Rapid COVID-19 tests will soon be covered by insurance

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Thu, 12/02/2021 - 11:31

Private insurers will soon be required to reimburse people enrolled in their plans for the cost of at-home, rapid COVID-19 tests, and mask mandates will be extended for air, rail and bus travelers through at least mid-March.

The measures are part of a suite of new actions President Joe Biden is expected to announce later today, Dec. 2, in the wake of the arrival of the Omicron variant in the United States. The White House’s initiatives are designed to fight an expected winter surge of COVID-19 infections, according to sources familiar with the president’s plans.

At about $24 per package, rapid COVID-19 testing remains prohibitively expensive for many, even after a promise to bring the tests to Americans at a wholesale cost.

Other countries have rapid tests available for free or about $1 per test, and many experts say more frequent use of rapid tests could help stop transmission of COVID-19 virus.

About 150 million Americans would be eligible for reimbursement for rapid tests through their insurance plans.

In addition to those steps, international travelers flying into the United States will soon be required to show proof of a negative COVID-19 test within 24 hours of their departure, whether they are vaccinated or not.

In keeping with the six-part plan to fight COVID-19 the administration outlined in August, the president’s new plan is centered around vaccinations for all eligible Americans, including booster doses for the estimated 100 million adults who are now at least 6 months past their second doses of a Pfizer or Moderna vaccine or 2 months past a Johnson & Johnson shot.

Those plans, which relied on vaccine mandates for most workers, have been stymied by recent court rulings blocking implementation of those requirements.

As the issue makes its way through the courts, Biden is expected to call on companies to voluntarily implement vaccination requirements for their workers, which he says are helping to close vaccination gaps.

Biden is also expected to outline a new push to get booster shots to all adults, with an emphasis on reaching seniors, who are at greatest risk for hospitalization and death from COVID-19.

The president is scheduled to speak at 1:40 PM on Dec. 2 at the National Institutes of Health.

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

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Private insurers will soon be required to reimburse people enrolled in their plans for the cost of at-home, rapid COVID-19 tests, and mask mandates will be extended for air, rail and bus travelers through at least mid-March.

The measures are part of a suite of new actions President Joe Biden is expected to announce later today, Dec. 2, in the wake of the arrival of the Omicron variant in the United States. The White House’s initiatives are designed to fight an expected winter surge of COVID-19 infections, according to sources familiar with the president’s plans.

At about $24 per package, rapid COVID-19 testing remains prohibitively expensive for many, even after a promise to bring the tests to Americans at a wholesale cost.

Other countries have rapid tests available for free or about $1 per test, and many experts say more frequent use of rapid tests could help stop transmission of COVID-19 virus.

About 150 million Americans would be eligible for reimbursement for rapid tests through their insurance plans.

In addition to those steps, international travelers flying into the United States will soon be required to show proof of a negative COVID-19 test within 24 hours of their departure, whether they are vaccinated or not.

In keeping with the six-part plan to fight COVID-19 the administration outlined in August, the president’s new plan is centered around vaccinations for all eligible Americans, including booster doses for the estimated 100 million adults who are now at least 6 months past their second doses of a Pfizer or Moderna vaccine or 2 months past a Johnson & Johnson shot.

Those plans, which relied on vaccine mandates for most workers, have been stymied by recent court rulings blocking implementation of those requirements.

As the issue makes its way through the courts, Biden is expected to call on companies to voluntarily implement vaccination requirements for their workers, which he says are helping to close vaccination gaps.

Biden is also expected to outline a new push to get booster shots to all adults, with an emphasis on reaching seniors, who are at greatest risk for hospitalization and death from COVID-19.

The president is scheduled to speak at 1:40 PM on Dec. 2 at the National Institutes of Health.

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

Private insurers will soon be required to reimburse people enrolled in their plans for the cost of at-home, rapid COVID-19 tests, and mask mandates will be extended for air, rail and bus travelers through at least mid-March.

The measures are part of a suite of new actions President Joe Biden is expected to announce later today, Dec. 2, in the wake of the arrival of the Omicron variant in the United States. The White House’s initiatives are designed to fight an expected winter surge of COVID-19 infections, according to sources familiar with the president’s plans.

At about $24 per package, rapid COVID-19 testing remains prohibitively expensive for many, even after a promise to bring the tests to Americans at a wholesale cost.

Other countries have rapid tests available for free or about $1 per test, and many experts say more frequent use of rapid tests could help stop transmission of COVID-19 virus.

About 150 million Americans would be eligible for reimbursement for rapid tests through their insurance plans.

In addition to those steps, international travelers flying into the United States will soon be required to show proof of a negative COVID-19 test within 24 hours of their departure, whether they are vaccinated or not.

In keeping with the six-part plan to fight COVID-19 the administration outlined in August, the president’s new plan is centered around vaccinations for all eligible Americans, including booster doses for the estimated 100 million adults who are now at least 6 months past their second doses of a Pfizer or Moderna vaccine or 2 months past a Johnson & Johnson shot.

Those plans, which relied on vaccine mandates for most workers, have been stymied by recent court rulings blocking implementation of those requirements.

As the issue makes its way through the courts, Biden is expected to call on companies to voluntarily implement vaccination requirements for their workers, which he says are helping to close vaccination gaps.

Biden is also expected to outline a new push to get booster shots to all adults, with an emphasis on reaching seniors, who are at greatest risk for hospitalization and death from COVID-19.

The president is scheduled to speak at 1:40 PM on Dec. 2 at the National Institutes of Health.

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

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Retinopathy risk in children higher in T2D than T1D

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Tue, 05/03/2022 - 15:02

Children diagnosed with type 2 diabetes (T2D) appear significantly more likely to develop retinopathy and other ocular complications over time than children who are diagnosed with type 1 diabetes (T1D), researchers report.

Patricia Bai

Among a population-based cohort of children (defined as younger than 22 years), the risk of diabetic retinopathy was 88% greater in those with T2D than T1D within the first 15 years of disease diagnosis.

“The purpose of this study was to assess the risk of developing diabetes-associated ocular complications among a population-based cohort of children diagnosed with either T1D or T2D during a 50-year period,” lead author Patricia Bai, BA, of Mayo Clinic, Phoenix, and colleagues reported in JAMA Ophthalmology.

The researchers retrospectively reviewed medical records from all residents of Olmsted County, Minn., from 1970 to 2019. The study cohort included 606 children with a confirmed a diagnosis of T1D or T2D, 525 (87%) of whom had at least one ocular examination.

The mean age at diabetes diagnosis was 12 years (standard deviation, 5.4 years); most participants were White (95.7% in 1990), and half (50%) were male. Diabetes-associated ocular complications occurred in 31.9% and 26.6% of children with T1D and T2D, respectively.

The hazard ratios illustrating the risk between T2D and T1D rates were 1.88 (95% confidence interval, 1.13-3.12; P = .02) for any diabetic retinopathy, 2.33 (95% CI, 0.99-5.50; P = .048) for proliferative diabetic retinopathy, 1.49 (95% CI, 0.46-4.89; P = .50) for diabetic macular edema, 2.43 (95% CI, 0.54-11.07; P = .24) for a visually significant cataract, and 4.06 (95% CI, 1.34-12.33; P = .007) for requiring pars plana vitrectomy within the first 15 years of diagnosis.

These results suggest that earlier surveillance and intervention may help prevent vision-threatening complications, the researchers explained.

“After adjusting for race using self-identified categories of White or not White, the adjusted HR of developing any retinopathy was 1.63 (95% CI, 0.96-2.79; P = .07), and the adjusted HR of developing proliferative diabetic retinopathy was 2.02 (95% CI, 0.79-5.16; P = .14)” in T2D versus T1D patients, the researchers wrote.

“We would expect the reported rate of type 2 diabetes to be potentially underestimated in our study cohort,” Ms. Bai commented in an interview. “Race has been suggested to be a surrogate for other social determinants of health, such as lower rates of optimal follow-up care received by racial and ethnic minorities, which could influence subsequent retinopathy rates.”
 

Understanding retinopathy outcomes in youth

In an accompanying editorial, Jennifer K. Sun, MD, MPH, from Harvard Medical School, Boston, wrote that the present study indicates the natural history of retinopathy may differ between patients with T1D and T2D.

While the pathophysiology of diabetic retinopathy in T1D and T2D appears similar, other patient-related factors such as lipid profiles, the presence of hypertension, and body mass index may differ between the two disease states.

She wrote that “there is a particular need to document retinopathy outcomes and risk factors for advanced disease in youth with T2D, for whom there is a paucity of information.”

Ms. Bai and colleagues acknowledged that a key limitation of the study was the retrospective design. As a result, irregular follow-up and incomplete data may limit the applicability of the findings.

“Some children with milder forms of diabetes may have eluded detection, a limitation that is more likely to affect T2D, which may exist undetected for years before a diagnosis,” Bai explained.

Dr. Sun recommended that further epidemiologic studies are needed to help optimize guidelines for screening and follow-up for young people diagnosed with diabetes. “Such efforts may potentially lead to increased understanding of the mechanistic differences between pathology in T1D versus T2D,” she concluded.

This study used the resources of the Rochester Epidemiology Project (REP) medical records linkage system, which is supported by grant funding from the National Institute on Aging, the Mayo Clinic Research Committee, and by fees paid annually by REP users. The study authors disclosed no conflicts of interest.

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Children diagnosed with type 2 diabetes (T2D) appear significantly more likely to develop retinopathy and other ocular complications over time than children who are diagnosed with type 1 diabetes (T1D), researchers report.

Patricia Bai

Among a population-based cohort of children (defined as younger than 22 years), the risk of diabetic retinopathy was 88% greater in those with T2D than T1D within the first 15 years of disease diagnosis.

“The purpose of this study was to assess the risk of developing diabetes-associated ocular complications among a population-based cohort of children diagnosed with either T1D or T2D during a 50-year period,” lead author Patricia Bai, BA, of Mayo Clinic, Phoenix, and colleagues reported in JAMA Ophthalmology.

The researchers retrospectively reviewed medical records from all residents of Olmsted County, Minn., from 1970 to 2019. The study cohort included 606 children with a confirmed a diagnosis of T1D or T2D, 525 (87%) of whom had at least one ocular examination.

The mean age at diabetes diagnosis was 12 years (standard deviation, 5.4 years); most participants were White (95.7% in 1990), and half (50%) were male. Diabetes-associated ocular complications occurred in 31.9% and 26.6% of children with T1D and T2D, respectively.

The hazard ratios illustrating the risk between T2D and T1D rates were 1.88 (95% confidence interval, 1.13-3.12; P = .02) for any diabetic retinopathy, 2.33 (95% CI, 0.99-5.50; P = .048) for proliferative diabetic retinopathy, 1.49 (95% CI, 0.46-4.89; P = .50) for diabetic macular edema, 2.43 (95% CI, 0.54-11.07; P = .24) for a visually significant cataract, and 4.06 (95% CI, 1.34-12.33; P = .007) for requiring pars plana vitrectomy within the first 15 years of diagnosis.

These results suggest that earlier surveillance and intervention may help prevent vision-threatening complications, the researchers explained.

“After adjusting for race using self-identified categories of White or not White, the adjusted HR of developing any retinopathy was 1.63 (95% CI, 0.96-2.79; P = .07), and the adjusted HR of developing proliferative diabetic retinopathy was 2.02 (95% CI, 0.79-5.16; P = .14)” in T2D versus T1D patients, the researchers wrote.

“We would expect the reported rate of type 2 diabetes to be potentially underestimated in our study cohort,” Ms. Bai commented in an interview. “Race has been suggested to be a surrogate for other social determinants of health, such as lower rates of optimal follow-up care received by racial and ethnic minorities, which could influence subsequent retinopathy rates.”
 

Understanding retinopathy outcomes in youth

In an accompanying editorial, Jennifer K. Sun, MD, MPH, from Harvard Medical School, Boston, wrote that the present study indicates the natural history of retinopathy may differ between patients with T1D and T2D.

While the pathophysiology of diabetic retinopathy in T1D and T2D appears similar, other patient-related factors such as lipid profiles, the presence of hypertension, and body mass index may differ between the two disease states.

She wrote that “there is a particular need to document retinopathy outcomes and risk factors for advanced disease in youth with T2D, for whom there is a paucity of information.”

Ms. Bai and colleagues acknowledged that a key limitation of the study was the retrospective design. As a result, irregular follow-up and incomplete data may limit the applicability of the findings.

“Some children with milder forms of diabetes may have eluded detection, a limitation that is more likely to affect T2D, which may exist undetected for years before a diagnosis,” Bai explained.

Dr. Sun recommended that further epidemiologic studies are needed to help optimize guidelines for screening and follow-up for young people diagnosed with diabetes. “Such efforts may potentially lead to increased understanding of the mechanistic differences between pathology in T1D versus T2D,” she concluded.

This study used the resources of the Rochester Epidemiology Project (REP) medical records linkage system, which is supported by grant funding from the National Institute on Aging, the Mayo Clinic Research Committee, and by fees paid annually by REP users. The study authors disclosed no conflicts of interest.

Children diagnosed with type 2 diabetes (T2D) appear significantly more likely to develop retinopathy and other ocular complications over time than children who are diagnosed with type 1 diabetes (T1D), researchers report.

Patricia Bai

Among a population-based cohort of children (defined as younger than 22 years), the risk of diabetic retinopathy was 88% greater in those with T2D than T1D within the first 15 years of disease diagnosis.

“The purpose of this study was to assess the risk of developing diabetes-associated ocular complications among a population-based cohort of children diagnosed with either T1D or T2D during a 50-year period,” lead author Patricia Bai, BA, of Mayo Clinic, Phoenix, and colleagues reported in JAMA Ophthalmology.

