User login
Bringing you the latest news, research and reviews, exclusive interviews, podcasts, quizzes, and more.
div[contains(@class, 'read-next-article')]
div[contains(@class, 'nav-primary')]
nav[contains(@class, 'nav-primary')]
section[contains(@class, 'footer-nav-section-wrapper')]
nav[contains(@class, 'nav-ce-stack nav-ce-stack__large-screen')]
header[@id='header']
div[contains(@class, 'header__large-screen')]
div[contains(@class, 'read-next-article')]
div[contains(@class, 'main-prefix')]
div[contains(@class, 'nav-primary')]
nav[contains(@class, 'nav-primary')]
section[contains(@class, 'footer-nav-section-wrapper')]
footer[@id='footer']
section[contains(@class, 'nav-hidden')]
div[contains(@class, 'ce-card-content')]
nav[contains(@class, 'nav-ce-stack')]
div[contains(@class, 'view-medstat-quiz-listing-panes')]
div[contains(@class, 'pane-article-sidebar-latest-news')]
Food insecurity a growing problem for many with CVD
A growing number of Americans with cardiovascular disease (CVD) have limited or uncertain access to food, results of a new study suggest.
An analysis of data from the National Health and Nutrition Examination Survey (NHANES) representing more than 300 million American adults found that, overall, 38.1% of people with cardiovascular disease were food insecure in 2017-2019.
Twenty years earlier, that rate was 16.3%.
“What really stood out from our study is how frequent food insecurity is among people with cardiovascular disease, compared to those without cardiovascular disease,” lead author, Eric J. Brandt, MD, MHS, a cardiologist at the University of Michigan Health Frankel Cardiovascular Center, Ann Arbor, said in an interview.
“We believe that the relationship between food insecurity and cardiovascular disease is bidirectional. Food insecurity puts people at risk for cardiovascular disease, which then makes them vulnerable to events like myocardial infarction or stroke, which in turn may make them less able to work, thereby worsening their financial situation and increasing their vulnerability to food insecurity,” Dr. Brandt said.
For the analysis, Dr. Brandt and his team used an analytic sample of 57,517 adults to represent 312 million non-institutionalized adults in the United States.
Overall, 6,770 individuals (11.8%) in the analytic sample reported food insecurity.
Food insecurity was more prevalent among Hispanic people (n = 1,938, 24.0%) and non-Hispanic Black people (n = 1,202, 18.2%), compared with non-Hispanic Asian people (n = 100, 8.0%), and non-Hispanic White people (n = 3,221, 8.5%).
The prevalence of cardiovascular disease in the sample was 7.9% (n = 4,527).
Hypertension was the most prevalent CVD risk factor, reported in 49.6% of the sample. This was followed by obesity in 33.2%, dyslipidemia in 30.8%, and diabetes in 11.2%.
The findings were published online in JAMA Cardiology.
“All cardiovascular disease and cardiometabolic diseases except coronary artery disease were more prevalent among those with food insecurity,” Dr. Brandt noted.
“The results of our study are especially timely, as the White House just hosted its first conference on Hunger, Nutrition, and Health in over 50 years. Food insecurity is a focus of that conference. In the last few years, especially in relation to the pandemic, there has been expansion of some of the federal programs to prevent food insecurity. I would like to see a continued effort to solve this,” he said.
Dr. Brandt added that he hopes clinicians will be more cognizant of the problem of food insecurity and other social determinants of health when they see their patients.
“If someone is not going to be able to afford the food on their table, they’re probably not going to pay for their medications. Recognizing these social determinants in the clinical setting and helping our patients access local resources may address the underlying factors contributing to heart disease,” he said.
Uphill battle
Johanna Contreras, MD, advanced heart failure and transplant cardiologist at the Mount Sinai Hospital, New York, treats food insecure cardiovascular patients in her practice and tries to educate them about good nutrition. But it is an uphill battle.
“A lot of my patients live in the South Bronx. They have hypertension, hypercholesterolemia, and there are no grocery stores where they can buy fresh vegetables. I talk to them about eating healthy. They tell me it’s impossible. The stores only have pre-packaged foods. So even in the South Bronx, even though it is in New York, it is very hard to get fresh food. And when it is available, it is very expensive,” Dr. Contreras told this news organization.
“Fresh pineapples can cost $8. A fast-food burger costs $3. So that is what they buy: It’s what they can afford. Even the store managers don’t want to stock fresh produce because it can spoil. They open stores, like Whole Foods, but in the more affluent neighborhoods. They should open one in poor neighborhoods,” she said.
Dr. Contreras says she spends much of her time educating her patients about good nutrition. She asks them to keep a food diary and analyzes the results at each visit.
