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Motherhood can get old fast, and snubbing can become phubbing

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Changed
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Killer babies and their aging mommies

The joys of new parenthood are endless, like the long nights and functioning on 4 hours of sleep. But those babies sure are sweet, and deadly. That’s right, little Johnny junior is shaving years off of your life.

LWA/Dann Tardif/Getty Images

Investigators at the University of California, Los Angeles, found that new mothers who slept less than 7 hours a night 6 months after giving birth were, biologically, 3-7 years older than were those who slept 7 or more hours. But hold on, that doesn’t mean mothers need to update their driver licenses. There’s a difference between biological and chronological age.

Biological aging is measured by epigenetics, which analyzes changes in DNA over time by determining whether coding for certain proteins is turned on or off. The process acts as a sort of clock, lead author Judith E. Carroll, PhD, said in a separate statement, allowing scientists to estimate a person’s biological age.

Although loss of sleep may accelerate biological aging and increase health risks, the researchers don’t want people to think that lack of sleep during infant care is going to automatically cause permanent damage. The jury is still out on whether the effects are long lasting. Instead, they emphasized the importance of prioritizing sleep needs and getting some help from others to do it.

“With every hour of additional sleep, the mother’s biological age was younger,” Dr. Carroll said. “I, and many other sleep scientists, consider sleep health to be just as vital to overall health as diet and exercise.”

So, new moms, fix that gourmet dinner after you go for that run because you’re already up at 4 a.m. anyway. It’s all about balance.
 

Me and my phone-y phriends

It’s been months since you’ve seen your friends in person. You got your vaccine and so, after all this time, you can finally meet with your friends in real life. No more Zoom. It’s a strange dream come true.

nemke/E+

The problem is that half your friends barely seem interested, spending much of your time together staring at their phones. Naturally, there’s a clever term for this: You’ve just been the victim of phubbing, specifically friend phubbing or fphubbing (we’re not sure there are enough “f” sounds at the beginning of that word), and it’s been the focus of a new study from the University of Georgia.

So who are these fphubbers? Researchers found that neurotic and depressed individuals are more likely to fphub, as were those with social anxiety, since they may actually prefer online interaction over face-to-face conversation. On the flip side, people with agreeable traits were less likely to fphub, as they felt doing so would be rude and impolite. Quite a bold stance right there, we know.

The researchers noted the complete ordinariness of people pulling their phones out while with friends, and the rapid acceptance of something many people may still consider rude. It could speak to casual smartphone addiction and the urge we all get when we hear that notification in our pocket. Maybe what we need when we see friends is the equivalent of those PSAs before movies telling you to turn off your cell phones. Then you can all go down to the lobby and get yourselves a treat.
 

 

 

Who needs a vaccine when there’s horse paste?

It’s not the first time, and it won’t be the last, that some people think they know best when it comes to COVID-19 safety.

Mario Olaya/Pixabay

What is the newest “trend” for prevention and treatment? Enter, ivermectin, a Food and Drug Administration–approved drug for treating conditions caused by parasitic worms. The prescription form is hard to find these days, so some folks have been “raiding rural tractor supply stores in search of ivermectin horse paste (packed with ‘apple flavor’!) and [weighing] the benefits of taking ivermectin ‘sheep drench’,” according to the Daily Beast.

The FDA does not condone the use of ivermectin for COVID-19 and warns that the types meant for animals can be harmful to humans if taken in large doses. Facebook has played its part, as groups are forming to share conflicting information about how the drug can be used for COVID-19. The medication often comes from sketchy sources, and it’s seemingly causing more harm than good. Pharmacies are even starting to treat ivermectin as if it’s an opioid.

“My ‘horse’ had no negative side effects, and now he tells me he feels like a million bucks and is now COVID free,” one social media poster wrote in code, according to the Daily Beast.
 

When the card fits, COVID-19 will take a hit

Good news! We have figured out the problem behind the whole COVID-19 vaccine-denial business.

Richard Franki/MDedge

And by “we,” of course, we mean someone else. But we’re telling you about it, and isn’t that really the important part?

Anyway, back to the problem. It’s not the vaccines themselves, it’s the vaccine cards. They’re the wrong size.

The Atlantic’s Amanda Mull explains: “When I got my first shot, in late February, I sat in the mandatory waiting area, holding my new card in one hand and my wallet in the other, trying to understand why the two objects weren’t compatible.”

She didn’t get very far with the CDC, but Chelsea Cirruzzo, a public-health reporter at U.S. News & World Report who has been tweeting about the vaccine cards, suggested that “someone just printed out a bunch of cards that are easy to write your name and vaccine brand on, without thinking about wallets.”

The evidence does fit the nobody-really-gave-it-any-thought argument. The template was available to the public on some state government websites when the vaccine was approved and can still be found on Florida’s, Ms. Mull notes. “Try to imagine governments freely distributing their templates for driver’s licenses, passports, or other documents intended to certify a particular identity or status.” The FBI, we understand, frowns upon this sort of thing.

Well, there you have it, America. When the card fits in a wallet, the vaccine problem will go away. Just remember where you read it, not where we read it.

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Killer babies and their aging mommies

The joys of new parenthood are endless, like the long nights and functioning on 4 hours of sleep. But those babies sure are sweet, and deadly. That’s right, little Johnny junior is shaving years off of your life.

LWA/Dann Tardif/Getty Images

Investigators at the University of California, Los Angeles, found that new mothers who slept less than 7 hours a night 6 months after giving birth were, biologically, 3-7 years older than were those who slept 7 or more hours. But hold on, that doesn’t mean mothers need to update their driver licenses. There’s a difference between biological and chronological age.

Biological aging is measured by epigenetics, which analyzes changes in DNA over time by determining whether coding for certain proteins is turned on or off. The process acts as a sort of clock, lead author Judith E. Carroll, PhD, said in a separate statement, allowing scientists to estimate a person’s biological age.

Although loss of sleep may accelerate biological aging and increase health risks, the researchers don’t want people to think that lack of sleep during infant care is going to automatically cause permanent damage. The jury is still out on whether the effects are long lasting. Instead, they emphasized the importance of prioritizing sleep needs and getting some help from others to do it.

“With every hour of additional sleep, the mother’s biological age was younger,” Dr. Carroll said. “I, and many other sleep scientists, consider sleep health to be just as vital to overall health as diet and exercise.”

So, new moms, fix that gourmet dinner after you go for that run because you’re already up at 4 a.m. anyway. It’s all about balance.
 

Me and my phone-y phriends

It’s been months since you’ve seen your friends in person. You got your vaccine and so, after all this time, you can finally meet with your friends in real life. No more Zoom. It’s a strange dream come true.

nemke/E+

The problem is that half your friends barely seem interested, spending much of your time together staring at their phones. Naturally, there’s a clever term for this: You’ve just been the victim of phubbing, specifically friend phubbing or fphubbing (we’re not sure there are enough “f” sounds at the beginning of that word), and it’s been the focus of a new study from the University of Georgia.

So who are these fphubbers? Researchers found that neurotic and depressed individuals are more likely to fphub, as were those with social anxiety, since they may actually prefer online interaction over face-to-face conversation. On the flip side, people with agreeable traits were less likely to fphub, as they felt doing so would be rude and impolite. Quite a bold stance right there, we know.

The researchers noted the complete ordinariness of people pulling their phones out while with friends, and the rapid acceptance of something many people may still consider rude. It could speak to casual smartphone addiction and the urge we all get when we hear that notification in our pocket. Maybe what we need when we see friends is the equivalent of those PSAs before movies telling you to turn off your cell phones. Then you can all go down to the lobby and get yourselves a treat.
 

 

 

Who needs a vaccine when there’s horse paste?

It’s not the first time, and it won’t be the last, that some people think they know best when it comes to COVID-19 safety.

Mario Olaya/Pixabay

What is the newest “trend” for prevention and treatment? Enter, ivermectin, a Food and Drug Administration–approved drug for treating conditions caused by parasitic worms. The prescription form is hard to find these days, so some folks have been “raiding rural tractor supply stores in search of ivermectin horse paste (packed with ‘apple flavor’!) and [weighing] the benefits of taking ivermectin ‘sheep drench’,” according to the Daily Beast.

The FDA does not condone the use of ivermectin for COVID-19 and warns that the types meant for animals can be harmful to humans if taken in large doses. Facebook has played its part, as groups are forming to share conflicting information about how the drug can be used for COVID-19. The medication often comes from sketchy sources, and it’s seemingly causing more harm than good. Pharmacies are even starting to treat ivermectin as if it’s an opioid.

“My ‘horse’ had no negative side effects, and now he tells me he feels like a million bucks and is now COVID free,” one social media poster wrote in code, according to the Daily Beast.
 

When the card fits, COVID-19 will take a hit

Good news! We have figured out the problem behind the whole COVID-19 vaccine-denial business.

Richard Franki/MDedge

And by “we,” of course, we mean someone else. But we’re telling you about it, and isn’t that really the important part?

Anyway, back to the problem. It’s not the vaccines themselves, it’s the vaccine cards. They’re the wrong size.

The Atlantic’s Amanda Mull explains: “When I got my first shot, in late February, I sat in the mandatory waiting area, holding my new card in one hand and my wallet in the other, trying to understand why the two objects weren’t compatible.”

She didn’t get very far with the CDC, but Chelsea Cirruzzo, a public-health reporter at U.S. News & World Report who has been tweeting about the vaccine cards, suggested that “someone just printed out a bunch of cards that are easy to write your name and vaccine brand on, without thinking about wallets.”

The evidence does fit the nobody-really-gave-it-any-thought argument. The template was available to the public on some state government websites when the vaccine was approved and can still be found on Florida’s, Ms. Mull notes. “Try to imagine governments freely distributing their templates for driver’s licenses, passports, or other documents intended to certify a particular identity or status.” The FBI, we understand, frowns upon this sort of thing.

Well, there you have it, America. When the card fits in a wallet, the vaccine problem will go away. Just remember where you read it, not where we read it.

 

Killer babies and their aging mommies

The joys of new parenthood are endless, like the long nights and functioning on 4 hours of sleep. But those babies sure are sweet, and deadly. That’s right, little Johnny junior is shaving years off of your life.

LWA/Dann Tardif/Getty Images

Investigators at the University of California, Los Angeles, found that new mothers who slept less than 7 hours a night 6 months after giving birth were, biologically, 3-7 years older than were those who slept 7 or more hours. But hold on, that doesn’t mean mothers need to update their driver licenses. There’s a difference between biological and chronological age.

Biological aging is measured by epigenetics, which analyzes changes in DNA over time by determining whether coding for certain proteins is turned on or off. The process acts as a sort of clock, lead author Judith E. Carroll, PhD, said in a separate statement, allowing scientists to estimate a person’s biological age.

Although loss of sleep may accelerate biological aging and increase health risks, the researchers don’t want people to think that lack of sleep during infant care is going to automatically cause permanent damage. The jury is still out on whether the effects are long lasting. Instead, they emphasized the importance of prioritizing sleep needs and getting some help from others to do it.

“With every hour of additional sleep, the mother’s biological age was younger,” Dr. Carroll said. “I, and many other sleep scientists, consider sleep health to be just as vital to overall health as diet and exercise.”

So, new moms, fix that gourmet dinner after you go for that run because you’re already up at 4 a.m. anyway. It’s all about balance.
 

Me and my phone-y phriends

It’s been months since you’ve seen your friends in person. You got your vaccine and so, after all this time, you can finally meet with your friends in real life. No more Zoom. It’s a strange dream come true.

nemke/E+

The problem is that half your friends barely seem interested, spending much of your time together staring at their phones. Naturally, there’s a clever term for this: You’ve just been the victim of phubbing, specifically friend phubbing or fphubbing (we’re not sure there are enough “f” sounds at the beginning of that word), and it’s been the focus of a new study from the University of Georgia.

So who are these fphubbers? Researchers found that neurotic and depressed individuals are more likely to fphub, as were those with social anxiety, since they may actually prefer online interaction over face-to-face conversation. On the flip side, people with agreeable traits were less likely to fphub, as they felt doing so would be rude and impolite. Quite a bold stance right there, we know.

The researchers noted the complete ordinariness of people pulling their phones out while with friends, and the rapid acceptance of something many people may still consider rude. It could speak to casual smartphone addiction and the urge we all get when we hear that notification in our pocket. Maybe what we need when we see friends is the equivalent of those PSAs before movies telling you to turn off your cell phones. Then you can all go down to the lobby and get yourselves a treat.
 

 

 

Who needs a vaccine when there’s horse paste?

It’s not the first time, and it won’t be the last, that some people think they know best when it comes to COVID-19 safety.

Mario Olaya/Pixabay

What is the newest “trend” for prevention and treatment? Enter, ivermectin, a Food and Drug Administration–approved drug for treating conditions caused by parasitic worms. The prescription form is hard to find these days, so some folks have been “raiding rural tractor supply stores in search of ivermectin horse paste (packed with ‘apple flavor’!) and [weighing] the benefits of taking ivermectin ‘sheep drench’,” according to the Daily Beast.

The FDA does not condone the use of ivermectin for COVID-19 and warns that the types meant for animals can be harmful to humans if taken in large doses. Facebook has played its part, as groups are forming to share conflicting information about how the drug can be used for COVID-19. The medication often comes from sketchy sources, and it’s seemingly causing more harm than good. Pharmacies are even starting to treat ivermectin as if it’s an opioid.

“My ‘horse’ had no negative side effects, and now he tells me he feels like a million bucks and is now COVID free,” one social media poster wrote in code, according to the Daily Beast.
 

When the card fits, COVID-19 will take a hit

Good news! We have figured out the problem behind the whole COVID-19 vaccine-denial business.

Richard Franki/MDedge

And by “we,” of course, we mean someone else. But we’re telling you about it, and isn’t that really the important part?

Anyway, back to the problem. It’s not the vaccines themselves, it’s the vaccine cards. They’re the wrong size.

The Atlantic’s Amanda Mull explains: “When I got my first shot, in late February, I sat in the mandatory waiting area, holding my new card in one hand and my wallet in the other, trying to understand why the two objects weren’t compatible.”

She didn’t get very far with the CDC, but Chelsea Cirruzzo, a public-health reporter at U.S. News & World Report who has been tweeting about the vaccine cards, suggested that “someone just printed out a bunch of cards that are easy to write your name and vaccine brand on, without thinking about wallets.”

The evidence does fit the nobody-really-gave-it-any-thought argument. The template was available to the public on some state government websites when the vaccine was approved and can still be found on Florida’s, Ms. Mull notes. “Try to imagine governments freely distributing their templates for driver’s licenses, passports, or other documents intended to certify a particular identity or status.” The FBI, we understand, frowns upon this sort of thing.

Well, there you have it, America. When the card fits in a wallet, the vaccine problem will go away. Just remember where you read it, not where we read it.

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Why aren’t more women doctors in the top-paying specialties?

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Wed, 08/11/2021 - 15:15

Less than one in five women physicians are practicing in the top five high-paying specialties. Women compose only 6% of orthopedic surgeons, 8% of interventional cardiologists, 10% of urologists, 17% of plastic surgeons, and 18% of otolaryngologists, according to the 2020 Association of American Medical Colleges Physician Specialty Data Report.

Plastic surgeons earn an average of $526,000 annually, which is the highest-paying specialty. Otolaryngologists earn an average of $417,000 annually, and urologists earn $427,000, according to the Medscape Physician Compensation Report 2021: The Recovery Begins.

Yet, far more women are practicing in specialties that pay less. Women are the majority in pediatrics (64%), ob.gyn. (59%), internal medicine (53%), and endocrinology (51%), the AAMC data show. The exception is dermatology, which pays well and in which 51% are women. The annual average pay is $394,000.

Why are so many women avoiding the top-paying specialties?

Several physician researchers and leaders in the top-paying specialties point to four main factors: Women are attracted to specialties that have more women in faculty and leadership positions, women prioritize work-life balance over pay, women residents may be deterred from the high-paying specialties because of gender discrimination and sexual harassment, and the longer training periods for surgical specialties may be a deterrent for women who want to have children.
 

Lack of women leaders

The specialties with the most women tend to have the highest proportion of women in leadership positions. For example, obstetrics and gynecology had the highest proportion of women department chairs (24.1%) and vice chairs (38.8). Pediatrics had the highest proportion of women division directors (31.5%) and residency program directors (64.6%), a study shows.

Surgical specialties, on the other hand, may have a harder time attracting female residents, possibly because of a lack of women in leadership positions. A recent study that examined gender differences in attitudes toward surgery training found that women would be more likely to go into surgery if there were more surgical faculty and residents of their same gender.

An analysis of orthopedic residency programs shows that more trainees were drawn to programs that had more female faculty members, including associate professors and women in leadership positions.

Dr. Terri Malcolm

Terri Malcolm, MD, a board-certified ob.gyn. and CEO/founder of Master Physician Leaders, said women need to consider whether they want to be a trailblazer in a specialty that has fewer women. “What support systems are in place to accommodate your goals, whether it’s career advancement, having a family, or mentorship? Where can you show up as your whole self and be supported in that?”

Being the only woman in a residency program can be a challenge, said Dr. Malcolm. If the residents and attendings are predominantly men, for example, they may not think about creating a call schedule that takes into account maternity leave or the fact that women tend to be caretakers for their children and parents.

The study of gender differences toward surgery training shows that 75% of women, in comparison with 46% of men, would be more willing to enter surgery if maternity leave and childcare were made available to female residents and attending physicians.
 

 

 

Women want work-life balance

Although both men and women want families, women still shoulder more family and childcare responsibilities. That may explain why women physicians ranked work-life balance first and compensation second in the Medscape Women Physicians 2020 Report: The Issues They Care About.

“My physician colleagues have been and are supportive of intellectual abilities, but I feel they don’t fully understand the uneven distribution of childcare issues on women,” a woman dermatologist commented.

Dr. Julie Samora

Women may want to work fewer hours or have a more flexible schedule to take care of children. “I can count on one hand the number of women who have a part-time job in orthopedics. It’s very rare, and working part time absolutely is a barrier for someone who wants to be a surgeon,” said Julie Samora, MD, PhD, a researcher and pediatric hand surgeon at Nationwide Children’s Hospital, in Columbus, Ohio. She is also a spokesperson for the American Association of Orthopedic Surgeons.

Preeti Malani, MD, a professor of medicine who specializes in infectious diseases at the University of Michigan, chose to work full-time in academia while raising two children with her husband. In a decade, she rose through the ranks to full professor. “I took the advice of a woman who wanted to recruit me to have a full-time position with maximum flexibility rather than work part time, often for more hours and less pay. I also have tried to build my career so I was not doing all clinical work.”

Her husband is a surgeon at the University of Michigan. His schedule was not flexible, and he was unable to take on family responsibilities, said Dr. Malani. “I knew someone had to be able to grab the kids from daycare or pick them up at school if they were sick.” She also took work home and worked weekends.

Young women physicians in particular are thinking about combining parenting with work – in the Medscape report, that issue ranked third among the issues women care about. Seeing other women doctors navigate that in their particular specialty can have a positive impact.

“When I chose adolescent medicine, I remember working with a doctor in this field who talked about how much she enjoyed raising her kids even as teenagers and how much she was enjoying them as young adults. She seemed so balanced and happy in her family, and it gave me a nice feeling about the field,” said Nancy Dodson, MD, MPH, a pediatrician specializing in adolescent medicine at Pediatrics on Hudson in New York.

Rachel Zhuk, MD, a reproductive psychiatrist in New York, took a break after medical school to spend time with her newborn son. She met a woman who was also a young parent and a psychiatrist. “We were both figuring out parenting together – it was like looking into my future.” That friendship and her desire to have more time with patients influenced her decision to pursue psychiatry instead of internal medicine.
 

 

 

Discrimination and harassment influence specialty choice

Women doctors in the top-paying surgical and other specialties have reported experiencing more discrimination and harassment than men.

Of 927 orthopedic surgeons who responded to an AAOS survey, 66% said they experienced gender discrimination, bullying, sexual harassment, or harassment in the health care workplace. More than twice as many women (81%) experienced these behaviors as men (35%).

“This study shows that women in orthopedic surgery disproportionately experience these negative behaviors, and only a handful of institutions in the United States provide any type of training to prevent them,” said Dr. Samora, the lead author of the AAOS report.

Radiology is another male-dominated field – women represent 26% of all radiologists, the 2020 AAMC specialty report shows. A systematic review shows that 40% of women radiologists experienced gender discrimination at work, compared with 1% of men, and that 47% of women experienced sexual harassment.

