Cardiology News

Across the country, taxes unite us. Not that we all share the same, rather that we all have to do them. It was recently tax weekend in our house: The Saturday and Sunday that cap off weeks of hunting and gathering faded receipts and sorting through reams of credit card bills to find all the dollars we spent on work. The task is more tedious than all the Wednesdays of taking out trash bins combined, and equally as exciting. But wait, that’s not all.

This weekend I’ve been chatting with bots from a solar company trying to solve our drop in energy production and sat on terminal hold with apparently one person who answers the phone for Amazon. There’s also an homeowner’s association meeting to prepare for and research to be done on ceiling fans.

“Life admin” is a crisp phrase coined by Elizabeth Emens, JD, PhD, that captures the never-ending to-do list that comes with running a household. An accomplished law professor at Columbia University, New York, Dr. Emens noticed the negative impact this life admin has on our quality of life. Reading her book, “Life Admin: How I Learned to Do Less, Do Better, and Live More” (New York: HarperOne, 2019), your eyes widen as she magically makes salient all this hidden work that is stealing our time. Life admin, kidmin, mom and dadmin, just rattling them off feels like donning x-ray glasses allowing us to see how much work we do outside of our work. As doctors, I would add “family house calls,” as a contributing factor: Random family and friends who want to talk for a minute about their knee replacement or what drug the ICU should give Uncle Larry who is fighting COVID. (I only know ivermectin, but it would only help if he just had scabies).

By all accounts, the amount of life admin is growing insidiously, worsened by the great pandemic. There are events to plan and reply to, more DIY customer service to fix your own problems, more work to find a VRBO for a weekend getaway at the beach. (There are none on the entire coast of California this summer, so I just saved you time there. You’re welcome.)

There is no good time to do this work and combined with the heavy burden of our responsibilities as physicians, it can feel like fuel feeding the burnout fire.

Dr. Emens has some top tips to help. First up, know your admin type. Are you a super doer, reluctant doer, admin denier, or admin avoider? I’m mostly in the avoider quadrant, dropping into reluctant doer when consequences loom. Next, choose strategies that fit you. Instead of avoiding, there are some things I might deflect. For example, When your aunt in Peoria asks where she can get a COVID test, you can use LMGTFY.com to generate a link that will show them how to use Google to help with their question. Dr. Emens is joking, but the point rang true. We can lighten the load a bit if we delegate or push back the excessive or undue requests. For some tasks, we’d be better off paying someone to take it over. Last tip here, try doing life admin with a partner, be it spouse, friend, or colleague. This is particularly useful when your partner is a super doer, as mine is. Not only can they make the work lighter, but also less dreary.

We physicians are focused on fixing physician burnout. Maybe we should also be looking at what happens in the “second shift” at home. Tax season is over, but will be back soon.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected]

Across the country, taxes unite us. Not that we all share the same, rather that we all have to do them. It was recently tax weekend in our house: The Saturday and Sunday that cap off weeks of hunting and gathering faded receipts and sorting through reams of credit card bills to find all the dollars we spent on work. The task is more tedious than all the Wednesdays of taking out trash bins combined, and equally as exciting. But wait, that’s not all.

This weekend I’ve been chatting with bots from a solar company trying to solve our drop in energy production and sat on terminal hold with apparently one person who answers the phone for Amazon. There’s also an homeowner’s association meeting to prepare for and research to be done on ceiling fans.

“Life admin” is a crisp phrase coined by Elizabeth Emens, JD, PhD, that captures the never-ending to-do list that comes with running a household. An accomplished law professor at Columbia University, New York, Dr. Emens noticed the negative impact this life admin has on our quality of life. Reading her book, “Life Admin: How I Learned to Do Less, Do Better, and Live More” (New York: HarperOne, 2019), your eyes widen as she magically makes salient all this hidden work that is stealing our time. Life admin, kidmin, mom and dadmin, just rattling them off feels like donning x-ray glasses allowing us to see how much work we do outside of our work. As doctors, I would add “family house calls,” as a contributing factor: Random family and friends who want to talk for a minute about their knee replacement or what drug the ICU should give Uncle Larry who is fighting COVID. (I only know ivermectin, but it would only help if he just had scabies).

By all accounts, the amount of life admin is growing insidiously, worsened by the great pandemic. There are events to plan and reply to, more DIY customer service to fix your own problems, more work to find a VRBO for a weekend getaway at the beach. (There are none on the entire coast of California this summer, so I just saved you time there. You’re welcome.)

There is no good time to do this work and combined with the heavy burden of our responsibilities as physicians, it can feel like fuel feeding the burnout fire.

Dr. Emens has some top tips to help. First up, know your admin type. Are you a super doer, reluctant doer, admin denier, or admin avoider? I’m mostly in the avoider quadrant, dropping into reluctant doer when consequences loom. Next, choose strategies that fit you. Instead of avoiding, there are some things I might deflect. For example, When your aunt in Peoria asks where she can get a COVID test, you can use LMGTFY.com to generate a link that will show them how to use Google to help with their question. Dr. Emens is joking, but the point rang true. We can lighten the load a bit if we delegate or push back the excessive or undue requests. For some tasks, we’d be better off paying someone to take it over. Last tip here, try doing life admin with a partner, be it spouse, friend, or colleague. This is particularly useful when your partner is a super doer, as mine is. Not only can they make the work lighter, but also less dreary.

We physicians are focused on fixing physician burnout. Maybe we should also be looking at what happens in the “second shift” at home. Tax season is over, but will be back soon.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected]

Across the country, taxes unite us. Not that we all share the same, rather that we all have to do them. It was recently tax weekend in our house: The Saturday and Sunday that cap off weeks of hunting and gathering faded receipts and sorting through reams of credit card bills to find all the dollars we spent on work. The task is more tedious than all the Wednesdays of taking out trash bins combined, and equally as exciting. But wait, that’s not all.

This weekend I’ve been chatting with bots from a solar company trying to solve our drop in energy production and sat on terminal hold with apparently one person who answers the phone for Amazon. There’s also an homeowner’s association meeting to prepare for and research to be done on ceiling fans.

“Life admin” is a crisp phrase coined by Elizabeth Emens, JD, PhD, that captures the never-ending to-do list that comes with running a household. An accomplished law professor at Columbia University, New York, Dr. Emens noticed the negative impact this life admin has on our quality of life. Reading her book, “Life Admin: How I Learned to Do Less, Do Better, and Live More” (New York: HarperOne, 2019), your eyes widen as she magically makes salient all this hidden work that is stealing our time. Life admin, kidmin, mom and dadmin, just rattling them off feels like donning x-ray glasses allowing us to see how much work we do outside of our work. As doctors, I would add “family house calls,” as a contributing factor: Random family and friends who want to talk for a minute about their knee replacement or what drug the ICU should give Uncle Larry who is fighting COVID. (I only know ivermectin, but it would only help if he just had scabies).

By all accounts, the amount of life admin is growing insidiously, worsened by the great pandemic. There are events to plan and reply to, more DIY customer service to fix your own problems, more work to find a VRBO for a weekend getaway at the beach. (There are none on the entire coast of California this summer, so I just saved you time there. You’re welcome.)

There is no good time to do this work and combined with the heavy burden of our responsibilities as physicians, it can feel like fuel feeding the burnout fire.

Dr. Emens has some top tips to help. First up, know your admin type. Are you a super doer, reluctant doer, admin denier, or admin avoider? I’m mostly in the avoider quadrant, dropping into reluctant doer when consequences loom. Next, choose strategies that fit you. Instead of avoiding, there are some things I might deflect. For example, When your aunt in Peoria asks where she can get a COVID test, you can use LMGTFY.com to generate a link that will show them how to use Google to help with their question. Dr. Emens is joking, but the point rang true. We can lighten the load a bit if we delegate or push back the excessive or undue requests. For some tasks, we’d be better off paying someone to take it over. Last tip here, try doing life admin with a partner, be it spouse, friend, or colleague. This is particularly useful when your partner is a super doer, as mine is. Not only can they make the work lighter, but also less dreary.

We physicians are focused on fixing physician burnout. Maybe we should also be looking at what happens in the “second shift” at home. Tax season is over, but will be back soon.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected]

Although it disputed the allegations, Saint James School of Medicine has settled a complaint with the Federal Trade Commission that the school used deceptive marketing tactics to lure students. The complaint referenced the school’s medical license exam test pass rate and residency matches along with violations of rules that protect consumers, including those dealing with credit contracts.

The school, based in the Caribbean with operations in Illinois, agreed to pay $1.2 million toward refunds and debt cancellation for students harmed by the marketing in the past 5 years.

“While we strongly disagree with the FTC’s approach to this matter, we did not want a lengthy legal process to distract from our mission of providing a quality medical education at an affordable cost,” Kaushik Guha, executive vice president of the parent of the school, Human Resources Development Services, said in a YouTube statement posted on the school’s website.

“Saint James lured students by lying about their chances of success,” Samuel Levine, director of the FTC’s Bureau of Consumer Protection, said in a press release. The settlement agreement was with HRDS, which bills itself as providing students from “non-traditional backgrounds the opportunity to pursue a medical degree and practice in the U.S. or Canada,” according to the school’s statement.

The complaint alleges that, since at least April 2018, the school, HRDS, and its operator Mr. Guha has lured students using “phony claims about the standardized test pass rate and students’ residency or job prospects. They lured consumers with false guarantees of student success at passing a critical medical school standardized test, the United States Medical Licensing Examination Step 1 Exam.”

For example, a brochure distributed at open houses claimed a first-time Step 1 pass rate of about 96.8%. The brochure further claimed: “Saint James is the first and only medical school to offer a USMLE Step 1 Pass Guarantee,” according to the FTC complaint.

The FTC said the USMLE rate is lower than touted and lower than reported by other U.S. and Canadian medical schools. “Since 2017, only 35% of Saint James students who have completed the necessary coursework to take the USMLE Step 1 exam passed the test.”

The school also misrepresented the residency match rate as “the same” as American medical schools, according to the complaint. For example, the school instructed telemarketers to tell consumers that the match rate for the school’s students was 85%-90%. The school stated on its website that the residency match rate for Saint James students was 83%. “In fact, the match rate for SJSM students is lower than touted and lower than that reported by U.S. medical schools. Since 2018, defendants’ average match rate has been 63%.”

The FTC also claims the school used illegal credit contracts when marketing financing for tuition and living expenses for students. “The financing contracts contained language attempting to waive consumers’ rights under federal law and omit legally mandated disclosures.”

Saint James’ tuition ranges from about $6,650 to $9,859 per trimester, depending on campus and course study, the complaint states. Between 2016 and 2020, about 1,300 students were enrolled each year in Saint James’ schools. Students who attended the schools between 2016 and 2022 are eligible for a refund under the settlement.

Saint James is required to notify consumers whose debts are being canceled through Delta Financial Solutions, Saint James’ financing partner. The debt will also be deleted from consumers’ credit reports.

“We have chosen to settle with the FTC over its allegations that disclosures on our website and in Delta’s loan agreements were insufficient,” Mr. Guha stated on the school website. “However, we have added additional language and clarifications any time the USMLE pass rate and placement rates are mentioned.”

He said he hopes the school will be “an industry leader for transparency and accountability” and that the school’s “efforts will lead to lasting change throughout the for-profit educational industry.”

Mr. Guha added that more than 600 of the school’s alumni are serving as doctors, including many “working to bridge the health equity gap in underserved areas in North America.”

The FTC has been cracking down on deceptive practices by for-profit institutions. In October, the FTC put 70 for-profit colleges on notice that it would investigate false promises the schools make about their graduates’ job prospects, expected earnings, and other educational outcomes and would levy significant financial penalties against violators. Saint James was not on that list, which included several of the largest for-profit universities in the nation, including Capella University, DeVry University, Strayer University, and Walden University.

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

Although it disputed the allegations, Saint James School of Medicine has settled a complaint with the Federal Trade Commission that the school used deceptive marketing tactics to lure students. The complaint referenced the school’s medical license exam test pass rate and residency matches along with violations of rules that protect consumers, including those dealing with credit contracts.

The school, based in the Caribbean with operations in Illinois, agreed to pay $1.2 million toward refunds and debt cancellation for students harmed by the marketing in the past 5 years.

“While we strongly disagree with the FTC’s approach to this matter, we did not want a lengthy legal process to distract from our mission of providing a quality medical education at an affordable cost,” Kaushik Guha, executive vice president of the parent of the school, Human Resources Development Services, said in a YouTube statement posted on the school’s website.

“Saint James lured students by lying about their chances of success,” Samuel Levine, director of the FTC’s Bureau of Consumer Protection, said in a press release. The settlement agreement was with HRDS, which bills itself as providing students from “non-traditional backgrounds the opportunity to pursue a medical degree and practice in the U.S. or Canada,” according to the school’s statement.

The complaint alleges that, since at least April 2018, the school, HRDS, and its operator Mr. Guha has lured students using “phony claims about the standardized test pass rate and students’ residency or job prospects. They lured consumers with false guarantees of student success at passing a critical medical school standardized test, the United States Medical Licensing Examination Step 1 Exam.”

For example, a brochure distributed at open houses claimed a first-time Step 1 pass rate of about 96.8%. The brochure further claimed: “Saint James is the first and only medical school to offer a USMLE Step 1 Pass Guarantee,” according to the FTC complaint.

The FTC said the USMLE rate is lower than touted and lower than reported by other U.S. and Canadian medical schools. “Since 2017, only 35% of Saint James students who have completed the necessary coursework to take the USMLE Step 1 exam passed the test.”

The school also misrepresented the residency match rate as “the same” as American medical schools, according to the complaint. For example, the school instructed telemarketers to tell consumers that the match rate for the school’s students was 85%-90%. The school stated on its website that the residency match rate for Saint James students was 83%. “In fact, the match rate for SJSM students is lower than touted and lower than that reported by U.S. medical schools. Since 2018, defendants’ average match rate has been 63%.”

