reported no relevant financial relationships.

Adding community health workers (CHW) to a primary care setting was linked with improved type 2 diabetes management in a safety-net population, new research indicates.

The researchers, led by Robert L. Ferrer, MD, MPH, with the department of family and community medicine at the University of Texas Health Science Center, San Antonio, enrolled 986 people in a Latino, inner-city cohort in primary care in San Antonio. Patients had uncontrolled type 2 diabetes and psychosocial risk factors. The study was published in Annals of Family Medicine.

The primary outcome measured was whether patients progressed through three stages of self-care: outreach (meeting face to face with a community health care worker), stabilization (collaborating with community health care workers to address life circumstances), and a third stage the researchers called “self-care generativity” (being able to manage blood sugar levels at home). The intervention lasted up to 12 weeks and had a 4-year follow-up.

Of participating patients, the researchers reported, 27% remained in outreach, 41% progressed to stabilization, 32% achieved self-care generativity status.

Coauthor Carlos Roberto Jaén, MD, PhD, also from the UT Health Science Center at San Antonio, said in an interview, “I don’t know any other intervention for diabetes that has 32% of participants having this kind of effect 4 years later.”

Dr. Jaén added that the study is unusual in that it had a 4-year follow-up and showed positive effects throughout that period, as most CHW studies have followed patients only up to one year.

The positive results over the 4 years after a short intervention “is a testimony of the power of intervention,” he said.

A1c drops with more progress in the intervention

The secondary outcome was change in hemoglobin A1c and need for urgent care or emergency department or hospital care.

Study participants who worked with a CHW – regardless of which group they were in at the end of the intervention – collectively saw a 2% drop in blood sugar.

Over a similar time period to when the study was conducted, the researchers analyzed 27,000 A1c measurements of patients with type 2 diabetes in a comparator group. For these patients, who did not receive the study intervention but were part of the same practice as those who received the intervention, the researchers observed a reduction in A1c levels of 0.05%.

Among the study participants, for those who remained in outreach, hospital visits were 6% higher than for those who advanced to the level of self-care generativity, but this difference was not statistically significant. Hospital visits were 90% higher for those who achieved stabilization versus those who remained in outreach (P = .014) The average count of emergency department visits was 74% higher for those who achieved stabilization versus those who achieved self-care generativity, and 31% higher in the group remaining at outreach versus those who reached the highest level of self-care.
 

Advantages of community workers

In San Antonio, the authors noted, type 2 diabetes prevalence is high: 15.5% of its 1.6 million residents have been diagnosed with the disease.

The CHWs built trust with patients and helped them set goals, navigate the health system and connect to community resources. They worked with behavioral health clinicians, nurse care managers, and medical assistants toward population management.

“Community health workers’ detailed understanding of patients’ circumstances help to tailor their care rather than apply fixed interventions,” the authors wrote.

Ricardo Correa, MD, director of the endocrinology, diabetes, and metabolism fellowship program in the University of Arizona, Phoenix, who was not involved with the study, said in an interview he was not surprised by the positive results.

He described the difference when CHWs get involved with type 2 diabetes care, particularly in the Latino community.

“They understand the culture, not just the language,” he said. “They have the trust of the community.”

It’s different when a provider not from the community tells a person with type 2 diabetes he or she needs to eat healthier or exercise more, he said.

The CHW can understand, for instance, that the nearest fresh market may be two towns away and open only on Saturdays and the parks are not safe for exercise outside at certain times of the day. Then they can help the patient find a sustainable solution.

“Community workers also won’t be looking at your immigration status,” something important to many in the Latino community, he explained.

Though this study looked at type 2 diabetes management, community health workers are also effective in other areas, he explained, such as increasing COVID-19 vaccinations, also do them being trustworthy and understanding.
 

Other study strengths

The group of people with type 2 diabetes they studied has the highest rates of poverty – “the poorest of the poor” – and the highest rates of diabetes-related amputations in San Antonio, Dr. Jaén said.

The intervention “is more focused on what people want to do, less so on the disease,” he explained. People are asked what goals they want to achieve and how the care team can help.

“It becomes an alliance between the community health worker and the patient,” he continued.

Others interested in implementing a program should know that building that relationship takes time and takes a broad multidisciplinary team working together, he said. “We would not necessarily see these effects in 6 months. You have to use a larger perspective.”

The researchers include with this study under the first-page tab “more online” access to tools, including resources for training, for others who want to implement such a program.

The study authors and Dr. Correa reported no relevant financial relationships.

From our first days as medical students, we are told that politics and religion are topics to be avoided with patients, but I disagree. Knowing more about our patients allows us to deliver better care. I propose that we consider adding politics and religion to our list of risk factors.

Politics and religion: New risk factors

The importance of politics and religion in the health of patients was clearly demonstrated during the COVID-19 pandemic. Lives were needlessly lost because of stands taken based on religious beliefs or a political ideology. Families, friends, and the community at large were impacted.