Female trainees in surgery have also reported disproportionate rates of discrimination and harassment. Female general surgical residents have experienced more gender discrimination than male residents (65.1% vs. 10.0%) and more sexual harassment than male residents (19.9% vs. 3.9), a national survey indicates.

When medical students are exposed to these behaviors through personal experience, witnessing, or hearing about them, it can affect which specialty they choose. A survey of fourth-year medical students shows that far more women than men reported that exposure to gender discrimination and sexual harassment influenced their specialty choices (45.3% vs. 16.4%) and residency rankings (25.3% vs. 10.9%). Women who chose general surgery were the most likely to experience gender discrimination and sexual harassment during residency selection; women who chose psychiatry were the least likely to experience such behaviors, the report shows.

“If young trainees witness such behaviors in a specific field, they would naturally migrate toward a different specialty,” said Dr. Samora.

Trainees can also be put off by residency directors asking them inappropriate questions. Of nearly 500 female orthopedic surgeons surveyed, 62% reported that they were asked inappropriate questions during their residency interviews. “Inappropriate questions and comments directed toward women during residency interviews are clearly not conducive to women entering the field,” the authors stated. They found that little changed during the study period from 1971 to 2015.

The most frequent inappropriate questions concerned whether the prospective residents would be getting pregnant or raising children during residency and their marital status. One female orthopedic surgeon reported: “I was asked if I have children and was told that it would be too difficult to complete an orthopedic residency with children.”

The interviewers also made frequent comments about the inferiority of women to men. For example, “I was told by one program interviewer that ‘I don’t have a bias about women in medicine, I have a bias about women in orthopedic surgery,’ ” another female orthopedic surgeon commented.
 

Longer training

Residency training for the top-paying surgical specialties, including orthopedic surgery, plastic surgery, and otolaryngology, lasts 5-6 years. This compares with 3-4 years for the lower-paying specialties, such as pediatrics, internal medicine, and ob.gyn., according to data from the American Medical Association.

Women doctors are in their prime childbearing years during residency. Women who want to start a family will consider whether they want to get pregnant during residency or wait until they finish their training, said Dr. Malcolm.

The vast majority (84%) of 190 female orthopedic surgery trainees who responded to a survey indicated that they did not have children or were pregnant during residency. Nearly half (48%) reported that they had postponed having children because they were in training.

“The longer training is definitely a concerning issue for women of childbearing age. Many professional women are waiting to have children, for multiple reasons, but one major fear is the stigma due to taking time off from work obligations. There is a risk of irritating your peers because they may have to take on more work and cover more calls for you during your absence,” said Dr. Samora.

That fear is not unfounded. At least half of the 190 female orthopedic residents reported that they encountered bias against becoming pregnant during training from both coresidents (60%) and attendings (50%), according to the study.

Another recent survey suggests that pregnant surgical residents face several barriers during their training, including a lack of salary for extended family leave, resentment from fellow residents who need to cover for them during maternity leave, and a lack of formal lactation policies.

A few policy changes by national board organizations, including those in the surgical specialties, may make life a little easier for female trainees to have children, suggested Dr. Samora.

Residents and fellows are now allowed a minimum of 6 weeks away for medical leave or caregiving once during training, without having to use vacation or sick leave and without having to extend their training, the American Board of Medical Specialties has announced.

In addition, the American Board of Orthopaedic Surgery and the American Board of Surgery have enacted policies that allow lactating women to take a break to pump during their board exams.

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

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Less than one in five women physicians are practicing in the top five high-paying specialties. Women compose only 6% of orthopedic surgeons, 8% of interventional cardiologists, 10% of urologists, 17% of plastic surgeons, and 18% of otolaryngologists, according to the 2020 Association of American Medical Colleges Physician Specialty Data Report.

Plastic surgeons earn an average of $526,000 annually, which is the highest-paying specialty. Otolaryngologists earn an average of $417,000 annually, and urologists earn $427,000, according to the Medscape Physician Compensation Report 2021: The Recovery Begins.

Yet, far more women are practicing in specialties that pay less. Women are the majority in pediatrics (64%), ob.gyn. (59%), internal medicine (53%), and endocrinology (51%), the AAMC data show. The exception is dermatology, which pays well and in which 51% are women. The annual average pay is $394,000.

Why are so many women avoiding the top-paying specialties?

Several physician researchers and leaders in the top-paying specialties point to four main factors: Women are attracted to specialties that have more women in faculty and leadership positions, women prioritize work-life balance over pay, women residents may be deterred from the high-paying specialties because of gender discrimination and sexual harassment, and the longer training periods for surgical specialties may be a deterrent for women who want to have children.
 

Lack of women leaders

The specialties with the most women tend to have the highest proportion of women in leadership positions. For example, obstetrics and gynecology had the highest proportion of women department chairs (24.1%) and vice chairs (38.8). Pediatrics had the highest proportion of women division directors (31.5%) and residency program directors (64.6%), a study shows.

Surgical specialties, on the other hand, may have a harder time attracting female residents, possibly because of a lack of women in leadership positions. A recent study that examined gender differences in attitudes toward surgery training found that women would be more likely to go into surgery if there were more surgical faculty and residents of their same gender.

An analysis of orthopedic residency programs shows that more trainees were drawn to programs that had more female faculty members, including associate professors and women in leadership positions.

Dr. Terri Malcolm

Terri Malcolm, MD, a board-certified ob.gyn. and CEO/founder of Master Physician Leaders, said women need to consider whether they want to be a trailblazer in a specialty that has fewer women. “What support systems are in place to accommodate your goals, whether it’s career advancement, having a family, or mentorship? Where can you show up as your whole self and be supported in that?”

Being the only woman in a residency program can be a challenge, said Dr. Malcolm. If the residents and attendings are predominantly men, for example, they may not think about creating a call schedule that takes into account maternity leave or the fact that women tend to be caretakers for their children and parents.

The study of gender differences toward surgery training shows that 75% of women, in comparison with 46% of men, would be more willing to enter surgery if maternity leave and childcare were made available to female residents and attending physicians.
 

 

 

Women want work-life balance

Although both men and women want families, women still shoulder more family and childcare responsibilities. That may explain why women physicians ranked work-life balance first and compensation second in the Medscape Women Physicians 2020 Report: The Issues They Care About.

“My physician colleagues have been and are supportive of intellectual abilities, but I feel they don’t fully understand the uneven distribution of childcare issues on women,” a woman dermatologist commented.

Dr. Julie Samora

Women may want to work fewer hours or have a more flexible schedule to take care of children. “I can count on one hand the number of women who have a part-time job in orthopedics. It’s very rare, and working part time absolutely is a barrier for someone who wants to be a surgeon,” said Julie Samora, MD, PhD, a researcher and pediatric hand surgeon at Nationwide Children’s Hospital, in Columbus, Ohio. She is also a spokesperson for the American Association of Orthopedic Surgeons.

Preeti Malani, MD, a professor of medicine who specializes in infectious diseases at the University of Michigan, chose to work full-time in academia while raising two children with her husband. In a decade, she rose through the ranks to full professor. “I took the advice of a woman who wanted to recruit me to have a full-time position with maximum flexibility rather than work part time, often for more hours and less pay. I also have tried to build my career so I was not doing all clinical work.”

Her husband is a surgeon at the University of Michigan. His schedule was not flexible, and he was unable to take on family responsibilities, said Dr. Malani. “I knew someone had to be able to grab the kids from daycare or pick them up at school if they were sick.” She also took work home and worked weekends.

Young women physicians in particular are thinking about combining parenting with work – in the Medscape report, that issue ranked third among the issues women care about. Seeing other women doctors navigate that in their particular specialty can have a positive impact.

“When I chose adolescent medicine, I remember working with a doctor in this field who talked about how much she enjoyed raising her kids even as teenagers and how much she was enjoying them as young adults. She seemed so balanced and happy in her family, and it gave me a nice feeling about the field,” said Nancy Dodson, MD, MPH, a pediatrician specializing in adolescent medicine at Pediatrics on Hudson in New York.

Rachel Zhuk, MD, a reproductive psychiatrist in New York, took a break after medical school to spend time with her newborn son. She met a woman who was also a young parent and a psychiatrist. “We were both figuring out parenting together – it was like looking into my future.” That friendship and her desire to have more time with patients influenced her decision to pursue psychiatry instead of internal medicine.
 

 

 

Discrimination and harassment influence specialty choice

Women doctors in the top-paying surgical and other specialties have reported experiencing more discrimination and harassment than men.

Of 927 orthopedic surgeons who responded to an AAOS survey, 66% said they experienced gender discrimination, bullying, sexual harassment, or harassment in the health care workplace. More than twice as many women (81%) experienced these behaviors as men (35%).

“This study shows that women in orthopedic surgery disproportionately experience these negative behaviors, and only a handful of institutions in the United States provide any type of training to prevent them,” said Dr. Samora, the lead author of the AAOS report.

Radiology is another male-dominated field – women represent 26% of all radiologists, the 2020 AAMC specialty report shows. A systematic review shows that 40% of women radiologists experienced gender discrimination at work, compared with 1% of men, and that 47% of women experienced sexual harassment.

Female trainees in surgery have also reported disproportionate rates of discrimination and harassment. Female general surgical residents have experienced more gender discrimination than male residents (65.1% vs. 10.0%) and more sexual harassment than male residents (19.9% vs. 3.9), a national survey indicates.

When medical students are exposed to these behaviors through personal experience, witnessing, or hearing about them, it can affect which specialty they choose. A survey of fourth-year medical students shows that far more women than men reported that exposure to gender discrimination and sexual harassment influenced their specialty choices (45.3% vs. 16.4%) and residency rankings (25.3% vs. 10.9%). Women who chose general surgery were the most likely to experience gender discrimination and sexual harassment during residency selection; women who chose psychiatry were the least likely to experience such behaviors, the report shows.

“If young trainees witness such behaviors in a specific field, they would naturally migrate toward a different specialty,” said Dr. Samora.

Trainees can also be put off by residency directors asking them inappropriate questions. Of nearly 500 female orthopedic surgeons surveyed, 62% reported that they were asked inappropriate questions during their residency interviews. “Inappropriate questions and comments directed toward women during residency interviews are clearly not conducive to women entering the field,” the authors stated. They found that little changed during the study period from 1971 to 2015.

The most frequent inappropriate questions concerned whether the prospective residents would be getting pregnant or raising children during residency and their marital status. One female orthopedic surgeon reported: “I was asked if I have children and was told that it would be too difficult to complete an orthopedic residency with children.”

The interviewers also made frequent comments about the inferiority of women to men. For example, “I was told by one program interviewer that ‘I don’t have a bias about women in medicine, I have a bias about women in orthopedic surgery,’ ” another female orthopedic surgeon commented.
 

Longer training

Residency training for the top-paying surgical specialties, including orthopedic surgery, plastic surgery, and otolaryngology, lasts 5-6 years. This compares with 3-4 years for the lower-paying specialties, such as pediatrics, internal medicine, and ob.gyn., according to data from the American Medical Association.

Women doctors are in their prime childbearing years during residency. Women who want to start a family will consider whether they want to get pregnant during residency or wait until they finish their training, said Dr. Malcolm.

The vast majority (84%) of 190 female orthopedic surgery trainees who responded to a survey indicated that they did not have children or were pregnant during residency. Nearly half (48%) reported that they had postponed having children because they were in training.

“The longer training is definitely a concerning issue for women of childbearing age. Many professional women are waiting to have children, for multiple reasons, but one major fear is the stigma due to taking time off from work obligations. There is a risk of irritating your peers because they may have to take on more work and cover more calls for you during your absence,” said Dr. Samora.

That fear is not unfounded. At least half of the 190 female orthopedic residents reported that they encountered bias against becoming pregnant during training from both coresidents (60%) and attendings (50%), according to the study.

Another recent survey suggests that pregnant surgical residents face several barriers during their training, including a lack of salary for extended family leave, resentment from fellow residents who need to cover for them during maternity leave, and a lack of formal lactation policies.

A few policy changes by national board organizations, including those in the surgical specialties, may make life a little easier for female trainees to have children, suggested Dr. Samora.

Residents and fellows are now allowed a minimum of 6 weeks away for medical leave or caregiving once during training, without having to use vacation or sick leave and without having to extend their training, the American Board of Medical Specialties has announced.

In addition, the American Board of Orthopaedic Surgery and the American Board of Surgery have enacted policies that allow lactating women to take a break to pump during their board exams.

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

Less than one in five women physicians are practicing in the top five high-paying specialties. Women compose only 6% of orthopedic surgeons, 8% of interventional cardiologists, 10% of urologists, 17% of plastic surgeons, and 18% of otolaryngologists, according to the 2020 Association of American Medical Colleges Physician Specialty Data Report.

Plastic surgeons earn an average of $526,000 annually, which is the highest-paying specialty. Otolaryngologists earn an average of $417,000 annually, and urologists earn $427,000, according to the Medscape Physician Compensation Report 2021: The Recovery Begins.

Yet, far more women are practicing in specialties that pay less. Women are the majority in pediatrics (64%), ob.gyn. (59%), internal medicine (53%), and endocrinology (51%), the AAMC data show. The exception is dermatology, which pays well and in which 51% are women. The annual average pay is $394,000.

Why are so many women avoiding the top-paying specialties?

Several physician researchers and leaders in the top-paying specialties point to four main factors: Women are attracted to specialties that have more women in faculty and leadership positions, women prioritize work-life balance over pay, women residents may be deterred from the high-paying specialties because of gender discrimination and sexual harassment, and the longer training periods for surgical specialties may be a deterrent for women who want to have children.
 

Lack of women leaders

The specialties with the most women tend to have the highest proportion of women in leadership positions. For example, obstetrics and gynecology had the highest proportion of women department chairs (24.1%) and vice chairs (38.8). Pediatrics had the highest proportion of women division directors (31.5%) and residency program directors (64.6%), a study shows.

Surgical specialties, on the other hand, may have a harder time attracting female residents, possibly because of a lack of women in leadership positions. A recent study that examined gender differences in attitudes toward surgery training found that women would be more likely to go into surgery if there were more surgical faculty and residents of their same gender.

An analysis of orthopedic residency programs shows that more trainees were drawn to programs that had more female faculty members, including associate professors and women in leadership positions.

Dr. Terri Malcolm

Terri Malcolm, MD, a board-certified ob.gyn. and CEO/founder of Master Physician Leaders, said women need to consider whether they want to be a trailblazer in a specialty that has fewer women. “What support systems are in place to accommodate your goals, whether it’s career advancement, having a family, or mentorship? Where can you show up as your whole self and be supported in that?”

Being the only woman in a residency program can be a challenge, said Dr. Malcolm. If the residents and attendings are predominantly men, for example, they may not think about creating a call schedule that takes into account maternity leave or the fact that women tend to be caretakers for their children and parents.

The study of gender differences toward surgery training shows that 75% of women, in comparison with 46% of men, would be more willing to enter surgery if maternity leave and childcare were made available to female residents and attending physicians.
 

 

 

Women want work-life balance

Although both men and women want families, women still shoulder more family and childcare responsibilities. That may explain why women physicians ranked work-life balance first and compensation second in the Medscape Women Physicians 2020 Report: The Issues They Care About.

“My physician colleagues have been and are supportive of intellectual abilities, but I feel they don’t fully understand the uneven distribution of childcare issues on women,” a woman dermatologist commented.

Dr. Julie Samora

Women may want to work fewer hours or have a more flexible schedule to take care of children. “I can count on one hand the number of women who have a part-time job in orthopedics. It’s very rare, and working part time absolutely is a barrier for someone who wants to be a surgeon,” said Julie Samora, MD, PhD, a researcher and pediatric hand surgeon at Nationwide Children’s Hospital, in Columbus, Ohio. She is also a spokesperson for the American Association of Orthopedic Surgeons.

Preeti Malani, MD, a professor of medicine who specializes in infectious diseases at the University of Michigan, chose to work full-time in academia while raising two children with her husband. In a decade, she rose through the ranks to full professor. “I took the advice of a woman who wanted to recruit me to have a full-time position with maximum flexibility rather than work part time, often for more hours and less pay. I also have tried to build my career so I was not doing all clinical work.”

Her husband is a surgeon at the University of Michigan. His schedule was not flexible, and he was unable to take on family responsibilities, said Dr. Malani. “I knew someone had to be able to grab the kids from daycare or pick them up at school if they were sick.” She also took work home and worked weekends.

Young women physicians in particular are thinking about combining parenting with work – in the Medscape report, that issue ranked third among the issues women care about. Seeing other women doctors navigate that in their particular specialty can have a positive impact.

“When I chose adolescent medicine, I remember working with a doctor in this field who talked about how much she enjoyed raising her kids even as teenagers and how much she was enjoying them as young adults. She seemed so balanced and happy in her family, and it gave me a nice feeling about the field,” said Nancy Dodson, MD, MPH, a pediatrician specializing in adolescent medicine at Pediatrics on Hudson in New York.

Rachel Zhuk, MD, a reproductive psychiatrist in New York, took a break after medical school to spend time with her newborn son. She met a woman who was also a young parent and a psychiatrist. “We were both figuring out parenting together – it was like looking into my future.” That friendship and her desire to have more time with patients influenced her decision to pursue psychiatry instead of internal medicine.
 

 

 

Discrimination and harassment influence specialty choice

Women doctors in the top-paying surgical and other specialties have reported experiencing more discrimination and harassment than men.

Of 927 orthopedic surgeons who responded to an AAOS survey, 66% said they experienced gender discrimination, bullying, sexual harassment, or harassment in the health care workplace. More than twice as many women (81%) experienced these behaviors as men (35%).

“This study shows that women in orthopedic surgery disproportionately experience these negative behaviors, and only a handful of institutions in the United States provide any type of training to prevent them,” said Dr. Samora, the lead author of the AAOS report.

Radiology is another male-dominated field – women represent 26% of all radiologists, the 2020 AAMC specialty report shows. A systematic review shows that 40% of women radiologists experienced gender discrimination at work, compared with 1% of men, and that 47% of women experienced sexual harassment.

Female trainees in surgery have also reported disproportionate rates of discrimination and harassment. Female general surgical residents have experienced more gender discrimination than male residents (65.1% vs. 10.0%) and more sexual harassment than male residents (19.9% vs. 3.9), a national survey indicates.

When medical students are exposed to these behaviors through personal experience, witnessing, or hearing about them, it can affect which specialty they choose. A survey of fourth-year medical students shows that far more women than men reported that exposure to gender discrimination and sexual harassment influenced their specialty choices (45.3% vs. 16.4%) and residency rankings (25.3% vs. 10.9%). Women who chose general surgery were the most likely to experience gender discrimination and sexual harassment during residency selection; women who chose psychiatry were the least likely to experience such behaviors, the report shows.

“If young trainees witness such behaviors in a specific field, they would naturally migrate toward a different specialty,” said Dr. Samora.

Trainees can also be put off by residency directors asking them inappropriate questions. Of nearly 500 female orthopedic surgeons surveyed, 62% reported that they were asked inappropriate questions during their residency interviews. “Inappropriate questions and comments directed toward women during residency interviews are clearly not conducive to women entering the field,” the authors stated. They found that little changed during the study period from 1971 to 2015.

The most frequent inappropriate questions concerned whether the prospective residents would be getting pregnant or raising children during residency and their marital status. One female orthopedic surgeon reported: “I was asked if I have children and was told that it would be too difficult to complete an orthopedic residency with children.”

The interviewers also made frequent comments about the inferiority of women to men. For example, “I was told by one program interviewer that ‘I don’t have a bias about women in medicine, I have a bias about women in orthopedic surgery,’ ” another female orthopedic surgeon commented.
 

Longer training

Residency training for the top-paying surgical specialties, including orthopedic surgery, plastic surgery, and otolaryngology, lasts 5-6 years. This compares with 3-4 years for the lower-paying specialties, such as pediatrics, internal medicine, and ob.gyn., according to data from the American Medical Association.

Women doctors are in their prime childbearing years during residency. Women who want to start a family will consider whether they want to get pregnant during residency or wait until they finish their training, said Dr. Malcolm.

The vast majority (84%) of 190 female orthopedic surgery trainees who responded to a survey indicated that they did not have children or were pregnant during residency. Nearly half (48%) reported that they had postponed having children because they were in training.

“The longer training is definitely a concerning issue for women of childbearing age. Many professional women are waiting to have children, for multiple reasons, but one major fear is the stigma due to taking time off from work obligations. There is a risk of irritating your peers because they may have to take on more work and cover more calls for you during your absence,” said Dr. Samora.