“I look at what they eat, and I try to see how I can use this information in a good way. I advise them to use frozen foods, and avoid canned, because it is a lot healthier. I am pragmatic, because I know that if I tell my patients to eat salmon, for example, they aren’t going to be able to afford it, if they can even access it.”
She also informs them about relatively healthy fast-food choices.
“I tell them to order 100% fruit juice, water, or milk when they go to McDonalds or other fast-food places. So I think this study is very important. Food insecurity is a very important component of cardiovascular disease, and unfortunately, minority communities are where this occurs.”
Dr. Brandt and Dr. Contreras report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A growing number of Americans with cardiovascular disease (CVD) have limited or uncertain access to food, results of a new study suggest.
An analysis of data from the National Health and Nutrition Examination Survey (NHANES) representing more than 300 million American adults found that, overall, 38.1% of people with cardiovascular disease were food insecure in 2017-2019.
Twenty years earlier, that rate was 16.3%.
“What really stood out from our study is how frequent food insecurity is among people with cardiovascular disease, compared to those without cardiovascular disease,” lead author, Eric J. Brandt, MD, MHS, a cardiologist at the University of Michigan Health Frankel Cardiovascular Center, Ann Arbor, said in an interview.
“We believe that the relationship between food insecurity and cardiovascular disease is bidirectional. Food insecurity puts people at risk for cardiovascular disease, which then makes them vulnerable to events like myocardial infarction or stroke, which in turn may make them less able to work, thereby worsening their financial situation and increasing their vulnerability to food insecurity,” Dr. Brandt said.
For the analysis, Dr. Brandt and his team used an analytic sample of 57,517 adults to represent 312 million non-institutionalized adults in the United States.
Overall, 6,770 individuals (11.8%) in the analytic sample reported food insecurity.
Food insecurity was more prevalent among Hispanic people (n = 1,938, 24.0%) and non-Hispanic Black people (n = 1,202, 18.2%), compared with non-Hispanic Asian people (n = 100, 8.0%), and non-Hispanic White people (n = 3,221, 8.5%).
The prevalence of cardiovascular disease in the sample was 7.9% (n = 4,527).
Hypertension was the most prevalent CVD risk factor, reported in 49.6% of the sample. This was followed by obesity in 33.2%, dyslipidemia in 30.8%, and diabetes in 11.2%.
The findings were published online in JAMA Cardiology.
“All cardiovascular disease and cardiometabolic diseases except coronary artery disease were more prevalent among those with food insecurity,” Dr. Brandt noted.
“The results of our study are especially timely, as the White House just hosted its first conference on Hunger, Nutrition, and Health in over 50 years. Food insecurity is a focus of that conference. In the last few years, especially in relation to the pandemic, there has been expansion of some of the federal programs to prevent food insecurity. I would like to see a continued effort to solve this,” he said.
Dr. Brandt added that he hopes clinicians will be more cognizant of the problem of food insecurity and other social determinants of health when they see their patients.
“If someone is not going to be able to afford the food on their table, they’re probably not going to pay for their medications. Recognizing these social determinants in the clinical setting and helping our patients access local resources may address the underlying factors contributing to heart disease,” he said.
Uphill battle
Johanna Contreras, MD, advanced heart failure and transplant cardiologist at the Mount Sinai Hospital, New York, treats food insecure cardiovascular patients in her practice and tries to educate them about good nutrition. But it is an uphill battle.
“A lot of my patients live in the South Bronx. They have hypertension, hypercholesterolemia, and there are no grocery stores where they can buy fresh vegetables. I talk to them about eating healthy. They tell me it’s impossible. The stores only have pre-packaged foods. So even in the South Bronx, even though it is in New York, it is very hard to get fresh food. And when it is available, it is very expensive,” Dr. Contreras told this news organization.
“Fresh pineapples can cost $8. A fast-food burger costs $3. So that is what they buy: It’s what they can afford. Even the store managers don’t want to stock fresh produce because it can spoil. They open stores, like Whole Foods, but in the more affluent neighborhoods. They should open one in poor neighborhoods,” she said.
Dr. Contreras says she spends much of her time educating her patients about good nutrition. She asks them to keep a food diary and analyzes the results at each visit.
“I look at what they eat, and I try to see how I can use this information in a good way. I advise them to use frozen foods, and avoid canned, because it is a lot healthier. I am pragmatic, because I know that if I tell my patients to eat salmon, for example, they aren’t going to be able to afford it, if they can even access it.”
She also informs them about relatively healthy fast-food choices.
“I tell them to order 100% fruit juice, water, or milk when they go to McDonalds or other fast-food places. So I think this study is very important. Food insecurity is a very important component of cardiovascular disease, and unfortunately, minority communities are where this occurs.”
Dr. Brandt and Dr. Contreras report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A growing number of Americans with cardiovascular disease (CVD) have limited or uncertain access to food, results of a new study suggest.