The FTC also claims the school used illegal credit contracts when marketing financing for tuition and living expenses for students. “The financing contracts contained language attempting to waive consumers’ rights under federal law and omit legally mandated disclosures.”

Saint James’ tuition ranges from about $6,650 to $9,859 per trimester, depending on campus and course study, the complaint states. Between 2016 and 2020, about 1,300 students were enrolled each year in Saint James’ schools. Students who attended the schools between 2016 and 2022 are eligible for a refund under the settlement.

Saint James is required to notify consumers whose debts are being canceled through Delta Financial Solutions, Saint James’ financing partner. The debt will also be deleted from consumers’ credit reports.

“We have chosen to settle with the FTC over its allegations that disclosures on our website and in Delta’s loan agreements were insufficient,” Mr. Guha stated on the school website. “However, we have added additional language and clarifications any time the USMLE pass rate and placement rates are mentioned.”

He said he hopes the school will be “an industry leader for transparency and accountability” and that the school’s “efforts will lead to lasting change throughout the for-profit educational industry.”

Mr. Guha added that more than 600 of the school’s alumni are serving as doctors, including many “working to bridge the health equity gap in underserved areas in North America.”

The FTC has been cracking down on deceptive practices by for-profit institutions. In October, the FTC put 70 for-profit colleges on notice that it would investigate false promises the schools make about their graduates’ job prospects, expected earnings, and other educational outcomes and would levy significant financial penalties against violators. Saint James was not on that list, which included several of the largest for-profit universities in the nation, including Capella University, DeVry University, Strayer University, and Walden University.

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

Although it disputed the allegations, Saint James School of Medicine has settled a complaint with the Federal Trade Commission that the school used deceptive marketing tactics to lure students. The complaint referenced the school’s medical license exam test pass rate and residency matches along with violations of rules that protect consumers, including those dealing with credit contracts.

The school, based in the Caribbean with operations in Illinois, agreed to pay $1.2 million toward refunds and debt cancellation for students harmed by the marketing in the past 5 years.

“While we strongly disagree with the FTC’s approach to this matter, we did not want a lengthy legal process to distract from our mission of providing a quality medical education at an affordable cost,” Kaushik Guha, executive vice president of the parent of the school, Human Resources Development Services, said in a YouTube statement posted on the school’s website.

“Saint James lured students by lying about their chances of success,” Samuel Levine, director of the FTC’s Bureau of Consumer Protection, said in a press release. The settlement agreement was with HRDS, which bills itself as providing students from “non-traditional backgrounds the opportunity to pursue a medical degree and practice in the U.S. or Canada,” according to the school’s statement.

The complaint alleges that, since at least April 2018, the school, HRDS, and its operator Mr. Guha has lured students using “phony claims about the standardized test pass rate and students’ residency or job prospects. They lured consumers with false guarantees of student success at passing a critical medical school standardized test, the United States Medical Licensing Examination Step 1 Exam.”

For example, a brochure distributed at open houses claimed a first-time Step 1 pass rate of about 96.8%. The brochure further claimed: “Saint James is the first and only medical school to offer a USMLE Step 1 Pass Guarantee,” according to the FTC complaint.

The FTC said the USMLE rate is lower than touted and lower than reported by other U.S. and Canadian medical schools. “Since 2017, only 35% of Saint James students who have completed the necessary coursework to take the USMLE Step 1 exam passed the test.”

The school also misrepresented the residency match rate as “the same” as American medical schools, according to the complaint. For example, the school instructed telemarketers to tell consumers that the match rate for the school’s students was 85%-90%. The school stated on its website that the residency match rate for Saint James students was 83%. “In fact, the match rate for SJSM students is lower than touted and lower than that reported by U.S. medical schools. Since 2018, defendants’ average match rate has been 63%.”

The FTC also claims the school used illegal credit contracts when marketing financing for tuition and living expenses for students. “The financing contracts contained language attempting to waive consumers’ rights under federal law and omit legally mandated disclosures.”

Saint James’ tuition ranges from about $6,650 to $9,859 per trimester, depending on campus and course study, the complaint states. Between 2016 and 2020, about 1,300 students were enrolled each year in Saint James’ schools. Students who attended the schools between 2016 and 2022 are eligible for a refund under the settlement.

Saint James is required to notify consumers whose debts are being canceled through Delta Financial Solutions, Saint James’ financing partner. The debt will also be deleted from consumers’ credit reports.

“We have chosen to settle with the FTC over its allegations that disclosures on our website and in Delta’s loan agreements were insufficient,” Mr. Guha stated on the school website. “However, we have added additional language and clarifications any time the USMLE pass rate and placement rates are mentioned.”

He said he hopes the school will be “an industry leader for transparency and accountability” and that the school’s “efforts will lead to lasting change throughout the for-profit educational industry.”

Mr. Guha added that more than 600 of the school’s alumni are serving as doctors, including many “working to bridge the health equity gap in underserved areas in North America.”

The FTC has been cracking down on deceptive practices by for-profit institutions. In October, the FTC put 70 for-profit colleges on notice that it would investigate false promises the schools make about their graduates’ job prospects, expected earnings, and other educational outcomes and would levy significant financial penalties against violators. Saint James was not on that list, which included several of the largest for-profit universities in the nation, including Capella University, DeVry University, Strayer University, and Walden University.

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

As coprescribing drugs for erectile dysfunction and oral organic nitrates for ischemic heart disease (IHD) surged, cardiovascular adverse events did not significantly increase, a new study finds.

The authors of the new research specifically examined how frequently phosphodiesterase type 5 (PDE5) inhibitors, such as Viagra, were prescribed. The U.S. Food and Drug Administration and the European Medicines Agency have warned that these drugs for erectile dysfunction are contraindicated for use with nitrates because of concerns about cardiovascular risks.

“Small, randomized, pharmacologic studies have reported an amplified decrease in blood pressure during controlled coexposure with nitrates and [phosphodiesterase type 5 inhibitors], both in healthy participants and in participants with IHD,” wrote lead author Anders Holt, MD, of Copenhagen University Hospital–Herlev and Gentofte and colleagues, in Annals of Internal Medicine. “Potentially, this increases the risk for vascular ischemic events including myocardial infarction and stroke.”

But there is a scarcity of real-world data showing that using both types of drugs together increase these risks, the researchers noted.

To address this knowledge gap, Dr. Holt and colleagues conducted a retrospective study involving 249,541 Danish men with IHD. In this overall population, from 2000 to 2018, prescriptions for PDE5 inhibitors increased 10-fold, from 3.1 to 30.9 prescriptions per 100 persons per year. Within a subgroup of 42,073 patients continuously prescribed oral organic nitrates, PDE5-inhibitor prescriptions jumped twice that magnitude, from 0.9 to 19.7 prescriptions per 100 persons per year.

Despite this surge in coprescribing, the investigators did not observe a significant increase in either of two composite measures of cardiovascular adverse events. The first composite included ischemic stroke, shock, cardiac arrest, myocardial infarction, or acute coronary arteriography (odds ratio, 0.58; 95% confidence interval, 0.28-1.13). The second composite included drug-related adverse events, angina pectoris, or syncope (OR, 0.73; CI, 0.40-1.32).
 

Lead author speculates on reasons for findings

“I propose several explanations [for these findings],” Dr. Holt said in an interview, “but I want to emphasize that our study does not contain any data to back it up. It is just speculation. First, the observed drop in blood pressure may not cause a condition for which patients seek a hospital. A drop in blood pressure has been shown in pharmacologic trials, but it might not translate to a real-life risk for cardiovascular outcomes. Second, patients could be well informed and adherent to guidance that the prescribing physician has provided. For example, patients are aware of the recommended pause in nitrate treatment before PDE5-inhibitor use and follow these recommendations. Third, nitrates are often taken in the morning, and with the careful assumption that most PDE5-inhibitor activities take place in the evening, the nitrates could be metabolized to a degree such that the synergistic interaction is negligible.”

Dr. Holt went on to suggest a novel clinical approach based on the new findings.

“Coadministration should still be contraindicated due to the proven drop in blood pressure,” he said. “However, perhaps physicians can allow for coprescription if patients are adequately informed.”

A qualitative study is needed to determine how patients and physicians discuss coprescription, including avoidance of coadministration, Dr. Holt added.
 

Findings call for a reassessment of whether the contraindication is warranted

Robert A. Kloner, MD, PhD, chief science officer at the Huntington Medical Research Institutes in Pasadena, Calif., and professor of medicine at University of Southern California, Los Angeles, previously conducted research exploring drug interactions with PDE5 inhibitors, and in 2018, coauthored a literature review that concluded that PDE5 inhibitors and nitrates are contraindicated.

But now, considering these new findings, Dr. Kloner is offering a fresh perspective.

“This study is reassuring,” Dr. Kloner said in an interview. “I think that it’s time to reassess whether there should be an absolute contraindication, or this should be more of like a warning.”

He noted that in controlled studies, like the ones he previously conducted, PDE5 inhibitors and nitrates were administered “very close to each other, on purpose,” yet this probably doesn’t reflect typical practice, in which clinicians can guide usage based on durations of drug metabolism.

“I think that physicians might be more comfortable now prescribing the drugs at the same time, but then telling patients that they shouldn’t take the two drugs simultaneously; they should wait and take the nitrate 24 hours after the last Viagra, or the nitrate 48 hours after the last Cialis,” Dr. Kloner said. “I suspect that that is happening. I suspect also the fact that people would be more likely to take the nitrate in the morning and the PDE5 inhibitor at night probably also contributes to the safety findings.”

Dr. Kloner noted that blood pressures vary throughout the day based on circadian rhythm, and that the body can adapt to some fluctuations without negative effects.

There could still be some people who experience a drop in blood pressure and get sick from it from the two drugs interacting, but that’s probably not that common, he said.

The study was supported by several grants. The investigators disclosed relationships with Merck, BMS, Bayer, and others. Dr. Kloner consults for Sanofi.

As coprescribing drugs for erectile dysfunction and oral organic nitrates for ischemic heart disease (IHD) surged, cardiovascular adverse events did not significantly increase, a new study finds.

The authors of the new research specifically examined how frequently phosphodiesterase type 5 (PDE5) inhibitors, such as Viagra, were prescribed. The U.S. Food and Drug Administration and the European Medicines Agency have warned that these drugs for erectile dysfunction are contraindicated for use with nitrates because of concerns about cardiovascular risks.

“Small, randomized, pharmacologic studies have reported an amplified decrease in blood pressure during controlled coexposure with nitrates and [phosphodiesterase type 5 inhibitors], both in healthy participants and in participants with IHD,” wrote lead author Anders Holt, MD, of Copenhagen University Hospital–Herlev and Gentofte and colleagues, in Annals of Internal Medicine. “Potentially, this increases the risk for vascular ischemic events including myocardial infarction and stroke.”

But there is a scarcity of real-world data showing that using both types of drugs together increase these risks, the researchers noted.

To address this knowledge gap, Dr. Holt and colleagues conducted a retrospective study involving 249,541 Danish men with IHD. In this overall population, from 2000 to 2018, prescriptions for PDE5 inhibitors increased 10-fold, from 3.1 to 30.9 prescriptions per 100 persons per year. Within a subgroup of 42,073 patients continuously prescribed oral organic nitrates, PDE5-inhibitor prescriptions jumped twice that magnitude, from 0.9 to 19.7 prescriptions per 100 persons per year.

Despite this surge in coprescribing, the investigators did not observe a significant increase in either of two composite measures of cardiovascular adverse events. The first composite included ischemic stroke, shock, cardiac arrest, myocardial infarction, or acute coronary arteriography (odds ratio, 0.58; 95% confidence interval, 0.28-1.13). The second composite included drug-related adverse events, angina pectoris, or syncope (OR, 0.73; CI, 0.40-1.32).
 

Lead author speculates on reasons for findings

“I propose several explanations [for these findings],” Dr. Holt said in an interview, “but I want to emphasize that our study does not contain any data to back it up. It is just speculation. First, the observed drop in blood pressure may not cause a condition for which patients seek a hospital. A drop in blood pressure has been shown in pharmacologic trials, but it might not translate to a real-life risk for cardiovascular outcomes. Second, patients could be well informed and adherent to guidance that the prescribing physician has provided. For example, patients are aware of the recommended pause in nitrate treatment before PDE5-inhibitor use and follow these recommendations. Third, nitrates are often taken in the morning, and with the careful assumption that most PDE5-inhibitor activities take place in the evening, the nitrates could be metabolized to a degree such that the synergistic interaction is negligible.”

Dr. Holt went on to suggest a novel clinical approach based on the new findings.

“Coadministration should still be contraindicated due to the proven drop in blood pressure,” he said. “However, perhaps physicians can allow for coprescription if patients are adequately informed.”

A qualitative study is needed to determine how patients and physicians discuss coprescription, including avoidance of coadministration, Dr. Holt added.
 

Findings call for a reassessment of whether the contraindication is warranted

Robert A. Kloner, MD, PhD, chief science officer at the Huntington Medical Research Institutes in Pasadena, Calif., and professor of medicine at University of Southern California, Los Angeles, previously conducted research exploring drug interactions with PDE5 inhibitors, and in 2018, coauthored a literature review that concluded that PDE5 inhibitors and nitrates are contraindicated.

But now, considering these new findings, Dr. Kloner is offering a fresh perspective.

“This study is reassuring,” Dr. Kloner said in an interview. “I think that it’s time to reassess whether there should be an absolute contraindication, or this should be more of like a warning.”

He noted that in controlled studies, like the ones he previously conducted, PDE5 inhibitors and nitrates were administered “very close to each other, on purpose,” yet this probably doesn’t reflect typical practice, in which clinicians can guide usage based on durations of drug metabolism.