That fear is not unfounded. At least half of the 190 female orthopedic residents reported that they encountered bias against becoming pregnant during training from both coresidents (60%) and attendings (50%), according to the study.

Another recent survey suggests that pregnant surgical residents face several barriers during their training, including a lack of salary for extended family leave, resentment from fellow residents who need to cover for them during maternity leave, and a lack of formal lactation policies.

A few policy changes by national board organizations, including those in the surgical specialties, may make life a little easier for female trainees to have children, suggested Dr. Samora.

Residents and fellows are now allowed a minimum of 6 weeks away for medical leave or caregiving once during training, without having to use vacation or sick leave and without having to extend their training, the American Board of Medical Specialties has announced.

In addition, the American Board of Orthopaedic Surgery and the American Board of Surgery have enacted policies that allow lactating women to take a break to pump during their board exams.

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

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Tirzepatide questions persist despite serial phase 3 success in type 2 diabetes

Article Type
Changed
Tue, 05/03/2022 - 15:04

The streak of positive phase 3 trial results for the novel “twincretin” tirzepatide when treating patients with type 2 diabetes continued in a report in The Lancet on results from the SURPASS-3 trial, which compared weekly subcutaneous injections of tirzepatide against daily treatment with insulin degludec in patients inadequately controlled on metformin alone or on metformin plus a sodium-glucose cotransporter 2 inhibitor.

Despite positive results in SURPASS-3, as well as in four other pivotal trials that are in the process of releasing full results, the safety and efficacy picture of tirzepatide still includes several as-yet unresolved issues, including the true incidence rate of gastrointestinal adverse effects, the role these effects play in weight loss during tirzepatide treatment, and the drug’s effect on important endpoints beyond weight loss and glycemic control such as cardiovascular outcomes and renal function, said two Australian experts who coauthored a comment on the new SURPASS-3 report.



Tirzepatide is called a “twincretin” because the molecule acts as both a glucagonlike peptide–1 receptor agonist, the drug class that includes semaglutide (Ozempic, Rybelsus, Wegovy) and liraglutide (Saxenda, Victoza), and also as a glucose-dependent insulinotropic polypeptide (GIP). Trial results reported to date suggest that tirzepatide “might be more potent than available GLP-1 receptor agonists,” based on evidence of superior glycemic control it produced relative to semaglutide in results from the SURPASS-2 phase 3 trial reported in August 2021, wrote Christopher K. Rayner, MD, and Michael Horowitz, MD, in their comment.

Uncertainty about gastrointestinal adverse effects

“Limitations of SURPASS-3 include the relatively small number of Asian and Black” patients enrolled, “and an open-label design that carries a risk for bias” when tallying the incidence of gastrointestinal adverse effects, which the trial recorded based on self-reports by enrolled patients.

A better design would use validated questionnaires geared to discerning gastrointestinal symptoms like the ones used in trials involving patients with functional gastrointestinal disorders, wrote Dr. Rayner, a professor of gastroenterology at the University of Adelaide, and Dr. Horowitz, a professor at the same institution and also director of the endocrine and metabolic unit at Royal Adelaide Hospital.

This approach would “allow for more robust evaluation of whether gastrointestinal symptoms are associated with increased weight loss,” they proposed, a possible partial explanation for the weight loss of some patients treated with a GLP-1 receptor agonist.

Additional outstanding questions about tirzepatide include the contribution resulting from the drug’s stimulation of the GIP receptor, as well as the role of GLP-1 receptor stimulation by tirzepatide in slowing gastric emptying. And they also cite the still-unreported effects of tirzepatide on cardiovascular events, fatty liver disease, and kidney function, and its longer-term effects with chronic treatment beyond a year.

All five of the recently completed SURPASS trials ran for 40-52 weeks.



Tirzepatide surpasses insulin degludec’s glycemic control

SURPASS-3 enrolled 1,444 patients with type 2 diabetes at 122 sites in 13 countries during 2019. The study’s primary endpoint was mean change in hemoglobin A1c from baseline after 52 weeks on treatment. The results showed that the A1c reduction with tirzepatide treatment significantly exceeded the drop produced by insulin degludec by 0.59%, 0.86%, and 1.04%, respectively, across the three tirzepatide dosages tested in a dose-response fashion, according to the recent publication.

The most common treatment-emergent adverse effects were gastrointestinal, which decreased with continued treatment, and tirzepatide produced fewer episodes of hypoglycemia, compared with insulin degludec (Tresiba).



In addition to full reports now out from SURPASS-2 and SURPASS-3, researchers also recently published full primary results from SURPASS-1. Results from SURPASS-5 appeared in a poster presented at the American Diabetes Association scientific sessions in June 2021 but have not yet been published in a full report, and the primary results from SURPASS-4are expected in a report during the European Association for the Study of Diabetes in September 2021.

SURPASS-3 and the other trials of tirzepatide were funded by Lilly, the company developing the drug. Dr. Rayner has been an adviser to Allergen and Glyscend, and has received research funding from Sanofi and Novartis. Dr. Horowitz has received symposia fees from Lilly, as well as from AstraZeneca and Boehringer Ingelheim.

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The streak of positive phase 3 trial results for the novel “twincretin” tirzepatide when treating patients with type 2 diabetes continued in a report in The Lancet on results from the SURPASS-3 trial, which compared weekly subcutaneous injections of tirzepatide against daily treatment with insulin degludec in patients inadequately controlled on metformin alone or on metformin plus a sodium-glucose cotransporter 2 inhibitor.

Despite positive results in SURPASS-3, as well as in four other pivotal trials that are in the process of releasing full results, the safety and efficacy picture of tirzepatide still includes several as-yet unresolved issues, including the true incidence rate of gastrointestinal adverse effects, the role these effects play in weight loss during tirzepatide treatment, and the drug’s effect on important endpoints beyond weight loss and glycemic control such as cardiovascular outcomes and renal function, said two Australian experts who coauthored a comment on the new SURPASS-3 report.



Tirzepatide is called a “twincretin” because the molecule acts as both a glucagonlike peptide–1 receptor agonist, the drug class that includes semaglutide (Ozempic, Rybelsus, Wegovy) and liraglutide (Saxenda, Victoza), and also as a glucose-dependent insulinotropic polypeptide (GIP). Trial results reported to date suggest that tirzepatide “might be more potent than available GLP-1 receptor agonists,” based on evidence of superior glycemic control it produced relative to semaglutide in results from the SURPASS-2 phase 3 trial reported in August 2021, wrote Christopher K. Rayner, MD, and Michael Horowitz, MD, in their comment.

Uncertainty about gastrointestinal adverse effects

“Limitations of SURPASS-3 include the relatively small number of Asian and Black” patients enrolled, “and an open-label design that carries a risk for bias” when tallying the incidence of gastrointestinal adverse effects, which the trial recorded based on self-reports by enrolled patients.

A better design would use validated questionnaires geared to discerning gastrointestinal symptoms like the ones used in trials involving patients with functional gastrointestinal disorders, wrote Dr. Rayner, a professor of gastroenterology at the University of Adelaide, and Dr. Horowitz, a professor at the same institution and also director of the endocrine and metabolic unit at Royal Adelaide Hospital.

This approach would “allow for more robust evaluation of whether gastrointestinal symptoms are associated with increased weight loss,” they proposed, a possible partial explanation for the weight loss of some patients treated with a GLP-1 receptor agonist.

Additional outstanding questions about tirzepatide include the contribution resulting from the drug’s stimulation of the GIP receptor, as well as the role of GLP-1 receptor stimulation by tirzepatide in slowing gastric emptying. And they also cite the still-unreported effects of tirzepatide on cardiovascular events, fatty liver disease, and kidney function, and its longer-term effects with chronic treatment beyond a year.

All five of the recently completed SURPASS trials ran for 40-52 weeks.



Tirzepatide surpasses insulin degludec’s glycemic control

SURPASS-3 enrolled 1,444 patients with type 2 diabetes at 122 sites in 13 countries during 2019. The study’s primary endpoint was mean change in hemoglobin A1c from baseline after 52 weeks on treatment. The results showed that the A1c reduction with tirzepatide treatment significantly exceeded the drop produced by insulin degludec by 0.59%, 0.86%, and 1.04%, respectively, across the three tirzepatide dosages tested in a dose-response fashion, according to the recent publication.

The most common treatment-emergent adverse effects were gastrointestinal, which decreased with continued treatment, and tirzepatide produced fewer episodes of hypoglycemia, compared with insulin degludec (Tresiba).



In addition to full reports now out from SURPASS-2 and SURPASS-3, researchers also recently published full primary results from SURPASS-1. Results from SURPASS-5 appeared in a poster presented at the American Diabetes Association scientific sessions in June 2021 but have not yet been published in a full report, and the primary results from SURPASS-4are expected in a report during the European Association for the Study of Diabetes in September 2021.

SURPASS-3 and the other trials of tirzepatide were funded by Lilly, the company developing the drug. Dr. Rayner has been an adviser to Allergen and Glyscend, and has received research funding from Sanofi and Novartis. Dr. Horowitz has received symposia fees from Lilly, as well as from AstraZeneca and Boehringer Ingelheim.

The streak of positive phase 3 trial results for the novel “twincretin” tirzepatide when treating patients with type 2 diabetes continued in a report in The Lancet on results from the SURPASS-3 trial, which compared weekly subcutaneous injections of tirzepatide against daily treatment with insulin degludec in patients inadequately controlled on metformin alone or on metformin plus a sodium-glucose cotransporter 2 inhibitor.

Despite positive results in SURPASS-3, as well as in four other pivotal trials that are in the process of releasing full results, the safety and efficacy picture of tirzepatide still includes several as-yet unresolved issues, including the true incidence rate of gastrointestinal adverse effects, the role these effects play in weight loss during tirzepatide treatment, and the drug’s effect on important endpoints beyond weight loss and glycemic control such as cardiovascular outcomes and renal function, said two Australian experts who coauthored a comment on the new SURPASS-3 report.



Tirzepatide is called a “twincretin” because the molecule acts as both a glucagonlike peptide–1 receptor agonist, the drug class that includes semaglutide (Ozempic, Rybelsus, Wegovy) and liraglutide (Saxenda, Victoza), and also as a glucose-dependent insulinotropic polypeptide (GIP). Trial results reported to date suggest that tirzepatide “might be more potent than available GLP-1 receptor agonists,” based on evidence of superior glycemic control it produced relative to semaglutide in results from the SURPASS-2 phase 3 trial reported in August 2021, wrote Christopher K. Rayner, MD, and Michael Horowitz, MD, in their comment.

Uncertainty about gastrointestinal adverse effects

“Limitations of SURPASS-3 include the relatively small number of Asian and Black” patients enrolled, “and an open-label design that carries a risk for bias” when tallying the incidence of gastrointestinal adverse effects, which the trial recorded based on self-reports by enrolled patients.

A better design would use validated questionnaires geared to discerning gastrointestinal symptoms like the ones used in trials involving patients with functional gastrointestinal disorders, wrote Dr. Rayner, a professor of gastroenterology at the University of Adelaide, and Dr. Horowitz, a professor at the same institution and also director of the endocrine and metabolic unit at Royal Adelaide Hospital.

This approach would “allow for more robust evaluation of whether gastrointestinal symptoms are associated with increased weight loss,” they proposed, a possible partial explanation for the weight loss of some patients treated with a GLP-1 receptor agonist.

Additional outstanding questions about tirzepatide include the contribution resulting from the drug’s stimulation of the GIP receptor, as well as the role of GLP-1 receptor stimulation by tirzepatide in slowing gastric emptying. And they also cite the still-unreported effects of tirzepatide on cardiovascular events, fatty liver disease, and kidney function, and its longer-term effects with chronic treatment beyond a year.

All five of the recently completed SURPASS trials ran for 40-52 weeks.



Tirzepatide surpasses insulin degludec’s glycemic control

SURPASS-3 enrolled 1,444 patients with type 2 diabetes at 122 sites in 13 countries during 2019. The study’s primary endpoint was mean change in hemoglobin A1c from baseline after 52 weeks on treatment. The results showed that the A1c reduction with tirzepatide treatment significantly exceeded the drop produced by insulin degludec by 0.59%, 0.86%, and 1.04%, respectively, across the three tirzepatide dosages tested in a dose-response fashion, according to the recent publication.

The most common treatment-emergent adverse effects were gastrointestinal, which decreased with continued treatment, and tirzepatide produced fewer episodes of hypoglycemia, compared with insulin degludec (Tresiba).



In addition to full reports now out from SURPASS-2 and SURPASS-3, researchers also recently published full primary results from SURPASS-1. Results from SURPASS-5 appeared in a poster presented at the American Diabetes Association scientific sessions in June 2021 but have not yet been published in a full report, and the primary results from SURPASS-4are expected in a report during the European Association for the Study of Diabetes in September 2021.

SURPASS-3 and the other trials of tirzepatide were funded by Lilly, the company developing the drug. Dr. Rayner has been an adviser to Allergen and Glyscend, and has received research funding from Sanofi and Novartis. Dr. Horowitz has received symposia fees from Lilly, as well as from AstraZeneca and Boehringer Ingelheim.

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Ultraprocessed foods comprise most of the calories for youths

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In the 2 decades from 1999 to 2018, ultraprocessed foods consistently accounted for the majority of energy intake by American young people, a large cross-sectional study of National Health and Nutrition Examination Survey (NHANES) data shows.

In young people aged 2-19 years, the estimated percentage of total energy from consumption of ultraprocessed foods increased from 61.4% to 67.0%, for a difference of 5.6% (95% confidence interval [CI] 3.5-7.7, P < .001 for trend), according to Lu Wang, PhD, MPH, a postdoctoral fellow at the Friedman School of Nutrition Science and Policy at Tufts University in Boston, and colleagues.

In contrast, total energy from non- or minimally processed foods decreased from 28.8% to 23.5% (difference −5.3%, 95% CI, −7.5 to −3.2, P < .001 for trend).

“The estimated percentage of energy consumed from ultraprocessed foods increased from 1999 to 2018, with an increasing trend in ready-to-heat and -eat mixed dishes and a decreasing trend in sugar-sweetened beverages,” the authors wrote. The report was published online Aug. 10 in JAMA.

The findings held regardless of the educational and socioeconomic status of the children’s parents.

Significant disparities by race and ethnicity emerged, however, with the ultraprocessed food phenomenon more marked in non-Hispanic Black youths and Mexican-American youths than in their non-Hispanic White counterparts. “Targeted marketing of junk foods toward racial/ethnic minority youths may partly contribute to such differences,” the authors wrote. “However, persistently lower consumption of ultraprocessed foods among Mexican-American youths may reflect more home cooking among Hispanic families.”

Among non-Hispanic Black youths consumption rose from 62.2% to 72.5% (difference 10.3%, 95% CI, 6.8-13.8) and among Mexican-American youths from 55.8% to 63.5% (difference 7.6%, 95% CI, 4.4-10.9). In non-Hispanic White youths intake rose from 63.4% to 68.6% (difference 5.2%, 95% CI, 2.1-8.3, P = .04 for trends).

In addition, a higher consumption of ultraprocessed foods among school-aged youths than among preschool children aged 2-5 years may reflect increased marketing, availability, and selection of ultraprocessed foods for older youths, the authors noted.

Food processing, with its potential adverse effects, may need to be considered as a food dimension in addition to nutrients and food groups in future dietary recommendations and food policies, they added.

“An increasing number of studies are showing a link between ultraprocessed food consumption and adverse health outcomes in children,” corresponding author Fang Fang Zhang, MD, PhD, Neely Family Professor and associate professor at Tufts’ Friedman School of Nutrition Science and Policy, said in an interview. “Health care providers can play a larger role in encouraging patients – and their parents – to replace unhealthy ultraprocessed foods such as ultraprocessed sweet bakery products with healthy unprocessed or minimally processed foods in their diet such as less processed whole grains. “

Dr. Fang Fang Zhang

In Dr. Zhang’s view, teachers also have a part to play in promoting nutrition literacy. “Schools can play an important role in empowering children with knowledge and skills to make healthy food choices,” she said. “Nutrition literacy should be an integral part of the health education curriculum in all K-12 schools.”

Commenting on the study but not involved in it, Michelle Katzow, MD, a pediatrician/obesity medicine specialist and assistant professor at the Feinstein Institutes for Medical Research in Manhasset, N.Y., said the work highlights an often overlooked aspect of the modern American diet that may well be contributing to poor health outcomes in young people.

Dr. Michelle Katzow

“It suggests that even as the science advances and we learn more about the adverse health effects of ultraprocessed foods, public health efforts to improve nutrition and food quality in children have not been successful,” she said in an interview. “This is because it is so hard for public health advocates to compete with the food industry, which stands to really benefit financially from hooking kids on processed foods that are not good for their health.”

Dr. Katzow added that the observed racial/ethnic disparities are not surprising in light of a growing body of evidence that racism exists in food marketing. “We need to put forward policies that regulate the food industry, particularly in relation to its most susceptible targets, our kids.”
 

 

 

Study details

The serial cross-sectional analysis used 24-hour dietary recall data from a nationally representative sample from 10 NHANES cycles for the range of 1999-2000 to 2017-2018. The weighted mean age of the cohort was 10.7 years and 49.1% were girls.

Among the subgroups of ultraprocessed foods, the estimated percentage of energy from ready-to-heat and ready-to-eat mixed dishes increased from 2.2% to 11.2% (difference 8.9%; 95%, CI, 7.7-10.2).

Energy from sweets and sweet snacks increased from 10.7% to 12.9% (difference 2.3%; 95% CI, 1.0-3.6), but the estimated percentage of energy decreased for sugar-sweetened beverages from 10.8% to 5.3% (difference −5.5%; 95% CI, −6.5 to −4.5).

In other categories, estimated energy intake from processed fats and oils, condiments, and sauces fell from 7.1% to 4.0% (difference −3.1%; 95% CI, −3.7 to −2.6, all P < .05 for trend).

Not surprisingly, ultraprocessed foods had an overall poorer nutrient profile than that of nonultraprocessed, although they often contained less saturated fat, and they also contained more carbohydrates, mostly from low-quality sources with added sugars and low levels of dietary fiber and protein.

And despite a higher total folate content in ultraprocessed foods because of fortification, higher-level consumers took in less total folate owing to their lower consumption of whole foods.

The authors cautioned that in addition to poor nutrient profiles, processing itself may harm health by changing the physical structure and chemical composition of food, which could lead to elevated glycemic response and reduced satiety. Furthermore, recent research has linked food additives such as emulsifiers, stabilizers, and artificial sweeteners to adverse metabolomic effects and obesity risk. Pointing to the recent success of efforts to reduce consumption of sugary beverages, Dr. Zhang said, “We need to mobilize the same energy and level of commitment when it comes to other unhealthy ultraprocessed foods such as cakes, cookies, doughnuts, and brownies.”

The trends identified by the Tufts study “are concerning and potentially have major public health significance,” according to an accompanying JAMA editorial.

“Better dietary assessment methods are needed to document trends and understand the unique role of ultraprocessed foods to inform future evidence-based policy and dietary recommendations,” wrote Katie A. Meyer, ScD, and Lindsey Smith Taillie, PhD, of the Gillings School of Global Public Health at the University of North Carolina in Chapel Hill.

The editorialists share the authors’ view that “a conceptual advancement would be to consider the level and characteristics of processing as just one of multiple dimensions (including nutrients and food groups) used to classify foods as healthy or unhealthy.” They pointed out that the Pan American Health Organization already recommends targeting products that are ultraprocessed and high in concerning add-in nutrients.

They cautioned, however, that the classification of ultraprocessed foods will not be easy because it requires data on a full list of ingredients, and the effects of processing generally cannot be separated from the composite nutrients of ultraprocessed foods.

This presents a challenge for national food consumption research “given that most large epidemiological studies rely on food frequency questionnaires that lack the information necessary to classify processing levels,” they wrote.

This study was supported by the National Institutes of Health and the São Paulo Research Foundation. Coauthor Dariush Mozaffarian, MD, a cardiologist at Tufts University, disclosed support from the Bill & Melinda Gates Foundation, the National Institutes of Health, and the Rockefeller Foundation as well as personal fees from several commercial companies. He has served on several scientific advisory boards and received royalties from UpToDate, all outside of the submitted work. Dr. Meyer reported a grant from choline manufacturer Balchem. Dr. Taillie reported funding from Bloomberg Philanthropies. Dr. Zhang had no disclosures. Dr. Katzow disclosed no competing interests.