The researchers retrospectively reviewed medical records from all residents of Olmsted County, Minn., from 1970 to 2019. The study cohort included 606 children with a confirmed a diagnosis of T1D or T2D, 525 (87%) of whom had at least one ocular examination.

The mean age at diabetes diagnosis was 12 years (standard deviation, 5.4 years); most participants were White (95.7% in 1990), and half (50%) were male. Diabetes-associated ocular complications occurred in 31.9% and 26.6% of children with T1D and T2D, respectively.

The hazard ratios illustrating the risk between T2D and T1D rates were 1.88 (95% confidence interval, 1.13-3.12; P = .02) for any diabetic retinopathy, 2.33 (95% CI, 0.99-5.50; P = .048) for proliferative diabetic retinopathy, 1.49 (95% CI, 0.46-4.89; P = .50) for diabetic macular edema, 2.43 (95% CI, 0.54-11.07; P = .24) for a visually significant cataract, and 4.06 (95% CI, 1.34-12.33; P = .007) for requiring pars plana vitrectomy within the first 15 years of diagnosis.

These results suggest that earlier surveillance and intervention may help prevent vision-threatening complications, the researchers explained.

“After adjusting for race using self-identified categories of White or not White, the adjusted HR of developing any retinopathy was 1.63 (95% CI, 0.96-2.79; P = .07), and the adjusted HR of developing proliferative diabetic retinopathy was 2.02 (95% CI, 0.79-5.16; P = .14)” in T2D versus T1D patients, the researchers wrote.

“We would expect the reported rate of type 2 diabetes to be potentially underestimated in our study cohort,” Ms. Bai commented in an interview. “Race has been suggested to be a surrogate for other social determinants of health, such as lower rates of optimal follow-up care received by racial and ethnic minorities, which could influence subsequent retinopathy rates.”
 

Understanding retinopathy outcomes in youth

In an accompanying editorial, Jennifer K. Sun, MD, MPH, from Harvard Medical School, Boston, wrote that the present study indicates the natural history of retinopathy may differ between patients with T1D and T2D.

While the pathophysiology of diabetic retinopathy in T1D and T2D appears similar, other patient-related factors such as lipid profiles, the presence of hypertension, and body mass index may differ between the two disease states.

She wrote that “there is a particular need to document retinopathy outcomes and risk factors for advanced disease in youth with T2D, for whom there is a paucity of information.”

Ms. Bai and colleagues acknowledged that a key limitation of the study was the retrospective design. As a result, irregular follow-up and incomplete data may limit the applicability of the findings.

“Some children with milder forms of diabetes may have eluded detection, a limitation that is more likely to affect T2D, which may exist undetected for years before a diagnosis,” Bai explained.

Dr. Sun recommended that further epidemiologic studies are needed to help optimize guidelines for screening and follow-up for young people diagnosed with diabetes. “Such efforts may potentially lead to increased understanding of the mechanistic differences between pathology in T1D versus T2D,” she concluded.

This study used the resources of the Rochester Epidemiology Project (REP) medical records linkage system, which is supported by grant funding from the National Institute on Aging, the Mayo Clinic Research Committee, and by fees paid annually by REP users. The study authors disclosed no conflicts of interest.

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AHA statement on impact of major life events on physical activity

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Thu, 12/02/2021 - 16:43

Physical activity levels may decline during major life events, and it’s important for health care professionals to encourage patients to maintain regular physical activity during times of significant changes in their lives, the American Heart Association says in a new scientific statement.

With this statement, “We hope health care providers, public health workers, and individuals understand that a major life change can lead to decreases in physical activity or increases in sedentary behavior,” writing group chair Abbi D. Lane-Cordova, PhD, said in an interview.

The statement includes “tips for screening for physical activity and talking to people about their activity during these big life events and resources that can be used by health care providers to help people achieve healthy levels of physical activity,” said Dr. Lane-Cordova, assistant professor in exercise science, Arnold School of Public Health, University of South Carolina, Columbia.

The statement was published online Dec. 1 in the journal Circulation.

The AHA Committee on Physical Activity, part of the organization’s Council on Lifestyle and Cardiometabolic Health, began discussing this topic back in 2019, Dr. Lane-Cordova explained.

“We spoke as a group about how much activity levels can change when something big happens in life, like becoming a parent or retiring. The change in activity behavior (physical activity or sedentary behavior) is important because these activity behaviors can influence heart health,” she said.

The group started work on the scientific statement in early 2020 – “and then the pandemic hit, and it seemed more important than ever to create awareness and a resource for people to help improve, or at least maintain, favorable activity behaviors when there’s a profound change or event in life,” Dr. Lane-Cordova said.
 

Some more vulnerable than others

The writing group examined data on 17 different life events or transitions and found evidence that physical activity levels may decline during nine events: beginning a new school (elementary, middle, high school, or college); a first job or career change; a marriage or civil union; pregnancy; parenting; retirement; or moving into a long-term care facility.

The authors also identified individuals who may be particularly susceptible to lower levels of physical activity in general and during important life events. They include those with lower levels of education; those who live alone; those who lack access to a safe outdoor space; Black Americans; some members of the LGBTQ+ community; and women who are pregnant and new parents.

They offer practical strategies for health care professionals to support routine physical activity levels during major life events and transitions. These include asking simple questions about how life transitions may be changing physical activity patterns and encouraging the use of wearable step trackers to monitor levels and changes.

“It’s important to maintain or improve physical activity when major life events happen, which is often a time when exercise is most needed,” Dr. Lane-Cordova said in a news release.

“Clinicians should express compassion as they ask about life transitions and initiate conversations about physical activity during life events and transitions,” the writing group advises.

The group also says its important “to look beyond the health care setting and engage organizations, communities, workplaces, faith-based communities, and assisted living facilities to promote physical activity.”

The statement provides a list of resources for individuals and health care professionals, many of which are free and online.

This research had no commercial funding. Members of the writing group have disclosed no relevant financial relationships.

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

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Physical activity levels may decline during major life events, and it’s important for health care professionals to encourage patients to maintain regular physical activity during times of significant changes in their lives, the American Heart Association says in a new scientific statement.

With this statement, “We hope health care providers, public health workers, and individuals understand that a major life change can lead to decreases in physical activity or increases in sedentary behavior,” writing group chair Abbi D. Lane-Cordova, PhD, said in an interview.

The statement includes “tips for screening for physical activity and talking to people about their activity during these big life events and resources that can be used by health care providers to help people achieve healthy levels of physical activity,” said Dr. Lane-Cordova, assistant professor in exercise science, Arnold School of Public Health, University of South Carolina, Columbia.

The statement was published online Dec. 1 in the journal Circulation.

The AHA Committee on Physical Activity, part of the organization’s Council on Lifestyle and Cardiometabolic Health, began discussing this topic back in 2019, Dr. Lane-Cordova explained.

“We spoke as a group about how much activity levels can change when something big happens in life, like becoming a parent or retiring. The change in activity behavior (physical activity or sedentary behavior) is important because these activity behaviors can influence heart health,” she said.

The group started work on the scientific statement in early 2020 – “and then the pandemic hit, and it seemed more important than ever to create awareness and a resource for people to help improve, or at least maintain, favorable activity behaviors when there’s a profound change or event in life,” Dr. Lane-Cordova said.
 

Some more vulnerable than others

The writing group examined data on 17 different life events or transitions and found evidence that physical activity levels may decline during nine events: beginning a new school (elementary, middle, high school, or college); a first job or career change; a marriage or civil union; pregnancy; parenting; retirement; or moving into a long-term care facility.

The authors also identified individuals who may be particularly susceptible to lower levels of physical activity in general and during important life events. They include those with lower levels of education; those who live alone; those who lack access to a safe outdoor space; Black Americans; some members of the LGBTQ+ community; and women who are pregnant and new parents.

They offer practical strategies for health care professionals to support routine physical activity levels during major life events and transitions. These include asking simple questions about how life transitions may be changing physical activity patterns and encouraging the use of wearable step trackers to monitor levels and changes.

“It’s important to maintain or improve physical activity when major life events happen, which is often a time when exercise is most needed,” Dr. Lane-Cordova said in a news release.

“Clinicians should express compassion as they ask about life transitions and initiate conversations about physical activity during life events and transitions,” the writing group advises.

The group also says its important “to look beyond the health care setting and engage organizations, communities, workplaces, faith-based communities, and assisted living facilities to promote physical activity.”

The statement provides a list of resources for individuals and health care professionals, many of which are free and online.

This research had no commercial funding. Members of the writing group have disclosed no relevant financial relationships.

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

Physical activity levels may decline during major life events, and it’s important for health care professionals to encourage patients to maintain regular physical activity during times of significant changes in their lives, the American Heart Association says in a new scientific statement.

With this statement, “We hope health care providers, public health workers, and individuals understand that a major life change can lead to decreases in physical activity or increases in sedentary behavior,” writing group chair Abbi D. Lane-Cordova, PhD, said in an interview.

The statement includes “tips for screening for physical activity and talking to people about their activity during these big life events and resources that can be used by health care providers to help people achieve healthy levels of physical activity,” said Dr. Lane-Cordova, assistant professor in exercise science, Arnold School of Public Health, University of South Carolina, Columbia.

The statement was published online Dec. 1 in the journal Circulation.

The AHA Committee on Physical Activity, part of the organization’s Council on Lifestyle and Cardiometabolic Health, began discussing this topic back in 2019, Dr. Lane-Cordova explained.

“We spoke as a group about how much activity levels can change when something big happens in life, like becoming a parent or retiring. The change in activity behavior (physical activity or sedentary behavior) is important because these activity behaviors can influence heart health,” she said.

The group started work on the scientific statement in early 2020 – “and then the pandemic hit, and it seemed more important than ever to create awareness and a resource for people to help improve, or at least maintain, favorable activity behaviors when there’s a profound change or event in life,” Dr. Lane-Cordova said.
 

Some more vulnerable than others

The writing group examined data on 17 different life events or transitions and found evidence that physical activity levels may decline during nine events: beginning a new school (elementary, middle, high school, or college); a first job or career change; a marriage or civil union; pregnancy; parenting; retirement; or moving into a long-term care facility.

The authors also identified individuals who may be particularly susceptible to lower levels of physical activity in general and during important life events. They include those with lower levels of education; those who live alone; those who lack access to a safe outdoor space; Black Americans; some members of the LGBTQ+ community; and women who are pregnant and new parents.

They offer practical strategies for health care professionals to support routine physical activity levels during major life events and transitions. These include asking simple questions about how life transitions may be changing physical activity patterns and encouraging the use of wearable step trackers to monitor levels and changes.

“It’s important to maintain or improve physical activity when major life events happen, which is often a time when exercise is most needed,” Dr. Lane-Cordova said in a news release.

“Clinicians should express compassion as they ask about life transitions and initiate conversations about physical activity during life events and transitions,” the writing group advises.

The group also says its important “to look beyond the health care setting and engage organizations, communities, workplaces, faith-based communities, and assisted living facilities to promote physical activity.”

The statement provides a list of resources for individuals and health care professionals, many of which are free and online.

This research had no commercial funding. Members of the writing group have disclosed no relevant financial relationships.

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

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Misinterpretation is a science, not an art

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Changed
Thu, 12/02/2021 - 10:36

 

It isn’t autocorrect’s fault this time, we swear

We’ve come a long way with communication technology. Back in the day, when Gondor needed to call for aid, they had to pull off the greatest signal fire montage of all time. Now we can send each other texts back and forth in an instant. (“Hey Theoden, send army, need help pls” doesn’t quite have the same gravitas though.) The question is, how do our brains keep up with such rapidly advancing technology?

Deagreez/iStock/Getty Images Plus

Er, they don’t. Not really. Instead, our brains create shortcuts called “good-enough language processing,” which is exactly what it sounds like.

Psychologists and psycholinguists have been studying misinterpretations such as good-enough language processing since the 1970s. Recently, however, psycholinguists from the Centre for Language and Brain at Higher School of Economics in Moscow have found that, when it comes to reading comprehension over text, older adults are using their knowledge of the world over how it’s grammatically formed in the sentence.

In the study, 349 people were asked to read and interpret four sentences, the third of which (translated from Russian) was: “Misha met the firefighter’s dentist, who had put out a fire in the warehouse.” When asked who put the fire out, 79% of older adults (aged 55 years and older), utilizing good-enough language processing, said the firefighter put out the fire. You probably glossed over that sentence and assumed the same thing. But this time, the dentist was the real hero.

That said, adolescents (aged 13-17) and young adults (aged 20-30) weren’t much better, and got that particular sentence wrong 63%-68% of the time. According to the researchers, good-enough language processing forms in adolescence and intensifies throughout adulthood.

Moral of the story? We should utilize signal fires more often. Less room for misinterpretation. When the beacons of Minas Tirith were lit, Rohan answered.
 

Singing … your … lungs … out

There’s nothing quite like a karaoke bar to unleash your inner rock star. Hey, why not just go for it, everyone is just as bad at singing as you. That’s part of the fun.

lisegagne/E+/Getty Images

A 25-year-old man named Wang Zhe may have taken the karaoke concept a bit too far, however. While out with friends at a birthday party, Mr. Zhe let loose on a song with a particularly large number of high notes. He tried his best, gamely attacking the song until he felt a pain in his chest. He didn’t think much of it, although he did cut his performance short, but then he awoke the next morning unable to breathe properly.

After a trip to the hospital, he explained the sequence of events to the doctors, and an x-ray found that the culprit of the pain and difficulty breathing was a life-threatening condition in which air bubbles are created between the chest and lung. All the force Mr. Zhe had used trying to sing made air sacks in his lung burst, causing the air bubbles and his lung to be compressed to 15% of what it should be. Mr. Zhe needed surgery to remove the air bubbles, but fortunately turned out just fine.

So, if you’re ever at a karaoke bar, looking for a song to sing, maybe avoid the ones with super high notes and stick with something a little lower. We’re picturing something like Paul Robeson singing Ol’ Man River. That oughta do the trick.
 