“I think that physicians might be more comfortable now prescribing the drugs at the same time, but then telling patients that they shouldn’t take the two drugs simultaneously; they should wait and take the nitrate 24 hours after the last Viagra, or the nitrate 48 hours after the last Cialis,” Dr. Kloner said. “I suspect that that is happening. I suspect also the fact that people would be more likely to take the nitrate in the morning and the PDE5 inhibitor at night probably also contributes to the safety findings.”

Dr. Kloner noted that blood pressures vary throughout the day based on circadian rhythm, and that the body can adapt to some fluctuations without negative effects.

There could still be some people who experience a drop in blood pressure and get sick from it from the two drugs interacting, but that’s probably not that common, he said.

The study was supported by several grants. The investigators disclosed relationships with Merck, BMS, Bayer, and others. Dr. Kloner consults for Sanofi.

As coprescribing drugs for erectile dysfunction and oral organic nitrates for ischemic heart disease (IHD) surged, cardiovascular adverse events did not significantly increase, a new study finds.

The authors of the new research specifically examined how frequently phosphodiesterase type 5 (PDE5) inhibitors, such as Viagra, were prescribed. The U.S. Food and Drug Administration and the European Medicines Agency have warned that these drugs for erectile dysfunction are contraindicated for use with nitrates because of concerns about cardiovascular risks.

“Small, randomized, pharmacologic studies have reported an amplified decrease in blood pressure during controlled coexposure with nitrates and [phosphodiesterase type 5 inhibitors], both in healthy participants and in participants with IHD,” wrote lead author Anders Holt, MD, of Copenhagen University Hospital–Herlev and Gentofte and colleagues, in Annals of Internal Medicine. “Potentially, this increases the risk for vascular ischemic events including myocardial infarction and stroke.”

But there is a scarcity of real-world data showing that using both types of drugs together increase these risks, the researchers noted.

To address this knowledge gap, Dr. Holt and colleagues conducted a retrospective study involving 249,541 Danish men with IHD. In this overall population, from 2000 to 2018, prescriptions for PDE5 inhibitors increased 10-fold, from 3.1 to 30.9 prescriptions per 100 persons per year. Within a subgroup of 42,073 patients continuously prescribed oral organic nitrates, PDE5-inhibitor prescriptions jumped twice that magnitude, from 0.9 to 19.7 prescriptions per 100 persons per year.

Despite this surge in coprescribing, the investigators did not observe a significant increase in either of two composite measures of cardiovascular adverse events. The first composite included ischemic stroke, shock, cardiac arrest, myocardial infarction, or acute coronary arteriography (odds ratio, 0.58; 95% confidence interval, 0.28-1.13). The second composite included drug-related adverse events, angina pectoris, or syncope (OR, 0.73; CI, 0.40-1.32).
 

Lead author speculates on reasons for findings

“I propose several explanations [for these findings],” Dr. Holt said in an interview, “but I want to emphasize that our study does not contain any data to back it up. It is just speculation. First, the observed drop in blood pressure may not cause a condition for which patients seek a hospital. A drop in blood pressure has been shown in pharmacologic trials, but it might not translate to a real-life risk for cardiovascular outcomes. Second, patients could be well informed and adherent to guidance that the prescribing physician has provided. For example, patients are aware of the recommended pause in nitrate treatment before PDE5-inhibitor use and follow these recommendations. Third, nitrates are often taken in the morning, and with the careful assumption that most PDE5-inhibitor activities take place in the evening, the nitrates could be metabolized to a degree such that the synergistic interaction is negligible.”

Dr. Holt went on to suggest a novel clinical approach based on the new findings.

“Coadministration should still be contraindicated due to the proven drop in blood pressure,” he said. “However, perhaps physicians can allow for coprescription if patients are adequately informed.”

A qualitative study is needed to determine how patients and physicians discuss coprescription, including avoidance of coadministration, Dr. Holt added.
 

Findings call for a reassessment of whether the contraindication is warranted

Robert A. Kloner, MD, PhD, chief science officer at the Huntington Medical Research Institutes in Pasadena, Calif., and professor of medicine at University of Southern California, Los Angeles, previously conducted research exploring drug interactions with PDE5 inhibitors, and in 2018, coauthored a literature review that concluded that PDE5 inhibitors and nitrates are contraindicated.

But now, considering these new findings, Dr. Kloner is offering a fresh perspective.

“This study is reassuring,” Dr. Kloner said in an interview. “I think that it’s time to reassess whether there should be an absolute contraindication, or this should be more of like a warning.”

He noted that in controlled studies, like the ones he previously conducted, PDE5 inhibitors and nitrates were administered “very close to each other, on purpose,” yet this probably doesn’t reflect typical practice, in which clinicians can guide usage based on durations of drug metabolism.

“I think that physicians might be more comfortable now prescribing the drugs at the same time, but then telling patients that they shouldn’t take the two drugs simultaneously; they should wait and take the nitrate 24 hours after the last Viagra, or the nitrate 48 hours after the last Cialis,” Dr. Kloner said. “I suspect that that is happening. I suspect also the fact that people would be more likely to take the nitrate in the morning and the PDE5 inhibitor at night probably also contributes to the safety findings.”

Dr. Kloner noted that blood pressures vary throughout the day based on circadian rhythm, and that the body can adapt to some fluctuations without negative effects.

There could still be some people who experience a drop in blood pressure and get sick from it from the two drugs interacting, but that’s probably not that common, he said.

The study was supported by several grants. The investigators disclosed relationships with Merck, BMS, Bayer, and others. Dr. Kloner consults for Sanofi.

Key takeaways

Metformin may be associated with a lower risk of neurodegenerative disease, in particular when the drug has been prescribed for at least 4 years, according to a systematic review and meta-analysis of longitudinal data.

However, the heterogeneity between the available studies and the potential heterogeneity of diagnostic criteria may mean that validation studies are needed.
 

Why is this important?

Data suggest that metformin, the most commonly prescribed antidiabetic drug, may be neuroprotective, while diabetes is associated with an excess risk of neurodegenerative disease. Results of studies conducted specifically to investigate the benefit of the antidiabetic drug on cognitive prognosis have been unclear. A meta-analysis was published in 2020, but it included cross-sectional and case-control studies. Given the long observation period needed to measure such an outcome, only cohort studies conducted over several years can provide reliable results. This new meta-analysis attempts to circumvent this limitation.

Methods

The meta-analysis was conducted using studies published up to March 2021 that met the inclusion criteria (population-based cohort studies published in English in which the administration of metformin and associated risk of exposure were reported).

Main results

Twelve studies were included in this analysis, of which eight were retrospective and 11 were considered to be of good methodologic quality. In total, 194,792 patients were included.

Pooled data showed that the relative risk associated with onset of neurodegenerative disease was 0.77 (95% CI, 0.67-0.88) for patients with diabetes taking metformin versus those not taking metformin. However, heterogeneity between studies was high (I2; 78.8%; P < .001).

The effect was greater with longer metformin use, with an RR of 0.29 (95% CI, 0.13-0.44) for those who took metformin for 4 years or more. Similarly, the studies conducted in Asian countries versus other locations suggested an added benefit for this population (RR, 0.69; 95% CI, 0.64-0.74).

Sensitivity analyses confirmed these results, and subtype analyses showed no difference according to the nature of the neurodegenerative disease.

A version of this article first appeared on Univadis.

Key takeaways

Metformin may be associated with a lower risk of neurodegenerative disease, in particular when the drug has been prescribed for at least 4 years, according to a systematic review and meta-analysis of longitudinal data.

However, the heterogeneity between the available studies and the potential heterogeneity of diagnostic criteria may mean that validation studies are needed.
 

Why is this important?

Data suggest that metformin, the most commonly prescribed antidiabetic drug, may be neuroprotective, while diabetes is associated with an excess risk of neurodegenerative disease. Results of studies conducted specifically to investigate the benefit of the antidiabetic drug on cognitive prognosis have been unclear. A meta-analysis was published in 2020, but it included cross-sectional and case-control studies. Given the long observation period needed to measure such an outcome, only cohort studies conducted over several years can provide reliable results. This new meta-analysis attempts to circumvent this limitation.

Methods

The meta-analysis was conducted using studies published up to March 2021 that met the inclusion criteria (population-based cohort studies published in English in which the administration of metformin and associated risk of exposure were reported).

Main results

Twelve studies were included in this analysis, of which eight were retrospective and 11 were considered to be of good methodologic quality. In total, 194,792 patients were included.

Pooled data showed that the relative risk associated with onset of neurodegenerative disease was 0.77 (95% CI, 0.67-0.88) for patients with diabetes taking metformin versus those not taking metformin. However, heterogeneity between studies was high (I2; 78.8%; P < .001).

The effect was greater with longer metformin use, with an RR of 0.29 (95% CI, 0.13-0.44) for those who took metformin for 4 years or more. Similarly, the studies conducted in Asian countries versus other locations suggested an added benefit for this population (RR, 0.69; 95% CI, 0.64-0.74).

Sensitivity analyses confirmed these results, and subtype analyses showed no difference according to the nature of the neurodegenerative disease.

A version of this article first appeared on Univadis.

Key takeaways

Metformin may be associated with a lower risk of neurodegenerative disease, in particular when the drug has been prescribed for at least 4 years, according to a systematic review and meta-analysis of longitudinal data.

However, the heterogeneity between the available studies and the potential heterogeneity of diagnostic criteria may mean that validation studies are needed.
 

Why is this important?

Data suggest that metformin, the most commonly prescribed antidiabetic drug, may be neuroprotective, while diabetes is associated with an excess risk of neurodegenerative disease. Results of studies conducted specifically to investigate the benefit of the antidiabetic drug on cognitive prognosis have been unclear. A meta-analysis was published in 2020, but it included cross-sectional and case-control studies. Given the long observation period needed to measure such an outcome, only cohort studies conducted over several years can provide reliable results. This new meta-analysis attempts to circumvent this limitation.

Methods

The meta-analysis was conducted using studies published up to March 2021 that met the inclusion criteria (population-based cohort studies published in English in which the administration of metformin and associated risk of exposure were reported).

Main results

Twelve studies were included in this analysis, of which eight were retrospective and 11 were considered to be of good methodologic quality. In total, 194,792 patients were included.

Pooled data showed that the relative risk associated with onset of neurodegenerative disease was 0.77 (95% CI, 0.67-0.88) for patients with diabetes taking metformin versus those not taking metformin. However, heterogeneity between studies was high (I2; 78.8%; P < .001).

The effect was greater with longer metformin use, with an RR of 0.29 (95% CI, 0.13-0.44) for those who took metformin for 4 years or more. Similarly, the studies conducted in Asian countries versus other locations suggested an added benefit for this population (RR, 0.69; 95% CI, 0.64-0.74).

Sensitivity analyses confirmed these results, and subtype analyses showed no difference according to the nature of the neurodegenerative disease.

A version of this article first appeared on Univadis.

Bariatric surgery can reduce the risk of long-term cardiovascular outcomes in older Medicare beneficiaries with obesity, a large new observational study in which a third of the patients were over age 65 years suggests.

Overall, patients who underwent bariatric surgery had 37% lower all-cause mortality and were significantly less likely to have admissions for new-onset heart failure (64% risk reduction), myocardial infarction (37% risk reduction), and ischemic stroke (29% risk reduction), compared with similar patients who received more conservative treatment, after a median of 4 years of follow-up, report Amgad Mentias, MD, MS, a clinical cardiologist at the Cleveland Clinic Foundation, Ohio, and colleagues.

The results were published in the Journal of the American College of Cardiology.

Previous studies on bariatric surgery outcomes have primarily focused on individuals from select health care networks or medical facilities with restricted coverage in the United States or on patients with diabetes, noted Tiffany M. Powell-Wiley, MD, MPH, of the National Institutes of Health’s National Heart, Lung, and Blood Institute, Bethesda, Maryland, and colleagues in an accompanying editorial.

Contemporary cohort of patients

“A lot of the studies showed long-term outcomes outside of the U.S., specifically in Europe,” Dr. Mentias added.

The aim of this study was to evaluate the long-term association between bariatric surgery and risk of adverse cardiovascular outcomes in a contemporary large cohort from the United States.

Older patients (> 65 years) and those without diabetes were looked at as specific subgroups.

The researchers assessed 189,770 patients. There were 94,885 matched patients in each cohort. Mean age was 62.33 years. Female patients comprised 70% of the cohort. The study group had an average BMI of 44.7 kg/m2.

The study cohort was matched 1:1. Participants were either part of a control group with obesity or a group of Medicare beneficiaries who had bariatric surgery between 2013 and 2019. Sex, propensity score matching on 87 clinical variables, age, and BMI were used to match patients.

Myocardial infarction, new-onset heart failure, ischemic stroke, and all-cause mortality were all study outcomes. As a sensitivity analysis, the study team conducted an instrumental variable assessment.

More specifically, the findings showed that bariatric surgery was linked with the following after a median follow-up of 4.0 years:

• Myocardial infarction (hazard ratio, 0.63; 95% confidence interval, 0.59-0.68)
• Stroke (HR, 0.71; 95% CI, 0.65-0.79)
• New-onset heart failure (HR, 0.46; 95% CI, 0.44-0.49)
• Reduced risk of death (9.2 vs. 14.7 per 1000 person-years; HR, 0.63; 95% CI, 0.60-0.66)

Findings for those over the age of 65 were similar – lower risks of all-cause mortality (HR, 0.64), new-onset heart failure (HR, 0.52), myocardial infarction (HR, 0.70), and stroke (HR, 0.76; all P < .001). Similar findings were shown in subgroup analyses in men and women and in patients with and without diabetes.