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In the 2 decades from 1999 to 2018, ultraprocessed foods consistently accounted for the majority of energy intake by American young people, a large cross-sectional study of National Health and Nutrition Examination Survey (NHANES) data shows.

In young people aged 2-19 years, the estimated percentage of total energy from consumption of ultraprocessed foods increased from 61.4% to 67.0%, for a difference of 5.6% (95% confidence interval [CI] 3.5-7.7, P < .001 for trend), according to Lu Wang, PhD, MPH, a postdoctoral fellow at the Friedman School of Nutrition Science and Policy at Tufts University in Boston, and colleagues.

In contrast, total energy from non- or minimally processed foods decreased from 28.8% to 23.5% (difference −5.3%, 95% CI, −7.5 to −3.2, P < .001 for trend).

“The estimated percentage of energy consumed from ultraprocessed foods increased from 1999 to 2018, with an increasing trend in ready-to-heat and -eat mixed dishes and a decreasing trend in sugar-sweetened beverages,” the authors wrote. The report was published online Aug. 10 in JAMA.

The findings held regardless of the educational and socioeconomic status of the children’s parents.

Significant disparities by race and ethnicity emerged, however, with the ultraprocessed food phenomenon more marked in non-Hispanic Black youths and Mexican-American youths than in their non-Hispanic White counterparts. “Targeted marketing of junk foods toward racial/ethnic minority youths may partly contribute to such differences,” the authors wrote. “However, persistently lower consumption of ultraprocessed foods among Mexican-American youths may reflect more home cooking among Hispanic families.”

Among non-Hispanic Black youths consumption rose from 62.2% to 72.5% (difference 10.3%, 95% CI, 6.8-13.8) and among Mexican-American youths from 55.8% to 63.5% (difference 7.6%, 95% CI, 4.4-10.9). In non-Hispanic White youths intake rose from 63.4% to 68.6% (difference 5.2%, 95% CI, 2.1-8.3, P = .04 for trends).

In addition, a higher consumption of ultraprocessed foods among school-aged youths than among preschool children aged 2-5 years may reflect increased marketing, availability, and selection of ultraprocessed foods for older youths, the authors noted.

Food processing, with its potential adverse effects, may need to be considered as a food dimension in addition to nutrients and food groups in future dietary recommendations and food policies, they added.

“An increasing number of studies are showing a link between ultraprocessed food consumption and adverse health outcomes in children,” corresponding author Fang Fang Zhang, MD, PhD, Neely Family Professor and associate professor at Tufts’ Friedman School of Nutrition Science and Policy, said in an interview. “Health care providers can play a larger role in encouraging patients – and their parents – to replace unhealthy ultraprocessed foods such as ultraprocessed sweet bakery products with healthy unprocessed or minimally processed foods in their diet such as less processed whole grains. “

Dr. Fang Fang Zhang

In Dr. Zhang’s view, teachers also have a part to play in promoting nutrition literacy. “Schools can play an important role in empowering children with knowledge and skills to make healthy food choices,” she said. “Nutrition literacy should be an integral part of the health education curriculum in all K-12 schools.”

Commenting on the study but not involved in it, Michelle Katzow, MD, a pediatrician/obesity medicine specialist and assistant professor at the Feinstein Institutes for Medical Research in Manhasset, N.Y., said the work highlights an often overlooked aspect of the modern American diet that may well be contributing to poor health outcomes in young people.

Dr. Michelle Katzow

“It suggests that even as the science advances and we learn more about the adverse health effects of ultraprocessed foods, public health efforts to improve nutrition and food quality in children have not been successful,” she said in an interview. “This is because it is so hard for public health advocates to compete with the food industry, which stands to really benefit financially from hooking kids on processed foods that are not good for their health.”

Dr. Katzow added that the observed racial/ethnic disparities are not surprising in light of a growing body of evidence that racism exists in food marketing. “We need to put forward policies that regulate the food industry, particularly in relation to its most susceptible targets, our kids.”
 

 

 

Study details

The serial cross-sectional analysis used 24-hour dietary recall data from a nationally representative sample from 10 NHANES cycles for the range of 1999-2000 to 2017-2018. The weighted mean age of the cohort was 10.7 years and 49.1% were girls.

Among the subgroups of ultraprocessed foods, the estimated percentage of energy from ready-to-heat and ready-to-eat mixed dishes increased from 2.2% to 11.2% (difference 8.9%; 95%, CI, 7.7-10.2).

Energy from sweets and sweet snacks increased from 10.7% to 12.9% (difference 2.3%; 95% CI, 1.0-3.6), but the estimated percentage of energy decreased for sugar-sweetened beverages from 10.8% to 5.3% (difference −5.5%; 95% CI, −6.5 to −4.5).

In other categories, estimated energy intake from processed fats and oils, condiments, and sauces fell from 7.1% to 4.0% (difference −3.1%; 95% CI, −3.7 to −2.6, all P < .05 for trend).

Not surprisingly, ultraprocessed foods had an overall poorer nutrient profile than that of nonultraprocessed, although they often contained less saturated fat, and they also contained more carbohydrates, mostly from low-quality sources with added sugars and low levels of dietary fiber and protein.

And despite a higher total folate content in ultraprocessed foods because of fortification, higher-level consumers took in less total folate owing to their lower consumption of whole foods.

The authors cautioned that in addition to poor nutrient profiles, processing itself may harm health by changing the physical structure and chemical composition of food, which could lead to elevated glycemic response and reduced satiety. Furthermore, recent research has linked food additives such as emulsifiers, stabilizers, and artificial sweeteners to adverse metabolomic effects and obesity risk. Pointing to the recent success of efforts to reduce consumption of sugary beverages, Dr. Zhang said, “We need to mobilize the same energy and level of commitment when it comes to other unhealthy ultraprocessed foods such as cakes, cookies, doughnuts, and brownies.”

The trends identified by the Tufts study “are concerning and potentially have major public health significance,” according to an accompanying JAMA editorial.

“Better dietary assessment methods are needed to document trends and understand the unique role of ultraprocessed foods to inform future evidence-based policy and dietary recommendations,” wrote Katie A. Meyer, ScD, and Lindsey Smith Taillie, PhD, of the Gillings School of Global Public Health at the University of North Carolina in Chapel Hill.

The editorialists share the authors’ view that “a conceptual advancement would be to consider the level and characteristics of processing as just one of multiple dimensions (including nutrients and food groups) used to classify foods as healthy or unhealthy.” They pointed out that the Pan American Health Organization already recommends targeting products that are ultraprocessed and high in concerning add-in nutrients.

They cautioned, however, that the classification of ultraprocessed foods will not be easy because it requires data on a full list of ingredients, and the effects of processing generally cannot be separated from the composite nutrients of ultraprocessed foods.

This presents a challenge for national food consumption research “given that most large epidemiological studies rely on food frequency questionnaires that lack the information necessary to classify processing levels,” they wrote.

This study was supported by the National Institutes of Health and the São Paulo Research Foundation. Coauthor Dariush Mozaffarian, MD, a cardiologist at Tufts University, disclosed support from the Bill & Melinda Gates Foundation, the National Institutes of Health, and the Rockefeller Foundation as well as personal fees from several commercial companies. He has served on several scientific advisory boards and received royalties from UpToDate, all outside of the submitted work. Dr. Meyer reported a grant from choline manufacturer Balchem. Dr. Taillie reported funding from Bloomberg Philanthropies. Dr. Zhang had no disclosures. Dr. Katzow disclosed no competing interests.

In the 2 decades from 1999 to 2018, ultraprocessed foods consistently accounted for the majority of energy intake by American young people, a large cross-sectional study of National Health and Nutrition Examination Survey (NHANES) data shows.

In young people aged 2-19 years, the estimated percentage of total energy from consumption of ultraprocessed foods increased from 61.4% to 67.0%, for a difference of 5.6% (95% confidence interval [CI] 3.5-7.7, P < .001 for trend), according to Lu Wang, PhD, MPH, a postdoctoral fellow at the Friedman School of Nutrition Science and Policy at Tufts University in Boston, and colleagues.

In contrast, total energy from non- or minimally processed foods decreased from 28.8% to 23.5% (difference −5.3%, 95% CI, −7.5 to −3.2, P < .001 for trend).

“The estimated percentage of energy consumed from ultraprocessed foods increased from 1999 to 2018, with an increasing trend in ready-to-heat and -eat mixed dishes and a decreasing trend in sugar-sweetened beverages,” the authors wrote. The report was published online Aug. 10 in JAMA.

The findings held regardless of the educational and socioeconomic status of the children’s parents.

Significant disparities by race and ethnicity emerged, however, with the ultraprocessed food phenomenon more marked in non-Hispanic Black youths and Mexican-American youths than in their non-Hispanic White counterparts. “Targeted marketing of junk foods toward racial/ethnic minority youths may partly contribute to such differences,” the authors wrote. “However, persistently lower consumption of ultraprocessed foods among Mexican-American youths may reflect more home cooking among Hispanic families.”

Among non-Hispanic Black youths consumption rose from 62.2% to 72.5% (difference 10.3%, 95% CI, 6.8-13.8) and among Mexican-American youths from 55.8% to 63.5% (difference 7.6%, 95% CI, 4.4-10.9). In non-Hispanic White youths intake rose from 63.4% to 68.6% (difference 5.2%, 95% CI, 2.1-8.3, P = .04 for trends).

In addition, a higher consumption of ultraprocessed foods among school-aged youths than among preschool children aged 2-5 years may reflect increased marketing, availability, and selection of ultraprocessed foods for older youths, the authors noted.

Food processing, with its potential adverse effects, may need to be considered as a food dimension in addition to nutrients and food groups in future dietary recommendations and food policies, they added.

“An increasing number of studies are showing a link between ultraprocessed food consumption and adverse health outcomes in children,” corresponding author Fang Fang Zhang, MD, PhD, Neely Family Professor and associate professor at Tufts’ Friedman School of Nutrition Science and Policy, said in an interview. “Health care providers can play a larger role in encouraging patients – and their parents – to replace unhealthy ultraprocessed foods such as ultraprocessed sweet bakery products with healthy unprocessed or minimally processed foods in their diet such as less processed whole grains. “

Dr. Fang Fang Zhang

In Dr. Zhang’s view, teachers also have a part to play in promoting nutrition literacy. “Schools can play an important role in empowering children with knowledge and skills to make healthy food choices,” she said. “Nutrition literacy should be an integral part of the health education curriculum in all K-12 schools.”

Commenting on the study but not involved in it, Michelle Katzow, MD, a pediatrician/obesity medicine specialist and assistant professor at the Feinstein Institutes for Medical Research in Manhasset, N.Y., said the work highlights an often overlooked aspect of the modern American diet that may well be contributing to poor health outcomes in young people.

Dr. Michelle Katzow

“It suggests that even as the science advances and we learn more about the adverse health effects of ultraprocessed foods, public health efforts to improve nutrition and food quality in children have not been successful,” she said in an interview. “This is because it is so hard for public health advocates to compete with the food industry, which stands to really benefit financially from hooking kids on processed foods that are not good for their health.”

Dr. Katzow added that the observed racial/ethnic disparities are not surprising in light of a growing body of evidence that racism exists in food marketing. “We need to put forward policies that regulate the food industry, particularly in relation to its most susceptible targets, our kids.”
 

 

 

Study details

The serial cross-sectional analysis used 24-hour dietary recall data from a nationally representative sample from 10 NHANES cycles for the range of 1999-2000 to 2017-2018. The weighted mean age of the cohort was 10.7 years and 49.1% were girls.

Among the subgroups of ultraprocessed foods, the estimated percentage of energy from ready-to-heat and ready-to-eat mixed dishes increased from 2.2% to 11.2% (difference 8.9%; 95%, CI, 7.7-10.2).

Energy from sweets and sweet snacks increased from 10.7% to 12.9% (difference 2.3%; 95% CI, 1.0-3.6), but the estimated percentage of energy decreased for sugar-sweetened beverages from 10.8% to 5.3% (difference −5.5%; 95% CI, −6.5 to −4.5).

In other categories, estimated energy intake from processed fats and oils, condiments, and sauces fell from 7.1% to 4.0% (difference −3.1%; 95% CI, −3.7 to −2.6, all P < .05 for trend).

Not surprisingly, ultraprocessed foods had an overall poorer nutrient profile than that of nonultraprocessed, although they often contained less saturated fat, and they also contained more carbohydrates, mostly from low-quality sources with added sugars and low levels of dietary fiber and protein.

And despite a higher total folate content in ultraprocessed foods because of fortification, higher-level consumers took in less total folate owing to their lower consumption of whole foods.

The authors cautioned that in addition to poor nutrient profiles, processing itself may harm health by changing the physical structure and chemical composition of food, which could lead to elevated glycemic response and reduced satiety. Furthermore, recent research has linked food additives such as emulsifiers, stabilizers, and artificial sweeteners to adverse metabolomic effects and obesity risk. Pointing to the recent success of efforts to reduce consumption of sugary beverages, Dr. Zhang said, “We need to mobilize the same energy and level of commitment when it comes to other unhealthy ultraprocessed foods such as cakes, cookies, doughnuts, and brownies.”

The trends identified by the Tufts study “are concerning and potentially have major public health significance,” according to an accompanying JAMA editorial.

“Better dietary assessment methods are needed to document trends and understand the unique role of ultraprocessed foods to inform future evidence-based policy and dietary recommendations,” wrote Katie A. Meyer, ScD, and Lindsey Smith Taillie, PhD, of the Gillings School of Global Public Health at the University of North Carolina in Chapel Hill.

The editorialists share the authors’ view that “a conceptual advancement would be to consider the level and characteristics of processing as just one of multiple dimensions (including nutrients and food groups) used to classify foods as healthy or unhealthy.” They pointed out that the Pan American Health Organization already recommends targeting products that are ultraprocessed and high in concerning add-in nutrients.

They cautioned, however, that the classification of ultraprocessed foods will not be easy because it requires data on a full list of ingredients, and the effects of processing generally cannot be separated from the composite nutrients of ultraprocessed foods.

This presents a challenge for national food consumption research “given that most large epidemiological studies rely on food frequency questionnaires that lack the information necessary to classify processing levels,” they wrote.

This study was supported by the National Institutes of Health and the São Paulo Research Foundation. Coauthor Dariush Mozaffarian, MD, a cardiologist at Tufts University, disclosed support from the Bill & Melinda Gates Foundation, the National Institutes of Health, and the Rockefeller Foundation as well as personal fees from several commercial companies. He has served on several scientific advisory boards and received royalties from UpToDate, all outside of the submitted work. Dr. Meyer reported a grant from choline manufacturer Balchem. Dr. Taillie reported funding from Bloomberg Philanthropies. Dr. Zhang had no disclosures. Dr. Katzow disclosed no competing interests.

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Physician ‘predator’ sentenced for opioid-related patient death; more

Article Type
Changed
Fri, 08/13/2021 - 12:53

 

Doctor’s illegal opioid distribution results in patient death

Thomas K. Ballard III, MD, of Jackson, Tenn., pleaded guilty to causing the death of one of his patients in 2015 by illegally prescribing hydrocodone. He faces a minimum of 20 years in prison for one count of illegal drug distribution resulting in death. He will be sentenced in September.

Dr. Ballard, 63, owned and operated the Ballard Clinic, from which he prescribed dangerous and addictive drugs without legitimate medical purpose. Dr. Ballard also engaged in inappropriate sexual contact with several female patients while ignoring signs that they were abusing the medications he prescribed, according to the U.S. Department of Justice.

Dr. Ballard’s treatment records show that he believed a patient had psychiatric problems and was abusing her medication, evidenced by positive drug screens and prescriptions obtained elsewhere for suboxone, a drug used to treat opioid dependency. However, Dr. Ballard continued to prescribe hydrocodone to the patient, including on May 28, 2015, when the patient fatally overdosed on the drug.

“Ballard has proven himself to be nothing more than a predator in a white lab coat, and he should expect to be punished accordingly,” said Special Agent in Charge J. Todd Scott of the Drug Enforcement Administration’s Louisville Division. “Doctors take an oath to first do no harm, and instead, Ballard chose to put his own licentious interests above his patients’ well-being.”
 

Clinical researchers falsify drug trial data

Eduardo Navarro, of Miami, and Nayade Varona, of Port St. Lucie, Fla., pleaded guilty to conspiring to falsify clinical trial data. Mr. Navarro, 52, was sentenced to 46 months in prison and Ms. Varona, 50, received 30 months in prison.

The court also ordered the defendants to pay $2,134,503 in restitution.

Mr. Navarro and Ms. Varona both worked for Tellus Clinical Research, where Mr. Navarro was a subinvestigator and nurse practitioner, and Ms. Varona was an assistant study coordinator. They admitted to agreeing with one another and others to falsify data in medical records for two clinical trials that were evaluating a treatment for irritable bowel syndrome. Mr. Navarro and Ms. Varona falsified data to make it appear as though patients were participating in the trials, which never occurred.
 

Doctor faces decade in prison for $6 million health care fraud

Keyvan Amirikhorheh, MD, a family physician in Seal Beach, Calif., pleaded guilty to conspiring to commit health care fraud. He faces a maximum of 10 years in prison.

While working at Los Angeles Community Clinic, Dr. Amirikhorheh submitted fraudulent claims for family planning services, diagnostic testing, and prescriptions for nonexistent patients, defrauding the Family Planning, Access, Care and Treatment (Family PACT) program administered by Medi-Cal, the California Medicaid program.

Between March 2016 and April 2019, Los Angeles Community Clinic and associated laboratories and pharmacies submitted approximately $8,406,204 in claims to Medi-Cal and were paid approximately $6,660,028. Dr. Amirikhorheh, 61, is the final defendant of five to plead guilty in the case, according to the DOJ.
 

Dentist office sued for HIV discrimination

Night and Day Dental, of North Carolina, settled with the DOJ to resolve a claim that it discriminated against a woman with HIV in violation of the Americans With Disabilities Act.

Title III of the ADA prohibits health care professionals from discriminating against people with disabilities, including those with HIV. The DOJ found that Night and Day Dental refused to accept a woman as a new patient because of her HIV-positive status. The patient was seeking routine dental care, including a cleaning and check-up. Night and Day Dental additionally requires certain blood work results from patients with HIV before deciding whether to provide dental care, when requiring such results is not medically necessary.

They will pay $30,000 to the victim of the discrimination, train their staff on the ADA, develop an antidiscrimination policy, and report to the DOJ every time they refuse to treat a person with HIV or stop providing treatment after learning of a patient’s HIV-positive status. “Turning away patients with HIV or requiring them to provide information that is not medically recommended creates unfair barriers to health care for people with HIV,” said Kristen Clarke, assistant attorney general in the DOJ’s Civil Rights Division.

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

This article was updated 8/12/21.

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Doctor’s illegal opioid distribution results in patient death

Thomas K. Ballard III, MD, of Jackson, Tenn., pleaded guilty to causing the death of one of his patients in 2015 by illegally prescribing hydrocodone. He faces a minimum of 20 years in prison for one count of illegal drug distribution resulting in death. He will be sentenced in September.

Dr. Ballard, 63, owned and operated the Ballard Clinic, from which he prescribed dangerous and addictive drugs without legitimate medical purpose. Dr. Ballard also engaged in inappropriate sexual contact with several female patients while ignoring signs that they were abusing the medications he prescribed, according to the U.S. Department of Justice.

Dr. Ballard’s treatment records show that he believed a patient had psychiatric problems and was abusing her medication, evidenced by positive drug screens and prescriptions obtained elsewhere for suboxone, a drug used to treat opioid dependency. However, Dr. Ballard continued to prescribe hydrocodone to the patient, including on May 28, 2015, when the patient fatally overdosed on the drug.

“Ballard has proven himself to be nothing more than a predator in a white lab coat, and he should expect to be punished accordingly,” said Special Agent in Charge J. Todd Scott of the Drug Enforcement Administration’s Louisville Division. “Doctors take an oath to first do no harm, and instead, Ballard chose to put his own licentious interests above his patients’ well-being.”
 

Clinical researchers falsify drug trial data

Eduardo Navarro, of Miami, and Nayade Varona, of Port St. Lucie, Fla., pleaded guilty to conspiring to falsify clinical trial data. Mr. Navarro, 52, was sentenced to 46 months in prison and Ms. Varona, 50, received 30 months in prison.

The court also ordered the defendants to pay $2,134,503 in restitution.