 

 

And the word of the year is …

Flibbertigibbet. Bamboozle. Gobbledygook. If the LOTME staff had any say, those would be the words of the year every year, but sadly, we’re not in charge of such things. Instead, we’ll just have to defer to Oxford and Merriam-Webster, both of whom have recently chosen their words of the year. No word yet on whether or not they made their announcement at a red carpet gala dinner attended by all the most fashionable and powerful words out there, but we’re hoping that’s what happened.

NoSystem images/Getty Images

We’ll start with Oxford, since they did choose first. We all know Oxford is the bad boy of the dictionary world, so they’ve chosen a casual colloquialism related to the big COVID-sized elephant in the room (or should it be elephant-sized COVID in the room?): Vax. According to them, while vax has been hanging around since the 1980s, it’s only been in the past year that it’s exploded in popularity in a wide range of contexts (we can’t imagine what those would be). According to Oxford, “as a short pithy word, it appeals, perhaps especially to media commentators, when more formal alternatives are much more long-winded.”

Speaking of long-winded, that brings us to Merriam-Webster, the sheltered nerd of the dictionary world. Clearly they’re too good for vax, so they’ve gone with vaccine as their 2021 word of the year. Vaccine, according to Merriam-Webster, carries two big stories: The impressive and herculean feat of bringing a COVID-19 vaccine so quickly to so many people, and the complex political and social upheaval between vaccine supporters and deniers.

Vaccine also serves as a great bookend for Merriam-Webster’s 2020 word of the year: Pandemic. In 2020, the pandemic started, and in 2021, thanks to the vaccine, the pandemic ends. That’s how it works, right? We have a vaccine, it’s all over now. What’s that? Omicron? No! Bad COVID! You do that outside, not on the carpet!

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It isn’t autocorrect’s fault this time, we swear

We’ve come a long way with communication technology. Back in the day, when Gondor needed to call for aid, they had to pull off the greatest signal fire montage of all time. Now we can send each other texts back and forth in an instant. (“Hey Theoden, send army, need help pls” doesn’t quite have the same gravitas though.) The question is, how do our brains keep up with such rapidly advancing technology?

Deagreez/iStock/Getty Images Plus

Er, they don’t. Not really. Instead, our brains create shortcuts called “good-enough language processing,” which is exactly what it sounds like.

Psychologists and psycholinguists have been studying misinterpretations such as good-enough language processing since the 1970s. Recently, however, psycholinguists from the Centre for Language and Brain at Higher School of Economics in Moscow have found that, when it comes to reading comprehension over text, older adults are using their knowledge of the world over how it’s grammatically formed in the sentence.

In the study, 349 people were asked to read and interpret four sentences, the third of which (translated from Russian) was: “Misha met the firefighter’s dentist, who had put out a fire in the warehouse.” When asked who put the fire out, 79% of older adults (aged 55 years and older), utilizing good-enough language processing, said the firefighter put out the fire. You probably glossed over that sentence and assumed the same thing. But this time, the dentist was the real hero.

That said, adolescents (aged 13-17) and young adults (aged 20-30) weren’t much better, and got that particular sentence wrong 63%-68% of the time. According to the researchers, good-enough language processing forms in adolescence and intensifies throughout adulthood.

Moral of the story? We should utilize signal fires more often. Less room for misinterpretation. When the beacons of Minas Tirith were lit, Rohan answered.
 

Singing … your … lungs … out

There’s nothing quite like a karaoke bar to unleash your inner rock star. Hey, why not just go for it, everyone is just as bad at singing as you. That’s part of the fun.

lisegagne/E+/Getty Images

A 25-year-old man named Wang Zhe may have taken the karaoke concept a bit too far, however. While out with friends at a birthday party, Mr. Zhe let loose on a song with a particularly large number of high notes. He tried his best, gamely attacking the song until he felt a pain in his chest. He didn’t think much of it, although he did cut his performance short, but then he awoke the next morning unable to breathe properly.

After a trip to the hospital, he explained the sequence of events to the doctors, and an x-ray found that the culprit of the pain and difficulty breathing was a life-threatening condition in which air bubbles are created between the chest and lung. All the force Mr. Zhe had used trying to sing made air sacks in his lung burst, causing the air bubbles and his lung to be compressed to 15% of what it should be. Mr. Zhe needed surgery to remove the air bubbles, but fortunately turned out just fine.

So, if you’re ever at a karaoke bar, looking for a song to sing, maybe avoid the ones with super high notes and stick with something a little lower. We’re picturing something like Paul Robeson singing Ol’ Man River. That oughta do the trick.
 

 

 

And the word of the year is …

Flibbertigibbet. Bamboozle. Gobbledygook. If the LOTME staff had any say, those would be the words of the year every year, but sadly, we’re not in charge of such things. Instead, we’ll just have to defer to Oxford and Merriam-Webster, both of whom have recently chosen their words of the year. No word yet on whether or not they made their announcement at a red carpet gala dinner attended by all the most fashionable and powerful words out there, but we’re hoping that’s what happened.

NoSystem images/Getty Images

We’ll start with Oxford, since they did choose first. We all know Oxford is the bad boy of the dictionary world, so they’ve chosen a casual colloquialism related to the big COVID-sized elephant in the room (or should it be elephant-sized COVID in the room?): Vax. According to them, while vax has been hanging around since the 1980s, it’s only been in the past year that it’s exploded in popularity in a wide range of contexts (we can’t imagine what those would be). According to Oxford, “as a short pithy word, it appeals, perhaps especially to media commentators, when more formal alternatives are much more long-winded.”

Speaking of long-winded, that brings us to Merriam-Webster, the sheltered nerd of the dictionary world. Clearly they’re too good for vax, so they’ve gone with vaccine as their 2021 word of the year. Vaccine, according to Merriam-Webster, carries two big stories: The impressive and herculean feat of bringing a COVID-19 vaccine so quickly to so many people, and the complex political and social upheaval between vaccine supporters and deniers.

Vaccine also serves as a great bookend for Merriam-Webster’s 2020 word of the year: Pandemic. In 2020, the pandemic started, and in 2021, thanks to the vaccine, the pandemic ends. That’s how it works, right? We have a vaccine, it’s all over now. What’s that? Omicron? No! Bad COVID! You do that outside, not on the carpet!

 

It isn’t autocorrect’s fault this time, we swear

We’ve come a long way with communication technology. Back in the day, when Gondor needed to call for aid, they had to pull off the greatest signal fire montage of all time. Now we can send each other texts back and forth in an instant. (“Hey Theoden, send army, need help pls” doesn’t quite have the same gravitas though.) The question is, how do our brains keep up with such rapidly advancing technology?

Deagreez/iStock/Getty Images Plus

Er, they don’t. Not really. Instead, our brains create shortcuts called “good-enough language processing,” which is exactly what it sounds like.

Psychologists and psycholinguists have been studying misinterpretations such as good-enough language processing since the 1970s. Recently, however, psycholinguists from the Centre for Language and Brain at Higher School of Economics in Moscow have found that, when it comes to reading comprehension over text, older adults are using their knowledge of the world over how it’s grammatically formed in the sentence.

In the study, 349 people were asked to read and interpret four sentences, the third of which (translated from Russian) was: “Misha met the firefighter’s dentist, who had put out a fire in the warehouse.” When asked who put the fire out, 79% of older adults (aged 55 years and older), utilizing good-enough language processing, said the firefighter put out the fire. You probably glossed over that sentence and assumed the same thing. But this time, the dentist was the real hero.

That said, adolescents (aged 13-17) and young adults (aged 20-30) weren’t much better, and got that particular sentence wrong 63%-68% of the time. According to the researchers, good-enough language processing forms in adolescence and intensifies throughout adulthood.

Moral of the story? We should utilize signal fires more often. Less room for misinterpretation. When the beacons of Minas Tirith were lit, Rohan answered.
 

Singing … your … lungs … out

There’s nothing quite like a karaoke bar to unleash your inner rock star. Hey, why not just go for it, everyone is just as bad at singing as you. That’s part of the fun.

lisegagne/E+/Getty Images

A 25-year-old man named Wang Zhe may have taken the karaoke concept a bit too far, however. While out with friends at a birthday party, Mr. Zhe let loose on a song with a particularly large number of high notes. He tried his best, gamely attacking the song until he felt a pain in his chest. He didn’t think much of it, although he did cut his performance short, but then he awoke the next morning unable to breathe properly.

After a trip to the hospital, he explained the sequence of events to the doctors, and an x-ray found that the culprit of the pain and difficulty breathing was a life-threatening condition in which air bubbles are created between the chest and lung. All the force Mr. Zhe had used trying to sing made air sacks in his lung burst, causing the air bubbles and his lung to be compressed to 15% of what it should be. Mr. Zhe needed surgery to remove the air bubbles, but fortunately turned out just fine.

So, if you’re ever at a karaoke bar, looking for a song to sing, maybe avoid the ones with super high notes and stick with something a little lower. We’re picturing something like Paul Robeson singing Ol’ Man River. That oughta do the trick.
 

 

 

And the word of the year is …

Flibbertigibbet. Bamboozle. Gobbledygook. If the LOTME staff had any say, those would be the words of the year every year, but sadly, we’re not in charge of such things. Instead, we’ll just have to defer to Oxford and Merriam-Webster, both of whom have recently chosen their words of the year. No word yet on whether or not they made their announcement at a red carpet gala dinner attended by all the most fashionable and powerful words out there, but we’re hoping that’s what happened.

NoSystem images/Getty Images

We’ll start with Oxford, since they did choose first. We all know Oxford is the bad boy of the dictionary world, so they’ve chosen a casual colloquialism related to the big COVID-sized elephant in the room (or should it be elephant-sized COVID in the room?): Vax. According to them, while vax has been hanging around since the 1980s, it’s only been in the past year that it’s exploded in popularity in a wide range of contexts (we can’t imagine what those would be). According to Oxford, “as a short pithy word, it appeals, perhaps especially to media commentators, when more formal alternatives are much more long-winded.”

Speaking of long-winded, that brings us to Merriam-Webster, the sheltered nerd of the dictionary world. Clearly they’re too good for vax, so they’ve gone with vaccine as their 2021 word of the year. Vaccine, according to Merriam-Webster, carries two big stories: The impressive and herculean feat of bringing a COVID-19 vaccine so quickly to so many people, and the complex political and social upheaval between vaccine supporters and deniers.

Vaccine also serves as a great bookend for Merriam-Webster’s 2020 word of the year: Pandemic. In 2020, the pandemic started, and in 2021, thanks to the vaccine, the pandemic ends. That’s how it works, right? We have a vaccine, it’s all over now. What’s that? Omicron? No! Bad COVID! You do that outside, not on the carpet!

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SGLT2 inhibitor use tied to fewer atrial arrhythmias

Article Type
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Tue, 05/03/2022 - 15:02

Patients with cardiac implantable electronic devices (CIEDs) who received treatment with an sodium-glucose cotransporter 2 inhibitor had significantly fewer atrial arrhythmia events, compared with those who never received such a drug, in a prospective analysis of nearly 14,000 patients with a device who were followed for an average of nearly 2 years.

Dr. Ilan Goldenberg

The findings suggest that use of an agent from the class of SGLT2 inhibitors “is associated with a pronounced reduction in atrial arrhythmia burden and all-cause mortality in patients with a CIED in a real-world setting,” said Ilan Goldenberg, MD, at the American Heart Association scientific sessions. “These data indicate possible antiarrhythmic properties of SGLT2 inhibitors that are incremental to the beneficial effects of the drug on heart failure outcomes,” added Dr. Goldenberg, director of the Clinical Cardiovascular Research Center at the University of Rochester (N.Y.).

In a propensity score–matched analysis that included more than 5,000 of the enrolled patients with a CIED, treatment with an SGLT2 inhibitor was tied to a significant 23% relative reduction in atrial arrhythmia events and a 44% relative drop in all-cause death, he reported.
 

Effect mediated by reduced left atrial pressure?

“Other heart failure drugs have shown some decrease in the rate of sudden cardiac death, but this is the first [heart failure] drug to associate with a reduction in atrial arrhythmias,” Dr. Goldenberg noted. “We think that a reduction in left atrial pressure” produced by treatment with an SGLT2 inhibitor “may be linked to the reduction in atrial arrhythmias.”

The study did not show an association of SGLT2-inhibitor use and a change in ventricular arrhythmias, compared with patients with CIEDs who did not receive an agent from this class.

The findings suggest “expanding the possible indications for SGLT2 inhibitors,” commented Harriette G.C. Van Spall, MD, a cardiologist at McMaster University, Hamilton, Ont., who moderated the session where Dr. Goldenberg gave his report.

The study included 13,890 consecutive, prospectively enrolled patients who received a CIED during January 2015–April 2020 at any of five hospitals operated by either of two tertiary health care systems, one run by the University of Rochester and the second based at Sheba Medical Center in Tel HaShomer, Israel. The devices that made patients eligible for the study included permanent pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy devices, and implantable cardiac monitors. A blinded adjudication committee composed of electrophysiologists identified the arrhythmic episodes.

At entry into the study (the time of device implantation), 12,992 patients were not receiving an SGLT2 inhibitor (94%) and 898 (6%) were receiving a drug from this class. Of those, 39% were on dapagliflozin (Farxiga), 35% were on empagliflozin (Jardiance), and 26% were on canagliflozin (Invokana).

Patients receiving an SGLT2 inhibitor at baseline were on average substantially younger than the patients not on this drug class (59 years vs. 69 years); they had a substantially higher prevalence of diabetes (78% vs. 25%), and ischemic cardiomyopathy (63% vs. 39%). Patients on an SGLT2 inhibitor at baseline also had more modestly higher prevalence rates of prior heart failure (38% vs. 31%), and hypertension (69% vs. 63%). Prevalence of a history of atrial fibrillation (AFib) was nearly the same in both groups: 31% in patients on an SGLT2 inhibitor and 35% in those not on these drugs.