The study cohort primarily consisted of Medicare patients, which limits the generalizability of the data. Lack of data on medications taken for cardiovascular and weight loss purposes and potential coding errors because the information was gathered from an administrative database were all limitations of the study, the researchers note.

An additional limitation was that residual unmeasured confounders, particularly patient-focused physical, social, and mental support factors, could play a role in whether a patient opted to have bariatric surgery, the study authors note.

“Additional studies are needed to compare cardiovascular outcomes after bariatric surgery with weight loss medications like glucagon-like peptide-1 (GLP-1) analogues,” the researchers add.

This study was partially funded by philanthropic contributions by the Khouri family, Bailey family, and Haslam family to the Cleveland Clinic for co-author Dr. Milind Y. Desai’s research. Dr. Mentias has disclosed no relevant financial relationships. Dr. Powell-Wiley disclosed relationships with the National Institute on Minority Health and Health Disparities and the Division of Intramural Research of the National, Heart, Lung, and Blood Institute of the National Institutes of Health.

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

Bariatric surgery can reduce the risk of long-term cardiovascular outcomes in older Medicare beneficiaries with obesity, a large new observational study in which a third of the patients were over age 65 years suggests.

Overall, patients who underwent bariatric surgery had 37% lower all-cause mortality and were significantly less likely to have admissions for new-onset heart failure (64% risk reduction), myocardial infarction (37% risk reduction), and ischemic stroke (29% risk reduction), compared with similar patients who received more conservative treatment, after a median of 4 years of follow-up, report Amgad Mentias, MD, MS, a clinical cardiologist at the Cleveland Clinic Foundation, Ohio, and colleagues.

The results were published in the Journal of the American College of Cardiology.

Previous studies on bariatric surgery outcomes have primarily focused on individuals from select health care networks or medical facilities with restricted coverage in the United States or on patients with diabetes, noted Tiffany M. Powell-Wiley, MD, MPH, of the National Institutes of Health’s National Heart, Lung, and Blood Institute, Bethesda, Maryland, and colleagues in an accompanying editorial.

Contemporary cohort of patients

“A lot of the studies showed long-term outcomes outside of the U.S., specifically in Europe,” Dr. Mentias added.

The aim of this study was to evaluate the long-term association between bariatric surgery and risk of adverse cardiovascular outcomes in a contemporary large cohort from the United States.

Older patients (> 65 years) and those without diabetes were looked at as specific subgroups.

The researchers assessed 189,770 patients. There were 94,885 matched patients in each cohort. Mean age was 62.33 years. Female patients comprised 70% of the cohort. The study group had an average BMI of 44.7 kg/m2.

The study cohort was matched 1:1. Participants were either part of a control group with obesity or a group of Medicare beneficiaries who had bariatric surgery between 2013 and 2019. Sex, propensity score matching on 87 clinical variables, age, and BMI were used to match patients.

Myocardial infarction, new-onset heart failure, ischemic stroke, and all-cause mortality were all study outcomes. As a sensitivity analysis, the study team conducted an instrumental variable assessment.

More specifically, the findings showed that bariatric surgery was linked with the following after a median follow-up of 4.0 years:

• Myocardial infarction (hazard ratio, 0.63; 95% confidence interval, 0.59-0.68)
• Stroke (HR, 0.71; 95% CI, 0.65-0.79)
• New-onset heart failure (HR, 0.46; 95% CI, 0.44-0.49)
• Reduced risk of death (9.2 vs. 14.7 per 1000 person-years; HR, 0.63; 95% CI, 0.60-0.66)

Findings for those over the age of 65 were similar – lower risks of all-cause mortality (HR, 0.64), new-onset heart failure (HR, 0.52), myocardial infarction (HR, 0.70), and stroke (HR, 0.76; all P < .001). Similar findings were shown in subgroup analyses in men and women and in patients with and without diabetes.

The study cohort primarily consisted of Medicare patients, which limits the generalizability of the data. Lack of data on medications taken for cardiovascular and weight loss purposes and potential coding errors because the information was gathered from an administrative database were all limitations of the study, the researchers note.

An additional limitation was that residual unmeasured confounders, particularly patient-focused physical, social, and mental support factors, could play a role in whether a patient opted to have bariatric surgery, the study authors note.

“Additional studies are needed to compare cardiovascular outcomes after bariatric surgery with weight loss medications like glucagon-like peptide-1 (GLP-1) analogues,” the researchers add.

This study was partially funded by philanthropic contributions by the Khouri family, Bailey family, and Haslam family to the Cleveland Clinic for co-author Dr. Milind Y. Desai’s research. Dr. Mentias has disclosed no relevant financial relationships. Dr. Powell-Wiley disclosed relationships with the National Institute on Minority Health and Health Disparities and the Division of Intramural Research of the National, Heart, Lung, and Blood Institute of the National Institutes of Health.

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

Bariatric surgery can reduce the risk of long-term cardiovascular outcomes in older Medicare beneficiaries with obesity, a large new observational study in which a third of the patients were over age 65 years suggests.

Overall, patients who underwent bariatric surgery had 37% lower all-cause mortality and were significantly less likely to have admissions for new-onset heart failure (64% risk reduction), myocardial infarction (37% risk reduction), and ischemic stroke (29% risk reduction), compared with similar patients who received more conservative treatment, after a median of 4 years of follow-up, report Amgad Mentias, MD, MS, a clinical cardiologist at the Cleveland Clinic Foundation, Ohio, and colleagues.

The results were published in the Journal of the American College of Cardiology.

Previous studies on bariatric surgery outcomes have primarily focused on individuals from select health care networks or medical facilities with restricted coverage in the United States or on patients with diabetes, noted Tiffany M. Powell-Wiley, MD, MPH, of the National Institutes of Health’s National Heart, Lung, and Blood Institute, Bethesda, Maryland, and colleagues in an accompanying editorial.

Contemporary cohort of patients

“A lot of the studies showed long-term outcomes outside of the U.S., specifically in Europe,” Dr. Mentias added.

The aim of this study was to evaluate the long-term association between bariatric surgery and risk of adverse cardiovascular outcomes in a contemporary large cohort from the United States.

Older patients (> 65 years) and those without diabetes were looked at as specific subgroups.

The researchers assessed 189,770 patients. There were 94,885 matched patients in each cohort. Mean age was 62.33 years. Female patients comprised 70% of the cohort. The study group had an average BMI of 44.7 kg/m2.

The study cohort was matched 1:1. Participants were either part of a control group with obesity or a group of Medicare beneficiaries who had bariatric surgery between 2013 and 2019. Sex, propensity score matching on 87 clinical variables, age, and BMI were used to match patients.

Myocardial infarction, new-onset heart failure, ischemic stroke, and all-cause mortality were all study outcomes. As a sensitivity analysis, the study team conducted an instrumental variable assessment.

More specifically, the findings showed that bariatric surgery was linked with the following after a median follow-up of 4.0 years:

• Myocardial infarction (hazard ratio, 0.63; 95% confidence interval, 0.59-0.68)
• Stroke (HR, 0.71; 95% CI, 0.65-0.79)
• New-onset heart failure (HR, 0.46; 95% CI, 0.44-0.49)
• Reduced risk of death (9.2 vs. 14.7 per 1000 person-years; HR, 0.63; 95% CI, 0.60-0.66)

Findings for those over the age of 65 were similar – lower risks of all-cause mortality (HR, 0.64), new-onset heart failure (HR, 0.52), myocardial infarction (HR, 0.70), and stroke (HR, 0.76; all P < .001). Similar findings were shown in subgroup analyses in men and women and in patients with and without diabetes.

The study cohort primarily consisted of Medicare patients, which limits the generalizability of the data. Lack of data on medications taken for cardiovascular and weight loss purposes and potential coding errors because the information was gathered from an administrative database were all limitations of the study, the researchers note.

An additional limitation was that residual unmeasured confounders, particularly patient-focused physical, social, and mental support factors, could play a role in whether a patient opted to have bariatric surgery, the study authors note.

“Additional studies are needed to compare cardiovascular outcomes after bariatric surgery with weight loss medications like glucagon-like peptide-1 (GLP-1) analogues,” the researchers add.

This study was partially funded by philanthropic contributions by the Khouri family, Bailey family, and Haslam family to the Cleveland Clinic for co-author Dr. Milind Y. Desai’s research. Dr. Mentias has disclosed no relevant financial relationships. Dr. Powell-Wiley disclosed relationships with the National Institute on Minority Health and Health Disparities and the Division of Intramural Research of the National, Heart, Lung, and Blood Institute of the National Institutes of Health.

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

A federal judge in Florida has struck down the Biden administration’s mandate that travelers on airlines, buses, trains, and other public transit wear masks.

The mandate, enacted in February 2021, is unconstitutional because Congress never granted the Centers for Disease Control and Prevention the power to create such a requirement, U.S. District Judge Kathryn Kimball Mizelle said in her order issued April 18.

“Congress addressed whether the CDC may enact preventative measures that condition the interstate travel of an entire population to CDC dictates. It may not,” the order says.

While the government argued that the definition of “sanitation” in federal law allows it to create travel restrictions like the use of masks, Judge Mizelle disagreed.

“A power to improve ‘sanitation’ would easily extend to requiring vaccinations against COVID-19, the seasonal flu, or other diseases. Or to mandatory social distancing, coughing-into-elbows, and daily multivitamins,” she wrote.

The Biden administration has extended the mask mandate several times since it was first announced. Most recently, the mandate was extended last week and was set to end May 3.

The rule has been alternately praised and criticized by airlines, pilots, and flight attendants. Lawsuits have been filed over the mandate, but Judge Mizelle ruled in favor of two people and the Health Freedom Defense Fund, who filed suit in July 2021.

It is not yet clear if the Biden administration will appeal the decision.

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

A federal judge in Florida has struck down the Biden administration’s mandate that travelers on airlines, buses, trains, and other public transit wear masks.

The mandate, enacted in February 2021, is unconstitutional because Congress never granted the Centers for Disease Control and Prevention the power to create such a requirement, U.S. District Judge Kathryn Kimball Mizelle said in her order issued April 18.

“Congress addressed whether the CDC may enact preventative measures that condition the interstate travel of an entire population to CDC dictates. It may not,” the order says.

While the government argued that the definition of “sanitation” in federal law allows it to create travel restrictions like the use of masks, Judge Mizelle disagreed.

“A power to improve ‘sanitation’ would easily extend to requiring vaccinations against COVID-19, the seasonal flu, or other diseases. Or to mandatory social distancing, coughing-into-elbows, and daily multivitamins,” she wrote.

The Biden administration has extended the mask mandate several times since it was first announced. Most recently, the mandate was extended last week and was set to end May 3.

The rule has been alternately praised and criticized by airlines, pilots, and flight attendants. Lawsuits have been filed over the mandate, but Judge Mizelle ruled in favor of two people and the Health Freedom Defense Fund, who filed suit in July 2021.

It is not yet clear if the Biden administration will appeal the decision.

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

A federal judge in Florida has struck down the Biden administration’s mandate that travelers on airlines, buses, trains, and other public transit wear masks.

The mandate, enacted in February 2021, is unconstitutional because Congress never granted the Centers for Disease Control and Prevention the power to create such a requirement, U.S. District Judge Kathryn Kimball Mizelle said in her order issued April 18.

“Congress addressed whether the CDC may enact preventative measures that condition the interstate travel of an entire population to CDC dictates. It may not,” the order says.

While the government argued that the definition of “sanitation” in federal law allows it to create travel restrictions like the use of masks, Judge Mizelle disagreed.

“A power to improve ‘sanitation’ would easily extend to requiring vaccinations against COVID-19, the seasonal flu, or other diseases. Or to mandatory social distancing, coughing-into-elbows, and daily multivitamins,” she wrote.

The Biden administration has extended the mask mandate several times since it was first announced. Most recently, the mandate was extended last week and was set to end May 3.

The rule has been alternately praised and criticized by airlines, pilots, and flight attendants. Lawsuits have been filed over the mandate, but Judge Mizelle ruled in favor of two people and the Health Freedom Defense Fund, who filed suit in July 2021.

It is not yet clear if the Biden administration will appeal the decision.

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

A scientific analysis of metabolites from plant-based-diets – especially those rich in whole grains, fruits, and vegetables – may in the future yield clues as to how such eating patterns lower the risk of type 2 diabetes, finds a new study of more than 8,000 people.

The research looked at healthy, unhealthy, and overall plant-based diets, but only metabolic profiles for the healthy and overall plant-based diets showed an inverse relationship with type 2 diabetes.

Lisovskaya/iStock/Getty Images Plus

A primarily “unhealthy” plant-based diet was one including mainly refined grains (e.g., white bread and pasta), fruit juices, potatoes, sugar-sweetened beverages, and sweets/desserts.

“Individual metabolites from consumption of polyphenol-rich plant foods like fruits, vegetables, coffee, and legumes are all closely linked to healthy plant-based diet and lower risk of diabetes,” lead author Frank Hu, MD, said in a press release.

Dr. Hu, of the department of nutrition at Harvard T.H. Chan School of Public Health, Boston, and colleagues reported their findings in Diabetologia.
 

High-throughput profiling of the metabolome

Given that an individual’s metabolic profile reflects their diet, there is a growing trend in nutritional research to use a technique called high-throughput metabolomics to profile biological samples.

The team conducted an analysis of blood plasma samples and dietary intake using food frequency questionnaires of 10,684 participants from three prospective cohorts (Nurses’ Health Study, Nurses’ Health Study II, and Health Professionals Follow-Up Study). Participants were predominantly White and middle-aged (mean age 54 years), with a mean body mass index of 25.6 kg/m².

Metabolite profile scores were generated from the blood samples, taken in the 1980s and 1990s, and matched to any cases of incident type 2 diabetes reported during follow-up, which ended in 2016-2017.