Mr. Navarro and Ms. Varona both worked for Tellus Clinical Research, where Mr. Navarro was a subinvestigator and nurse practitioner, and Ms. Varona was an assistant study coordinator. They admitted to agreeing with one another and others to falsify data in medical records for two clinical trials that were evaluating a treatment for irritable bowel syndrome. Mr. Navarro and Ms. Varona falsified data to make it appear as though patients were participating in the trials, which never occurred.
 

Doctor faces decade in prison for $6 million health care fraud

Keyvan Amirikhorheh, MD, a family physician in Seal Beach, Calif., pleaded guilty to conspiring to commit health care fraud. He faces a maximum of 10 years in prison.

While working at Los Angeles Community Clinic, Dr. Amirikhorheh submitted fraudulent claims for family planning services, diagnostic testing, and prescriptions for nonexistent patients, defrauding the Family Planning, Access, Care and Treatment (Family PACT) program administered by Medi-Cal, the California Medicaid program.

Between March 2016 and April 2019, Los Angeles Community Clinic and associated laboratories and pharmacies submitted approximately $8,406,204 in claims to Medi-Cal and were paid approximately $6,660,028. Dr. Amirikhorheh, 61, is the final defendant of five to plead guilty in the case, according to the DOJ.
 

Dentist office sued for HIV discrimination

Night and Day Dental, of North Carolina, settled with the DOJ to resolve a claim that it discriminated against a woman with HIV in violation of the Americans With Disabilities Act.

Title III of the ADA prohibits health care professionals from discriminating against people with disabilities, including those with HIV. The DOJ found that Night and Day Dental refused to accept a woman as a new patient because of her HIV-positive status. The patient was seeking routine dental care, including a cleaning and check-up. Night and Day Dental additionally requires certain blood work results from patients with HIV before deciding whether to provide dental care, when requiring such results is not medically necessary.

They will pay $30,000 to the victim of the discrimination, train their staff on the ADA, develop an antidiscrimination policy, and report to the DOJ every time they refuse to treat a person with HIV or stop providing treatment after learning of a patient’s HIV-positive status. “Turning away patients with HIV or requiring them to provide information that is not medically recommended creates unfair barriers to health care for people with HIV,” said Kristen Clarke, assistant attorney general in the DOJ’s Civil Rights Division.

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

This article was updated 8/12/21.

 

Doctor’s illegal opioid distribution results in patient death

Thomas K. Ballard III, MD, of Jackson, Tenn., pleaded guilty to causing the death of one of his patients in 2015 by illegally prescribing hydrocodone. He faces a minimum of 20 years in prison for one count of illegal drug distribution resulting in death. He will be sentenced in September.

Dr. Ballard, 63, owned and operated the Ballard Clinic, from which he prescribed dangerous and addictive drugs without legitimate medical purpose. Dr. Ballard also engaged in inappropriate sexual contact with several female patients while ignoring signs that they were abusing the medications he prescribed, according to the U.S. Department of Justice.

Dr. Ballard’s treatment records show that he believed a patient had psychiatric problems and was abusing her medication, evidenced by positive drug screens and prescriptions obtained elsewhere for suboxone, a drug used to treat opioid dependency. However, Dr. Ballard continued to prescribe hydrocodone to the patient, including on May 28, 2015, when the patient fatally overdosed on the drug.

“Ballard has proven himself to be nothing more than a predator in a white lab coat, and he should expect to be punished accordingly,” said Special Agent in Charge J. Todd Scott of the Drug Enforcement Administration’s Louisville Division. “Doctors take an oath to first do no harm, and instead, Ballard chose to put his own licentious interests above his patients’ well-being.”
 

Clinical researchers falsify drug trial data

Eduardo Navarro, of Miami, and Nayade Varona, of Port St. Lucie, Fla., pleaded guilty to conspiring to falsify clinical trial data. Mr. Navarro, 52, was sentenced to 46 months in prison and Ms. Varona, 50, received 30 months in prison.

The court also ordered the defendants to pay $2,134,503 in restitution.

Mr. Navarro and Ms. Varona both worked for Tellus Clinical Research, where Mr. Navarro was a subinvestigator and nurse practitioner, and Ms. Varona was an assistant study coordinator. They admitted to agreeing with one another and others to falsify data in medical records for two clinical trials that were evaluating a treatment for irritable bowel syndrome. Mr. Navarro and Ms. Varona falsified data to make it appear as though patients were participating in the trials, which never occurred.
 

Doctor faces decade in prison for $6 million health care fraud

Keyvan Amirikhorheh, MD, a family physician in Seal Beach, Calif., pleaded guilty to conspiring to commit health care fraud. He faces a maximum of 10 years in prison.

While working at Los Angeles Community Clinic, Dr. Amirikhorheh submitted fraudulent claims for family planning services, diagnostic testing, and prescriptions for nonexistent patients, defrauding the Family Planning, Access, Care and Treatment (Family PACT) program administered by Medi-Cal, the California Medicaid program.

Between March 2016 and April 2019, Los Angeles Community Clinic and associated laboratories and pharmacies submitted approximately $8,406,204 in claims to Medi-Cal and were paid approximately $6,660,028. Dr. Amirikhorheh, 61, is the final defendant of five to plead guilty in the case, according to the DOJ.
 

Dentist office sued for HIV discrimination

Night and Day Dental, of North Carolina, settled with the DOJ to resolve a claim that it discriminated against a woman with HIV in violation of the Americans With Disabilities Act.

Title III of the ADA prohibits health care professionals from discriminating against people with disabilities, including those with HIV. The DOJ found that Night and Day Dental refused to accept a woman as a new patient because of her HIV-positive status. The patient was seeking routine dental care, including a cleaning and check-up. Night and Day Dental additionally requires certain blood work results from patients with HIV before deciding whether to provide dental care, when requiring such results is not medically necessary.

They will pay $30,000 to the victim of the discrimination, train their staff on the ADA, develop an antidiscrimination policy, and report to the DOJ every time they refuse to treat a person with HIV or stop providing treatment after learning of a patient’s HIV-positive status. “Turning away patients with HIV or requiring them to provide information that is not medically recommended creates unfair barriers to health care for people with HIV,” said Kristen Clarke, assistant attorney general in the DOJ’s Civil Rights Division.

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

This article was updated 8/12/21.

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Task force affirms routine gestational diabetes testing

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Asymptomatic pregnant women with no previous diagnosis of type 1 or 2 diabetes should be screened for gestational diabetes at 24 weeks’ gestation or later, according to an updated recommendation from the U.S. Preventive Services Task Force.

Pregnant individuals who develop gestational diabetes are at increased risk for complications including preeclampsia, fetal macrosomia, and neonatal hypoglycemia, as well as negative long-term outcomes for themselves and their children, wrote lead author Karina W. Davidson, PhD, of Feinstein Institute for Medical Research, Manhasset, N.Y., and colleagues. The statement was published online in JAMA.

The B recommendation and I statement reflect “moderate certainty” that current evidence supports the recommendation in terms of harms versus benefits, and is consistent with the 2014 USPSTF recommendation.

The statement calls for a one-time screening using a glucose tolerance test at or after 24 weeks’ gestation. Although most screening in the United States takes place prior to 28 weeks’ gestation, it can be performed later in patients who begin prenatal care after 28 weeks’ gestation, according to the statement. Data on the harms and benefits of gestational diabetes screening prior to 24 weeks’ gestation are limited, the authors noted. Gestational diabetes was defined as diabetes that develops during pregnancy that is not clearly overt diabetes.

To update the 2014 recommendation, the USPSTF commissioned a systematic review. In 45 prospective studies on the accuracy of gestational diabetes screening, several tests, included oral glucose challenge test, oral glucose tolerance test, and fasting plasma glucose using either a one- or two-step approach were accurate detectors of gestational diabetes; therefore, the USPSTF does not recommend a specific test.

In 13 trials on the impact of treating gestational diabetes on intermediate and health outcomes, treatment was associated with a reduced risk of outcomes, including primary cesarean delivery (but not total cesarean delivery) and preterm delivery, but not with a reduced risk of outcomes including preeclampsia, emergency cesarean delivery, induction of labor, or maternal birth trauma.

The task force also reviewed seven studies of harms associated with screening for gestational diabetes, including three on psychosocial harms, three on hospital experiences, and one of the odds of cesarean delivery after a diagnosis of gestational diabetes. No increase in anxiety or depression occurred following a positive diagnosis or false-positive test result, but data suggested that a gestational diabetes diagnosis may be associated with higher rates of cesarean delivery.

A total of 13 trials evaluated the harms associated with treatment of gestational diabetes, and found no association between treatment and increased risk of several outcomes including severe maternal hypoglycemia, low birth weight, and small for gestational age, and no effect was noted on the number of cesarean deliveries.

Evidence gaps that require additional research include randomized, controlled trials on the effects of gestational diabetes screening on health outcomes, as well as benefits versus harms of screening for pregnant individuals prior to 24 weeks, and studies on the effects of screening in subpopulations of race/ethnicity, age, and socioeconomic factors, according to the task force. Additional research also is needed in areas of maternal health outcomes, long-term outcomes, and the effect on outcomes of one-step versus two-step screening, the USPSTF said.

However, “screening for and detecting gestational diabetes provides a potential opportunity to control blood glucose levels (through lifestyle changes, pharmacological interventions, or both) and reduce the risk of macrosomia and LGA [large for gestational age] infants,” the task force wrote. “In turn, this can prevent associated complications such as primary cesarean delivery, shoulder dystocia, and [neonatal] ICU admissions.”
 

 

 

Support screening with counseling on risk reduction

The USPSTF recommendation is important at this time because “the prevalence of gestational diabetes is increasing secondary to rising rates of obesity,” Iris Krishna, MD, of Emory University, Atlanta, said in an interview.

“In 2014, based on a systematic review of literature, the USPSTF recommended screening all asymptomatic pregnant women for gestational diabetes mellitus [GDM] starting at 24 weeks’ gestation. The recommended gestational age for screening coincides with increasing insulin resistance during pregnancy with advancing gestational age,” Dr. Krishna said.

“An updated systematic review by the USPSTF concluded that existing literature continues to affirm current recommendations of universal screening for GDM at 24 weeks gestation or later. There continues, however, to be no consensus on the optimal approach to screening,” she noted.

“Screening can be performed as a two-step or one-step approach,” said Dr. Krishna. “The two-step approach is commonly used in the United States, and all pregnant women are first screened with a 50-gram oral glucose solution followed by a diagnostic test if they have a positive initial screening.

“Women with risk factors for diabetes, such as prior GDM, obesity, strong family history of diabetes, or history of fetal macrosomia, should be screened early in pregnancy for GDM and have the GDM screen repeated at 24 weeks’ gestation or later if normal in early pregnancy,” Dr. Krishna said. “Pregnant women should be counseled on the importance of diet and exercise and appropriate weight gain in pregnancy to reduce the risk of GDM. Overall, timely diagnosis of gestational diabetes is crucial to improving maternal and fetal pregnancy outcomes.”

The full recommendation statement is also available on the USPSTF website. The research was supported by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose. Dr. Krishna had no disclosures, but serves on the editorial advisory board of Ob.Gyn News.

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Asymptomatic pregnant women with no previous diagnosis of type 1 or 2 diabetes should be screened for gestational diabetes at 24 weeks’ gestation or later, according to an updated recommendation from the U.S. Preventive Services Task Force.

Pregnant individuals who develop gestational diabetes are at increased risk for complications including preeclampsia, fetal macrosomia, and neonatal hypoglycemia, as well as negative long-term outcomes for themselves and their children, wrote lead author Karina W. Davidson, PhD, of Feinstein Institute for Medical Research, Manhasset, N.Y., and colleagues. The statement was published online in JAMA.

The B recommendation and I statement reflect “moderate certainty” that current evidence supports the recommendation in terms of harms versus benefits, and is consistent with the 2014 USPSTF recommendation.

The statement calls for a one-time screening using a glucose tolerance test at or after 24 weeks’ gestation. Although most screening in the United States takes place prior to 28 weeks’ gestation, it can be performed later in patients who begin prenatal care after 28 weeks’ gestation, according to the statement. Data on the harms and benefits of gestational diabetes screening prior to 24 weeks’ gestation are limited, the authors noted. Gestational diabetes was defined as diabetes that develops during pregnancy that is not clearly overt diabetes.

To update the 2014 recommendation, the USPSTF commissioned a systematic review. In 45 prospective studies on the accuracy of gestational diabetes screening, several tests, included oral glucose challenge test, oral glucose tolerance test, and fasting plasma glucose using either a one- or two-step approach were accurate detectors of gestational diabetes; therefore, the USPSTF does not recommend a specific test.

In 13 trials on the impact of treating gestational diabetes on intermediate and health outcomes, treatment was associated with a reduced risk of outcomes, including primary cesarean delivery (but not total cesarean delivery) and preterm delivery, but not with a reduced risk of outcomes including preeclampsia, emergency cesarean delivery, induction of labor, or maternal birth trauma.

The task force also reviewed seven studies of harms associated with screening for gestational diabetes, including three on psychosocial harms, three on hospital experiences, and one of the odds of cesarean delivery after a diagnosis of gestational diabetes. No increase in anxiety or depression occurred following a positive diagnosis or false-positive test result, but data suggested that a gestational diabetes diagnosis may be associated with higher rates of cesarean delivery.

A total of 13 trials evaluated the harms associated with treatment of gestational diabetes, and found no association between treatment and increased risk of several outcomes including severe maternal hypoglycemia, low birth weight, and small for gestational age, and no effect was noted on the number of cesarean deliveries.

Evidence gaps that require additional research include randomized, controlled trials on the effects of gestational diabetes screening on health outcomes, as well as benefits versus harms of screening for pregnant individuals prior to 24 weeks, and studies on the effects of screening in subpopulations of race/ethnicity, age, and socioeconomic factors, according to the task force. Additional research also is needed in areas of maternal health outcomes, long-term outcomes, and the effect on outcomes of one-step versus two-step screening, the USPSTF said.

However, “screening for and detecting gestational diabetes provides a potential opportunity to control blood glucose levels (through lifestyle changes, pharmacological interventions, or both) and reduce the risk of macrosomia and LGA [large for gestational age] infants,” the task force wrote. “In turn, this can prevent associated complications such as primary cesarean delivery, shoulder dystocia, and [neonatal] ICU admissions.”
 

 

 

Support screening with counseling on risk reduction

The USPSTF recommendation is important at this time because “the prevalence of gestational diabetes is increasing secondary to rising rates of obesity,” Iris Krishna, MD, of Emory University, Atlanta, said in an interview.

“In 2014, based on a systematic review of literature, the USPSTF recommended screening all asymptomatic pregnant women for gestational diabetes mellitus [GDM] starting at 24 weeks’ gestation. The recommended gestational age for screening coincides with increasing insulin resistance during pregnancy with advancing gestational age,” Dr. Krishna said.

“An updated systematic review by the USPSTF concluded that existing literature continues to affirm current recommendations of universal screening for GDM at 24 weeks gestation or later. There continues, however, to be no consensus on the optimal approach to screening,” she noted.

“Screening can be performed as a two-step or one-step approach,” said Dr. Krishna. “The two-step approach is commonly used in the United States, and all pregnant women are first screened with a 50-gram oral glucose solution followed by a diagnostic test if they have a positive initial screening.

“Women with risk factors for diabetes, such as prior GDM, obesity, strong family history of diabetes, or history of fetal macrosomia, should be screened early in pregnancy for GDM and have the GDM screen repeated at 24 weeks’ gestation or later if normal in early pregnancy,” Dr. Krishna said. “Pregnant women should be counseled on the importance of diet and exercise and appropriate weight gain in pregnancy to reduce the risk of GDM. Overall, timely diagnosis of gestational diabetes is crucial to improving maternal and fetal pregnancy outcomes.”

The full recommendation statement is also available on the USPSTF website. The research was supported by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose. Dr. Krishna had no disclosures, but serves on the editorial advisory board of Ob.Gyn News.

Asymptomatic pregnant women with no previous diagnosis of type 1 or 2 diabetes should be screened for gestational diabetes at 24 weeks’ gestation or later, according to an updated recommendation from the U.S. Preventive Services Task Force.

Pregnant individuals who develop gestational diabetes are at increased risk for complications including preeclampsia, fetal macrosomia, and neonatal hypoglycemia, as well as negative long-term outcomes for themselves and their children, wrote lead author Karina W. Davidson, PhD, of Feinstein Institute for Medical Research, Manhasset, N.Y., and colleagues. The statement was published online in JAMA.

The B recommendation and I statement reflect “moderate certainty” that current evidence supports the recommendation in terms of harms versus benefits, and is consistent with the 2014 USPSTF recommendation.

The statement calls for a one-time screening using a glucose tolerance test at or after 24 weeks’ gestation. Although most screening in the United States takes place prior to 28 weeks’ gestation, it can be performed later in patients who begin prenatal care after 28 weeks’ gestation, according to the statement. Data on the harms and benefits of gestational diabetes screening prior to 24 weeks’ gestation are limited, the authors noted. Gestational diabetes was defined as diabetes that develops during pregnancy that is not clearly overt diabetes.

To update the 2014 recommendation, the USPSTF commissioned a systematic review. In 45 prospective studies on the accuracy of gestational diabetes screening, several tests, included oral glucose challenge test, oral glucose tolerance test, and fasting plasma glucose using either a one- or two-step approach were accurate detectors of gestational diabetes; therefore, the USPSTF does not recommend a specific test.

In 13 trials on the impact of treating gestational diabetes on intermediate and health outcomes, treatment was associated with a reduced risk of outcomes, including primary cesarean delivery (but not total cesarean delivery) and preterm delivery, but not with a reduced risk of outcomes including preeclampsia, emergency cesarean delivery, induction of labor, or maternal birth trauma.

The task force also reviewed seven studies of harms associated with screening for gestational diabetes, including three on psychosocial harms, three on hospital experiences, and one of the odds of cesarean delivery after a diagnosis of gestational diabetes. No increase in anxiety or depression occurred following a positive diagnosis or false-positive test result, but data suggested that a gestational diabetes diagnosis may be associated with higher rates of cesarean delivery.

A total of 13 trials evaluated the harms associated with treatment of gestational diabetes, and found no association between treatment and increased risk of several outcomes including severe maternal hypoglycemia, low birth weight, and small for gestational age, and no effect was noted on the number of cesarean deliveries.

Evidence gaps that require additional research include randomized, controlled trials on the effects of gestational diabetes screening on health outcomes, as well as benefits versus harms of screening for pregnant individuals prior to 24 weeks, and studies on the effects of screening in subpopulations of race/ethnicity, age, and socioeconomic factors, according to the task force. Additional research also is needed in areas of maternal health outcomes, long-term outcomes, and the effect on outcomes of one-step versus two-step screening, the USPSTF said.

However, “screening for and detecting gestational diabetes provides a potential opportunity to control blood glucose levels (through lifestyle changes, pharmacological interventions, or both) and reduce the risk of macrosomia and LGA [large for gestational age] infants,” the task force wrote. “In turn, this can prevent associated complications such as primary cesarean delivery, shoulder dystocia, and [neonatal] ICU admissions.”
 

 

 

Support screening with counseling on risk reduction

The USPSTF recommendation is important at this time because “the prevalence of gestational diabetes is increasing secondary to rising rates of obesity,” Iris Krishna, MD, of Emory University, Atlanta, said in an interview.

“In 2014, based on a systematic review of literature, the USPSTF recommended screening all asymptomatic pregnant women for gestational diabetes mellitus [GDM] starting at 24 weeks’ gestation. The recommended gestational age for screening coincides with increasing insulin resistance during pregnancy with advancing gestational age,” Dr. Krishna said.

“An updated systematic review by the USPSTF concluded that existing literature continues to affirm current recommendations of universal screening for GDM at 24 weeks gestation or later. There continues, however, to be no consensus on the optimal approach to screening,” she noted.

“Screening can be performed as a two-step or one-step approach,” said Dr. Krishna. “The two-step approach is commonly used in the United States, and all pregnant women are first screened with a 50-gram oral glucose solution followed by a diagnostic test if they have a positive initial screening.

“Women with risk factors for diabetes, such as prior GDM, obesity, strong family history of diabetes, or history of fetal macrosomia, should be screened early in pregnancy for GDM and have the GDM screen repeated at 24 weeks’ gestation or later if normal in early pregnancy,” Dr. Krishna said. “Pregnant women should be counseled on the importance of diet and exercise and appropriate weight gain in pregnancy to reduce the risk of GDM. Overall, timely diagnosis of gestational diabetes is crucial to improving maternal and fetal pregnancy outcomes.”