An analysis of data from the National Health and Nutrition Examination Survey (NHANES) representing more than 300 million American adults found that, overall, 38.1% of people with cardiovascular disease were food insecure in 2017-2019.
Twenty years earlier, that rate was 16.3%.
“What really stood out from our study is how frequent food insecurity is among people with cardiovascular disease, compared to those without cardiovascular disease,” lead author, Eric J. Brandt, MD, MHS, a cardiologist at the University of Michigan Health Frankel Cardiovascular Center, Ann Arbor, said in an interview.
“We believe that the relationship between food insecurity and cardiovascular disease is bidirectional. Food insecurity puts people at risk for cardiovascular disease, which then makes them vulnerable to events like myocardial infarction or stroke, which in turn may make them less able to work, thereby worsening their financial situation and increasing their vulnerability to food insecurity,” Dr. Brandt said.
For the analysis, Dr. Brandt and his team used an analytic sample of 57,517 adults to represent 312 million non-institutionalized adults in the United States.
Overall, 6,770 individuals (11.8%) in the analytic sample reported food insecurity.
Food insecurity was more prevalent among Hispanic people (n = 1,938, 24.0%) and non-Hispanic Black people (n = 1,202, 18.2%), compared with non-Hispanic Asian people (n = 100, 8.0%), and non-Hispanic White people (n = 3,221, 8.5%).
The prevalence of cardiovascular disease in the sample was 7.9% (n = 4,527).
Hypertension was the most prevalent CVD risk factor, reported in 49.6% of the sample. This was followed by obesity in 33.2%, dyslipidemia in 30.8%, and diabetes in 11.2%.
The findings were published online in JAMA Cardiology.
“All cardiovascular disease and cardiometabolic diseases except coronary artery disease were more prevalent among those with food insecurity,” Dr. Brandt noted.
“The results of our study are especially timely, as the White House just hosted its first conference on Hunger, Nutrition, and Health in over 50 years. Food insecurity is a focus of that conference. In the last few years, especially in relation to the pandemic, there has been expansion of some of the federal programs to prevent food insecurity. I would like to see a continued effort to solve this,” he said.
Dr. Brandt added that he hopes clinicians will be more cognizant of the problem of food insecurity and other social determinants of health when they see their patients.
“If someone is not going to be able to afford the food on their table, they’re probably not going to pay for their medications. Recognizing these social determinants in the clinical setting and helping our patients access local resources may address the underlying factors contributing to heart disease,” he said.
Uphill battle
Johanna Contreras, MD, advanced heart failure and transplant cardiologist at the Mount Sinai Hospital, New York, treats food insecure cardiovascular patients in her practice and tries to educate them about good nutrition. But it is an uphill battle.
“A lot of my patients live in the South Bronx. They have hypertension, hypercholesterolemia, and there are no grocery stores where they can buy fresh vegetables. I talk to them about eating healthy. They tell me it’s impossible. The stores only have pre-packaged foods. So even in the South Bronx, even though it is in New York, it is very hard to get fresh food. And when it is available, it is very expensive,” Dr. Contreras told this news organization.
“Fresh pineapples can cost $8. A fast-food burger costs $3. So that is what they buy: It’s what they can afford. Even the store managers don’t want to stock fresh produce because it can spoil. They open stores, like Whole Foods, but in the more affluent neighborhoods. They should open one in poor neighborhoods,” she said.
Dr. Contreras says she spends much of her time educating her patients about good nutrition. She asks them to keep a food diary and analyzes the results at each visit.
“I look at what they eat, and I try to see how I can use this information in a good way. I advise them to use frozen foods, and avoid canned, because it is a lot healthier. I am pragmatic, because I know that if I tell my patients to eat salmon, for example, they aren’t going to be able to afford it, if they can even access it.”
She also informs them about relatively healthy fast-food choices.
“I tell them to order 100% fruit juice, water, or milk when they go to McDonalds or other fast-food places. So I think this study is very important. Food insecurity is a very important component of cardiovascular disease, and unfortunately, minority communities are where this occurs.”
Dr. Brandt and Dr. Contreras report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Gardasil 9 HPV vaccine advised for MSM living with HIV
Men who have sex with men (MSM) living with HIV, especially those who are young or who’ve had gonorrhea, should get the human papillomavirus (HPV) 9-valent vaccine (Gardasil 9), findings of a newly published study in the Journal of Acquired Immune Deficiency Syndromes suggest.
According to the World Health Organization, only 30% of the target population worldwide has received the HPV vaccine. Despite increased risk for HPV anal infection (an estimated three out of four MSM develop an anal infection from any HPV genotype in their lifetime, epidemiological studies in MSM have been lacking, leaving gaps in data in terms of prevalence rates and prevention.