The team looked at three different plant-based diets – by definition, higher in plant foods and lower in animal foods – and further categorized them according to the actual foods consumed, to generate an overall plant diet index (PDI), a healthy PDI, or an unhealthy PDI.

In all, 8,827 participants completed the study, and 270 cases of diabetes were reported.

Multi-metabolite profiles were composed of 55 metabolites for the overall PDI, 93 metabolites for healthy PDI, and 75 metabolites for unhealthy PDI.

The findings are that metabolomics can be harnessed and “the identified metabolic profiles could be used to assess adherence to ... plant-based diets as part of type 2 diabetes prevention ... and provide new insights for future investigation,” the researchers concluded.

One coauthor received research support from the California Walnut Commission and Swiss ReManagement; another reported being a scientific consultant to LayerIV. The other authors have reported no relevant financial relationships.

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

A scientific analysis of metabolites from plant-based-diets – especially those rich in whole grains, fruits, and vegetables – may in the future yield clues as to how such eating patterns lower the risk of type 2 diabetes, finds a new study of more than 8,000 people.

The research looked at healthy, unhealthy, and overall plant-based diets, but only metabolic profiles for the healthy and overall plant-based diets showed an inverse relationship with type 2 diabetes.

Lisovskaya/iStock/Getty Images Plus

A primarily “unhealthy” plant-based diet was one including mainly refined grains (e.g., white bread and pasta), fruit juices, potatoes, sugar-sweetened beverages, and sweets/desserts.

“Individual metabolites from consumption of polyphenol-rich plant foods like fruits, vegetables, coffee, and legumes are all closely linked to healthy plant-based diet and lower risk of diabetes,” lead author Frank Hu, MD, said in a press release.

Dr. Hu, of the department of nutrition at Harvard T.H. Chan School of Public Health, Boston, and colleagues reported their findings in Diabetologia.
 

High-throughput profiling of the metabolome

Given that an individual’s metabolic profile reflects their diet, there is a growing trend in nutritional research to use a technique called high-throughput metabolomics to profile biological samples.

The team conducted an analysis of blood plasma samples and dietary intake using food frequency questionnaires of 10,684 participants from three prospective cohorts (Nurses’ Health Study, Nurses’ Health Study II, and Health Professionals Follow-Up Study). Participants were predominantly White and middle-aged (mean age 54 years), with a mean body mass index of 25.6 kg/m².

Metabolite profile scores were generated from the blood samples, taken in the 1980s and 1990s, and matched to any cases of incident type 2 diabetes reported during follow-up, which ended in 2016-2017.

The team looked at three different plant-based diets – by definition, higher in plant foods and lower in animal foods – and further categorized them according to the actual foods consumed, to generate an overall plant diet index (PDI), a healthy PDI, or an unhealthy PDI.

In all, 8,827 participants completed the study, and 270 cases of diabetes were reported.

Multi-metabolite profiles were composed of 55 metabolites for the overall PDI, 93 metabolites for healthy PDI, and 75 metabolites for unhealthy PDI.

The findings are that metabolomics can be harnessed and “the identified metabolic profiles could be used to assess adherence to ... plant-based diets as part of type 2 diabetes prevention ... and provide new insights for future investigation,” the researchers concluded.

One coauthor received research support from the California Walnut Commission and Swiss ReManagement; another reported being a scientific consultant to LayerIV. The other authors have reported no relevant financial relationships.

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

A scientific analysis of metabolites from plant-based-diets – especially those rich in whole grains, fruits, and vegetables – may in the future yield clues as to how such eating patterns lower the risk of type 2 diabetes, finds a new study of more than 8,000 people.

The research looked at healthy, unhealthy, and overall plant-based diets, but only metabolic profiles for the healthy and overall plant-based diets showed an inverse relationship with type 2 diabetes.

Lisovskaya/iStock/Getty Images Plus

A primarily “unhealthy” plant-based diet was one including mainly refined grains (e.g., white bread and pasta), fruit juices, potatoes, sugar-sweetened beverages, and sweets/desserts.

“Individual metabolites from consumption of polyphenol-rich plant foods like fruits, vegetables, coffee, and legumes are all closely linked to healthy plant-based diet and lower risk of diabetes,” lead author Frank Hu, MD, said in a press release.

Dr. Hu, of the department of nutrition at Harvard T.H. Chan School of Public Health, Boston, and colleagues reported their findings in Diabetologia.
 

High-throughput profiling of the metabolome

Given that an individual’s metabolic profile reflects their diet, there is a growing trend in nutritional research to use a technique called high-throughput metabolomics to profile biological samples.

The team conducted an analysis of blood plasma samples and dietary intake using food frequency questionnaires of 10,684 participants from three prospective cohorts (Nurses’ Health Study, Nurses’ Health Study II, and Health Professionals Follow-Up Study). Participants were predominantly White and middle-aged (mean age 54 years), with a mean body mass index of 25.6 kg/m².

Metabolite profile scores were generated from the blood samples, taken in the 1980s and 1990s, and matched to any cases of incident type 2 diabetes reported during follow-up, which ended in 2016-2017.

The team looked at three different plant-based diets – by definition, higher in plant foods and lower in animal foods – and further categorized them according to the actual foods consumed, to generate an overall plant diet index (PDI), a healthy PDI, or an unhealthy PDI.

In all, 8,827 participants completed the study, and 270 cases of diabetes were reported.

Multi-metabolite profiles were composed of 55 metabolites for the overall PDI, 93 metabolites for healthy PDI, and 75 metabolites for unhealthy PDI.

The findings are that metabolomics can be harnessed and “the identified metabolic profiles could be used to assess adherence to ... plant-based diets as part of type 2 diabetes prevention ... and provide new insights for future investigation,” the researchers concluded.

One coauthor received research support from the California Walnut Commission and Swiss ReManagement; another reported being a scientific consultant to LayerIV. The other authors have reported no relevant financial relationships.

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

A new study has found that aged black garlic (ABG) on top of dietary guidance lowers diastolic blood pressure (DBP) in men with moderately elevated cholesterol.

After 6 weeks, consumption of ABG with a high concentration of s-allyl-L-cystine (SAC) was associated with a nearly 6-mm Hg reduction in DBP in men. Other cardiovascular disease (CVD) risk factors were not significantly affected.

“The observed reduction in DBP by ABG extract was similar to the effects of dietary approaches, including the effects of the Dietary Approaches to Stop Hypertension(DASH) diet on BP,” say Rosa M. Valls, PhD, Universitat Rovira i Virgili, Reus, Spain, and colleagues.

“The potential beneficial effects of ABG may contribute to obtaining an optimal DBP” but were “better observed in men and in nonoptimal DBP populations,” they write in the study, published in Nutrients.

Pure SAC and aged garlics have shown healthy effects on multiple targets in in vitro and in vivo tests. However, previous studies in humans have not focused on ABG but rather on other types of aged garlic in patients with some type of CVD risk factor and suffered from methodologic or design weaknesses, the authors note.

To address this gap, Dr. Valls and colleagues randomly assigned 67 individuals with moderate hypercholesterolemia (defined as LDL levels of at least 115 mg/dL) to receive one ABG tablet (250 mg ABG extract/1.25 mg SAC) or placebo daily for 6 weeks. Following a 3-week washout, the groups were reversed and the new intervention continued for another 6 weeks.

Participants received dietary recommendations regarding CVD risk factors and had their dietary habits assessed through a 3-day food record at baseline and after 6 weeks during both treatments.

Individuals receiving lipid-lowering treatment or antihypertensives were excluded, as were those with a body mass index of 35 kg/m² or higher, those with a fasting blood glucose of at least 126 mg/dL, or active smokers.

There were no differences in baseline characteristics between the two groups. The mean systolic and diastolic pressures at baseline were 124/75 mm Hg in the ABG group and 121/74 mm Hg in the placebo group. Their mean age was 53 years.

Adherence with the protocol was “high” at 96.5% in both groups, and no adverse effects were reported.
 

Reduced risk of death from stroke, ischemic heart disease

Although no significant differences between ABG and placebo were observed at 3 weeks, the decline in DBP after consumption of the ABG extract became significant at 6 weeks (mean change, –3.7 mm Hg vs. –0.10 mm Hg; P = .007).

When stratified by sex and categories of DBP, the mean change in DBP after 6 weeks of ABG consumption was particularly prominent in men and in those with a baseline DBP of at least 75 mm Hg.

Small study

Commenting for this news organization, Linda Van Horn, PhD, RDN, professor and chief of the department of preventive medicine’s nutrition division, Northwestern University, Chicago, said that for many years, garlic has been “reported to be an adjunct to the benefits of a healthy eating pattern, with inconclusive results.”

She noted that ABG is “literally aged for many months to years, and the resulting concentrate is found higher in many organosulfur compounds and phytochemicals that suggest enhanced response.”

Dr. Van Horn, a member of the American Heart Association’s Nutrition Committee, who was not involved with the study, continued: “The data suggest that ABG that is much more highly concentrated than fresh or processed garlic might be helpful in lowering BP in certain subgroups, in this case men with higher BP.”

However, she cautioned, “these results are limited in a small study, and ... potential other issues, such as sodium, potassium, or other nutrients known to be associated with blood pressure, were not reported, thereby raising questions about the exclusivity of the ABG over other accompanying dietary factors.”

The study was funded by the Center for the Development of Industrial Technology of the Spanish Ministry of Science and Innovation. Two authors are employees of Pharmactive Biotech Products, SL (Madrid), which manufactured the ABG product, but neither played a role in any result or conclusion. The other authors and Dr. Van Horn report no relevant financial relationships.

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

A new study has found that aged black garlic (ABG) on top of dietary guidance lowers diastolic blood pressure (DBP) in men with moderately elevated cholesterol.

After 6 weeks, consumption of ABG with a high concentration of s-allyl-L-cystine (SAC) was associated with a nearly 6-mm Hg reduction in DBP in men. Other cardiovascular disease (CVD) risk factors were not significantly affected.

“The observed reduction in DBP by ABG extract was similar to the effects of dietary approaches, including the effects of the Dietary Approaches to Stop Hypertension(DASH) diet on BP,” say Rosa M. Valls, PhD, Universitat Rovira i Virgili, Reus, Spain, and colleagues.

“The potential beneficial effects of ABG may contribute to obtaining an optimal DBP” but were “better observed in men and in nonoptimal DBP populations,” they write in the study, published in Nutrients.

Pure SAC and aged garlics have shown healthy effects on multiple targets in in vitro and in vivo tests. However, previous studies in humans have not focused on ABG but rather on other types of aged garlic in patients with some type of CVD risk factor and suffered from methodologic or design weaknesses, the authors note.

To address this gap, Dr. Valls and colleagues randomly assigned 67 individuals with moderate hypercholesterolemia (defined as LDL levels of at least 115 mg/dL) to receive one ABG tablet (250 mg ABG extract/1.25 mg SAC) or placebo daily for 6 weeks. Following a 3-week washout, the groups were reversed and the new intervention continued for another 6 weeks.

Participants received dietary recommendations regarding CVD risk factors and had their dietary habits assessed through a 3-day food record at baseline and after 6 weeks during both treatments.

Individuals receiving lipid-lowering treatment or antihypertensives were excluded, as were those with a body mass index of 35 kg/m² or higher, those with a fasting blood glucose of at least 126 mg/dL, or active smokers.

There were no differences in baseline characteristics between the two groups. The mean systolic and diastolic pressures at baseline were 124/75 mm Hg in the ABG group and 121/74 mm Hg in the placebo group. Their mean age was 53 years.

Adherence with the protocol was “high” at 96.5% in both groups, and no adverse effects were reported.
 

Reduced risk of death from stroke, ischemic heart disease

Although no significant differences between ABG and placebo were observed at 3 weeks, the decline in DBP after consumption of the ABG extract became significant at 6 weeks (mean change, –3.7 mm Hg vs. –0.10 mm Hg; P = .007).

When stratified by sex and categories of DBP, the mean change in DBP after 6 weeks of ABG consumption was particularly prominent in men and in those with a baseline DBP of at least 75 mm Hg.

Small study

Commenting for this news organization, Linda Van Horn, PhD, RDN, professor and chief of the department of preventive medicine’s nutrition division, Northwestern University, Chicago, said that for many years, garlic has been “reported to be an adjunct to the benefits of a healthy eating pattern, with inconclusive results.”

She noted that ABG is “literally aged for many months to years, and the resulting concentrate is found higher in many organosulfur compounds and phytochemicals that suggest enhanced response.”

Dr. Van Horn, a member of the American Heart Association’s Nutrition Committee, who was not involved with the study, continued: “The data suggest that ABG that is much more highly concentrated than fresh or processed garlic might be helpful in lowering BP in certain subgroups, in this case men with higher BP.”

However, she cautioned, “these results are limited in a small study, and ... potential other issues, such as sodium, potassium, or other nutrients known to be associated with blood pressure, were not reported, thereby raising questions about the exclusivity of the ABG over other accompanying dietary factors.”

The study was funded by the Center for the Development of Industrial Technology of the Spanish Ministry of Science and Innovation. Two authors are employees of Pharmactive Biotech Products, SL (Madrid), which manufactured the ABG product, but neither played a role in any result or conclusion. The other authors and Dr. Van Horn report no relevant financial relationships.

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

A new study has found that aged black garlic (ABG) on top of dietary guidance lowers diastolic blood pressure (DBP) in men with moderately elevated cholesterol.

After 6 weeks, consumption of ABG with a high concentration of s-allyl-L-cystine (SAC) was associated with a nearly 6-mm Hg reduction in DBP in men. Other cardiovascular disease (CVD) risk factors were not significantly affected.

“The observed reduction in DBP by ABG extract was similar to the effects of dietary approaches, including the effects of the Dietary Approaches to Stop Hypertension(DASH) diet on BP,” say Rosa M. Valls, PhD, Universitat Rovira i Virgili, Reus, Spain, and colleagues.