Over my years of practice, I have found that while these are difficult topics to address, they should not be avoided. Studies have shown that open acknowledgement of religious beliefs can affect both clinical outcomes and well-being. Religion and spirituality are as much a part of our patient’s lives as the physical parameters that we measure. To neglect these significant aspects is to miss the very essence of the individual.

I made it a practice to ask patients about their religious beliefs, the extent to which religion shaped their life, and whether they were part of a church community. Knowing this allowed me to separate deep personal belief from stances based on personal freedom, misinformation, conspiracies, and politics.

I found that information about political leanings flowed naturally in discussions with patients as we trusted and respected each other over time. If I approached politics objectively and nonjudgmentally, it generally led to meaningful conversation. This helped me to understand the patient as an individual and informed my diagnosis and treatment plan.
 

Politics as stress

For example, on more than one occasion, a patient with atrial fibrillation presented with persistent elevated blood pressure and pulse rate despite adherence to the medical regimen that I had prescribed. After a few minutes of discussion, it was clear that excessive attention to political commentary on TV and social media raised their anxiety and anger level, putting them at greater risk for adverse outcomes. I advised that they refocus their leisure activities rather than change or increase medication.

It is disappointing to see how one of the great scientific advances of our lifetime, vaccination science, has been tarnished because of political or religious ideology and to see the extent to which these beliefs influenced COVID-19 vaccination compliance. As health care providers, we must promote information based on the scientific method. If patients challenge us and point out that recommendations based on science seem to change over time, we must explain that science evolves on the basis of new information objectively gathered. We need to find out what information the patient has gotten from the Internet, TV, or conspiracy theories and counter this with scientific facts. If we do not discuss religion and politics with our patients along with other risk factors, we may compromise our ability to give them the best advice and treatment.

Our patients have a right to their own spiritual and political ideology. If it differs dramatically from our own, this should not influence our commitment to care for them. But we have an obligation to challenge unfounded beliefs about medicine and counter with scientific facts. There are times when individual freedoms must be secondary to public health. Ultimately, it is up to the patient to choose, but they should not be given a “free pass” on the basis of religion or politics. If I know something is true and I would do it myself or recommend it for my family, I have an obligation to provide this recommendation to my patients.

Religious preference is included in medical records. It is not appropriate to add political preference, but the patient benefits if a long-term caregiver knows this information.

During the pandemic, for the first time in my 40+ years of practice, some patients questioned my recommendations and placed equal or greater weight on religion, politics, or conspiracy theories. This continues to be a very real struggle.

Knowing and understanding our patients as individuals is critical to providing optimum care and that means tackling these formally taboo topics. If having a potentially uncomfortable conversation with patients allows us to save one life, it is worth it.
 

Dr. Francis is a cardiologist at Inova Heart and Vascular Institute, McLean, Va. He disclosed no relevant conflict of interest. A version of this article first appeared on Medscape.com.

From our first days as medical students, we are told that politics and religion are topics to be avoided with patients, but I disagree. Knowing more about our patients allows us to deliver better care. I propose that we consider adding politics and religion to our list of risk factors.

Politics and religion: New risk factors

The importance of politics and religion in the health of patients was clearly demonstrated during the COVID-19 pandemic. Lives were needlessly lost because of stands taken based on religious beliefs or a political ideology. Families, friends, and the community at large were impacted.

Over my years of practice, I have found that while these are difficult topics to address, they should not be avoided. Studies have shown that open acknowledgement of religious beliefs can affect both clinical outcomes and well-being. Religion and spirituality are as much a part of our patient’s lives as the physical parameters that we measure. To neglect these significant aspects is to miss the very essence of the individual.

I made it a practice to ask patients about their religious beliefs, the extent to which religion shaped their life, and whether they were part of a church community. Knowing this allowed me to separate deep personal belief from stances based on personal freedom, misinformation, conspiracies, and politics.

I found that information about political leanings flowed naturally in discussions with patients as we trusted and respected each other over time. If I approached politics objectively and nonjudgmentally, it generally led to meaningful conversation. This helped me to understand the patient as an individual and informed my diagnosis and treatment plan.
 

Politics as stress

For example, on more than one occasion, a patient with atrial fibrillation presented with persistent elevated blood pressure and pulse rate despite adherence to the medical regimen that I had prescribed. After a few minutes of discussion, it was clear that excessive attention to political commentary on TV and social media raised their anxiety and anger level, putting them at greater risk for adverse outcomes. I advised that they refocus their leisure activities rather than change or increase medication.