The full recommendation statement is also available on the USPSTF website. The research was supported by the Agency for Healthcare Research and Quality. The researchers had no financial conflicts to disclose. Dr. Krishna had no disclosures, but serves on the editorial advisory board of Ob.Gyn News.

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Heart doc offering ‘fountain of youth’ jailed for 6 1/2 years

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Cardiologist Samirkumar J. Shah, MD, was sentenced to 78 months in prison after his conviction on two counts of federal health care fraud involving more than $13 million.

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As part of his sentence, Dr. Shah, 58, of Fox Chapel, Pa., must pay $1.7 million in restitution and other penalties and undergo 3 years of supervised release after prison.

“Dr. Shah risked the health of his patients so he could make millions of dollars through unnecessary procedures, and lied and fabricated records for years to perpetuate his fraud scheme,” acting U.S. Attorney Stephen R. Kaufman said in an Aug. 5 statement from the Department of Justice.

As previously reported, Dr. Shah was convicted June 14, 2019, of submitting fraudulent claims to private and federal insurance programs between 2008 and 2013 for external counterpulsation (ECP) therapy, a lower limb compression treatment approved for patients with coronary artery disease and refractory angina.

Dr. Shah, however, advertised ECP as the “fountain of youth,” claimed it made patients “younger and smarter,” and offered the treatment for conditions such as obesity, hypertension, hypotension, diabetes, and erectile dysfunction.

Patients were required to undergo diagnostic ultrasounds as a precautionary measure prior to starting ECP, but witness testimony established that Dr. Shah did not review any of the imaging before approving new patients for ECP, placing his patients at risk for serious injury or even death, the DOJ stated.

The evidence also showed that Dr. Shah double-billed insurers, routinely submitted fabricated patient files, and made false statements concerning his practice, patient population, recording keeping, and compliance with coverage guidelines, the government said.

During the scheme, Dr. Shah submitted ECP-related claims for Medicare Part B, UPMC Health Plan, Highmark Blue Cross Blue Shield, and Gateway Health Plan beneficiaries totalling more than $13 million and received reimbursement payments in excess of $3.5 million.

“Rather than upholding the oath he swore and providing care for patients who trusted him, this defendant misled patients and drained critical Medicaid funds from families who needed it,” said Attorney General Josh Shapiro. “We will not let anyone put their patients’ lives at risk for a profit.”

“Today’s sentence holds Mr. Shah accountable for his appalling actions,” said FBI Pittsburgh Special Agent in Charge Mike Nordwall. “Mr. Shah used his position as a doctor to illegally profit from a health care program paid for by taxpayers. Fraud of this magnitude will not be tolerated.”

Dr. Shah has been in custody since July 15, 2021, after skipping out on his original July 14 sentencing date. The Tribune-Review reported that Dr. Shah filed a last-minute request for a continuance, claiming he had an adverse reaction to the Pfizer COVID-19 vaccination and was advised by his doctor that he needed “strict bedrest for at least 6 weeks.”

Dr. Shah reportedly turned himself after presiding U.S. District Judge David S. Cercone denied the motion and issued an arrest warrant.

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

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Cardiologist Samirkumar J. Shah, MD, was sentenced to 78 months in prison after his conviction on two counts of federal health care fraud involving more than $13 million.

Instants/Getty Images

As part of his sentence, Dr. Shah, 58, of Fox Chapel, Pa., must pay $1.7 million in restitution and other penalties and undergo 3 years of supervised release after prison.

“Dr. Shah risked the health of his patients so he could make millions of dollars through unnecessary procedures, and lied and fabricated records for years to perpetuate his fraud scheme,” acting U.S. Attorney Stephen R. Kaufman said in an Aug. 5 statement from the Department of Justice.

As previously reported, Dr. Shah was convicted June 14, 2019, of submitting fraudulent claims to private and federal insurance programs between 2008 and 2013 for external counterpulsation (ECP) therapy, a lower limb compression treatment approved for patients with coronary artery disease and refractory angina.

Dr. Shah, however, advertised ECP as the “fountain of youth,” claimed it made patients “younger and smarter,” and offered the treatment for conditions such as obesity, hypertension, hypotension, diabetes, and erectile dysfunction.

Patients were required to undergo diagnostic ultrasounds as a precautionary measure prior to starting ECP, but witness testimony established that Dr. Shah did not review any of the imaging before approving new patients for ECP, placing his patients at risk for serious injury or even death, the DOJ stated.

The evidence also showed that Dr. Shah double-billed insurers, routinely submitted fabricated patient files, and made false statements concerning his practice, patient population, recording keeping, and compliance with coverage guidelines, the government said.

During the scheme, Dr. Shah submitted ECP-related claims for Medicare Part B, UPMC Health Plan, Highmark Blue Cross Blue Shield, and Gateway Health Plan beneficiaries totalling more than $13 million and received reimbursement payments in excess of $3.5 million.

“Rather than upholding the oath he swore and providing care for patients who trusted him, this defendant misled patients and drained critical Medicaid funds from families who needed it,” said Attorney General Josh Shapiro. “We will not let anyone put their patients’ lives at risk for a profit.”

“Today’s sentence holds Mr. Shah accountable for his appalling actions,” said FBI Pittsburgh Special Agent in Charge Mike Nordwall. “Mr. Shah used his position as a doctor to illegally profit from a health care program paid for by taxpayers. Fraud of this magnitude will not be tolerated.”

Dr. Shah has been in custody since July 15, 2021, after skipping out on his original July 14 sentencing date. The Tribune-Review reported that Dr. Shah filed a last-minute request for a continuance, claiming he had an adverse reaction to the Pfizer COVID-19 vaccination and was advised by his doctor that he needed “strict bedrest for at least 6 weeks.”

Dr. Shah reportedly turned himself after presiding U.S. District Judge David S. Cercone denied the motion and issued an arrest warrant.

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

Cardiologist Samirkumar J. Shah, MD, was sentenced to 78 months in prison after his conviction on two counts of federal health care fraud involving more than $13 million.

Instants/Getty Images

As part of his sentence, Dr. Shah, 58, of Fox Chapel, Pa., must pay $1.7 million in restitution and other penalties and undergo 3 years of supervised release after prison.

“Dr. Shah risked the health of his patients so he could make millions of dollars through unnecessary procedures, and lied and fabricated records for years to perpetuate his fraud scheme,” acting U.S. Attorney Stephen R. Kaufman said in an Aug. 5 statement from the Department of Justice.

As previously reported, Dr. Shah was convicted June 14, 2019, of submitting fraudulent claims to private and federal insurance programs between 2008 and 2013 for external counterpulsation (ECP) therapy, a lower limb compression treatment approved for patients with coronary artery disease and refractory angina.

Dr. Shah, however, advertised ECP as the “fountain of youth,” claimed it made patients “younger and smarter,” and offered the treatment for conditions such as obesity, hypertension, hypotension, diabetes, and erectile dysfunction.

Patients were required to undergo diagnostic ultrasounds as a precautionary measure prior to starting ECP, but witness testimony established that Dr. Shah did not review any of the imaging before approving new patients for ECP, placing his patients at risk for serious injury or even death, the DOJ stated.

The evidence also showed that Dr. Shah double-billed insurers, routinely submitted fabricated patient files, and made false statements concerning his practice, patient population, recording keeping, and compliance with coverage guidelines, the government said.

During the scheme, Dr. Shah submitted ECP-related claims for Medicare Part B, UPMC Health Plan, Highmark Blue Cross Blue Shield, and Gateway Health Plan beneficiaries totalling more than $13 million and received reimbursement payments in excess of $3.5 million.

“Rather than upholding the oath he swore and providing care for patients who trusted him, this defendant misled patients and drained critical Medicaid funds from families who needed it,” said Attorney General Josh Shapiro. “We will not let anyone put their patients’ lives at risk for a profit.”

“Today’s sentence holds Mr. Shah accountable for his appalling actions,” said FBI Pittsburgh Special Agent in Charge Mike Nordwall. “Mr. Shah used his position as a doctor to illegally profit from a health care program paid for by taxpayers. Fraud of this magnitude will not be tolerated.”

Dr. Shah has been in custody since July 15, 2021, after skipping out on his original July 14 sentencing date. The Tribune-Review reported that Dr. Shah filed a last-minute request for a continuance, claiming he had an adverse reaction to the Pfizer COVID-19 vaccination and was advised by his doctor that he needed “strict bedrest for at least 6 weeks.”

Dr. Shah reportedly turned himself after presiding U.S. District Judge David S. Cercone denied the motion and issued an arrest warrant.

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

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Tackle obesity to drop risk for secondary cardiac event

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Patients who had been hospitalized for heart attack or cardiovascular revascularization procedures commonly were overweight (46%) or had obesity (35%), but at a follow-up visit, few had lost weight or planned to do so, according to researchers who conduced a large European study.

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The findings emphasize that obesity needs to be recognized as a disease that has to be optimally managed to lessen the risk for a secondary cardiovascular event, the authors stressed.

The study, by Dirk De Bacquer, PhD, professor, department of public health, Ghent (Belgium) University, and colleagues, was published recently in the European Heart Journal – Quality of Care and Clinical Outcomes.

The researchers analyzed data from more than 10,000 patients in the EUROASPIRE IV and V studies who were hospitalized for acute myocardial infarction (MI), coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) and answered a survey 16 months later on average.

Although 20% of the patients with obesity had lost 5% or more of their initial weight, 16% had gained 5% or more of their initial weight.

Notably, “the discharge letter did not record the weight status in a quarter of [the patients with obesity] and a substantial proportion reported to have never been told by a healthcare professional [that they were] overweight,” the investigators wrote.

“It seems,” Dr. De Bacquer and colleagues noted, “that obesity is not considered by physicians as a serious medical problem, which requires attention, recommendations, and obvious advice on personal weight targets.”

However, “the benefits for patients who lost weight in our study, resulting in a healthier cardiovascular risk profile, are really worthwhile,” they pointed out.
 

Cardiovascular rehabilitation should include weight loss intervention

“The safest and most effective approach for managing body weight” in patients with coronary artery disease and obesity “is adopting a healthy eating pattern and increasing levels of physical activity,” they wrote.

Their findings that “patients who reported reducing their fat and sugar intake, consuming more fruit, vegetables, and fish and doing more regular physical activity, had significant weight loss,” support this.

Dr. De Bacquer and colleagues recommend that cardiovascular prevention and rehabilitation programs “should include weight loss intervention, including different forms of self-support, as a specific component of a comprehensive intervention to reduce total cardiovascular risk, extend life expectancy, and improve quality of life.”

Clinicians should “consider the incremental value of telehealth intervention as well as recently described pharmacological interventions,” they added, noting that the study did not look at these options or at metabolic surgery.

Invited to comment, one expert pointed out that two new observational studies of metabolic surgery in patients with obesity and coronary artery disease reported positive outcomes.

Another expert took issue with the “patient blaming” tone of the article and the lack of actionable ways to help patients lose weight. 
 

Medical therapy or bariatric surgery as other options?

“The study demonstrated how prevalent obesity is in patients with heart disease“ and “confirmed how difficult it is to achieve weight loss, in particular, in patients with heart disease, where weight loss would be beneficial,” Erik Näslund, MD, PhD, said in an interview.

Even though “current guidelines stress weight-loss counseling, some patients actually gained weight,” observed Dr. Näslund, of Danderyd Hospital and Karolinska Institutet, Stockholm.

On the other hand, patients who lost 5% or more of their initial weight had reduced comorbidities that are associated with cardiovascular disease.

“The best way to achieve long-term weight loss in patients with severe obesity is metabolic (bariatric) surgery,” noted Dr. Näslund, who was not involved in the study. “There are now two recent papers in the journal Circulation that demonstrate that metabolic surgery has a role in the secondary prevention of cardiovascular disease in patients with severe obesity” – one study from Dr. Näslund’s group (Circulation. 2021;143:1458-67), as previously reported, and one study from researchers in Ontario, Canada (Circulation. 2021;143:1468-80).

However, those were observational studies, and the findings would need to be confirmed in a randomized clinical trial before they could be used as recommended practice of care, he cautioned. In addition, most patients in the current study would not fulfill the minimum body weight criteria for metabolic surgery.

“Therefore, there is a need for intensified medical therapy for these patients,” as another treatment option, said Dr. Näslund.

“It would be interesting,” he speculated, “to study how the new glucagon-like peptide-1 (GLP-1) receptor agonist therapies could work in this setting as a weight loss agent and perhaps have a positive independent cardiovascular benefit.”
 

Obesity is a disease; clinicians need to be respectful

Meanwhile, Obesity Society fellow and spokesperson Fatima Cody Stanford, MD, said in an interview that she didn’t think the language and tone of the article was respectful for patients with obesity, and the researchers “talked about the old narrative of how we support patients with obesity.”

Lifestyle modification can be at the core of treatment, but medication or bariatric surgery may be other options to “help patients get to their best selves.

“Patients with obesity deserve to be cared for and treated with respect,” said Dr. Stanford, an obesity medicine physician scientist at Massachusetts General Hospital and Harvard Medical School, Boston.

Treatment needs to be individualized and clinicians need to listen to patient concerns. For example, a patient with obesity may not be able to follow advice to walk more. “I can barely stand up,” one patient with obesity and osteoarthritis told Dr. Stanford.

And patients’ insurance may not cover cardiac rehabilitation – especially patients from racial minorities or those with lower socioeconomic status, she noted.

“My feeling has always been that it is important to be respectful to all patients,” Dr. Näslund agreed. “I do agree that we need to recognize obesity as a chronic disease, and the paper in EHJ demonstrates this, as obesity was not registered in many of the discharge notes.

“If we as healthcare workers measured a weight of our patients the same way that we take a blood pressure,” he said, “perhaps the [stigma] of obesity would be reduced.”
 

Study findings

The researchers examined pooled data from EUROASPIRE IV (2012-13) and EUROASPIRE V (2016-17) surveys of patients who were overweight or had obesity who had been discharged from hospital after MI, CABG, or PCI to determine if they had received lifestyle advice for weight loss, if they had acted on this advice, and if losing weight altered their cardiovascular disease risk factors.

They identified 10,507 adult patients in 29 mainly European countries who had complete survey data.

The mean age of the patients was 63 at the time of their hospitalization; 25% were women. Many had hypertension (66%-88%), dyslipidemia (69%-80%), or diabetes (16%-37%).

The prevalence of obesity varied from 8% to 46% in men and from 18% to 57% in women, in different countries. Patients with obesity had a mean body weight of 97 kg (213 pounds).

One of the most “striking” findings was the “apparent lack of motivation” to lose weight, Dr. De Bacquer and colleagues wrote. Half of the patients with obesity had not attempted to lose weight in the month before the follow-up visit and most did not plan to do so in the following month.

Goal setting is an important aspect of behavior modification techniques, they wrote, yet 7% of the patients did not know their body weight and 21% did not have an optimal weight target.

Half of the patients had been advised to follow a cardiac rehabilitation program and two-thirds had been advised to follow dietary recommendations and move more.

Those who made positive dietary changes and were more physically active were more likely to lose at least 5% of their weight.

And patients who lost at least 5% of their initial weight were less likely to have hypertension, dyslipidemia, or diabetes compared with patients who had gained this much weight, which “is likely to translate into improved prognosis on the long term,” the authors wrote.

EUROASPIRE IV and V were supported through research grants to the European Society of Cardiology from Amgen, AstraZeneca, Bristol-Myers Squibb/Emea Sarl, GlaxoSmithKline, Hoffmann-La Roche, and Merck, Sharp & Dohme (EUROASPIRE IV) and Amarin, Amgen, Daiichi Sankyo, Eli Lilly, Pfizer, Sanofi, Ferrer, and Novo Nordisk (EUROASPIRE V). Dr. De Bacquer, Dr. Näslund, and Dr. Stanford have no disclosed no relevant financial relationships.

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

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Patients who had been hospitalized for heart attack or cardiovascular revascularization procedures commonly were overweight (46%) or had obesity (35%), but at a follow-up visit, few had lost weight or planned to do so, according to researchers who conduced a large European study.

Creatas Images/ThinkStockPhotos

The findings emphasize that obesity needs to be recognized as a disease that has to be optimally managed to lessen the risk for a secondary cardiovascular event, the authors stressed.

The study, by Dirk De Bacquer, PhD, professor, department of public health, Ghent (Belgium) University, and colleagues, was published recently in the European Heart Journal – Quality of Care and Clinical Outcomes.

The researchers analyzed data from more than 10,000 patients in the EUROASPIRE IV and V studies who were hospitalized for acute myocardial infarction (MI), coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) and answered a survey 16 months later on average.

Although 20% of the patients with obesity had lost 5% or more of their initial weight, 16% had gained 5% or more of their initial weight.

Notably, “the discharge letter did not record the weight status in a quarter of [the patients with obesity] and a substantial proportion reported to have never been told by a healthcare professional [that they were] overweight,” the investigators wrote.

“It seems,” Dr. De Bacquer and colleagues noted, “that obesity is not considered by physicians as a serious medical problem, which requires attention, recommendations, and obvious advice on personal weight targets.”

However, “the benefits for patients who lost weight in our study, resulting in a healthier cardiovascular risk profile, are really worthwhile,” they pointed out.
 

Cardiovascular rehabilitation should include weight loss intervention

“The safest and most effective approach for managing body weight” in patients with coronary artery disease and obesity “is adopting a healthy eating pattern and increasing levels of physical activity,” they wrote.

Their findings that “patients who reported reducing their fat and sugar intake, consuming more fruit, vegetables, and fish and doing more regular physical activity, had significant weight loss,” support this.

Dr. De Bacquer and colleagues recommend that cardiovascular prevention and rehabilitation programs “should include weight loss intervention, including different forms of self-support, as a specific component of a comprehensive intervention to reduce total cardiovascular risk, extend life expectancy, and improve quality of life.”

Clinicians should “consider the incremental value of telehealth intervention as well as recently described pharmacological interventions,” they added, noting that the study did not look at these options or at metabolic surgery.

Invited to comment, one expert pointed out that two new observational studies of metabolic surgery in patients with obesity and coronary artery disease reported positive outcomes.

Another expert took issue with the “patient blaming” tone of the article and the lack of actionable ways to help patients lose weight. 
 

Medical therapy or bariatric surgery as other options?

“The study demonstrated how prevalent obesity is in patients with heart disease“ and “confirmed how difficult it is to achieve weight loss, in particular, in patients with heart disease, where weight loss would be beneficial,” Erik Näslund, MD, PhD, said in an interview.

Even though “current guidelines stress weight-loss counseling, some patients actually gained weight,” observed Dr. Näslund, of Danderyd Hospital and Karolinska Institutet, Stockholm.

On the other hand, patients who lost 5% or more of their initial weight had reduced comorbidities that are associated with cardiovascular disease.

“The best way to achieve long-term weight loss in patients with severe obesity is metabolic (bariatric) surgery,” noted Dr. Näslund, who was not involved in the study. “There are now two recent papers in the journal Circulation that demonstrate that metabolic surgery has a role in the secondary prevention of cardiovascular disease in patients with severe obesity” – one study from Dr. Näslund’s group (Circulation. 2021;143:1458-67), as previously reported, and one study from researchers in Ontario, Canada (Circulation. 2021;143:1468-80).

However, those were observational studies, and the findings would need to be confirmed in a randomized clinical trial before they could be used as recommended practice of care, he cautioned. In addition, most patients in the current study would not fulfill the minimum body weight criteria for metabolic surgery.

“Therefore, there is a need for intensified medical therapy for these patients,” as another treatment option, said Dr. Näslund.

“It would be interesting,” he speculated, “to study how the new glucagon-like peptide-1 (GLP-1) receptor agonist therapies could work in this setting as a weight loss agent and perhaps have a positive independent cardiovascular benefit.”
 

Obesity is a disease; clinicians need to be respectful

Meanwhile, Obesity Society fellow and spokesperson Fatima Cody Stanford, MD, said in an interview that she didn’t think the language and tone of the article was respectful for patients with obesity, and the researchers “talked about the old narrative of how we support patients with obesity.”

Lifestyle modification can be at the core of treatment, but medication or bariatric surgery may be other options to “help patients get to their best selves.

“Patients with obesity deserve to be cared for and treated with respect,” said Dr. Stanford, an obesity medicine physician scientist at Massachusetts General Hospital and Harvard Medical School, Boston.

Treatment needs to be individualized and clinicians need to listen to patient concerns. For example, a patient with obesity may not be able to follow advice to walk more. “I can barely stand up,” one patient with obesity and osteoarthritis told Dr. Stanford.