“The potential beneficial effects of ABG may contribute to obtaining an optimal DBP” but were “better observed in men and in nonoptimal DBP populations,” they write in the study, published in Nutrients.

Pure SAC and aged garlics have shown healthy effects on multiple targets in in vitro and in vivo tests. However, previous studies in humans have not focused on ABG but rather on other types of aged garlic in patients with some type of CVD risk factor and suffered from methodologic or design weaknesses, the authors note.

To address this gap, Dr. Valls and colleagues randomly assigned 67 individuals with moderate hypercholesterolemia (defined as LDL levels of at least 115 mg/dL) to receive one ABG tablet (250 mg ABG extract/1.25 mg SAC) or placebo daily for 6 weeks. Following a 3-week washout, the groups were reversed and the new intervention continued for another 6 weeks.

Participants received dietary recommendations regarding CVD risk factors and had their dietary habits assessed through a 3-day food record at baseline and after 6 weeks during both treatments.

Individuals receiving lipid-lowering treatment or antihypertensives were excluded, as were those with a body mass index of 35 kg/m² or higher, those with a fasting blood glucose of at least 126 mg/dL, or active smokers.

There were no differences in baseline characteristics between the two groups. The mean systolic and diastolic pressures at baseline were 124/75 mm Hg in the ABG group and 121/74 mm Hg in the placebo group. Their mean age was 53 years.

Adherence with the protocol was “high” at 96.5% in both groups, and no adverse effects were reported.
 

Reduced risk of death from stroke, ischemic heart disease

Although no significant differences between ABG and placebo were observed at 3 weeks, the decline in DBP after consumption of the ABG extract became significant at 6 weeks (mean change, –3.7 mm Hg vs. –0.10 mm Hg; P = .007).

When stratified by sex and categories of DBP, the mean change in DBP after 6 weeks of ABG consumption was particularly prominent in men and in those with a baseline DBP of at least 75 mm Hg.

Small study

Commenting for this news organization, Linda Van Horn, PhD, RDN, professor and chief of the department of preventive medicine’s nutrition division, Northwestern University, Chicago, said that for many years, garlic has been “reported to be an adjunct to the benefits of a healthy eating pattern, with inconclusive results.”

She noted that ABG is “literally aged for many months to years, and the resulting concentrate is found higher in many organosulfur compounds and phytochemicals that suggest enhanced response.”

Dr. Van Horn, a member of the American Heart Association’s Nutrition Committee, who was not involved with the study, continued: “The data suggest that ABG that is much more highly concentrated than fresh or processed garlic might be helpful in lowering BP in certain subgroups, in this case men with higher BP.”

However, she cautioned, “these results are limited in a small study, and ... potential other issues, such as sodium, potassium, or other nutrients known to be associated with blood pressure, were not reported, thereby raising questions about the exclusivity of the ABG over other accompanying dietary factors.”

The study was funded by the Center for the Development of Industrial Technology of the Spanish Ministry of Science and Innovation. Two authors are employees of Pharmactive Biotech Products, SL (Madrid), which manufactured the ABG product, but neither played a role in any result or conclusion. The other authors and Dr. Van Horn report no relevant financial relationships.

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

Klay Noto wants to be the kind of doctor he never had when he began to question his gender identity.

A second-year student at Tulane University in New Orleans, he wants to listen compassionately to patients’ concerns and recognize the hurt when they question who they are. He will be the kind of doctor who knows that a breast exam can be traumatizing if someone has been breast binding or that instructing a patient to take everything off and put on a gown can be triggering for someone with gender dysphoria.

Being in the room for hard conversations is part of why he pursued med school. “There aren’t many LGBT people in medicine and as I started to understand all the dynamics that go into it, I started to see that I could do it and I could be that different kind of doctor,” he told this news organization.

Mr. Noto, who transitioned after college, wants to see more transgender people like himself teaching gender medicine, and for all medical students to be trained in what it means to be transgender and how to give compassionate and comprehensive care to all patients.

Gains have been made in providing curriculum in transgender care that trains medical students in such concepts as how to approach gender identity with sensitivity and how to manage hormone therapy and surgery for transitioning patients who request that, according to those interviewed for this story.

But they agree there’s a long way to go to having widespread medical school integration of the health care needs of about 1.4 million transgender people in the United States.

According to the Association of American Medical Colleges (AAMC) Curriculum Inventory data collected from 131 U.S. medical schools, more than 65% offered some form of transgender-related education in 2018, and more than 80% of those provided such curriculum in required courses.
 

Lack of transgender, nonbinary faculty

Jason Klein, MD, is a pediatric endocrinologist and medical director of the Transgender Youth Health Program at New York (N.Y.) University.

He said in an interview that the number of programs nationally that have gender medicine as a structured part of their curriculum has increased over the last 5-10 years, but that education is not standardized from program to program.

The program at NYU includes lecture-style learning, case presentations, real-world conversations with people in the community, group discussions, and patient care, Dr. Klein said. There are formal lectures as part of adolescent medicine where students learn the differences between gender and sexual identity, and education on medical treatment of transgender and nonbinary adolescents, starting with puberty blockers and moving into affirming hormones.

Doctors also learn to know their limits and decide when to refer patients to a specialist.

“The focus is really about empathic and supportive care,” said Dr. Klein, assistant professor in the department of pediatrics at Hassenfeld Children’s Hospital at NYU Langone Health. “It’s about communication and understanding and the language we use and how to deliver affirming care in a health care setting in general.”

Imagine the potential stressors, he said, of a transgender person entering a typical health care setting. The electronic health record may only have room for the legal name of a person and not the name a person may currently be using. The intake form typically asks patients to check either male or female. The bathrooms give the same two choices. 

“Every physician should know how to speak with, treat, emote with, and empathize with care for the trans and nonbinary individual,” Dr. Klein said.

Dr. Klein noted there is a glaring shortage of trans and nonbinary physicians to lead efforts to expand education on integrating the medical, psychological, and psychosocial care that patients will receive.

Currently, gender medicine is not included on board exams for adolescent medicine or endocrinology, he said.

“Adding formal training in gender medicine to board exams would really help solidify the importance of this arena of medicine,” he noted.
 

First AAMC standards

In 2014, the AAMC released the first standards to guide curricula across medical school and residency to support training doctors to be competent in caring for transgender patients.

The standards include recommending that all doctors be able to communicate with patients related to their gender identity and understand how to deliver high-quality care to transgender and gender-diverse patients within their specialty, Kristen L. Eckstrand, MD, a coauthor of the guidelines, told this news organization.

“Many medical schools have developed their own curricula to meet these standards,” said Dr. Eckstrand, medical director for LGBTQIA+ Health at the University of Pittsburgh Medical Center.

Norma Poll-Hunter, PhD, AAMC’s senior director for workforce diversity, noted that the organization recently released its diversity, equity, and inclusion competencies that guide the medical education of students, residents, and faculty.

Dr. Poll-Hunter told this news organization that AAMC partners with the Building the Next Generation of Academic Physicians LGBT Health Workforce Conference “to support safe spaces for scholarly efforts and mentorship to advance this area of work.”
 

Team approach at Rutgers

Among the medical schools that incorporate comprehensive transgender care into the curriculum is Rutgers University’s Robert Wood Johnson Medical School in New Brunswick, N.J.

Gloria Bachmann, MD, is professor of obstetrics and gynecology at the school and medical director of its partner, the PROUD Gender Center of New Jersey. PROUD stands for “Promoting Respect, Outreach, Understanding, and Dignity,” and the center provides comprehensive care for transgender and nonbinary patients in one location.

Courtesy Rutgers University

Dr. Bachmann said Rutgers takes a team approach with both instructors and learners teaching medical students about transgender care. The teachers are not only professors in traditional classroom lectures, but patient navigators and nurses at the PROUD center, established as part of the medical school in 2020. Students learn from the navigators, for instance, how to help patients through the spectrum of inpatient and outpatient care.

“All of our learners do get to care for individuals who identify as transgender,” said Dr. Bachmann.

Among the improvements in educating students on transgender care over the years, she said, is the emphasis on social determinants of health. In the transgender population, initial questions may include whether the person is able to access care through insurance as laws vary widely on what care and procedures are covered.

As another example, Dr. Bachmann cites: “If they are seen on an emergency basis and are sent home with medication and follow-up, can they afford it?”

Another consideration is whether there is a home to which they can return.

“Many individuals who are transgender may not have a home. Their family may not be accepting of them. Therefore, it’s the social determinants of health as well as their transgender identity that have to be put into the equation of best care,” she said.
 

Giving back to the trans community

Mr. Noto doesn’t know whether he will specialize in gender medicine, but he is committed to serving the transgender community in whatever physician path he chooses.

He said he realizes he is fortunate to have strong family support and good insurance and that he can afford fees, such as the copay to see transgender care specialists. Many in the community do not have those resources and are likely to get care “only if they have to.”

At Tulane, training in transgender care starts during orientation week and continues on different levels, with different options, throughout medical school and residency, he added.

Mr. Noto said he would like to see more mandatory learning such as a “queer-centered exam, where you have to give an organ inventory and you have to ask patients if it’s OK to talk about X, Y, and Z.” He’d also like more opportunities for clinical interaction with transgender patients, such as queer-centered rotations.

When physicians aren’t well trained in transgender care, you have patients educating the doctors, which, Mr. Noto said, should not be acceptable.

“People come to you on their worst day. And to not be informed about them in my mind is negligent. In what other population can you choose not to learn about someone just because you don’t want to?” he said.

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

Klay Noto wants to be the kind of doctor he never had when he began to question his gender identity.

A second-year student at Tulane University in New Orleans, he wants to listen compassionately to patients’ concerns and recognize the hurt when they question who they are. He will be the kind of doctor who knows that a breast exam can be traumatizing if someone has been breast binding or that instructing a patient to take everything off and put on a gown can be triggering for someone with gender dysphoria.

Being in the room for hard conversations is part of why he pursued med school. “There aren’t many LGBT people in medicine and as I started to understand all the dynamics that go into it, I started to see that I could do it and I could be that different kind of doctor,” he told this news organization.

Mr. Noto, who transitioned after college, wants to see more transgender people like himself teaching gender medicine, and for all medical students to be trained in what it means to be transgender and how to give compassionate and comprehensive care to all patients.

Gains have been made in providing curriculum in transgender care that trains medical students in such concepts as how to approach gender identity with sensitivity and how to manage hormone therapy and surgery for transitioning patients who request that, according to those interviewed for this story.

But they agree there’s a long way to go to having widespread medical school integration of the health care needs of about 1.4 million transgender people in the United States.

According to the Association of American Medical Colleges (AAMC) Curriculum Inventory data collected from 131 U.S. medical schools, more than 65% offered some form of transgender-related education in 2018, and more than 80% of those provided such curriculum in required courses.
 

Lack of transgender, nonbinary faculty

Jason Klein, MD, is a pediatric endocrinologist and medical director of the Transgender Youth Health Program at New York (N.Y.) University.

He said in an interview that the number of programs nationally that have gender medicine as a structured part of their curriculum has increased over the last 5-10 years, but that education is not standardized from program to program.

The program at NYU includes lecture-style learning, case presentations, real-world conversations with people in the community, group discussions, and patient care, Dr. Klein said. There are formal lectures as part of adolescent medicine where students learn the differences between gender and sexual identity, and education on medical treatment of transgender and nonbinary adolescents, starting with puberty blockers and moving into affirming hormones.

Doctors also learn to know their limits and decide when to refer patients to a specialist.

“The focus is really about empathic and supportive care,” said Dr. Klein, assistant professor in the department of pediatrics at Hassenfeld Children’s Hospital at NYU Langone Health. “It’s about communication and understanding and the language we use and how to deliver affirming care in a health care setting in general.”

Imagine the potential stressors, he said, of a transgender person entering a typical health care setting. The electronic health record may only have room for the legal name of a person and not the name a person may currently be using. The intake form typically asks patients to check either male or female. The bathrooms give the same two choices. 

“Every physician should know how to speak with, treat, emote with, and empathize with care for the trans and nonbinary individual,” Dr. Klein said.

Dr. Klein noted there is a glaring shortage of trans and nonbinary physicians to lead efforts to expand education on integrating the medical, psychological, and psychosocial care that patients will receive.

Currently, gender medicine is not included on board exams for adolescent medicine or endocrinology, he said.

“Adding formal training in gender medicine to board exams would really help solidify the importance of this arena of medicine,” he noted.
 

First AAMC standards

In 2014, the AAMC released the first standards to guide curricula across medical school and residency to support training doctors to be competent in caring for transgender patients.

The standards include recommending that all doctors be able to communicate with patients related to their gender identity and understand how to deliver high-quality care to transgender and gender-diverse patients within their specialty, Kristen L. Eckstrand, MD, a coauthor of the guidelines, told this news organization.

“Many medical schools have developed their own curricula to meet these standards,” said Dr. Eckstrand, medical director for LGBTQIA+ Health at the University of Pittsburgh Medical Center.

Norma Poll-Hunter, PhD, AAMC’s senior director for workforce diversity, noted that the organization recently released its diversity, equity, and inclusion competencies that guide the medical education of students, residents, and faculty.

Dr. Poll-Hunter told this news organization that AAMC partners with the Building the Next Generation of Academic Physicians LGBT Health Workforce Conference “to support safe spaces for scholarly efforts and mentorship to advance this area of work.”
 

Team approach at Rutgers

Among the medical schools that incorporate comprehensive transgender care into the curriculum is Rutgers University’s Robert Wood Johnson Medical School in New Brunswick, N.J.

Gloria Bachmann, MD, is professor of obstetrics and gynecology at the school and medical director of its partner, the PROUD Gender Center of New Jersey. PROUD stands for “Promoting Respect, Outreach, Understanding, and Dignity,” and the center provides comprehensive care for transgender and nonbinary patients in one location.