It is disappointing to see how one of the great scientific advances of our lifetime, vaccination science, has been tarnished because of political or religious ideology and to see the extent to which these beliefs influenced COVID-19 vaccination compliance. As health care providers, we must promote information based on the scientific method. If patients challenge us and point out that recommendations based on science seem to change over time, we must explain that science evolves on the basis of new information objectively gathered. We need to find out what information the patient has gotten from the Internet, TV, or conspiracy theories and counter this with scientific facts. If we do not discuss religion and politics with our patients along with other risk factors, we may compromise our ability to give them the best advice and treatment.

Our patients have a right to their own spiritual and political ideology. If it differs dramatically from our own, this should not influence our commitment to care for them. But we have an obligation to challenge unfounded beliefs about medicine and counter with scientific facts. There are times when individual freedoms must be secondary to public health. Ultimately, it is up to the patient to choose, but they should not be given a “free pass” on the basis of religion or politics. If I know something is true and I would do it myself or recommend it for my family, I have an obligation to provide this recommendation to my patients.

Religious preference is included in medical records. It is not appropriate to add political preference, but the patient benefits if a long-term caregiver knows this information.

During the pandemic, for the first time in my 40+ years of practice, some patients questioned my recommendations and placed equal or greater weight on religion, politics, or conspiracy theories. This continues to be a very real struggle.

Knowing and understanding our patients as individuals is critical to providing optimum care and that means tackling these formally taboo topics. If having a potentially uncomfortable conversation with patients allows us to save one life, it is worth it.
 

Dr. Francis is a cardiologist at Inova Heart and Vascular Institute, McLean, Va. He disclosed no relevant conflict of interest. A version of this article first appeared on Medscape.com.

From our first days as medical students, we are told that politics and religion are topics to be avoided with patients, but I disagree. Knowing more about our patients allows us to deliver better care. I propose that we consider adding politics and religion to our list of risk factors.

Politics and religion: New risk factors

The importance of politics and religion in the health of patients was clearly demonstrated during the COVID-19 pandemic. Lives were needlessly lost because of stands taken based on religious beliefs or a political ideology. Families, friends, and the community at large were impacted.

Over my years of practice, I have found that while these are difficult topics to address, they should not be avoided. Studies have shown that open acknowledgement of religious beliefs can affect both clinical outcomes and well-being. Religion and spirituality are as much a part of our patient’s lives as the physical parameters that we measure. To neglect these significant aspects is to miss the very essence of the individual.

I made it a practice to ask patients about their religious beliefs, the extent to which religion shaped their life, and whether they were part of a church community. Knowing this allowed me to separate deep personal belief from stances based on personal freedom, misinformation, conspiracies, and politics.

I found that information about political leanings flowed naturally in discussions with patients as we trusted and respected each other over time. If I approached politics objectively and nonjudgmentally, it generally led to meaningful conversation. This helped me to understand the patient as an individual and informed my diagnosis and treatment plan.
 

Politics as stress

For example, on more than one occasion, a patient with atrial fibrillation presented with persistent elevated blood pressure and pulse rate despite adherence to the medical regimen that I had prescribed. After a few minutes of discussion, it was clear that excessive attention to political commentary on TV and social media raised their anxiety and anger level, putting them at greater risk for adverse outcomes. I advised that they refocus their leisure activities rather than change or increase medication.

It is disappointing to see how one of the great scientific advances of our lifetime, vaccination science, has been tarnished because of political or religious ideology and to see the extent to which these beliefs influenced COVID-19 vaccination compliance. As health care providers, we must promote information based on the scientific method. If patients challenge us and point out that recommendations based on science seem to change over time, we must explain that science evolves on the basis of new information objectively gathered. We need to find out what information the patient has gotten from the Internet, TV, or conspiracy theories and counter this with scientific facts. If we do not discuss religion and politics with our patients along with other risk factors, we may compromise our ability to give them the best advice and treatment.

Our patients have a right to their own spiritual and political ideology. If it differs dramatically from our own, this should not influence our commitment to care for them. But we have an obligation to challenge unfounded beliefs about medicine and counter with scientific facts. There are times when individual freedoms must be secondary to public health. Ultimately, it is up to the patient to choose, but they should not be given a “free pass” on the basis of religion or politics. If I know something is true and I would do it myself or recommend it for my family, I have an obligation to provide this recommendation to my patients.

Religious preference is included in medical records. It is not appropriate to add political preference, but the patient benefits if a long-term caregiver knows this information.

During the pandemic, for the first time in my 40+ years of practice, some patients questioned my recommendations and placed equal or greater weight on religion, politics, or conspiracy theories. This continues to be a very real struggle.

Knowing and understanding our patients as individuals is critical to providing optimum care and that means tackling these formally taboo topics. If having a potentially uncomfortable conversation with patients allows us to save one life, it is worth it.
 

Dr. Francis is a cardiologist at Inova Heart and Vascular Institute, McLean, Va. He disclosed no relevant conflict of interest. A version of this article first appeared on Medscape.com.