The study’s primary endpoint was the total number of arrhythmia events during follow-up of 24,442 patient-years, during which patients exhibited 19,633 atrial arrhythmia events and 3,231 ventricular arrhythmia events.
 

 

 

1% absolute reduction in atrial arrhythmias

A multivariate analysis of the entire population – adjusted for baseline differences in age, diabetes, sex, and history of AFib – showed that treatment with an SGLT2 inhibitor at baseline was linked with a significant 24% relative reduction in incident atrial arrhythmia events, a significant 24% reduction in both atrial and ventricular arrhythmia events, and a 42% relative reduction in all-cause deaths, compared with no SGLT2-inhibitor treatment.

The only analyzed endpoint that showed no significant between-group difference was incidence of ventricular arrhythmias, which was a relative 7% lower in the SGLT2-inhibitor group.

On an absolute basis, treatment with an SGLT2 inhibitor was tied to about a 1% lower rate of atrial arrhythmia events per year, a reduction from a 2.5% rate in those not on an SGLT2 inhibitor to about a 1.5% rate in those taking this drug class.



A second, confirmatory analysis used propensity score matching to identify 5,323 patients not on an SGLT2 inhibitor at baseline who closely matched the 898 patients on an SGLT2 inhibitor. The multivariate modeling for this analysis also adjusted for age, diabetes, sex, and history of AFib.

The results of these analyses closely matched the calculations that used the entire study population. Relative to patients not on an SGLT2 inhibitor those on a drug from this class had 23% fewer atrial arrhythmias, 44% fewer total death, and 22% fewer atrial or ventricular arrhythmias, all significant differences. However, ventricular arrhythmias only reduced by a relative 5%, a nonsignificant difference.

In the propensity score–matched analysis, the absolute reduction in atrial arrhythmias in those on an SGLT2 inhibitor at baseline was roughly 1.3% fewer per year, compared with those not on this drug class.

The study was funded by an unrestricted grant to the University of Rochester from AstraZeneca, the company that markets the SGLT2 inhibitor dapagliflozin (Farxiga). Dr. Goldenberg and Dr. Van Spall had no disclosures.

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Patients with cardiac implantable electronic devices (CIEDs) who received treatment with an sodium-glucose cotransporter 2 inhibitor had significantly fewer atrial arrhythmia events, compared with those who never received such a drug, in a prospective analysis of nearly 14,000 patients with a device who were followed for an average of nearly 2 years.

Dr. Ilan Goldenberg

The findings suggest that use of an agent from the class of SGLT2 inhibitors “is associated with a pronounced reduction in atrial arrhythmia burden and all-cause mortality in patients with a CIED in a real-world setting,” said Ilan Goldenberg, MD, at the American Heart Association scientific sessions. “These data indicate possible antiarrhythmic properties of SGLT2 inhibitors that are incremental to the beneficial effects of the drug on heart failure outcomes,” added Dr. Goldenberg, director of the Clinical Cardiovascular Research Center at the University of Rochester (N.Y.).

In a propensity score–matched analysis that included more than 5,000 of the enrolled patients with a CIED, treatment with an SGLT2 inhibitor was tied to a significant 23% relative reduction in atrial arrhythmia events and a 44% relative drop in all-cause death, he reported.
 

Effect mediated by reduced left atrial pressure?

“Other heart failure drugs have shown some decrease in the rate of sudden cardiac death, but this is the first [heart failure] drug to associate with a reduction in atrial arrhythmias,” Dr. Goldenberg noted. “We think that a reduction in left atrial pressure” produced by treatment with an SGLT2 inhibitor “may be linked to the reduction in atrial arrhythmias.”

The study did not show an association of SGLT2-inhibitor use and a change in ventricular arrhythmias, compared with patients with CIEDs who did not receive an agent from this class.

The findings suggest “expanding the possible indications for SGLT2 inhibitors,” commented Harriette G.C. Van Spall, MD, a cardiologist at McMaster University, Hamilton, Ont., who moderated the session where Dr. Goldenberg gave his report.

The study included 13,890 consecutive, prospectively enrolled patients who received a CIED during January 2015–April 2020 at any of five hospitals operated by either of two tertiary health care systems, one run by the University of Rochester and the second based at Sheba Medical Center in Tel HaShomer, Israel. The devices that made patients eligible for the study included permanent pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy devices, and implantable cardiac monitors. A blinded adjudication committee composed of electrophysiologists identified the arrhythmic episodes.

At entry into the study (the time of device implantation), 12,992 patients were not receiving an SGLT2 inhibitor (94%) and 898 (6%) were receiving a drug from this class. Of those, 39% were on dapagliflozin (Farxiga), 35% were on empagliflozin (Jardiance), and 26% were on canagliflozin (Invokana).

Patients receiving an SGLT2 inhibitor at baseline were on average substantially younger than the patients not on this drug class (59 years vs. 69 years); they had a substantially higher prevalence of diabetes (78% vs. 25%), and ischemic cardiomyopathy (63% vs. 39%). Patients on an SGLT2 inhibitor at baseline also had more modestly higher prevalence rates of prior heart failure (38% vs. 31%), and hypertension (69% vs. 63%). Prevalence of a history of atrial fibrillation (AFib) was nearly the same in both groups: 31% in patients on an SGLT2 inhibitor and 35% in those not on these drugs.

The study’s primary endpoint was the total number of arrhythmia events during follow-up of 24,442 patient-years, during which patients exhibited 19,633 atrial arrhythmia events and 3,231 ventricular arrhythmia events.
 

 

 

1% absolute reduction in atrial arrhythmias

A multivariate analysis of the entire population – adjusted for baseline differences in age, diabetes, sex, and history of AFib – showed that treatment with an SGLT2 inhibitor at baseline was linked with a significant 24% relative reduction in incident atrial arrhythmia events, a significant 24% reduction in both atrial and ventricular arrhythmia events, and a 42% relative reduction in all-cause deaths, compared with no SGLT2-inhibitor treatment.

The only analyzed endpoint that showed no significant between-group difference was incidence of ventricular arrhythmias, which was a relative 7% lower in the SGLT2-inhibitor group.

On an absolute basis, treatment with an SGLT2 inhibitor was tied to about a 1% lower rate of atrial arrhythmia events per year, a reduction from a 2.5% rate in those not on an SGLT2 inhibitor to about a 1.5% rate in those taking this drug class.



A second, confirmatory analysis used propensity score matching to identify 5,323 patients not on an SGLT2 inhibitor at baseline who closely matched the 898 patients on an SGLT2 inhibitor. The multivariate modeling for this analysis also adjusted for age, diabetes, sex, and history of AFib.

The results of these analyses closely matched the calculations that used the entire study population. Relative to patients not on an SGLT2 inhibitor those on a drug from this class had 23% fewer atrial arrhythmias, 44% fewer total death, and 22% fewer atrial or ventricular arrhythmias, all significant differences. However, ventricular arrhythmias only reduced by a relative 5%, a nonsignificant difference.

In the propensity score–matched analysis, the absolute reduction in atrial arrhythmias in those on an SGLT2 inhibitor at baseline was roughly 1.3% fewer per year, compared with those not on this drug class.

The study was funded by an unrestricted grant to the University of Rochester from AstraZeneca, the company that markets the SGLT2 inhibitor dapagliflozin (Farxiga). Dr. Goldenberg and Dr. Van Spall had no disclosures.

Patients with cardiac implantable electronic devices (CIEDs) who received treatment with an sodium-glucose cotransporter 2 inhibitor had significantly fewer atrial arrhythmia events, compared with those who never received such a drug, in a prospective analysis of nearly 14,000 patients with a device who were followed for an average of nearly 2 years.

Dr. Ilan Goldenberg

The findings suggest that use of an agent from the class of SGLT2 inhibitors “is associated with a pronounced reduction in atrial arrhythmia burden and all-cause mortality in patients with a CIED in a real-world setting,” said Ilan Goldenberg, MD, at the American Heart Association scientific sessions. “These data indicate possible antiarrhythmic properties of SGLT2 inhibitors that are incremental to the beneficial effects of the drug on heart failure outcomes,” added Dr. Goldenberg, director of the Clinical Cardiovascular Research Center at the University of Rochester (N.Y.).

In a propensity score–matched analysis that included more than 5,000 of the enrolled patients with a CIED, treatment with an SGLT2 inhibitor was tied to a significant 23% relative reduction in atrial arrhythmia events and a 44% relative drop in all-cause death, he reported.
 

Effect mediated by reduced left atrial pressure?

“Other heart failure drugs have shown some decrease in the rate of sudden cardiac death, but this is the first [heart failure] drug to associate with a reduction in atrial arrhythmias,” Dr. Goldenberg noted. “We think that a reduction in left atrial pressure” produced by treatment with an SGLT2 inhibitor “may be linked to the reduction in atrial arrhythmias.”

The study did not show an association of SGLT2-inhibitor use and a change in ventricular arrhythmias, compared with patients with CIEDs who did not receive an agent from this class.

The findings suggest “expanding the possible indications for SGLT2 inhibitors,” commented Harriette G.C. Van Spall, MD, a cardiologist at McMaster University, Hamilton, Ont., who moderated the session where Dr. Goldenberg gave his report.

The study included 13,890 consecutive, prospectively enrolled patients who received a CIED during January 2015–April 2020 at any of five hospitals operated by either of two tertiary health care systems, one run by the University of Rochester and the second based at Sheba Medical Center in Tel HaShomer, Israel. The devices that made patients eligible for the study included permanent pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy devices, and implantable cardiac monitors. A blinded adjudication committee composed of electrophysiologists identified the arrhythmic episodes.

At entry into the study (the time of device implantation), 12,992 patients were not receiving an SGLT2 inhibitor (94%) and 898 (6%) were receiving a drug from this class. Of those, 39% were on dapagliflozin (Farxiga), 35% were on empagliflozin (Jardiance), and 26% were on canagliflozin (Invokana).

Patients receiving an SGLT2 inhibitor at baseline were on average substantially younger than the patients not on this drug class (59 years vs. 69 years); they had a substantially higher prevalence of diabetes (78% vs. 25%), and ischemic cardiomyopathy (63% vs. 39%). Patients on an SGLT2 inhibitor at baseline also had more modestly higher prevalence rates of prior heart failure (38% vs. 31%), and hypertension (69% vs. 63%). Prevalence of a history of atrial fibrillation (AFib) was nearly the same in both groups: 31% in patients on an SGLT2 inhibitor and 35% in those not on these drugs.

The study’s primary endpoint was the total number of arrhythmia events during follow-up of 24,442 patient-years, during which patients exhibited 19,633 atrial arrhythmia events and 3,231 ventricular arrhythmia events.
 

 

 

1% absolute reduction in atrial arrhythmias

A multivariate analysis of the entire population – adjusted for baseline differences in age, diabetes, sex, and history of AFib – showed that treatment with an SGLT2 inhibitor at baseline was linked with a significant 24% relative reduction in incident atrial arrhythmia events, a significant 24% reduction in both atrial and ventricular arrhythmia events, and a 42% relative reduction in all-cause deaths, compared with no SGLT2-inhibitor treatment.

The only analyzed endpoint that showed no significant between-group difference was incidence of ventricular arrhythmias, which was a relative 7% lower in the SGLT2-inhibitor group.

On an absolute basis, treatment with an SGLT2 inhibitor was tied to about a 1% lower rate of atrial arrhythmia events per year, a reduction from a 2.5% rate in those not on an SGLT2 inhibitor to about a 1.5% rate in those taking this drug class.



A second, confirmatory analysis used propensity score matching to identify 5,323 patients not on an SGLT2 inhibitor at baseline who closely matched the 898 patients on an SGLT2 inhibitor. The multivariate modeling for this analysis also adjusted for age, diabetes, sex, and history of AFib.

The results of these analyses closely matched the calculations that used the entire study population. Relative to patients not on an SGLT2 inhibitor those on a drug from this class had 23% fewer atrial arrhythmias, 44% fewer total death, and 22% fewer atrial or ventricular arrhythmias, all significant differences. However, ventricular arrhythmias only reduced by a relative 5%, a nonsignificant difference.

In the propensity score–matched analysis, the absolute reduction in atrial arrhythmias in those on an SGLT2 inhibitor at baseline was roughly 1.3% fewer per year, compared with those not on this drug class.

The study was funded by an unrestricted grant to the University of Rochester from AstraZeneca, the company that markets the SGLT2 inhibitor dapagliflozin (Farxiga). Dr. Goldenberg and Dr. Van Spall had no disclosures.

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Poorly controlled asthma predicts COVID-19 hospitalization in children

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Thu, 12/02/2021 - 09:36

Children and adolescents with poorly controlled asthma were three to six times more likely to be hospitalized with COVID-19 infections, based on data from a national study of more than 750,000 children in Scotland.

Although the majority of COVID-19 cases in children have been mild, some children require hospitalization, wrote Ting Shi, PhD, of the University of Edinburgh (Scotland) and colleagues.

Vaccination policies to potentially reduce infection and hospitalization of children remain inconsistent, the researchers said. Identifying which school-age children would derive the greatest benefit from vaccination “could help to reduce the risk of infection and consequently the need for children to have time off school; and might also reduce the risk of spread of SARS-CoV-2 within schools and households,” but the potential benefits of vaccination for children with asthma in particular have not been well studied, they wrote.