Courtesy Rutgers University

Dr. Bachmann said Rutgers takes a team approach with both instructors and learners teaching medical students about transgender care. The teachers are not only professors in traditional classroom lectures, but patient navigators and nurses at the PROUD center, established as part of the medical school in 2020. Students learn from the navigators, for instance, how to help patients through the spectrum of inpatient and outpatient care.

“All of our learners do get to care for individuals who identify as transgender,” said Dr. Bachmann.

Among the improvements in educating students on transgender care over the years, she said, is the emphasis on social determinants of health. In the transgender population, initial questions may include whether the person is able to access care through insurance as laws vary widely on what care and procedures are covered.

As another example, Dr. Bachmann cites: “If they are seen on an emergency basis and are sent home with medication and follow-up, can they afford it?”

Another consideration is whether there is a home to which they can return.

“Many individuals who are transgender may not have a home. Their family may not be accepting of them. Therefore, it’s the social determinants of health as well as their transgender identity that have to be put into the equation of best care,” she said.
 

Giving back to the trans community

Mr. Noto doesn’t know whether he will specialize in gender medicine, but he is committed to serving the transgender community in whatever physician path he chooses.

He said he realizes he is fortunate to have strong family support and good insurance and that he can afford fees, such as the copay to see transgender care specialists. Many in the community do not have those resources and are likely to get care “only if they have to.”

At Tulane, training in transgender care starts during orientation week and continues on different levels, with different options, throughout medical school and residency, he added.

Mr. Noto said he would like to see more mandatory learning such as a “queer-centered exam, where you have to give an organ inventory and you have to ask patients if it’s OK to talk about X, Y, and Z.” He’d also like more opportunities for clinical interaction with transgender patients, such as queer-centered rotations.

When physicians aren’t well trained in transgender care, you have patients educating the doctors, which, Mr. Noto said, should not be acceptable.

“People come to you on their worst day. And to not be informed about them in my mind is negligent. In what other population can you choose not to learn about someone just because you don’t want to?” he said.

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

Klay Noto wants to be the kind of doctor he never had when he began to question his gender identity.

A second-year student at Tulane University in New Orleans, he wants to listen compassionately to patients’ concerns and recognize the hurt when they question who they are. He will be the kind of doctor who knows that a breast exam can be traumatizing if someone has been breast binding or that instructing a patient to take everything off and put on a gown can be triggering for someone with gender dysphoria.

Being in the room for hard conversations is part of why he pursued med school. “There aren’t many LGBT people in medicine and as I started to understand all the dynamics that go into it, I started to see that I could do it and I could be that different kind of doctor,” he told this news organization.

Mr. Noto, who transitioned after college, wants to see more transgender people like himself teaching gender medicine, and for all medical students to be trained in what it means to be transgender and how to give compassionate and comprehensive care to all patients.

Gains have been made in providing curriculum in transgender care that trains medical students in such concepts as how to approach gender identity with sensitivity and how to manage hormone therapy and surgery for transitioning patients who request that, according to those interviewed for this story.

But they agree there’s a long way to go to having widespread medical school integration of the health care needs of about 1.4 million transgender people in the United States.

According to the Association of American Medical Colleges (AAMC) Curriculum Inventory data collected from 131 U.S. medical schools, more than 65% offered some form of transgender-related education in 2018, and more than 80% of those provided such curriculum in required courses.
 

Lack of transgender, nonbinary faculty

Jason Klein, MD, is a pediatric endocrinologist and medical director of the Transgender Youth Health Program at New York (N.Y.) University.

He said in an interview that the number of programs nationally that have gender medicine as a structured part of their curriculum has increased over the last 5-10 years, but that education is not standardized from program to program.

The program at NYU includes lecture-style learning, case presentations, real-world conversations with people in the community, group discussions, and patient care, Dr. Klein said. There are formal lectures as part of adolescent medicine where students learn the differences between gender and sexual identity, and education on medical treatment of transgender and nonbinary adolescents, starting with puberty blockers and moving into affirming hormones.

Doctors also learn to know their limits and decide when to refer patients to a specialist.

“The focus is really about empathic and supportive care,” said Dr. Klein, assistant professor in the department of pediatrics at Hassenfeld Children’s Hospital at NYU Langone Health. “It’s about communication and understanding and the language we use and how to deliver affirming care in a health care setting in general.”

Imagine the potential stressors, he said, of a transgender person entering a typical health care setting. The electronic health record may only have room for the legal name of a person and not the name a person may currently be using. The intake form typically asks patients to check either male or female. The bathrooms give the same two choices. 

“Every physician should know how to speak with, treat, emote with, and empathize with care for the trans and nonbinary individual,” Dr. Klein said.

Dr. Klein noted there is a glaring shortage of trans and nonbinary physicians to lead efforts to expand education on integrating the medical, psychological, and psychosocial care that patients will receive.

Currently, gender medicine is not included on board exams for adolescent medicine or endocrinology, he said.

“Adding formal training in gender medicine to board exams would really help solidify the importance of this arena of medicine,” he noted.
 

First AAMC standards

In 2014, the AAMC released the first standards to guide curricula across medical school and residency to support training doctors to be competent in caring for transgender patients.

The standards include recommending that all doctors be able to communicate with patients related to their gender identity and understand how to deliver high-quality care to transgender and gender-diverse patients within their specialty, Kristen L. Eckstrand, MD, a coauthor of the guidelines, told this news organization.

“Many medical schools have developed their own curricula to meet these standards,” said Dr. Eckstrand, medical director for LGBTQIA+ Health at the University of Pittsburgh Medical Center.

Norma Poll-Hunter, PhD, AAMC’s senior director for workforce diversity, noted that the organization recently released its diversity, equity, and inclusion competencies that guide the medical education of students, residents, and faculty.

Dr. Poll-Hunter told this news organization that AAMC partners with the Building the Next Generation of Academic Physicians LGBT Health Workforce Conference “to support safe spaces for scholarly efforts and mentorship to advance this area of work.”
 

Team approach at Rutgers

Among the medical schools that incorporate comprehensive transgender care into the curriculum is Rutgers University’s Robert Wood Johnson Medical School in New Brunswick, N.J.

Gloria Bachmann, MD, is professor of obstetrics and gynecology at the school and medical director of its partner, the PROUD Gender Center of New Jersey. PROUD stands for “Promoting Respect, Outreach, Understanding, and Dignity,” and the center provides comprehensive care for transgender and nonbinary patients in one location.

Courtesy Rutgers University

Dr. Bachmann said Rutgers takes a team approach with both instructors and learners teaching medical students about transgender care. The teachers are not only professors in traditional classroom lectures, but patient navigators and nurses at the PROUD center, established as part of the medical school in 2020. Students learn from the navigators, for instance, how to help patients through the spectrum of inpatient and outpatient care.

“All of our learners do get to care for individuals who identify as transgender,” said Dr. Bachmann.

Among the improvements in educating students on transgender care over the years, she said, is the emphasis on social determinants of health. In the transgender population, initial questions may include whether the person is able to access care through insurance as laws vary widely on what care and procedures are covered.

As another example, Dr. Bachmann cites: “If they are seen on an emergency basis and are sent home with medication and follow-up, can they afford it?”

Another consideration is whether there is a home to which they can return.

“Many individuals who are transgender may not have a home. Their family may not be accepting of them. Therefore, it’s the social determinants of health as well as their transgender identity that have to be put into the equation of best care,” she said.
 

Giving back to the trans community

Mr. Noto doesn’t know whether he will specialize in gender medicine, but he is committed to serving the transgender community in whatever physician path he chooses.

He said he realizes he is fortunate to have strong family support and good insurance and that he can afford fees, such as the copay to see transgender care specialists. Many in the community do not have those resources and are likely to get care “only if they have to.”

At Tulane, training in transgender care starts during orientation week and continues on different levels, with different options, throughout medical school and residency, he added.

Mr. Noto said he would like to see more mandatory learning such as a “queer-centered exam, where you have to give an organ inventory and you have to ask patients if it’s OK to talk about X, Y, and Z.” He’d also like more opportunities for clinical interaction with transgender patients, such as queer-centered rotations.

When physicians aren’t well trained in transgender care, you have patients educating the doctors, which, Mr. Noto said, should not be acceptable.

“People come to you on their worst day. And to not be informed about them in my mind is negligent. In what other population can you choose not to learn about someone just because you don’t want to?” he said.

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

A network meta-analysis of 42 clinical trials concludes that rosuvastatin, simvastatin, and atorvastatin are the statins most effective at lowering non-high-density-lipoprotein cholesterol (non-HDL-C) in people with diabetes and at risk for cardiovascular disease.

The analysis focused on the efficacy of statin treatment on reducing non-HDL-C, as opposed to reducing low-density-lipoprotein cholesterol (LDL-C), which has traditionally been used as a surrogate to determine cardiovascular disease risk from hypercholesterolemia.

“The National Cholesterol Education Program in the United States recommends that LDL-C values should be used to estimate the risk of cardiovascular disease related to lipoproteins,” lead author Alexander Hodkinson, MD, senior National Institute for Health Research fellow, University of Manchester, England, told this news organization.

“But we believe that non-high-density-lipoprotein cholesterol is more strongly associated with the risk of cardiovascular disease, because non-HDL-C combines all the bad types of cholesterol, which LDL-C misses, so it could be a better tool than LDL-C for assessing CVD risk and effects of treatment. We already knew which of the statins reduce LDL-C, but we wanted to know which ones reduced non-HDL-C; hence the reason for our study,” Dr. Hodkinson said.

The findings were published online  in BMJ.

In April 2021, the National Institute for Health and Care Excellence (NICE) in the United Kingdom updated guidelines for adults with diabetes to recommend that non-HDL-C should replace LDL-C as the primary target for reducing the risk for cardiovascular disease with lipid-lowering treatment.

Currently, NICE is alone in its recommendation. Other international guidelines do not have a non-HDL-C target and use LDL-C reduction instead. These include guidelines from the European Society of Cardiology (ESC), the American College of Cardiology (ACC), the American Heart Association (AHA), and the National Lipid Association.

Non–HDL-C is simple to calculate and can easily be done by clinicians by subtracting HDL-C from the total cholesterol level, he added.

This analysis compared the effectiveness of different statins at different intensities in reducing levels of non-HDL-C in 42 randomized controlled trials that included 20,193 adults with diabetes.

Compared with placebo, rosuvastatin, given at moderate- and high-intensity doses, and simvastatin and atorvastatin at high-intensity doses, were the best at lowering levels of non-HDL-C over an average treatment period of 12 weeks.

High-intensity rosuvastatin led to a 2.31 mmol/L reduction in non-HDL-C (95% credible interval, –3.39 to –1.21). Moderate-intensity rosuvastatin led to a 2.27 mmol/L reduction in non-HDL-C (95% credible interval, –3.00 to –1.49).

High-intensity simvastatin led to a 2.26 mmol/L reduction in non-HDL-C (95% credible interval, –2.99 to –1.51).

High-intensity atorvastatin led to a 2.20 mmol/L reduction in non-HDL-C (95% credible interval, –2.69 to –1.70).

Atorvastatin and simvastatin at any intensity and pravastatin at low intensity were also effective in reducing levels of non-HDL-C, the researchers noted.

In 4,670 patients who were at great risk for a major cardiovascular event, atorvastatin at high intensity showed the largest reduction in levels of non-HDL-C (1.98 mmol/L; 95% credible interval, –4.16 to 0.26).

In addition, high-intensity simvastatin and rosuvastatin were the most effective in reducing LDL-C.

High-intensity simvastatin led to a 1.93 mmol/L reduction in LDL-C (95% credible interval, –2.63 to –1.21), and high-intensity rosuvastatin led to a 1.76 mmol/L reduction in LDL-C (95% credible interval, –2.37 to –1.15).

In four studies, significant reductions in nonfatal myocardial infarction were shown for atorvastatin at moderate intensity, compared with placebo (relative risk, 0.57; 95% confidence interval, 0.43-.76). No significant differences were seen for discontinuations, nonfatal stroke, or cardiovascular death.

“We hope our findings will help guide clinicians on statin selection itself, and what types of doses they should be giving patients. These results support using NICE’s new policy guidelines on cholesterol monitoring, using this non-HDL-C measure, which contains all the bad types of cholesterol for patients with diabetes,” Dr. Hodkinson said.

“This study further emphasizes what we have known about the benefit of statin therapy in patients with type 2 diabetes,” Prakash Deedwania, MD, professor of medicine, University of California, San Francisco, told this news organization.

Dr. Deedwania and others have published data on patients with diabetes that showed that treatment with high-intensity atorvastatin was associated with significant reductions in major adverse cardiovascular events.

“Here they use non-HDL cholesterol as a target. The NICE guidelines are the only guidelines looking at non-HDL cholesterol; however, all guidelines suggest an LDL to be less than 70 in all people with diabetes, and for those with recent acute coronary syndromes, the latest evidence suggests the LDL should actually be less than 50,” said Dr. Deedwania, spokesperson for the AHA and ACC.

As far as which measure to use, he believes both are useful. “It’s six of one and half a dozen of the other, in my opinion. The societies have not recommended non-HDL cholesterol and it’s easier to stay with what is readily available for clinicians, and using LDL cholesterol is still okay. The results of this analysis are confirmatory, in that looking at non-HDL cholesterol gives results very similar to what these statins have shown for their effect on LDL cholesterol,” he said.
 

Non-HDL cholesterol a better marker?

For Robert Rosenson, MD, director of metabolism and lipids at Mount Sinai Health System and professor of medicine and cardiology at the Icahn School of Medicine at Mount Sinai, New York, non-HDL cholesterol is becoming an important marker of risk for several reasons.