And patients’ insurance may not cover cardiac rehabilitation – especially patients from racial minorities or those with lower socioeconomic status, she noted.

“My feeling has always been that it is important to be respectful to all patients,” Dr. Näslund agreed. “I do agree that we need to recognize obesity as a chronic disease, and the paper in EHJ demonstrates this, as obesity was not registered in many of the discharge notes.

“If we as healthcare workers measured a weight of our patients the same way that we take a blood pressure,” he said, “perhaps the [stigma] of obesity would be reduced.”
 

Study findings

The researchers examined pooled data from EUROASPIRE IV (2012-13) and EUROASPIRE V (2016-17) surveys of patients who were overweight or had obesity who had been discharged from hospital after MI, CABG, or PCI to determine if they had received lifestyle advice for weight loss, if they had acted on this advice, and if losing weight altered their cardiovascular disease risk factors.

They identified 10,507 adult patients in 29 mainly European countries who had complete survey data.

The mean age of the patients was 63 at the time of their hospitalization; 25% were women. Many had hypertension (66%-88%), dyslipidemia (69%-80%), or diabetes (16%-37%).

The prevalence of obesity varied from 8% to 46% in men and from 18% to 57% in women, in different countries. Patients with obesity had a mean body weight of 97 kg (213 pounds).

One of the most “striking” findings was the “apparent lack of motivation” to lose weight, Dr. De Bacquer and colleagues wrote. Half of the patients with obesity had not attempted to lose weight in the month before the follow-up visit and most did not plan to do so in the following month.

Goal setting is an important aspect of behavior modification techniques, they wrote, yet 7% of the patients did not know their body weight and 21% did not have an optimal weight target.

Half of the patients had been advised to follow a cardiac rehabilitation program and two-thirds had been advised to follow dietary recommendations and move more.

Those who made positive dietary changes and were more physically active were more likely to lose at least 5% of their weight.

And patients who lost at least 5% of their initial weight were less likely to have hypertension, dyslipidemia, or diabetes compared with patients who had gained this much weight, which “is likely to translate into improved prognosis on the long term,” the authors wrote.

EUROASPIRE IV and V were supported through research grants to the European Society of Cardiology from Amgen, AstraZeneca, Bristol-Myers Squibb/Emea Sarl, GlaxoSmithKline, Hoffmann-La Roche, and Merck, Sharp & Dohme (EUROASPIRE IV) and Amarin, Amgen, Daiichi Sankyo, Eli Lilly, Pfizer, Sanofi, Ferrer, and Novo Nordisk (EUROASPIRE V). Dr. De Bacquer, Dr. Näslund, and Dr. Stanford have no disclosed no relevant financial relationships.

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

Patients who had been hospitalized for heart attack or cardiovascular revascularization procedures commonly were overweight (46%) or had obesity (35%), but at a follow-up visit, few had lost weight or planned to do so, according to researchers who conduced a large European study.

Creatas Images/ThinkStockPhotos

The findings emphasize that obesity needs to be recognized as a disease that has to be optimally managed to lessen the risk for a secondary cardiovascular event, the authors stressed.

The study, by Dirk De Bacquer, PhD, professor, department of public health, Ghent (Belgium) University, and colleagues, was published recently in the European Heart Journal – Quality of Care and Clinical Outcomes.

The researchers analyzed data from more than 10,000 patients in the EUROASPIRE IV and V studies who were hospitalized for acute myocardial infarction (MI), coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI) and answered a survey 16 months later on average.

Although 20% of the patients with obesity had lost 5% or more of their initial weight, 16% had gained 5% or more of their initial weight.

Notably, “the discharge letter did not record the weight status in a quarter of [the patients with obesity] and a substantial proportion reported to have never been told by a healthcare professional [that they were] overweight,” the investigators wrote.

“It seems,” Dr. De Bacquer and colleagues noted, “that obesity is not considered by physicians as a serious medical problem, which requires attention, recommendations, and obvious advice on personal weight targets.”

However, “the benefits for patients who lost weight in our study, resulting in a healthier cardiovascular risk profile, are really worthwhile,” they pointed out.
 

Cardiovascular rehabilitation should include weight loss intervention

“The safest and most effective approach for managing body weight” in patients with coronary artery disease and obesity “is adopting a healthy eating pattern and increasing levels of physical activity,” they wrote.

Their findings that “patients who reported reducing their fat and sugar intake, consuming more fruit, vegetables, and fish and doing more regular physical activity, had significant weight loss,” support this.

Dr. De Bacquer and colleagues recommend that cardiovascular prevention and rehabilitation programs “should include weight loss intervention, including different forms of self-support, as a specific component of a comprehensive intervention to reduce total cardiovascular risk, extend life expectancy, and improve quality of life.”

Clinicians should “consider the incremental value of telehealth intervention as well as recently described pharmacological interventions,” they added, noting that the study did not look at these options or at metabolic surgery.

Invited to comment, one expert pointed out that two new observational studies of metabolic surgery in patients with obesity and coronary artery disease reported positive outcomes.

Another expert took issue with the “patient blaming” tone of the article and the lack of actionable ways to help patients lose weight. 
 

Medical therapy or bariatric surgery as other options?

“The study demonstrated how prevalent obesity is in patients with heart disease“ and “confirmed how difficult it is to achieve weight loss, in particular, in patients with heart disease, where weight loss would be beneficial,” Erik Näslund, MD, PhD, said in an interview.

Even though “current guidelines stress weight-loss counseling, some patients actually gained weight,” observed Dr. Näslund, of Danderyd Hospital and Karolinska Institutet, Stockholm.

On the other hand, patients who lost 5% or more of their initial weight had reduced comorbidities that are associated with cardiovascular disease.

“The best way to achieve long-term weight loss in patients with severe obesity is metabolic (bariatric) surgery,” noted Dr. Näslund, who was not involved in the study. “There are now two recent papers in the journal Circulation that demonstrate that metabolic surgery has a role in the secondary prevention of cardiovascular disease in patients with severe obesity” – one study from Dr. Näslund’s group (Circulation. 2021;143:1458-67), as previously reported, and one study from researchers in Ontario, Canada (Circulation. 2021;143:1468-80).

However, those were observational studies, and the findings would need to be confirmed in a randomized clinical trial before they could be used as recommended practice of care, he cautioned. In addition, most patients in the current study would not fulfill the minimum body weight criteria for metabolic surgery.

“Therefore, there is a need for intensified medical therapy for these patients,” as another treatment option, said Dr. Näslund.

“It would be interesting,” he speculated, “to study how the new glucagon-like peptide-1 (GLP-1) receptor agonist therapies could work in this setting as a weight loss agent and perhaps have a positive independent cardiovascular benefit.”
 

Obesity is a disease; clinicians need to be respectful

Meanwhile, Obesity Society fellow and spokesperson Fatima Cody Stanford, MD, said in an interview that she didn’t think the language and tone of the article was respectful for patients with obesity, and the researchers “talked about the old narrative of how we support patients with obesity.”

Lifestyle modification can be at the core of treatment, but medication or bariatric surgery may be other options to “help patients get to their best selves.

“Patients with obesity deserve to be cared for and treated with respect,” said Dr. Stanford, an obesity medicine physician scientist at Massachusetts General Hospital and Harvard Medical School, Boston.

Treatment needs to be individualized and clinicians need to listen to patient concerns. For example, a patient with obesity may not be able to follow advice to walk more. “I can barely stand up,” one patient with obesity and osteoarthritis told Dr. Stanford.

And patients’ insurance may not cover cardiac rehabilitation – especially patients from racial minorities or those with lower socioeconomic status, she noted.

“My feeling has always been that it is important to be respectful to all patients,” Dr. Näslund agreed. “I do agree that we need to recognize obesity as a chronic disease, and the paper in EHJ demonstrates this, as obesity was not registered in many of the discharge notes.

“If we as healthcare workers measured a weight of our patients the same way that we take a blood pressure,” he said, “perhaps the [stigma] of obesity would be reduced.”
 

Study findings

The researchers examined pooled data from EUROASPIRE IV (2012-13) and EUROASPIRE V (2016-17) surveys of patients who were overweight or had obesity who had been discharged from hospital after MI, CABG, or PCI to determine if they had received lifestyle advice for weight loss, if they had acted on this advice, and if losing weight altered their cardiovascular disease risk factors.

They identified 10,507 adult patients in 29 mainly European countries who had complete survey data.

The mean age of the patients was 63 at the time of their hospitalization; 25% were women. Many had hypertension (66%-88%), dyslipidemia (69%-80%), or diabetes (16%-37%).

The prevalence of obesity varied from 8% to 46% in men and from 18% to 57% in women, in different countries. Patients with obesity had a mean body weight of 97 kg (213 pounds).

One of the most “striking” findings was the “apparent lack of motivation” to lose weight, Dr. De Bacquer and colleagues wrote. Half of the patients with obesity had not attempted to lose weight in the month before the follow-up visit and most did not plan to do so in the following month.

Goal setting is an important aspect of behavior modification techniques, they wrote, yet 7% of the patients did not know their body weight and 21% did not have an optimal weight target.

Half of the patients had been advised to follow a cardiac rehabilitation program and two-thirds had been advised to follow dietary recommendations and move more.

Those who made positive dietary changes and were more physically active were more likely to lose at least 5% of their weight.

And patients who lost at least 5% of their initial weight were less likely to have hypertension, dyslipidemia, or diabetes compared with patients who had gained this much weight, which “is likely to translate into improved prognosis on the long term,” the authors wrote.

EUROASPIRE IV and V were supported through research grants to the European Society of Cardiology from Amgen, AstraZeneca, Bristol-Myers Squibb/Emea Sarl, GlaxoSmithKline, Hoffmann-La Roche, and Merck, Sharp & Dohme (EUROASPIRE IV) and Amarin, Amgen, Daiichi Sankyo, Eli Lilly, Pfizer, Sanofi, Ferrer, and Novo Nordisk (EUROASPIRE V). Dr. De Bacquer, Dr. Näslund, and Dr. Stanford have no disclosed no relevant financial relationships.

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

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Plant-based lignan intake linked to lower CHD risk 

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Tue, 05/03/2022 - 15:04

Consumption of a plant-based diet rich in lignans is associated with a lower risk of coronary heart disease (CHD), new research suggests.

Kirby Hamilton/iStockphoto

In a prospective cohort study that followed almost 214,108 men and women who were free of CHD and cancer at baseline, increased long-term intake of lignans, polyphenolic substances produced by plants, was associated with significantly lower risk of total CHD in both men and women.

The benefit was increased in participants with a greater intake of fiber, suggesting that synergistic effects between the two might exist in relation to CHD reduction.

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

“Lignan is an estrogen-like molecule, so it exerts some estrogenic effects which are cardioprotective. It also has anti-inflammatory properties,” first author Yang Hu, ScD, a research fellow at the Harvard School of Public Health, Boston, said in an interview.

“Our results that showed an inverse association between lignan consumption and heart disease risk were expected, because it is known that lignans, which are predominantly from plant-based foods, like whole grains, fruit, vegetables, red wine, and coffee, are all associated with lower CHD risk,” Dr. Hu said.

What is novel about the current study is that it established a threshold for lignan consumption, above which there is no CHD benefit, he said.

“It is not a matter of the more you consume, the lower your risk. There is a certain amount of lignan you have to reach, after which there is no more benefit,” Dr. Hu said.

Dr. Hu and associates prospectively followed 214,108 men and women in three cohorts who did not have cardiovascular disease or cancer at baseline. The cohorts were the Health Professionals Follow-Up Study, Nurses’ Health Study, and Nurses’ Health Study II.

Diets were assessed using the Food Frequency Questionnaire every 2-4 years at follow-up visits.

During 5.5 million person-years of follow-up, Dr. Hu and associates documented 10,244 CHD cases, including 6,283 nonfatal myocardial infarctions and 3,961 fatal CHD cases.

The results showed that higher total lignan intake, and all individual lignan intake as well, were associated with significantly lower risk of total CHD.

Participants with higher total lignan intake were older and had more favorable health and lifestyle profiles including lower body mass index, lower prevalence of hypertension and hypercholesterolemia, high levels of physical activity, and better diet quality.

Overall, the pooled hazard ratios of CHD were 0.85 (95% confidence interval, 0.79-0.92) for total lignans, 0.76 (95% CI, 0.71-0.82) for matairesinol, 0.87 (95% CI, 0.81-0.93) for secoisolariciresinol, 0.89 (95% CI, 0.83-0.95) for pinoresinol, and 0.89 (95% CI: 0.83- 0.95) for lariciresinol (all P values for trend ≤ .003).

In addition, nonlinear relationships were found for total lignan, matairesinol, and secoisolariciresinol: The risk reduction plateaued at intakes above approximately 300 mcg/d for total lignan; 10 mcg/d for matairesinol, and 100 mcg/d for secoisolariciresinol.

The inverse associations for total lignan intake were more apparent among participants with higher total fiber intake.

In addition, lignan intake was more strongly associated with plasma concentrations of enterolactone when fiber intake was higher.

Dr. Hu said a next avenue of research will explore the synergistic association between lignans and fiber in further lowering CHD risk.

Lignans are exclusively metabolized by gut microbiota, Dr. Hu noted. “This opens another avenue of research because we can take further steps to see how the gut microbiota compositions and fiber interact with the production of lignans and how these might affect disease risk for other conditions, such as diabetes.”
 

 

 

An important study

“The evidence is building that there is an association between polyphenol intake and chronic disease, especially for CVD [cardiovascular disease],” David J.A. Jenkins, MD, PhD, and colleagues wrote in an accompanying editorial.

“Plant polyphenols may be important components of healthy plant-based diets that contribute to freedom from chronic diseases such as CVD, diabetes, and possibly cancer and so are associated with a reduction in all-cause mortality,” they wrote.

“I think this is an important study even though the results are not unexpected,” Dr. Jenkins, professor in the departments of medicine and nutritional sciences at the University of Toronto, said in an interview.

“We do know that plant polyphenols are important sources of antioxidants and may have many protective roles in preventing destruction of proteins and DNA destruction, so the results here reinforce very strongly the concept of plant foods and their importance in the diet,” he said.

The data reaffirmed the value of eating a variety of plant foods and eating them in a less processed form, because they have higher amounts of their phenolic compounds, Dr. Jenkins said.

“Things like wheat, oats, barley, [and] whole grain foods will have more phenolic components with them, as do fruits and vegetables,” he said.

Dr. Hu and Dr. Jenkins disclosed no relevant financial relationships.  

Aversion of this article first appeared on Medscape.com.

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Consumption of a plant-based diet rich in lignans is associated with a lower risk of coronary heart disease (CHD), new research suggests.

Kirby Hamilton/iStockphoto

In a prospective cohort study that followed almost 214,108 men and women who were free of CHD and cancer at baseline, increased long-term intake of lignans, polyphenolic substances produced by plants, was associated with significantly lower risk of total CHD in both men and women.

The benefit was increased in participants with a greater intake of fiber, suggesting that synergistic effects between the two might exist in relation to CHD reduction.

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

“Lignan is an estrogen-like molecule, so it exerts some estrogenic effects which are cardioprotective. It also has anti-inflammatory properties,” first author Yang Hu, ScD, a research fellow at the Harvard School of Public Health, Boston, said in an interview.

“Our results that showed an inverse association between lignan consumption and heart disease risk were expected, because it is known that lignans, which are predominantly from plant-based foods, like whole grains, fruit, vegetables, red wine, and coffee, are all associated with lower CHD risk,” Dr. Hu said.

What is novel about the current study is that it established a threshold for lignan consumption, above which there is no CHD benefit, he said.

“It is not a matter of the more you consume, the lower your risk. There is a certain amount of lignan you have to reach, after which there is no more benefit,” Dr. Hu said.

Dr. Hu and associates prospectively followed 214,108 men and women in three cohorts who did not have cardiovascular disease or cancer at baseline. The cohorts were the Health Professionals Follow-Up Study, Nurses’ Health Study, and Nurses’ Health Study II.

Diets were assessed using the Food Frequency Questionnaire every 2-4 years at follow-up visits.

During 5.5 million person-years of follow-up, Dr. Hu and associates documented 10,244 CHD cases, including 6,283 nonfatal myocardial infarctions and 3,961 fatal CHD cases.

The results showed that higher total lignan intake, and all individual lignan intake as well, were associated with significantly lower risk of total CHD.

Participants with higher total lignan intake were older and had more favorable health and lifestyle profiles including lower body mass index, lower prevalence of hypertension and hypercholesterolemia, high levels of physical activity, and better diet quality.

Overall, the pooled hazard ratios of CHD were 0.85 (95% confidence interval, 0.79-0.92) for total lignans, 0.76 (95% CI, 0.71-0.82) for matairesinol, 0.87 (95% CI, 0.81-0.93) for secoisolariciresinol, 0.89 (95% CI, 0.83-0.95) for pinoresinol, and 0.89 (95% CI: 0.83- 0.95) for lariciresinol (all P values for trend ≤ .003).

In addition, nonlinear relationships were found for total lignan, matairesinol, and secoisolariciresinol: The risk reduction plateaued at intakes above approximately 300 mcg/d for total lignan; 10 mcg/d for matairesinol, and 100 mcg/d for secoisolariciresinol.

The inverse associations for total lignan intake were more apparent among participants with higher total fiber intake.

In addition, lignan intake was more strongly associated with plasma concentrations of enterolactone when fiber intake was higher.

Dr. Hu said a next avenue of research will explore the synergistic association between lignans and fiber in further lowering CHD risk.

Lignans are exclusively metabolized by gut microbiota, Dr. Hu noted. “This opens another avenue of research because we can take further steps to see how the gut microbiota compositions and fiber interact with the production of lignans and how these might affect disease risk for other conditions, such as diabetes.”
 

 

 

An important study

“The evidence is building that there is an association between polyphenol intake and chronic disease, especially for CVD [cardiovascular disease],” David J.A. Jenkins, MD, PhD, and colleagues wrote in an accompanying editorial.

“Plant polyphenols may be important components of healthy plant-based diets that contribute to freedom from chronic diseases such as CVD, diabetes, and possibly cancer and so are associated with a reduction in all-cause mortality,” they wrote.

“I think this is an important study even though the results are not unexpected,” Dr. Jenkins, professor in the departments of medicine and nutritional sciences at the University of Toronto, said in an interview.

“We do know that plant polyphenols are important sources of antioxidants and may have many protective roles in preventing destruction of proteins and DNA destruction, so the results here reinforce very strongly the concept of plant foods and their importance in the diet,” he said.

The data reaffirmed the value of eating a variety of plant foods and eating them in a less processed form, because they have higher amounts of their phenolic compounds, Dr. Jenkins said.

“Things like wheat, oats, barley, [and] whole grain foods will have more phenolic components with them, as do fruits and vegetables,” he said.

Dr. Hu and Dr. Jenkins disclosed no relevant financial relationships.  

Aversion of this article first appeared on Medscape.com.

Consumption of a plant-based diet rich in lignans is associated with a lower risk of coronary heart disease (CHD), new research suggests.

Kirby Hamilton/iStockphoto

In a prospective cohort study that followed almost 214,108 men and women who were free of CHD and cancer at baseline, increased long-term intake of lignans, polyphenolic substances produced by plants, was associated with significantly lower risk of total CHD in both men and women.

The benefit was increased in participants with a greater intake of fiber, suggesting that synergistic effects between the two might exist in relation to CHD reduction.

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

“Lignan is an estrogen-like molecule, so it exerts some estrogenic effects which are cardioprotective. It also has anti-inflammatory properties,” first author Yang Hu, ScD, a research fellow at the Harvard School of Public Health, Boston, said in an interview.

“Our results that showed an inverse association between lignan consumption and heart disease risk were expected, because it is known that lignans, which are predominantly from plant-based foods, like whole grains, fruit, vegetables, red wine, and coffee, are all associated with lower CHD risk,” Dr. Hu said.

What is novel about the current study is that it established a threshold for lignan consumption, above which there is no CHD benefit, he said.

“It is not a matter of the more you consume, the lower your risk. There is a certain amount of lignan you have to reach, after which there is no more benefit,” Dr. Hu said.

Dr. Hu and associates prospectively followed 214,108 men and women in three cohorts who did not have cardiovascular disease or cancer at baseline. The cohorts were the Health Professionals Follow-Up Study, Nurses’ Health Study, and Nurses’ Health Study II.

Diets were assessed using the Food Frequency Questionnaire every 2-4 years at follow-up visits.