The United Kingdom’s Joint Commission on Vaccination and Immunisation commissioned research on the rates of hospitalization among children with poorly controlled asthma. In a national incidence cohort study published in The Lancet Respiratory Medicine, the researchers reviewed data from all children aged 5-17 years in Scotland who were enrolled in the linked dataset of Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II). The total number of children in the dataset was 752,867, and 63,463 (8.4%) of these had diagnosed asthma. Among the children with asthma, 4,339 (6.8%) had confirmed COVID-19 infections between March 1, 2020, and July 27, 2021. A total of 67 infected children were hospitalized. Of the 689,404 children without asthma, 40,231 (5.8%) had confirmed COVID-19 infections, and 382 (0.9%) of these children were hospitalized.

Overall, hospital admission rates for COVID-19 were significantly higher among children with asthma, compared to those without asthma (adjusted hazard ratio, 1.49), and the rates increased among children with poorly controlled asthma.

The researchers used previous hospital admission for asthma as a measure of uncontrolled asthma, and found that hospitalization was at least six times as likely for children with poorly controlled asthma, compared with those with no asthma (aHR, 6.40), although children with well-controlled asthma also had an increased risk of hospitalization, compared with those with no asthma (aHR, 1.36).

When the researchers used oral corticosteroid prescriptions as an indicator of uncontrolled asthma, the adjusted hazard ratios were 3.38, 3.53, 1.52, and 1.34 for children with prescribed corticosteroid courses of three or more, two, one, and none, respectively, compared with children with no asthma.

These hazard ratios remained significant after controlling for factors including age, sex, socioeconomic status, comorbidity, and previous hospital admission, the researchers wrote.

In an age-based analysis, results were similar for children aged 12-17 years, but in children aged 5-11 years, the hospitalization risk decreased for those with one course of corticosteroids and reached the highest rate for those with three or more courses, rather than two courses.

The study findings were limited by several factors including the relatively small numbers of COVID-19 hospitalizations, ICU admissions, and deaths in children with asthma, the researchers noted. Other limitations include potential changes in asthma control over the study period, and lack of data on certain confounders such as tobacco use, unsuitable housing, and ethnicity, they noted. However, the results were strengthened by the use of a large, national dataset, and access to electronic health records, they said.

The findings reflect data from previous studies suggesting increased risk of hospitalization for patients with respiratory illness who develop COVID-19 infections, the researchers wrote.

The results emphasize the importance of good asthma control to protect children from severe COVID-19, and careful monitoring of children with poorly controlled asthma who do become infected, they added.

“The findings from this linkage of multiple data sources have helped inform the prioritisation of school-aged children with poorly controlled asthma for vaccines,” they concluded.
 

 

 

Findings support value of vaccination for children with asthma

“Pediatricians see many children who suffer from asthma, and although one could assume that these children would have more serious consequences from contracting COVID-19, the current study examines a large database in a way not possible in the United States to address the severity question,” said Suzanne C. Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H. “The authors used prior hospitalization rate or two prescriptions for oral corticosteroids as markers of asthma severity prior to the onset of COVID-19 in Scotland, and they collected retrospective data for 16 months of the pandemic through July of 2021, showing a significant increase in hospitalization for those children,” she said. Dr. Boulter said she was not surprised by this finding, given the impact of COVID-19 on the respiratory system.

“Pediatricians have found significant challenges from some groups of parents when discussing the indications and need for vaccination in their patients,” said Dr. Boulter. “Having this data on the increased risk of morbidity and mortality in children with asthma might help parents who are uncertain about the risk/benefit ratio of the vaccine make their decision,” she said.

Dr. Boulter said she hoped that additional studies will yield ongoing information about hospitalization rates for COVID-19 not only about asthma, but also other diagnoses affecting children in the United States and worldwide.

“It would also be important to see a breakdown of ethnic factors and adverse childhood experiences and how they relate to hospitalization and death from COVID-19,” Dr. Boulter said.

“The results of this study are not surprising, as we have known for a long time that children with severe asthma are more susceptible to severe respiratory viruses,” Francis E. Rushton, MD, a pediatrician in Beaufort, S.C., said in an interview. “But the study is still important, as it helps us determine which children are most urgently in need of protection from COVID-19 in any of its forms,” he emphasized. In particular, the current study underlines the importance of vaccinating children with unstable asthma, Dr. Rushton said.

Going forward, “it would be interesting to do additional studies looking at other markers for poor asthma control that could guide our vaccine efforts so that they are focused on those most at risk,” he added.

The study was supported by the UK Research and Innovation (Medical Research Council), Research and Innovation Industrial Strategy Challenge Fund, Health Data Research UK, and the Scottish Government. Lead author Dr. Shi had no financial conflicts to disclose. Dr. Rushton and Dr. Boulter had no financial conflicts to disclose, but each serves on the Editorial Advisory Board of Pediatric News.

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Children and adolescents with poorly controlled asthma were three to six times more likely to be hospitalized with COVID-19 infections, based on data from a national study of more than 750,000 children in Scotland.

Although the majority of COVID-19 cases in children have been mild, some children require hospitalization, wrote Ting Shi, PhD, of the University of Edinburgh (Scotland) and colleagues.

Vaccination policies to potentially reduce infection and hospitalization of children remain inconsistent, the researchers said. Identifying which school-age children would derive the greatest benefit from vaccination “could help to reduce the risk of infection and consequently the need for children to have time off school; and might also reduce the risk of spread of SARS-CoV-2 within schools and households,” but the potential benefits of vaccination for children with asthma in particular have not been well studied, they wrote.

The United Kingdom’s Joint Commission on Vaccination and Immunisation commissioned research on the rates of hospitalization among children with poorly controlled asthma. In a national incidence cohort study published in The Lancet Respiratory Medicine, the researchers reviewed data from all children aged 5-17 years in Scotland who were enrolled in the linked dataset of Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II). The total number of children in the dataset was 752,867, and 63,463 (8.4%) of these had diagnosed asthma. Among the children with asthma, 4,339 (6.8%) had confirmed COVID-19 infections between March 1, 2020, and July 27, 2021. A total of 67 infected children were hospitalized. Of the 689,404 children without asthma, 40,231 (5.8%) had confirmed COVID-19 infections, and 382 (0.9%) of these children were hospitalized.

Overall, hospital admission rates for COVID-19 were significantly higher among children with asthma, compared to those without asthma (adjusted hazard ratio, 1.49), and the rates increased among children with poorly controlled asthma.

The researchers used previous hospital admission for asthma as a measure of uncontrolled asthma, and found that hospitalization was at least six times as likely for children with poorly controlled asthma, compared with those with no asthma (aHR, 6.40), although children with well-controlled asthma also had an increased risk of hospitalization, compared with those with no asthma (aHR, 1.36).

When the researchers used oral corticosteroid prescriptions as an indicator of uncontrolled asthma, the adjusted hazard ratios were 3.38, 3.53, 1.52, and 1.34 for children with prescribed corticosteroid courses of three or more, two, one, and none, respectively, compared with children with no asthma.

These hazard ratios remained significant after controlling for factors including age, sex, socioeconomic status, comorbidity, and previous hospital admission, the researchers wrote.

In an age-based analysis, results were similar for children aged 12-17 years, but in children aged 5-11 years, the hospitalization risk decreased for those with one course of corticosteroids and reached the highest rate for those with three or more courses, rather than two courses.

The study findings were limited by several factors including the relatively small numbers of COVID-19 hospitalizations, ICU admissions, and deaths in children with asthma, the researchers noted. Other limitations include potential changes in asthma control over the study period, and lack of data on certain confounders such as tobacco use, unsuitable housing, and ethnicity, they noted. However, the results were strengthened by the use of a large, national dataset, and access to electronic health records, they said.

The findings reflect data from previous studies suggesting increased risk of hospitalization for patients with respiratory illness who develop COVID-19 infections, the researchers wrote.

The results emphasize the importance of good asthma control to protect children from severe COVID-19, and careful monitoring of children with poorly controlled asthma who do become infected, they added.

“The findings from this linkage of multiple data sources have helped inform the prioritisation of school-aged children with poorly controlled asthma for vaccines,” they concluded.
 

 

 

Findings support value of vaccination for children with asthma

“Pediatricians see many children who suffer from asthma, and although one could assume that these children would have more serious consequences from contracting COVID-19, the current study examines a large database in a way not possible in the United States to address the severity question,” said Suzanne C. Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H. “The authors used prior hospitalization rate or two prescriptions for oral corticosteroids as markers of asthma severity prior to the onset of COVID-19 in Scotland, and they collected retrospective data for 16 months of the pandemic through July of 2021, showing a significant increase in hospitalization for those children,” she said. Dr. Boulter said she was not surprised by this finding, given the impact of COVID-19 on the respiratory system.

“Pediatricians have found significant challenges from some groups of parents when discussing the indications and need for vaccination in their patients,” said Dr. Boulter. “Having this data on the increased risk of morbidity and mortality in children with asthma might help parents who are uncertain about the risk/benefit ratio of the vaccine make their decision,” she said.

Dr. Boulter said she hoped that additional studies will yield ongoing information about hospitalization rates for COVID-19 not only about asthma, but also other diagnoses affecting children in the United States and worldwide.

“It would also be important to see a breakdown of ethnic factors and adverse childhood experiences and how they relate to hospitalization and death from COVID-19,” Dr. Boulter said.

“The results of this study are not surprising, as we have known for a long time that children with severe asthma are more susceptible to severe respiratory viruses,” Francis E. Rushton, MD, a pediatrician in Beaufort, S.C., said in an interview. “But the study is still important, as it helps us determine which children are most urgently in need of protection from COVID-19 in any of its forms,” he emphasized. In particular, the current study underlines the importance of vaccinating children with unstable asthma, Dr. Rushton said.

Going forward, “it would be interesting to do additional studies looking at other markers for poor asthma control that could guide our vaccine efforts so that they are focused on those most at risk,” he added.

The study was supported by the UK Research and Innovation (Medical Research Council), Research and Innovation Industrial Strategy Challenge Fund, Health Data Research UK, and the Scottish Government. Lead author Dr. Shi had no financial conflicts to disclose. Dr. Rushton and Dr. Boulter had no financial conflicts to disclose, but each serves on the Editorial Advisory Board of Pediatric News.

Children and adolescents with poorly controlled asthma were three to six times more likely to be hospitalized with COVID-19 infections, based on data from a national study of more than 750,000 children in Scotland.

Although the majority of COVID-19 cases in children have been mild, some children require hospitalization, wrote Ting Shi, PhD, of the University of Edinburgh (Scotland) and colleagues.

Vaccination policies to potentially reduce infection and hospitalization of children remain inconsistent, the researchers said. Identifying which school-age children would derive the greatest benefit from vaccination “could help to reduce the risk of infection and consequently the need for children to have time off school; and might also reduce the risk of spread of SARS-CoV-2 within schools and households,” but the potential benefits of vaccination for children with asthma in particular have not been well studied, they wrote.

The United Kingdom’s Joint Commission on Vaccination and Immunisation commissioned research on the rates of hospitalization among children with poorly controlled asthma. In a national incidence cohort study published in The Lancet Respiratory Medicine, the researchers reviewed data from all children aged 5-17 years in Scotland who were enrolled in the linked dataset of Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II). The total number of children in the dataset was 752,867, and 63,463 (8.4%) of these had diagnosed asthma. Among the children with asthma, 4,339 (6.8%) had confirmed COVID-19 infections between March 1, 2020, and July 27, 2021. A total of 67 infected children were hospitalized. Of the 689,404 children without asthma, 40,231 (5.8%) had confirmed COVID-19 infections, and 382 (0.9%) of these children were hospitalized.

Overall, hospital admission rates for COVID-19 were significantly higher among children with asthma, compared to those without asthma (adjusted hazard ratio, 1.49), and the rates increased among children with poorly controlled asthma.

The researchers used previous hospital admission for asthma as a measure of uncontrolled asthma, and found that hospitalization was at least six times as likely for children with poorly controlled asthma, compared with those with no asthma (aHR, 6.40), although children with well-controlled asthma also had an increased risk of hospitalization, compared with those with no asthma (aHR, 1.36).

When the researchers used oral corticosteroid prescriptions as an indicator of uncontrolled asthma, the adjusted hazard ratios were 3.38, 3.53, 1.52, and 1.34 for children with prescribed corticosteroid courses of three or more, two, one, and none, respectively, compared with children with no asthma.

These hazard ratios remained significant after controlling for factors including age, sex, socioeconomic status, comorbidity, and previous hospital admission, the researchers wrote.

In an age-based analysis, results were similar for children aged 12-17 years, but in children aged 5-11 years, the hospitalization risk decreased for those with one course of corticosteroids and reached the highest rate for those with three or more courses, rather than two courses.

The study findings were limited by several factors including the relatively small numbers of COVID-19 hospitalizations, ICU admissions, and deaths in children with asthma, the researchers noted. Other limitations include potential changes in asthma control over the study period, and lack of data on certain confounders such as tobacco use, unsuitable housing, and ethnicity, they noted. However, the results were strengthened by the use of a large, national dataset, and access to electronic health records, they said.

The findings reflect data from previous studies suggesting increased risk of hospitalization for patients with respiratory illness who develop COVID-19 infections, the researchers wrote.

The results emphasize the importance of good asthma control to protect children from severe COVID-19, and careful monitoring of children with poorly controlled asthma who do become infected, they added.

“The findings from this linkage of multiple data sources have helped inform the prioritisation of school-aged children with poorly controlled asthma for vaccines,” they concluded.
 

 

 

Findings support value of vaccination for children with asthma

“Pediatricians see many children who suffer from asthma, and although one could assume that these children would have more serious consequences from contracting COVID-19, the current study examines a large database in a way not possible in the United States to address the severity question,” said Suzanne C. Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H. “The authors used prior hospitalization rate or two prescriptions for oral corticosteroids as markers of asthma severity prior to the onset of COVID-19 in Scotland, and they collected retrospective data for 16 months of the pandemic through July of 2021, showing a significant increase in hospitalization for those children,” she said. Dr. Boulter said she was not surprised by this finding, given the impact of COVID-19 on the respiratory system.