“The focus on LDL cholesterol has been due to the causal relationship of LDL with atherosclerotic cardiovascular disease, but in the last few decades, non-HDL has emerged because more people are overweight, have insulin resistance, and have diabetes,” Dr. Rosenson told this news organization. “In those situations, the LDL cholesterol underrepresents the risk of the LDL particles. With insulin resistance, the particles become more triglycerides and less cholesterol, so on a per-particle basis, you need to get more LDL particles to get to a certain LDL cholesterol concentration.”

Non-HDL cholesterol testing does not require fasting, another advantage of using it to monitor cholesterol, he added.

What is often forgotten is that moderate- to high-intensity statins have very good triglyceride-lowering effects, Dr. Rosenson said.

“This article highlights that, by using higher doses, you get more triglyceride-lowering. Hopefully, this will get practitioners to recognize that non-HDL cholesterol is a better predictor of risk in people with diabetes,” he said.

The study was funded by the National Institute for Health Research. Dr. Hodkinson, Dr. Rosenson, and Dr. Deedwania report no relevant financial relationships.

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

A network meta-analysis of 42 clinical trials concludes that rosuvastatin, simvastatin, and atorvastatin are the statins most effective at lowering non-high-density-lipoprotein cholesterol (non-HDL-C) in people with diabetes and at risk for cardiovascular disease.

The analysis focused on the efficacy of statin treatment on reducing non-HDL-C, as opposed to reducing low-density-lipoprotein cholesterol (LDL-C), which has traditionally been used as a surrogate to determine cardiovascular disease risk from hypercholesterolemia.

“The National Cholesterol Education Program in the United States recommends that LDL-C values should be used to estimate the risk of cardiovascular disease related to lipoproteins,” lead author Alexander Hodkinson, MD, senior National Institute for Health Research fellow, University of Manchester, England, told this news organization.

“But we believe that non-high-density-lipoprotein cholesterol is more strongly associated with the risk of cardiovascular disease, because non-HDL-C combines all the bad types of cholesterol, which LDL-C misses, so it could be a better tool than LDL-C for assessing CVD risk and effects of treatment. We already knew which of the statins reduce LDL-C, but we wanted to know which ones reduced non-HDL-C; hence the reason for our study,” Dr. Hodkinson said.

The findings were published online  in BMJ.

In April 2021, the National Institute for Health and Care Excellence (NICE) in the United Kingdom updated guidelines for adults with diabetes to recommend that non-HDL-C should replace LDL-C as the primary target for reducing the risk for cardiovascular disease with lipid-lowering treatment.

Currently, NICE is alone in its recommendation. Other international guidelines do not have a non-HDL-C target and use LDL-C reduction instead. These include guidelines from the European Society of Cardiology (ESC), the American College of Cardiology (ACC), the American Heart Association (AHA), and the National Lipid Association.

Non–HDL-C is simple to calculate and can easily be done by clinicians by subtracting HDL-C from the total cholesterol level, he added.

This analysis compared the effectiveness of different statins at different intensities in reducing levels of non-HDL-C in 42 randomized controlled trials that included 20,193 adults with diabetes.

Compared with placebo, rosuvastatin, given at moderate- and high-intensity doses, and simvastatin and atorvastatin at high-intensity doses, were the best at lowering levels of non-HDL-C over an average treatment period of 12 weeks.

High-intensity rosuvastatin led to a 2.31 mmol/L reduction in non-HDL-C (95% credible interval, –3.39 to –1.21). Moderate-intensity rosuvastatin led to a 2.27 mmol/L reduction in non-HDL-C (95% credible interval, –3.00 to –1.49).

High-intensity simvastatin led to a 2.26 mmol/L reduction in non-HDL-C (95% credible interval, –2.99 to –1.51).

High-intensity atorvastatin led to a 2.20 mmol/L reduction in non-HDL-C (95% credible interval, –2.69 to –1.70).

Atorvastatin and simvastatin at any intensity and pravastatin at low intensity were also effective in reducing levels of non-HDL-C, the researchers noted.

In 4,670 patients who were at great risk for a major cardiovascular event, atorvastatin at high intensity showed the largest reduction in levels of non-HDL-C (1.98 mmol/L; 95% credible interval, –4.16 to 0.26).

In addition, high-intensity simvastatin and rosuvastatin were the most effective in reducing LDL-C.

High-intensity simvastatin led to a 1.93 mmol/L reduction in LDL-C (95% credible interval, –2.63 to –1.21), and high-intensity rosuvastatin led to a 1.76 mmol/L reduction in LDL-C (95% credible interval, –2.37 to –1.15).

In four studies, significant reductions in nonfatal myocardial infarction were shown for atorvastatin at moderate intensity, compared with placebo (relative risk, 0.57; 95% confidence interval, 0.43-.76). No significant differences were seen for discontinuations, nonfatal stroke, or cardiovascular death.

“We hope our findings will help guide clinicians on statin selection itself, and what types of doses they should be giving patients. These results support using NICE’s new policy guidelines on cholesterol monitoring, using this non-HDL-C measure, which contains all the bad types of cholesterol for patients with diabetes,” Dr. Hodkinson said.

“This study further emphasizes what we have known about the benefit of statin therapy in patients with type 2 diabetes,” Prakash Deedwania, MD, professor of medicine, University of California, San Francisco, told this news organization.

Dr. Deedwania and others have published data on patients with diabetes that showed that treatment with high-intensity atorvastatin was associated with significant reductions in major adverse cardiovascular events.

“Here they use non-HDL cholesterol as a target. The NICE guidelines are the only guidelines looking at non-HDL cholesterol; however, all guidelines suggest an LDL to be less than 70 in all people with diabetes, and for those with recent acute coronary syndromes, the latest evidence suggests the LDL should actually be less than 50,” said Dr. Deedwania, spokesperson for the AHA and ACC.

As far as which measure to use, he believes both are useful. “It’s six of one and half a dozen of the other, in my opinion. The societies have not recommended non-HDL cholesterol and it’s easier to stay with what is readily available for clinicians, and using LDL cholesterol is still okay. The results of this analysis are confirmatory, in that looking at non-HDL cholesterol gives results very similar to what these statins have shown for their effect on LDL cholesterol,” he said.
 

Non-HDL cholesterol a better marker?

For Robert Rosenson, MD, director of metabolism and lipids at Mount Sinai Health System and professor of medicine and cardiology at the Icahn School of Medicine at Mount Sinai, New York, non-HDL cholesterol is becoming an important marker of risk for several reasons.

“The focus on LDL cholesterol has been due to the causal relationship of LDL with atherosclerotic cardiovascular disease, but in the last few decades, non-HDL has emerged because more people are overweight, have insulin resistance, and have diabetes,” Dr. Rosenson told this news organization. “In those situations, the LDL cholesterol underrepresents the risk of the LDL particles. With insulin resistance, the particles become more triglycerides and less cholesterol, so on a per-particle basis, you need to get more LDL particles to get to a certain LDL cholesterol concentration.”

Non-HDL cholesterol testing does not require fasting, another advantage of using it to monitor cholesterol, he added.

What is often forgotten is that moderate- to high-intensity statins have very good triglyceride-lowering effects, Dr. Rosenson said.

“This article highlights that, by using higher doses, you get more triglyceride-lowering. Hopefully, this will get practitioners to recognize that non-HDL cholesterol is a better predictor of risk in people with diabetes,” he said.

The study was funded by the National Institute for Health Research. Dr. Hodkinson, Dr. Rosenson, and Dr. Deedwania report no relevant financial relationships.

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

A network meta-analysis of 42 clinical trials concludes that rosuvastatin, simvastatin, and atorvastatin are the statins most effective at lowering non-high-density-lipoprotein cholesterol (non-HDL-C) in people with diabetes and at risk for cardiovascular disease.

The analysis focused on the efficacy of statin treatment on reducing non-HDL-C, as opposed to reducing low-density-lipoprotein cholesterol (LDL-C), which has traditionally been used as a surrogate to determine cardiovascular disease risk from hypercholesterolemia.

“The National Cholesterol Education Program in the United States recommends that LDL-C values should be used to estimate the risk of cardiovascular disease related to lipoproteins,” lead author Alexander Hodkinson, MD, senior National Institute for Health Research fellow, University of Manchester, England, told this news organization.

“But we believe that non-high-density-lipoprotein cholesterol is more strongly associated with the risk of cardiovascular disease, because non-HDL-C combines all the bad types of cholesterol, which LDL-C misses, so it could be a better tool than LDL-C for assessing CVD risk and effects of treatment. We already knew which of the statins reduce LDL-C, but we wanted to know which ones reduced non-HDL-C; hence the reason for our study,” Dr. Hodkinson said.

The findings were published online  in BMJ.

In April 2021, the National Institute for Health and Care Excellence (NICE) in the United Kingdom updated guidelines for adults with diabetes to recommend that non-HDL-C should replace LDL-C as the primary target for reducing the risk for cardiovascular disease with lipid-lowering treatment.

Currently, NICE is alone in its recommendation. Other international guidelines do not have a non-HDL-C target and use LDL-C reduction instead. These include guidelines from the European Society of Cardiology (ESC), the American College of Cardiology (ACC), the American Heart Association (AHA), and the National Lipid Association.

Non–HDL-C is simple to calculate and can easily be done by clinicians by subtracting HDL-C from the total cholesterol level, he added.

This analysis compared the effectiveness of different statins at different intensities in reducing levels of non-HDL-C in 42 randomized controlled trials that included 20,193 adults with diabetes.

Compared with placebo, rosuvastatin, given at moderate- and high-intensity doses, and simvastatin and atorvastatin at high-intensity doses, were the best at lowering levels of non-HDL-C over an average treatment period of 12 weeks.

High-intensity rosuvastatin led to a 2.31 mmol/L reduction in non-HDL-C (95% credible interval, –3.39 to –1.21). Moderate-intensity rosuvastatin led to a 2.27 mmol/L reduction in non-HDL-C (95% credible interval, –3.00 to –1.49).

High-intensity simvastatin led to a 2.26 mmol/L reduction in non-HDL-C (95% credible interval, –2.99 to –1.51).

High-intensity atorvastatin led to a 2.20 mmol/L reduction in non-HDL-C (95% credible interval, –2.69 to –1.70).

Atorvastatin and simvastatin at any intensity and pravastatin at low intensity were also effective in reducing levels of non-HDL-C, the researchers noted.

In 4,670 patients who were at great risk for a major cardiovascular event, atorvastatin at high intensity showed the largest reduction in levels of non-HDL-C (1.98 mmol/L; 95% credible interval, –4.16 to 0.26).

In addition, high-intensity simvastatin and rosuvastatin were the most effective in reducing LDL-C.

High-intensity simvastatin led to a 1.93 mmol/L reduction in LDL-C (95% credible interval, –2.63 to –1.21), and high-intensity rosuvastatin led to a 1.76 mmol/L reduction in LDL-C (95% credible interval, –2.37 to –1.15).

In four studies, significant reductions in nonfatal myocardial infarction were shown for atorvastatin at moderate intensity, compared with placebo (relative risk, 0.57; 95% confidence interval, 0.43-.76). No significant differences were seen for discontinuations, nonfatal stroke, or cardiovascular death.

“We hope our findings will help guide clinicians on statin selection itself, and what types of doses they should be giving patients. These results support using NICE’s new policy guidelines on cholesterol monitoring, using this non-HDL-C measure, which contains all the bad types of cholesterol for patients with diabetes,” Dr. Hodkinson said.

“This study further emphasizes what we have known about the benefit of statin therapy in patients with type 2 diabetes,” Prakash Deedwania, MD, professor of medicine, University of California, San Francisco, told this news organization.

Dr. Deedwania and others have published data on patients with diabetes that showed that treatment with high-intensity atorvastatin was associated with significant reductions in major adverse cardiovascular events.

“Here they use non-HDL cholesterol as a target. The NICE guidelines are the only guidelines looking at non-HDL cholesterol; however, all guidelines suggest an LDL to be less than 70 in all people with diabetes, and for those with recent acute coronary syndromes, the latest evidence suggests the LDL should actually be less than 50,” said Dr. Deedwania, spokesperson for the AHA and ACC.

As far as which measure to use, he believes both are useful. “It’s six of one and half a dozen of the other, in my opinion. The societies have not recommended non-HDL cholesterol and it’s easier to stay with what is readily available for clinicians, and using LDL cholesterol is still okay. The results of this analysis are confirmatory, in that looking at non-HDL cholesterol gives results very similar to what these statins have shown for their effect on LDL cholesterol,” he said.
 

Non-HDL cholesterol a better marker?

For Robert Rosenson, MD, director of metabolism and lipids at Mount Sinai Health System and professor of medicine and cardiology at the Icahn School of Medicine at Mount Sinai, New York, non-HDL cholesterol is becoming an important marker of risk for several reasons.

“The focus on LDL cholesterol has been due to the causal relationship of LDL with atherosclerotic cardiovascular disease, but in the last few decades, non-HDL has emerged because more people are overweight, have insulin resistance, and have diabetes,” Dr. Rosenson told this news organization. “In those situations, the LDL cholesterol underrepresents the risk of the LDL particles. With insulin resistance, the particles become more triglycerides and less cholesterol, so on a per-particle basis, you need to get more LDL particles to get to a certain LDL cholesterol concentration.”

Non-HDL cholesterol testing does not require fasting, another advantage of using it to monitor cholesterol, he added.

What is often forgotten is that moderate- to high-intensity statins have very good triglyceride-lowering effects, Dr. Rosenson said.

“This article highlights that, by using higher doses, you get more triglyceride-lowering. Hopefully, this will get practitioners to recognize that non-HDL cholesterol is a better predictor of risk in people with diabetes,” he said.

The study was funded by the National Institute for Health Research. Dr. Hodkinson, Dr. Rosenson, and Dr. Deedwania report no relevant financial relationships.

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