During 5.5 million person-years of follow-up, Dr. Hu and associates documented 10,244 CHD cases, including 6,283 nonfatal myocardial infarctions and 3,961 fatal CHD cases.

The results showed that higher total lignan intake, and all individual lignan intake as well, were associated with significantly lower risk of total CHD.

Participants with higher total lignan intake were older and had more favorable health and lifestyle profiles including lower body mass index, lower prevalence of hypertension and hypercholesterolemia, high levels of physical activity, and better diet quality.

Overall, the pooled hazard ratios of CHD were 0.85 (95% confidence interval, 0.79-0.92) for total lignans, 0.76 (95% CI, 0.71-0.82) for matairesinol, 0.87 (95% CI, 0.81-0.93) for secoisolariciresinol, 0.89 (95% CI, 0.83-0.95) for pinoresinol, and 0.89 (95% CI: 0.83- 0.95) for lariciresinol (all P values for trend ≤ .003).

In addition, nonlinear relationships were found for total lignan, matairesinol, and secoisolariciresinol: The risk reduction plateaued at intakes above approximately 300 mcg/d for total lignan; 10 mcg/d for matairesinol, and 100 mcg/d for secoisolariciresinol.

The inverse associations for total lignan intake were more apparent among participants with higher total fiber intake.

In addition, lignan intake was more strongly associated with plasma concentrations of enterolactone when fiber intake was higher.

Dr. Hu said a next avenue of research will explore the synergistic association between lignans and fiber in further lowering CHD risk.

Lignans are exclusively metabolized by gut microbiota, Dr. Hu noted. “This opens another avenue of research because we can take further steps to see how the gut microbiota compositions and fiber interact with the production of lignans and how these might affect disease risk for other conditions, such as diabetes.”
 

 

 

An important study

“The evidence is building that there is an association between polyphenol intake and chronic disease, especially for CVD [cardiovascular disease],” David J.A. Jenkins, MD, PhD, and colleagues wrote in an accompanying editorial.

“Plant polyphenols may be important components of healthy plant-based diets that contribute to freedom from chronic diseases such as CVD, diabetes, and possibly cancer and so are associated with a reduction in all-cause mortality,” they wrote.

“I think this is an important study even though the results are not unexpected,” Dr. Jenkins, professor in the departments of medicine and nutritional sciences at the University of Toronto, said in an interview.

“We do know that plant polyphenols are important sources of antioxidants and may have many protective roles in preventing destruction of proteins and DNA destruction, so the results here reinforce very strongly the concept of plant foods and their importance in the diet,” he said.

The data reaffirmed the value of eating a variety of plant foods and eating them in a less processed form, because they have higher amounts of their phenolic compounds, Dr. Jenkins said.

“Things like wheat, oats, barley, [and] whole grain foods will have more phenolic components with them, as do fruits and vegetables,” he said.

Dr. Hu and Dr. Jenkins disclosed no relevant financial relationships.  

Aversion of this article first appeared on Medscape.com.

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Patients with diabetes more likely to be hospitalized, especially with foot infection

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Tue, 05/03/2022 - 15:04

People with diabetes are at increased risk of hospitalization for infection, as well as infection-related mortality, shows a large U.S. study that suggests the risk is even higher in younger and Black individuals.

Michael Fang, PhD, Johns Hopkins University, Baltimore, and colleagues studied more than 12,000 participants in a community cohort study who were followed for an average of 24 years, between 1987-1989 and 2019.

Participants with diabetes faced a 67% increase risk of infection-related hospitalization, compared with those without diabetes.

Of particular note, the risk of hospitalization with foot infection was almost sixfold higher for people with diabetes than those without.

The research, published in Diabetologia on August 4, also suggests that diabetes may be associated with a 72% increased risk of infection-related mortality, although the absolute numbers were small.

Dr. Fang explained to this news organization that they focused on infection-related hospitalization and mortality “because these are comprehensively tracked in administrative data and ... are the most severe types of outcomes.”

However, this is probably just the tip of the iceberg, as people with diabetes are “likely at increased risk for milder infection too,” which can have a “significant adverse impact on people’s well-being and quality of life.”

As a result of their findings, the authors call for “broader guidance on infection prevention and management” in people with diabetes. To achieve this, Dr. Fang said, “we need to better understand why diabetes is associated with an increased risk of infection-related complications.”

“One likely factor is glycemic control: Emerging research suggests patients with diabetes with better glycemic control may be at significantly lower risk of infection-related complications.”

He continued that, in younger patients, a factor for worse outcomes could be that “diabetes tends to be more aggressive when it emerges early in life,” while in Black patients “there is research highlighting Black-White differences in glycemic control, access to care, and beliefs around vaccines.”

Overall, their findings – coupled with recent data showing that diabetes is an important risk factor for adverse outcomes with COVID-19 infection – paint “a common picture,” Dr. Fang said.

“People with diabetes are much more susceptible to infection-related complications, including COVID-related hospitalization and mortality,” which suggests people with diabetes “may need to be especially cautious.”
 

Adds to existing literature; amputations begin with infections

Robert A. Gabbay, MD, PhD, chief scientific and medical officer for the American Diabetes Association (ADA), said the study “does add to the existing literature by having followed a larger number of people over time and linking them to serious complications from infections.”

“Sadly, we have seen this play out in real-time during the COVID-19 pandemic.”

“One of the sobering bits of data is the significant health disparities that exist in Black Americans and the fact that foot infections remain a significant problem,” he said in an interview.

“Given that amputation rates for [Black Americans] are three times higher than White Americans, amputations begin with infections,” Dr. Gabbay added, noting the ADA “has been taking a strong stand to prevent amputations and address the inequities in health that exist.”

Jamie Hartmann-Boyce, PhD, from the University of Oxford, U.K., who was not involved in the study, commented that diabetes is a “well-known risk factor for worse outcomes from all kinds of infection,” which is why they “are prioritized for flu vaccination every year.”

She told this news organization that the current study “further confirms that people with diabetes are more likely to be hospitalized for infection of any type and most markedly for foot infection.”

“These new data further highlight the need for public health interventions to prevent type 2 diabetes, and for preventive health care in people with diabetes, including access to diabetes medications and support and to vaccinations to prevent infection,” added Dr. Hartmann-Boyce, who is a senior research fellow in health behaviors.

Diabetes is thought to be associated with susceptibility to infection via mechanisms such as impaired neutrophil functioning and humoral immune responses, and studies have shown a link with both common and rare infections.

However, the authors point out that “most” of those included “small clinical populations and were cross-sectional or had short follow-up.”

Guidelines for diabetes management, they note, also “pay less attention” to infectious diseases than they do to the prevention of micro- and macrovascular complications.
 

 

 

ARIC data mined for infections in those with diabetes

The team analyzed data from the ongoing U.S. community-based Atherosclerosis Risk in Communities (ARIC) study.

The National Heart, Lung, and Blood Institute–sponsored cohort was comprised of adults aged 45-64 years from four U.S. communities, recruited between 1987 and 1989 for clinical examinations, medical interviews, and laboratory tests, repeated over five more visits up to 2018-2019.

For the current analysis, the team included 12,739 individuals with a mean age of 54.5 years, of whom 54.3% were female and 24.7% were Black.

Patients were defined as having diabetes if their baseline fasting blood glucose was greater than or equal to 7 mmol/L, or nonfasting glucose was greater than or equal to 11.1 mmol/l, they self-reported a diagnosis of diabetes by a physician, or they were taking glucose-lowering medication at the first study visit. The researchers weren’t able to distinguish between type 1 and type 2 diabetes.

In total, 1,485 individuals had diabetes at baseline. They were more likely to be older, Black, have a low socioeconomic status, and have worse cardiometabolic health than participants without diabetes.

Over an average follow-up of 23.8 years, there were 4,229 incident hospitalizations for infection, at an overall rate of 15.9 per 1,000 person-years.

Individuals with diabetes at baseline had a higher rate of hospitalizations than those without, at 25.4 per 1,000 person-years versus 15.2 per 1,000 person-years.

After taking into account sociodemographic characteristics, socioeconomic status, and cardiometabolic risk factors, this equated to a hazard ratio for hospitalization with any infection of 1.67 (P < .001).

The risk of hospitalization for any infection was significantly higher for younger patients with diabetes, defined as aged less than 55 years (P = .005), and for Black patients (P < .001).

While the increased risk was generally consistent across infection types, it was markedly increased for foot infection, at a hazard ratio of 5.99 (P < .001).

Overall, there were few deaths due to infection in the study, at just 362. The risk of infection mortality was nevertheless significantly increased in people with diabetes, at an adjusted hazard ratio of 1.72 (P < .001).

Dr. Fang has reported being supported by a grant from the National Institutes of Health/National Heart, Lung, and Blood Institute. Dr. Selvin has reported being supported by grants from the National Institutes of Health/National Heart, Lung, and Blood Institute and National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Selvin is an associate editor for Diabetologia and had no role in the peer review of the manuscript.

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

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People with diabetes are at increased risk of hospitalization for infection, as well as infection-related mortality, shows a large U.S. study that suggests the risk is even higher in younger and Black individuals.

Michael Fang, PhD, Johns Hopkins University, Baltimore, and colleagues studied more than 12,000 participants in a community cohort study who were followed for an average of 24 years, between 1987-1989 and 2019.

Participants with diabetes faced a 67% increase risk of infection-related hospitalization, compared with those without diabetes.

Of particular note, the risk of hospitalization with foot infection was almost sixfold higher for people with diabetes than those without.

The research, published in Diabetologia on August 4, also suggests that diabetes may be associated with a 72% increased risk of infection-related mortality, although the absolute numbers were small.

Dr. Fang explained to this news organization that they focused on infection-related hospitalization and mortality “because these are comprehensively tracked in administrative data and ... are the most severe types of outcomes.”

However, this is probably just the tip of the iceberg, as people with diabetes are “likely at increased risk for milder infection too,” which can have a “significant adverse impact on people’s well-being and quality of life.”

As a result of their findings, the authors call for “broader guidance on infection prevention and management” in people with diabetes. To achieve this, Dr. Fang said, “we need to better understand why diabetes is associated with an increased risk of infection-related complications.”

“One likely factor is glycemic control: Emerging research suggests patients with diabetes with better glycemic control may be at significantly lower risk of infection-related complications.”

He continued that, in younger patients, a factor for worse outcomes could be that “diabetes tends to be more aggressive when it emerges early in life,” while in Black patients “there is research highlighting Black-White differences in glycemic control, access to care, and beliefs around vaccines.”

Overall, their findings – coupled with recent data showing that diabetes is an important risk factor for adverse outcomes with COVID-19 infection – paint “a common picture,” Dr. Fang said.

“People with diabetes are much more susceptible to infection-related complications, including COVID-related hospitalization and mortality,” which suggests people with diabetes “may need to be especially cautious.”
 

Adds to existing literature; amputations begin with infections

Robert A. Gabbay, MD, PhD, chief scientific and medical officer for the American Diabetes Association (ADA), said the study “does add to the existing literature by having followed a larger number of people over time and linking them to serious complications from infections.”

“Sadly, we have seen this play out in real-time during the COVID-19 pandemic.”

“One of the sobering bits of data is the significant health disparities that exist in Black Americans and the fact that foot infections remain a significant problem,” he said in an interview.

“Given that amputation rates for [Black Americans] are three times higher than White Americans, amputations begin with infections,” Dr. Gabbay added, noting the ADA “has been taking a strong stand to prevent amputations and address the inequities in health that exist.”

Jamie Hartmann-Boyce, PhD, from the University of Oxford, U.K., who was not involved in the study, commented that diabetes is a “well-known risk factor for worse outcomes from all kinds of infection,” which is why they “are prioritized for flu vaccination every year.”

She told this news organization that the current study “further confirms that people with diabetes are more likely to be hospitalized for infection of any type and most markedly for foot infection.”

“These new data further highlight the need for public health interventions to prevent type 2 diabetes, and for preventive health care in people with diabetes, including access to diabetes medications and support and to vaccinations to prevent infection,” added Dr. Hartmann-Boyce, who is a senior research fellow in health behaviors.

Diabetes is thought to be associated with susceptibility to infection via mechanisms such as impaired neutrophil functioning and humoral immune responses, and studies have shown a link with both common and rare infections.

However, the authors point out that “most” of those included “small clinical populations and were cross-sectional or had short follow-up.”

Guidelines for diabetes management, they note, also “pay less attention” to infectious diseases than they do to the prevention of micro- and macrovascular complications.
 

 

 

ARIC data mined for infections in those with diabetes

The team analyzed data from the ongoing U.S. community-based Atherosclerosis Risk in Communities (ARIC) study.

The National Heart, Lung, and Blood Institute–sponsored cohort was comprised of adults aged 45-64 years from four U.S. communities, recruited between 1987 and 1989 for clinical examinations, medical interviews, and laboratory tests, repeated over five more visits up to 2018-2019.

For the current analysis, the team included 12,739 individuals with a mean age of 54.5 years, of whom 54.3% were female and 24.7% were Black.

Patients were defined as having diabetes if their baseline fasting blood glucose was greater than or equal to 7 mmol/L, or nonfasting glucose was greater than or equal to 11.1 mmol/l, they self-reported a diagnosis of diabetes by a physician, or they were taking glucose-lowering medication at the first study visit. The researchers weren’t able to distinguish between type 1 and type 2 diabetes.

In total, 1,485 individuals had diabetes at baseline. They were more likely to be older, Black, have a low socioeconomic status, and have worse cardiometabolic health than participants without diabetes.

Over an average follow-up of 23.8 years, there were 4,229 incident hospitalizations for infection, at an overall rate of 15.9 per 1,000 person-years.

Individuals with diabetes at baseline had a higher rate of hospitalizations than those without, at 25.4 per 1,000 person-years versus 15.2 per 1,000 person-years.

After taking into account sociodemographic characteristics, socioeconomic status, and cardiometabolic risk factors, this equated to a hazard ratio for hospitalization with any infection of 1.67 (P < .001).

The risk of hospitalization for any infection was significantly higher for younger patients with diabetes, defined as aged less than 55 years (P = .005), and for Black patients (P < .001).

While the increased risk was generally consistent across infection types, it was markedly increased for foot infection, at a hazard ratio of 5.99 (P < .001).

Overall, there were few deaths due to infection in the study, at just 362. The risk of infection mortality was nevertheless significantly increased in people with diabetes, at an adjusted hazard ratio of 1.72 (P < .001).

Dr. Fang has reported being supported by a grant from the National Institutes of Health/National Heart, Lung, and Blood Institute. Dr. Selvin has reported being supported by grants from the National Institutes of Health/National Heart, Lung, and Blood Institute and National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Selvin is an associate editor for Diabetologia and had no role in the peer review of the manuscript.

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

People with diabetes are at increased risk of hospitalization for infection, as well as infection-related mortality, shows a large U.S. study that suggests the risk is even higher in younger and Black individuals.

Michael Fang, PhD, Johns Hopkins University, Baltimore, and colleagues studied more than 12,000 participants in a community cohort study who were followed for an average of 24 years, between 1987-1989 and 2019.

Participants with diabetes faced a 67% increase risk of infection-related hospitalization, compared with those without diabetes.

Of particular note, the risk of hospitalization with foot infection was almost sixfold higher for people with diabetes than those without.

The research, published in Diabetologia on August 4, also suggests that diabetes may be associated with a 72% increased risk of infection-related mortality, although the absolute numbers were small.

Dr. Fang explained to this news organization that they focused on infection-related hospitalization and mortality “because these are comprehensively tracked in administrative data and ... are the most severe types of outcomes.”

However, this is probably just the tip of the iceberg, as people with diabetes are “likely at increased risk for milder infection too,” which can have a “significant adverse impact on people’s well-being and quality of life.”

As a result of their findings, the authors call for “broader guidance on infection prevention and management” in people with diabetes. To achieve this, Dr. Fang said, “we need to better understand why diabetes is associated with an increased risk of infection-related complications.”

“One likely factor is glycemic control: Emerging research suggests patients with diabetes with better glycemic control may be at significantly lower risk of infection-related complications.”

He continued that, in younger patients, a factor for worse outcomes could be that “diabetes tends to be more aggressive when it emerges early in life,” while in Black patients “there is research highlighting Black-White differences in glycemic control, access to care, and beliefs around vaccines.”

Overall, their findings – coupled with recent data showing that diabetes is an important risk factor for adverse outcomes with COVID-19 infection – paint “a common picture,” Dr. Fang said.

“People with diabetes are much more susceptible to infection-related complications, including COVID-related hospitalization and mortality,” which suggests people with diabetes “may need to be especially cautious.”
 

Adds to existing literature; amputations begin with infections

Robert A. Gabbay, MD, PhD, chief scientific and medical officer for the American Diabetes Association (ADA), said the study “does add to the existing literature by having followed a larger number of people over time and linking them to serious complications from infections.”

“Sadly, we have seen this play out in real-time during the COVID-19 pandemic.”

“One of the sobering bits of data is the significant health disparities that exist in Black Americans and the fact that foot infections remain a significant problem,” he said in an interview.

“Given that amputation rates for [Black Americans] are three times higher than White Americans, amputations begin with infections,” Dr. Gabbay added, noting the ADA “has been taking a strong stand to prevent amputations and address the inequities in health that exist.”

Jamie Hartmann-Boyce, PhD, from the University of Oxford, U.K., who was not involved in the study, commented that diabetes is a “well-known risk factor for worse outcomes from all kinds of infection,” which is why they “are prioritized for flu vaccination every year.”

She told this news organization that the current study “further confirms that people with diabetes are more likely to be hospitalized for infection of any type and most markedly for foot infection.”

“These new data further highlight the need for public health interventions to prevent type 2 diabetes, and for preventive health care in people with diabetes, including access to diabetes medications and support and to vaccinations to prevent infection,” added Dr. Hartmann-Boyce, who is a senior research fellow in health behaviors.

Diabetes is thought to be associated with susceptibility to infection via mechanisms such as impaired neutrophil functioning and humoral immune responses, and studies have shown a link with both common and rare infections.

However, the authors point out that “most” of those included “small clinical populations and were cross-sectional or had short follow-up.”

Guidelines for diabetes management, they note, also “pay less attention” to infectious diseases than they do to the prevention of micro- and macrovascular complications.
 

 

 

ARIC data mined for infections in those with diabetes

The team analyzed data from the ongoing U.S. community-based Atherosclerosis Risk in Communities (ARIC) study.

The National Heart, Lung, and Blood Institute–sponsored cohort was comprised of adults aged 45-64 years from four U.S. communities, recruited between 1987 and 1989 for clinical examinations, medical interviews, and laboratory tests, repeated over five more visits up to 2018-2019.

For the current analysis, the team included 12,739 individuals with a mean age of 54.5 years, of whom 54.3% were female and 24.7% were Black.

Patients were defined as having diabetes if their baseline fasting blood glucose was greater than or equal to 7 mmol/L, or nonfasting glucose was greater than or equal to 11.1 mmol/l, they self-reported a diagnosis of diabetes by a physician, or they were taking glucose-lowering medication at the first study visit. The researchers weren’t able to distinguish between type 1 and type 2 diabetes.

In total, 1,485 individuals had diabetes at baseline. They were more likely to be older, Black, have a low socioeconomic status, and have worse cardiometabolic health than participants without diabetes.

Over an average follow-up of 23.8 years, there were 4,229 incident hospitalizations for infection, at an overall rate of 15.9 per 1,000 person-years.

Individuals with diabetes at baseline had a higher rate of hospitalizations than those without, at 25.4 per 1,000 person-years versus 15.2 per 1,000 person-years.

After taking into account sociodemographic characteristics, socioeconomic status, and cardiometabolic risk factors, this equated to a hazard ratio for hospitalization with any infection of 1.67 (P < .001).

The risk of hospitalization for any infection was significantly higher for younger patients with diabetes, defined as aged less than 55 years (P = .005), and for Black patients (P < .001).

While the increased risk was generally consistent across infection types, it was markedly increased for foot infection, at a hazard ratio of 5.99 (P < .001).

Overall, there were few deaths due to infection in the study, at just 362. The risk of infection mortality was nevertheless significantly increased in people with diabetes, at an adjusted hazard ratio of 1.72 (P < .001).

Dr. Fang has reported being supported by a grant from the National Institutes of Health/National Heart, Lung, and Blood Institute. Dr. Selvin has reported being supported by grants from the National Institutes of Health/National Heart, Lung, and Blood Institute and National Institutes of Health/National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Selvin is an associate editor for Diabetologia and had no role in the peer review of the manuscript.

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

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