“Pediatricians have found significant challenges from some groups of parents when discussing the indications and need for vaccination in their patients,” said Dr. Boulter. “Having this data on the increased risk of morbidity and mortality in children with asthma might help parents who are uncertain about the risk/benefit ratio of the vaccine make their decision,” she said.

Dr. Boulter said she hoped that additional studies will yield ongoing information about hospitalization rates for COVID-19 not only about asthma, but also other diagnoses affecting children in the United States and worldwide.

“It would also be important to see a breakdown of ethnic factors and adverse childhood experiences and how they relate to hospitalization and death from COVID-19,” Dr. Boulter said.

“The results of this study are not surprising, as we have known for a long time that children with severe asthma are more susceptible to severe respiratory viruses,” Francis E. Rushton, MD, a pediatrician in Beaufort, S.C., said in an interview. “But the study is still important, as it helps us determine which children are most urgently in need of protection from COVID-19 in any of its forms,” he emphasized. In particular, the current study underlines the importance of vaccinating children with unstable asthma, Dr. Rushton said.

Going forward, “it would be interesting to do additional studies looking at other markers for poor asthma control that could guide our vaccine efforts so that they are focused on those most at risk,” he added.

The study was supported by the UK Research and Innovation (Medical Research Council), Research and Innovation Industrial Strategy Challenge Fund, Health Data Research UK, and the Scottish Government. Lead author Dr. Shi had no financial conflicts to disclose. Dr. Rushton and Dr. Boulter had no financial conflicts to disclose, but each serves on the Editorial Advisory Board of Pediatric News.

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‘Top’ surgery for trans youth: Advance or dangerous medicine?

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Tue, 02/14/2023 - 12:59

Is the gender-affirmative treatment approach an example of “medicine continuing on its progressive march of improving human life” or “a manifestation of dangerous medicine that ... will cause more harm than benefit to vulnerable youths?” wonders an Australian psychiatrist in a newly published letter that addresses the controversial procedure of masculinizing chest surgery – a double mastectomy – in young people with gender dysphoria (GD).

Alison Clayton, MBBS, explores the evidence for masculinizing chest surgery and looks back at examples of “dangerous medicine” in the past century while looking forward, wondering how future medics will retrospectively view gender affirmative treatment, especially so-called “top” or masculinizing chest surgery, which is in actual fact a double mastectomy, in a letter published Nov. 22 in the Archives of Sexual Behavior.

“It is surprising that clinicians and researchers claim chest surgery for GD youth is an evidence-based intervention, rather than acknowledging it is an experimental treatment that requires more rigorous and human research ethics committee [HREC] approved research,” she writes.

“The medical profession needs to consider whether, in its championing of the gender-affirmative approach for GD youth, it is also acting brashly and making mistakes that will negatively impact some young people for the rest of their lives,” she continues.

Ms. Clayton, after many years of experience as a psychiatrist, has recently returned to postgraduate research into the history of 20th-century psychiatry at the School of Historical and Philosophical Studies, University of Melbourne.

Meanwhile, the authors of a viewpoint published online Dec. 1 in JAMA Surgery, agree with Ms. Clayton on the issue of a lack of long-term studies on which to base decisions, particularly when it comes to insurance coverage for gender surgeries in the United States.  

Nnenaya Agochukwu-Mmonu, MD, and colleagues recommend use of the coverage with evidence development (CED) approach, which would, they say, provide a “rigorous evidence base for gender-affirming interventions and surgery while simultaneously allowing access and provisional coverage for these services.”
 

Threefold increase in gender-affirming surgeries in past decade

There has been a threefold rise in the rate of gender-affirming surgeries in the United States in the past decade, which can be attributed to increased recognition of gender dysphoria, decreasing social stigma toward these individuals, greater clinical experience, and expanding insurance coverage, according to Dr. Agochukwu-Mmonu, of the department of urology, NYU School of Medicine, and coauthors.

Ms. Clayton meanwhile notes that of the increasing number of adolescents being referred for treatment for gender dysphoria in the Western world, most were born female and many have “a history of psychiatric illness or neurodevelopmental disorders.”

Many of these youngsters also show a “high demand” for surgical removal of breasts, she adds, noting that this operation is being undertaken as routine treatment in patients as young as 13, with some clinicians arguing that “this surgery is an evidence-based intervention that improves mental health outcomes, and that it is discriminatory for it not to be available.”

She also notes that “chest dysphoria” is “a recently created term meaning discomfort with one’s breasts.” The term “breast” is therefore largely absent in publications talking about this surgery as it “may cause distress for transgender males,” to quote one source, Ms. Clayton says, and “this seems part of a broader pattern of removing this term from clinical language,” according to another article on the subject.

Ms. Clayton also says, “There are only a handful of published studies focusing on the potential benefits of masculinizing chest surgery,” and notes that these mostly report on surgery for individuals younger than 21 years old.
 

 

 

Significant methodological flaws in existing research

One study of 14 postsurgical youth (nine of whom were under 18 years) found that “all reported high aesthetic satisfaction and most self-reported low complication rates and improvement in mood.”

Another cross-sectional retrospective survey looked at 68 postsurgical transmasculine youth (72% of the eligible postsurgical population); 49% had surgery when younger than age 18, with the youngest being age 13 and the oldest age 24. At the time of the survey, only 14% of participants were more than 2 years postsurgery. The postsurgical participants were found to have reduced chest dysphoria (the outcome) compared with a convenience and nonmatched comparison sample of nonsurgical transmasculine youth.

And a 2021 qualitative study of 30 transmale youth – about half of whom had undergone chest surgery – concluded that the postsurgical cohort experienced “tremendous” benefits in chest dysphoria and a range of psychological outcomes.

On this particular study, Ms. Clayton notes that “in my opinion, they did not provide enough detail for the reader to make an informed judgment regarding this latter claim.”

She goes on to discuss genital surgery, sometimes called full gender-affirming surgery (or “bottom surgery”), and says proponents of these operations point out that the main objections to them in minors is to “surgical sterilization, and people get super worked up about that ... it is a barrier we have to overcome, and I think we are going to.”

Ms. Clayton asserts that it seems “this barrier is already being overcome, as it has been reported that in the United States, genital surgery is being undertaken on gender dysphoric minors as young as 15 years old.”

Reflecting on the available evidence, Ms. Clayton highlights the significant methodological flaws that limit the extent to which surgery can be linked to short-term improved mental health outcomes and adds that information on long-term outcomes and rates of regret is unavailable.

She also asserts that the research fails to assess “a role for psychological interventions which could be utilized, as a least-harm intervention, until maturity is reached.”
 

Historical examples of experimental medicine

Ms. Clayton goes on to draw parallels with experimental medicine performed on homosexuals in the 20th century, highlighting the medical and surgical interventions, which included metrazol convulsive therapy, chemical castration with estrogens, surgical castration, clitoridectomy, brain operations, and aversive electrotherapy.

She also refers to the historical practice of hormonal treatment for “tall girls” and “short boys” between the 1960s and 1980s. Hormones were given to young people who did not have any medical reason underpinning their stature but were distressed, and society considered their height to have a negative social impact.

“With the encouragement of physicians and school nurses, enthusiastic media promotion, and pharmaceutical companies’ advertising, parents sought hormonal interventions,” she writes, adding that, at the time the hormones were considered safe, but long-term adverse effects emerged, including impaired fertility and increased risk of cancers.

“This seems another part of the story of medicine acting to reinforce society’s sex stereotypes, and for some patients it came at disastrous personal cost,” writes Ms. Clayton.

The gender-affirming approach is based on endorsing the adolescent’s stated gender identity with minimal questioning and “that they should be supported to undertake social transition, medical transition, masculinizing chest surgery, and, some also argue, genital surgery,” she writes.

Objectors to this approach pinpoint the “limited and low-quality evidence base for the benefits” but also “the irreversible and long-term adverse impacts of these treatments on fertility and sexual function, as well as on bone, brain, and cardiovascular functioning.”
 

 

 

Current studies of gender-affirming surgeries lack standardization

In their viewpoint, Dr. Agochukwu-Mmonu and colleagues state that use of a CED would not only help provide an evidence base but would also ensure better-informed policy access and coverage decisions to help standardize approaches to gender surgery in the United States.

Currently, they note, “Studies examining the mental health benefit for patients undergoing gender-affirming surgeries include measures that lack standardization, evaluate different interventions (that is, surgeries are rarely done with concurrent hormone administration), include dissimilar patient populations, and use different study designs.”

This difference in study design leads to variation in reported outcomes. Although many studies have shown benefit, others report that patients have unrealistic expectations or experience regret, Dr. Agochukwu-Mmonu and coauthors conclude.

CED provides an option that would enable informed decisions. “It allows the deliberate use of innovative therapies, explicit integration of transgender and nonbinary patient input, and ongoing systematic evaluation aimed to identify specific patient groups who would or would not benefit from their use.”

This leads back to Ms. Clayton’s central question around whether the gender-affirmative approach is a medical advance or dangerous medicine.

“Why are these experimental interventions, with inherent risks and scarce, low-quality evidence for benefits being implemented outside HREC-regulated clinical trial settings?’” she wonders.

Ms. Clayton has declared no conflicts of interest.

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

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Is the gender-affirmative treatment approach an example of “medicine continuing on its progressive march of improving human life” or “a manifestation of dangerous medicine that ... will cause more harm than benefit to vulnerable youths?” wonders an Australian psychiatrist in a newly published letter that addresses the controversial procedure of masculinizing chest surgery – a double mastectomy – in young people with gender dysphoria (GD).

Alison Clayton, MBBS, explores the evidence for masculinizing chest surgery and looks back at examples of “dangerous medicine” in the past century while looking forward, wondering how future medics will retrospectively view gender affirmative treatment, especially so-called “top” or masculinizing chest surgery, which is in actual fact a double mastectomy, in a letter published Nov. 22 in the Archives of Sexual Behavior.

“It is surprising that clinicians and researchers claim chest surgery for GD youth is an evidence-based intervention, rather than acknowledging it is an experimental treatment that requires more rigorous and human research ethics committee [HREC] approved research,” she writes.

“The medical profession needs to consider whether, in its championing of the gender-affirmative approach for GD youth, it is also acting brashly and making mistakes that will negatively impact some young people for the rest of their lives,” she continues.

Ms. Clayton, after many years of experience as a psychiatrist, has recently returned to postgraduate research into the history of 20th-century psychiatry at the School of Historical and Philosophical Studies, University of Melbourne.

Meanwhile, the authors of a viewpoint published online Dec. 1 in JAMA Surgery, agree with Ms. Clayton on the issue of a lack of long-term studies on which to base decisions, particularly when it comes to insurance coverage for gender surgeries in the United States.  

Nnenaya Agochukwu-Mmonu, MD, and colleagues recommend use of the coverage with evidence development (CED) approach, which would, they say, provide a “rigorous evidence base for gender-affirming interventions and surgery while simultaneously allowing access and provisional coverage for these services.”
 

Threefold increase in gender-affirming surgeries in past decade

There has been a threefold rise in the rate of gender-affirming surgeries in the United States in the past decade, which can be attributed to increased recognition of gender dysphoria, decreasing social stigma toward these individuals, greater clinical experience, and expanding insurance coverage, according to Dr. Agochukwu-Mmonu, of the department of urology, NYU School of Medicine, and coauthors.

Ms. Clayton meanwhile notes that of the increasing number of adolescents being referred for treatment for gender dysphoria in the Western world, most were born female and many have “a history of psychiatric illness or neurodevelopmental disorders.”

Many of these youngsters also show a “high demand” for surgical removal of breasts, she adds, noting that this operation is being undertaken as routine treatment in patients as young as 13, with some clinicians arguing that “this surgery is an evidence-based intervention that improves mental health outcomes, and that it is discriminatory for it not to be available.”

She also notes that “chest dysphoria” is “a recently created term meaning discomfort with one’s breasts.” The term “breast” is therefore largely absent in publications talking about this surgery as it “may cause distress for transgender males,” to quote one source, Ms. Clayton says, and “this seems part of a broader pattern of removing this term from clinical language,” according to another article on the subject.

Ms. Clayton also says, “There are only a handful of published studies focusing on the potential benefits of masculinizing chest surgery,” and notes that these mostly report on surgery for individuals younger than 21 years old.
 

 

 

Significant methodological flaws in existing research

One study of 14 postsurgical youth (nine of whom were under 18 years) found that “all reported high aesthetic satisfaction and most self-reported low complication rates and improvement in mood.”

Another cross-sectional retrospective survey looked at 68 postsurgical transmasculine youth (72% of the eligible postsurgical population); 49% had surgery when younger than age 18, with the youngest being age 13 and the oldest age 24. At the time of the survey, only 14% of participants were more than 2 years postsurgery. The postsurgical participants were found to have reduced chest dysphoria (the outcome) compared with a convenience and nonmatched comparison sample of nonsurgical transmasculine youth.

And a 2021 qualitative study of 30 transmale youth – about half of whom had undergone chest surgery – concluded that the postsurgical cohort experienced “tremendous” benefits in chest dysphoria and a range of psychological outcomes.

On this particular study, Ms. Clayton notes that “in my opinion, they did not provide enough detail for the reader to make an informed judgment regarding this latter claim.”

She goes on to discuss genital surgery, sometimes called full gender-affirming surgery (or “bottom surgery”), and says proponents of these operations point out that the main objections to them in minors is to “surgical sterilization, and people get super worked up about that ... it is a barrier we have to overcome, and I think we are going to.”

Ms. Clayton asserts that it seems “this barrier is already being overcome, as it has been reported that in the United States, genital surgery is being undertaken on gender dysphoric minors as young as 15 years old.”

Reflecting on the available evidence, Ms. Clayton highlights the significant methodological flaws that limit the extent to which surgery can be linked to short-term improved mental health outcomes and adds that information on long-term outcomes and rates of regret is unavailable.

She also asserts that the research fails to assess “a role for psychological interventions which could be utilized, as a least-harm intervention, until maturity is reached.”
 

Historical examples of experimental medicine

Ms. Clayton goes on to draw parallels with experimental medicine performed on homosexuals in the 20th century, highlighting the medical and surgical interventions, which included metrazol convulsive therapy, chemical castration with estrogens, surgical castration, clitoridectomy, brain operations, and aversive electrotherapy.

She also refers to the historical practice of hormonal treatment for “tall girls” and “short boys” between the 1960s and 1980s. Hormones were given to young people who did not have any medical reason underpinning their stature but were distressed, and society considered their height to have a negative social impact.

“With the encouragement of physicians and school nurses, enthusiastic media promotion, and pharmaceutical companies’ advertising, parents sought hormonal interventions,” she writes, adding that, at the time the hormones were considered safe, but long-term adverse effects emerged, including impaired fertility and increased risk of cancers.

“This seems another part of the story of medicine acting to reinforce society’s sex stereotypes, and for some patients it came at disastrous personal cost,” writes Ms. Clayton.

The gender-affirming approach is based on endorsing the adolescent’s stated gender identity with minimal questioning and “that they should be supported to undertake social transition, medical transition, masculinizing chest surgery, and, some also argue, genital surgery,” she writes.

Objectors to this approach pinpoint the “limited and low-quality evidence base for the benefits” but also “the irreversible and long-term adverse impacts of these treatments on fertility and sexual function, as well as on bone, brain, and cardiovascular functioning.”
 

 

 

Current studies of gender-affirming surgeries lack standardization

In their viewpoint, Dr. Agochukwu-Mmonu and colleagues state that use of a CED would not only help provide an evidence base but would also ensure better-informed policy access and coverage decisions to help standardize approaches to gender surgery in the United States.

Currently, they note, “Studies examining the mental health benefit for patients undergoing gender-affirming surgeries include measures that lack standardization, evaluate different interventions (that is, surgeries are rarely done with concurrent hormone administration), include dissimilar patient populations, and use different study designs.”

This difference in study design leads to variation in reported outcomes. Although many studies have shown benefit, others report that patients have unrealistic expectations or experience regret, Dr. Agochukwu-Mmonu and coauthors conclude.

CED provides an option that would enable informed decisions. “It allows the deliberate use of innovative therapies, explicit integration of transgender and nonbinary patient input, and ongoing systematic evaluation aimed to identify specific patient groups who would or would not benefit from their use.”

This leads back to Ms. Clayton’s central question around whether the gender-affirmative approach is a medical advance or dangerous medicine.

“Why are these experimental interventions, with inherent risks and scarce, low-quality evidence for benefits being implemented outside HREC-regulated clinical trial settings?’” she wonders.

Ms. Clayton has declared no conflicts of interest.

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

Is the gender-affirmative treatment approach an example of “medicine continuing on its progressive march of improving human life” or “a manifestation of dangerous medicine that ... will cause more harm than benefit to vulnerable youths?” wonders an Australian psychiatrist in a newly published letter that addresses the controversial procedure of masculinizing chest surgery – a double mastectomy – in young people with gender dysphoria (GD).

Alison Clayton, MBBS, explores the evidence for masculinizing chest surgery and looks back at examples of “dangerous medicine” in the past century while looking forward, wondering how future medics will retrospectively view gender affirmative treatment, especially so-called “top” or masculinizing chest surgery, which is in actual fact a double mastectomy, in a letter published Nov. 22 in the Archives of Sexual Behavior.

“It is surprising that clinicians and researchers claim chest surgery for GD youth is an evidence-based intervention, rather than acknowledging it is an experimental treatment that requires more rigorous and human research ethics committee [HREC] approved research,” she writes.

“The medical profession needs to consider whether, in its championing of the gender-affirmative approach for GD youth, it is also acting brashly and making mistakes that will negatively impact some young people for the rest of their lives,” she continues.

Ms. Clayton, after many years of experience as a psychiatrist, has recently returned to postgraduate research into the history of 20th-century psychiatry at the School of Historical and Philosophical Studies, University of Melbourne.

Meanwhile, the authors of a viewpoint published online Dec. 1 in JAMA Surgery, agree with Ms. Clayton on the issue of a lack of long-term studies on which to base decisions, particularly when it comes to insurance coverage for gender surgeries in the United States.  

Nnenaya Agochukwu-Mmonu, MD, and colleagues recommend use of the coverage with evidence development (CED) approach, which would, they say, provide a “rigorous evidence base for gender-affirming interventions and surgery while simultaneously allowing access and provisional coverage for these services.”
 

Threefold increase in gender-affirming surgeries in past decade

There has been a threefold rise in the rate of gender-affirming surgeries in the United States in the past decade, which can be attributed to increased recognition of gender dysphoria, decreasing social stigma toward these individuals, greater clinical experience, and expanding insurance coverage, according to Dr. Agochukwu-Mmonu, of the department of urology, NYU School of Medicine, and coauthors.

Ms. Clayton meanwhile notes that of the increasing number of adolescents being referred for treatment for gender dysphoria in the Western world, most were born female and many have “a history of psychiatric illness or neurodevelopmental disorders.”

Many of these youngsters also show a “high demand” for surgical removal of breasts, she adds, noting that this operation is being undertaken as routine treatment in patients as young as 13, with some clinicians arguing that “this surgery is an evidence-based intervention that improves mental health outcomes, and that it is discriminatory for it not to be available.”

She also notes that “chest dysphoria” is “a recently created term meaning discomfort with one’s breasts.” The term “breast” is therefore largely absent in publications talking about this surgery as it “may cause distress for transgender males,” to quote one source, Ms. Clayton says, and “this seems part of a broader pattern of removing this term from clinical language,” according to another article on the subject.

Ms. Clayton also says, “There are only a handful of published studies focusing on the potential benefits of masculinizing chest surgery,” and notes that these mostly report on surgery for individuals younger than 21 years old.
 

 

 

Significant methodological flaws in existing research

One study of 14 postsurgical youth (nine of whom were under 18 years) found that “all reported high aesthetic satisfaction and most self-reported low complication rates and improvement in mood.”

Another cross-sectional retrospective survey looked at 68 postsurgical transmasculine youth (72% of the eligible postsurgical population); 49% had surgery when younger than age 18, with the youngest being age 13 and the oldest age 24. At the time of the survey, only 14% of participants were more than 2 years postsurgery. The postsurgical participants were found to have reduced chest dysphoria (the outcome) compared with a convenience and nonmatched comparison sample of nonsurgical transmasculine youth.

And a 2021 qualitative study of 30 transmale youth – about half of whom had undergone chest surgery – concluded that the postsurgical cohort experienced “tremendous” benefits in chest dysphoria and a range of psychological outcomes.

On this particular study, Ms. Clayton notes that “in my opinion, they did not provide enough detail for the reader to make an informed judgment regarding this latter claim.”

She goes on to discuss genital surgery, sometimes called full gender-affirming surgery (or “bottom surgery”), and says proponents of these operations point out that the main objections to them in minors is to “surgical sterilization, and people get super worked up about that ... it is a barrier we have to overcome, and I think we are going to.”

Ms. Clayton asserts that it seems “this barrier is already being overcome, as it has been reported that in the United States, genital surgery is being undertaken on gender dysphoric minors as young as 15 years old.”

Reflecting on the available evidence, Ms. Clayton highlights the significant methodological flaws that limit the extent to which surgery can be linked to short-term improved mental health outcomes and adds that information on long-term outcomes and rates of regret is unavailable.

She also asserts that the research fails to assess “a role for psychological interventions which could be utilized, as a least-harm intervention, until maturity is reached.”
 

Historical examples of experimental medicine

Ms. Clayton goes on to draw parallels with experimental medicine performed on homosexuals in the 20th century, highlighting the medical and surgical interventions, which included metrazol convulsive therapy, chemical castration with estrogens, surgical castration, clitoridectomy, brain operations, and aversive electrotherapy.

She also refers to the historical practice of hormonal treatment for “tall girls” and “short boys” between the 1960s and 1980s. Hormones were given to young people who did not have any medical reason underpinning their stature but were distressed, and society considered their height to have a negative social impact.

“With the encouragement of physicians and school nurses, enthusiastic media promotion, and pharmaceutical companies’ advertising, parents sought hormonal interventions,” she writes, adding that, at the time the hormones were considered safe, but long-term adverse effects emerged, including impaired fertility and increased risk of cancers.

“This seems another part of the story of medicine acting to reinforce society’s sex stereotypes, and for some patients it came at disastrous personal cost,” writes Ms. Clayton.

The gender-affirming approach is based on endorsing the adolescent’s stated gender identity with minimal questioning and “that they should be supported to undertake social transition, medical transition, masculinizing chest surgery, and, some also argue, genital surgery,” she writes.

Objectors to this approach pinpoint the “limited and low-quality evidence base for the benefits” but also “the irreversible and long-term adverse impacts of these treatments on fertility and sexual function, as well as on bone, brain, and cardiovascular functioning.”
 

 

 

Current studies of gender-affirming surgeries lack standardization

In their viewpoint, Dr. Agochukwu-Mmonu and colleagues state that use of a CED would not only help provide an evidence base but would also ensure better-informed policy access and coverage decisions to help standardize approaches to gender surgery in the United States.

Currently, they note, “Studies examining the mental health benefit for patients undergoing gender-affirming surgeries include measures that lack standardization, evaluate different interventions (that is, surgeries are rarely done with concurrent hormone administration), include dissimilar patient populations, and use different study designs.”

This difference in study design leads to variation in reported outcomes. Although many studies have shown benefit, others report that patients have unrealistic expectations or experience regret, Dr. Agochukwu-Mmonu and coauthors conclude.

CED provides an option that would enable informed decisions. “It allows the deliberate use of innovative therapies, explicit integration of transgender and nonbinary patient input, and ongoing systematic evaluation aimed to identify specific patient groups who would or would not benefit from their use.”

This leads back to Ms. Clayton’s central question around whether the gender-affirmative approach is a medical advance or dangerous medicine.

“Why are these experimental interventions, with inherent risks and scarce, low-quality evidence for benefits being implemented outside HREC-regulated clinical trial settings?’” she wonders.

Ms. Clayton has declared no conflicts of interest.

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

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Bullae on elderly woman’s toes

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Bullae on elderly woman’s toes

boils on toes

A biopsy was performed and sent for immunofluorescence; the results were negative. This, along with the patient’s history of diabetes, led us to the diagnosis of bullosis diabeticorum (BD). This condition, also known as bullous disease of diabetes, is characterized by abrupt development of noninflammatory bullae on acral areas in patients with diabetes.

The etiology of BD is unknown. The acral location suggests that trauma may be a contributing factor. Although electron microscopy has suggested an abnormality in anchoring fibrils, this cellular change does not fully explain the development of multiple blisters at varying sites.

A diagnosis of BD can be made when biopsy with immunofluorescence excludes other histologically similar diagnoses such as epidermolysis bullosa, noninflammatory bullous pemphigoid, and porphyria cutanea tarda. And, while immunofluorescence findings are typically negative, elevated levels of immunoglobulin M and C3 have, on occasion, been reported.1,2 Cultures are warranted only if a secondary infection is suspected.

The distribution of lesions and the presence—or absence—of systemic symptoms go a long way toward narrowing the differential of blistering diseases. The presence of generalized blistering and systemic symptoms would suggest conditions related to medication exposure, such as Stevens-Johnson syndrome or toxic epidermal necrolysis; infectious etiologies (eg, staphylococcal scalded skin syndrome); autoimmune causes; or underlying malignancy.3 Generalized blistering in the absence of systemic symptoms would support diagnoses such as bullous impetigo and pemphigoid.3

The blisters associated with BD spontaneously resolve over several weeks without treatment but tend to recur. The lesions typically heal without significant scarring, although they may have a darker pigmentation after the first occurrence. Treatment may be warranted if a patient develops a secondary infection. For this patient, the bullae resolved within 2 weeks without treatment, although mild hyperpigmentation remained.

This case was adapted from: Mims L, Savage A, Chessman A. Blisters on an elderly woman’s toes. J Fam Pract. 2014;63:273-274.

References

1. James WD, Odom RB, Goette DK. Bullous eruption of diabetes. A case with positive immunofluorescence microscopy findings. Arch Dermatol. 1980;116:1191-1192.

2. Basarab T, Munn SE, McGrath J, et al. Bullous diabeticorum. A case report and literature review. Clin Exp Dermatol. 1995;20:218-220. doi: 10.1111/j.1365-2230.1995.tb01305.x

3. Hull C, Zone JJ. Approach to the patient with cutaneous blisters. UpToDate. Updated July 30, 2019. Accessed September 14, 2021. www.uptodate.com/contents/approach-to-the-patient-with-cutaneous-blisters

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The Journal of Family Practice - 70(10)
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boils on toes

A biopsy was performed and sent for immunofluorescence; the results were negative. This, along with the patient’s history of diabetes, led us to the diagnosis of bullosis diabeticorum (BD). This condition, also known as bullous disease of diabetes, is characterized by abrupt development of noninflammatory bullae on acral areas in patients with diabetes.

The etiology of BD is unknown. The acral location suggests that trauma may be a contributing factor. Although electron microscopy has suggested an abnormality in anchoring fibrils, this cellular change does not fully explain the development of multiple blisters at varying sites.

A diagnosis of BD can be made when biopsy with immunofluorescence excludes other histologically similar diagnoses such as epidermolysis bullosa, noninflammatory bullous pemphigoid, and porphyria cutanea tarda. And, while immunofluorescence findings are typically negative, elevated levels of immunoglobulin M and C3 have, on occasion, been reported.1,2 Cultures are warranted only if a secondary infection is suspected.

The distribution of lesions and the presence—or absence—of systemic symptoms go a long way toward narrowing the differential of blistering diseases. The presence of generalized blistering and systemic symptoms would suggest conditions related to medication exposure, such as Stevens-Johnson syndrome or toxic epidermal necrolysis; infectious etiologies (eg, staphylococcal scalded skin syndrome); autoimmune causes; or underlying malignancy.3 Generalized blistering in the absence of systemic symptoms would support diagnoses such as bullous impetigo and pemphigoid.3

The blisters associated with BD spontaneously resolve over several weeks without treatment but tend to recur. The lesions typically heal without significant scarring, although they may have a darker pigmentation after the first occurrence. Treatment may be warranted if a patient develops a secondary infection. For this patient, the bullae resolved within 2 weeks without treatment, although mild hyperpigmentation remained.

This case was adapted from: Mims L, Savage A, Chessman A. Blisters on an elderly woman’s toes. J Fam Pract. 2014;63:273-274.

boils on toes

A biopsy was performed and sent for immunofluorescence; the results were negative. This, along with the patient’s history of diabetes, led us to the diagnosis of bullosis diabeticorum (BD). This condition, also known as bullous disease of diabetes, is characterized by abrupt development of noninflammatory bullae on acral areas in patients with diabetes.

The etiology of BD is unknown. The acral location suggests that trauma may be a contributing factor. Although electron microscopy has suggested an abnormality in anchoring fibrils, this cellular change does not fully explain the development of multiple blisters at varying sites.

A diagnosis of BD can be made when biopsy with immunofluorescence excludes other histologically similar diagnoses such as epidermolysis bullosa, noninflammatory bullous pemphigoid, and porphyria cutanea tarda. And, while immunofluorescence findings are typically negative, elevated levels of immunoglobulin M and C3 have, on occasion, been reported.1,2 Cultures are warranted only if a secondary infection is suspected.

The distribution of lesions and the presence—or absence—of systemic symptoms go a long way toward narrowing the differential of blistering diseases. The presence of generalized blistering and systemic symptoms would suggest conditions related to medication exposure, such as Stevens-Johnson syndrome or toxic epidermal necrolysis; infectious etiologies (eg, staphylococcal scalded skin syndrome); autoimmune causes; or underlying malignancy.3 Generalized blistering in the absence of systemic symptoms would support diagnoses such as bullous impetigo and pemphigoid.3

The blisters associated with BD spontaneously resolve over several weeks without treatment but tend to recur. The lesions typically heal without significant scarring, although they may have a darker pigmentation after the first occurrence. Treatment may be warranted if a patient develops a secondary infection. For this patient, the bullae resolved within 2 weeks without treatment, although mild hyperpigmentation remained.

This case was adapted from: Mims L, Savage A, Chessman A. Blisters on an elderly woman’s toes. J Fam Pract. 2014;63:273-274.

References

1. James WD, Odom RB, Goette DK. Bullous eruption of diabetes. A case with positive immunofluorescence microscopy findings. Arch Dermatol. 1980;116:1191-1192.

2. Basarab T, Munn SE, McGrath J, et al. Bullous diabeticorum. A case report and literature review. Clin Exp Dermatol. 1995;20:218-220. doi: 10.1111/j.1365-2230.1995.tb01305.x

3. Hull C, Zone JJ. Approach to the patient with cutaneous blisters. UpToDate. Updated July 30, 2019. Accessed September 14, 2021. www.uptodate.com/contents/approach-to-the-patient-with-cutaneous-blisters

References

1. James WD, Odom RB, Goette DK. Bullous eruption of diabetes. A case with positive immunofluorescence microscopy findings. Arch Dermatol. 1980;116:1191-1192.

2. Basarab T, Munn SE, McGrath J, et al. Bullous diabeticorum. A case report and literature review. Clin Exp Dermatol. 1995;20:218-220. doi: 10.1111/j.1365-2230.1995.tb01305.x

3. Hull C, Zone JJ. Approach to the patient with cutaneous blisters. UpToDate. Updated July 30, 2019. Accessed September 14, 2021. www.uptodate.com/contents/approach-to-the-patient-with-cutaneous-blisters

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Clinical Edge Journal Scan Commentary: Psoriasis December 2021

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Dr. Ferris scans the journals, so you don’t have to!

Laura Ferris, MD, PhD
Over the past several years we have seen several new biologics that inhibit the IL-17 pathway to become available to treat our patients. All have performed well in Phase 3 studies with high PASI response rates making it challenging to differentiate between them. This month, two studies provide data that can help dermatologists optimize their use of these drugs in clinical practice.

A retrospective observational study of nearly 1200 prior biologic-experienced adult patients with psoriasis now receiving either secukinumab (n=780) or ixekizumab (n=411), both of which inhibit IL-17A, examined drug persistence after 18 months. Ixekizumab was associated with significantly higher rates of high treatment adherence (42% vs 35%; P = .019) and persistence (44.9% vs 36.9%; P = .007) and lower discontinuation (48.4% vs 56.0%; P = .018) and switching (26.6% vs 34.0%; P = .009) rates than secukinumab. Both drugs are dosed monthly after an initial loading dose (Blauvelt A et al. Dermatol Ther (Heidelb).

With several biologic options available, patients may be switched from one biologic to another if they are not having an adequate response. Separate studies have shown that patients with an inadequate response to ustekinumab are likely to have a better response when switched to brodalumab or guselkumab, although this does not tell us if one is more likely to be effective than the other. In a recent matching-adjusted indirect comparison study using data for patients with psoriasis who responded inadequately to ustekinumab and switched to receive brodalumab (n=121) or guselkumab (n=135) the authors found that brodalumab was associated with greater improvements than guselkumab in inadequate responders to ustekinumab with a PASI 100 rate at week 36 of 40.3% for brodalumab vs 20.0% for guselkumab; P < 0.001. (Hampton P et al. Psoriasis (Auckl).

While biologics have revolutionized the treatment of psoriasis, not all patients with extensive disease desire or are appropriate for a systemic therapy. Topical steroids, the most commonly used topical psoriasis therapy, still carry some risk of systemic absorption and are associate with cutaneous side effects such as atrophy with prolonged use. Tarpinarof 1% cream is a novel aryl hydrocarbon receptor modulating agent that has been shown in phase 3 studies to be an effective treatment for psoriasis when applied once a day. A recent open label study of 21 adult patients with extensive plaque psoriasis (20% or more body surface area (BSA) involvement, mean baseline BSA 27.2%) who applied tapinarof cream 1% QD daily showed that 94.7% of patients had a decrease in their PASI score (mean PASI decrease of 59.6%). Despite the large BSA being treated, tapinarof plasma concentration were low and remained below the quantification level in the majority (67.9%) of samples tested. There were also no concerning EKG changes such as QT prolongation. Folliculitis and headache were the most common adverse events (each reported by 4 patients) (Jett JE et al. Am J Clin Dermatol).

These studies all provide valuable data in helping us to make the best treatment decisions for patients with moderate to severe plaque psoriasis.

Author and Disclosure Information

Laura K. Ferris, MD, PhD, Professor, Department of Dermatology, University of Pittsburgh, Pittsburgh, Pennsylvania

Laura K. Ferris, MD, PhD, has disclosed the following relevant financial relationships:

Received income in an amount equal to or greater than $250 from: Eli Lilly; Janssen; Bristol-Myers Squibb; Arcutis; Dermavant; AbbVie

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Laura K. Ferris, MD, PhD, Professor, Department of Dermatology, University of Pittsburgh, Pittsburgh, Pennsylvania

Laura K. Ferris, MD, PhD, has disclosed the following relevant financial relationships:

Received income in an amount equal to or greater than $250 from: Eli Lilly; Janssen; Bristol-Myers Squibb; Arcutis; Dermavant; AbbVie

Author and Disclosure Information

Laura K. Ferris, MD, PhD, Professor, Department of Dermatology, University of Pittsburgh, Pittsburgh, Pennsylvania

Laura K. Ferris, MD, PhD, has disclosed the following relevant financial relationships:

Received income in an amount equal to or greater than $250 from: Eli Lilly; Janssen; Bristol-Myers Squibb; Arcutis; Dermavant; AbbVie

Dr. Ferris scans the journals, so you don’t have to!
Dr. Ferris scans the journals, so you don’t have to!

Laura Ferris, MD, PhD
Over the past several years we have seen several new biologics that inhibit the IL-17 pathway to become available to treat our patients. All have performed well in Phase 3 studies with high PASI response rates making it challenging to differentiate between them. This month, two studies provide data that can help dermatologists optimize their use of these drugs in clinical practice.

A retrospective observational study of nearly 1200 prior biologic-experienced adult patients with psoriasis now receiving either secukinumab (n=780) or ixekizumab (n=411), both of which inhibit IL-17A, examined drug persistence after 18 months. Ixekizumab was associated with significantly higher rates of high treatment adherence (42% vs 35%; P = .019) and persistence (44.9% vs 36.9%; P = .007) and lower discontinuation (48.4% vs 56.0%; P = .018) and switching (26.6% vs 34.0%; P = .009) rates than secukinumab. Both drugs are dosed monthly after an initial loading dose (Blauvelt A et al. Dermatol Ther (Heidelb).

With several biologic options available, patients may be switched from one biologic to another if they are not having an adequate response. Separate studies have shown that patients with an inadequate response to ustekinumab are likely to have a better response when switched to brodalumab or guselkumab, although this does not tell us if one is more likely to be effective than the other. In a recent matching-adjusted indirect comparison study using data for patients with psoriasis who responded inadequately to ustekinumab and switched to receive brodalumab (n=121) or guselkumab (n=135) the authors found that brodalumab was associated with greater improvements than guselkumab in inadequate responders to ustekinumab with a PASI 100 rate at week 36 of 40.3% for brodalumab vs 20.0% for guselkumab; P < 0.001. (Hampton P et al. Psoriasis (Auckl).

While biologics have revolutionized the treatment of psoriasis, not all patients with extensive disease desire or are appropriate for a systemic therapy. Topical steroids, the most commonly used topical psoriasis therapy, still carry some risk of systemic absorption and are associate with cutaneous side effects such as atrophy with prolonged use. Tarpinarof 1% cream is a novel aryl hydrocarbon receptor modulating agent that has been shown in phase 3 studies to be an effective treatment for psoriasis when applied once a day. A recent open label study of 21 adult patients with extensive plaque psoriasis (20% or more body surface area (BSA) involvement, mean baseline BSA 27.2%) who applied tapinarof cream 1% QD daily showed that 94.7% of patients had a decrease in their PASI score (mean PASI decrease of 59.6%). Despite the large BSA being treated, tapinarof plasma concentration were low and remained below the quantification level in the majority (67.9%) of samples tested. There were also no concerning EKG changes such as QT prolongation. Folliculitis and headache were the most common adverse events (each reported by 4 patients) (Jett JE et al. Am J Clin Dermatol).

These studies all provide valuable data in helping us to make the best treatment decisions for patients with moderate to severe plaque psoriasis.

Laura Ferris, MD, PhD
Over the past several years we have seen several new biologics that inhibit the IL-17 pathway to become available to treat our patients. All have performed well in Phase 3 studies with high PASI response rates making it challenging to differentiate between them. This month, two studies provide data that can help dermatologists optimize their use of these drugs in clinical practice.

A retrospective observational study of nearly 1200 prior biologic-experienced adult patients with psoriasis now receiving either secukinumab (n=780) or ixekizumab (n=411), both of which inhibit IL-17A, examined drug persistence after 18 months. Ixekizumab was associated with significantly higher rates of high treatment adherence (42% vs 35%; P = .019) and persistence (44.9% vs 36.9%; P = .007) and lower discontinuation (48.4% vs 56.0%; P = .018) and switching (26.6% vs 34.0%; P = .009) rates than secukinumab. Both drugs are dosed monthly after an initial loading dose (Blauvelt A et al. Dermatol Ther (Heidelb).

With several biologic options available, patients may be switched from one biologic to another if they are not having an adequate response. Separate studies have shown that patients with an inadequate response to ustekinumab are likely to have a better response when switched to brodalumab or guselkumab, although this does not tell us if one is more likely to be effective than the other. In a recent matching-adjusted indirect comparison study using data for patients with psoriasis who responded inadequately to ustekinumab and switched to receive brodalumab (n=121) or guselkumab (n=135) the authors found that brodalumab was associated with greater improvements than guselkumab in inadequate responders to ustekinumab with a PASI 100 rate at week 36 of 40.3% for brodalumab vs 20.0% for guselkumab; P < 0.001. (Hampton P et al. Psoriasis (Auckl).

While biologics have revolutionized the treatment of psoriasis, not all patients with extensive disease desire or are appropriate for a systemic therapy. Topical steroids, the most commonly used topical psoriasis therapy, still carry some risk of systemic absorption and are associate with cutaneous side effects such as atrophy with prolonged use. Tarpinarof 1% cream is a novel aryl hydrocarbon receptor modulating agent that has been shown in phase 3 studies to be an effective treatment for psoriasis when applied once a day. A recent open label study of 21 adult patients with extensive plaque psoriasis (20% or more body surface area (BSA) involvement, mean baseline BSA 27.2%) who applied tapinarof cream 1% QD daily showed that 94.7% of patients had a decrease in their PASI score (mean PASI decrease of 59.6%). Despite the large BSA being treated, tapinarof plasma concentration were low and remained below the quantification level in the majority (67.9%) of samples tested. There were also no concerning EKG changes such as QT prolongation. Folliculitis and headache were the most common adverse events (each reported by 4 patients) (Jett JE et al. Am J Clin Dermatol).

These studies all provide valuable data in helping us to make the best treatment decisions for patients with moderate to severe plaque psoriasis.

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