To help characterize which MSM subgroups benefit the most from early 9-valent HPV vaccination, researchers from Vita-Salute San Raffaele University in Milan determined the prevalence of anal HPV genotypes in MSM who’d been living with HIV for 5 years, and they analyzed the risk factors for HPV anal infection.
Of the 1,352 study participants, 12% were not infected by any HPV genotypes, and the maximum number of genotypes infecting one person (six) was detected in 0.4% (six) people. The prevalence of HR-HPV genotypes or those present in the vaccine remained stable over time.
“Our findings suggest ... that all MSM with HIV would benefit from Gardasil 9 immunization, particularly the youngest and those with a prior gonococcal infection,” wrote Elena Bruzzesi, MD, of Vita-Salute San Raffaele University, and her coauthors.
To determine prevalence of HPV genotypes at anal sites and risk factors, the authors conducted a time-trend, monocentric study on participants who self-identified as MSM who engaged in anal intercourse. The participants underwent one or more anoscopies for HPV genotyping at one academic hospital in Milan between 2015 and 2019.
Swab specimens were collected from the anal canal mucosa, then soaked in thin-layer liquid medium, and sent for molecular analysis.
For detection of HPV phenotypes, the specimens were processed by multiplex real-time polymerase chain reaction.
Findings showed that:
- The overall prevalence of MSM with at least one anal HPV genotype was 88%, with prevalence ranging from 77% to 84%, and no trend difference over the 5-year period.
- Seventy-nine percent of participants were exposed to at least one high-risk (HR)-HPV genotype, and 67.4% by at least one low-risk (LR)-HPV genotype.
- HPV-53, in 27%, was the most prevalent genotype. HPV-6, 11, 16, and 18 prevalence was 22%, 13%, 23%, and 11%, respectively. Of the HR genotypes, HPV-16 and HPV-18 are most often linked with squamous cell cancers and adenocarcinomas, and in the study, prevalence did not change over time.
- Seventy-one percent of participants carried at least one genotype covered by the vaccine, with no change over time.
- On multivariable analysis, the risk of carrying at least one high-risk HPV genotype was linked with younger age (adjusted odds ratio [aOR] for 30 years or younger compared with older than 45 years 2.714; 95% confidence interval [CI], 1.484-4.961), and with having had gonorrhea (aOR, 2.118; 95% CI, 1.100-4.078).
- Also on multivariable analysis, the risk of having one or more genotypes targeted by the 9-valent vaccine was linked with younger age (aOR, 1.868; 95% CI, 1.141-3.060) and with having had gonorrhea (aOR, 1.785; 95% CI, 1.056-3.018).
Mehri S. McKellar, MD, an infectious disease specialist at Duke Health in Durham, N.C., told this news organization.
“This powerful study provides important data on HPV genotype prevalence in the MSM HIV+ population, validating that Gardasil 9 will greatly help these individuals,” said Dr. McKellar, who was not involved in the study.
Robert Salata, MD, infectious disease specialist and professor at Case Western Reserve University, Cleveland, also encourages MSM to get the vaccine.
“It is important to understand that the prevalence of anal HPV in men who have sex with men is very high, that the prevalence, including high-risk genotypes, has remained stable, and that the 9-valent vaccine is clearly indicated, especially in younger men and those with known gonorrhea and other STDs,” Dr. Salata (who was also not involved in the study) told this news organization.
“This is an important reminder for us to continue promoting and providing the vaccine to our patients, especially to HIV+ men who have sex with men, who have the highest rates of anal infection with HPV,” Dr. McKellar advised.
The authors, Dr. McKellar, and Dr. Salata report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Men who have sex with men (MSM) living with HIV, especially those who are young or who’ve had gonorrhea, should get the human papillomavirus (HPV) 9-valent vaccine (Gardasil 9), findings of a newly published study in the Journal of Acquired Immune Deficiency Syndromes suggest.
According to the World Health Organization, only 30% of the target population worldwide has received the HPV vaccine. Despite increased risk for HPV anal infection (an estimated three out of four MSM develop an anal infection from any HPV genotype in their lifetime, epidemiological studies in MSM have been lacking, leaving gaps in data in terms of prevalence rates and prevention.
To help characterize which MSM subgroups benefit the most from early 9-valent HPV vaccination, researchers from Vita-Salute San Raffaele University in Milan determined the prevalence of anal HPV genotypes in MSM who’d been living with HIV for 5 years, and they analyzed the risk factors for HPV anal infection.
Of the 1,352 study participants, 12% were not infected by any HPV genotypes, and the maximum number of genotypes infecting one person (six) was detected in 0.4% (six) people. The prevalence of HR-HPV genotypes or those present in the vaccine remained stable over time.
“Our findings suggest ... that all MSM with HIV would benefit from Gardasil 9 immunization, particularly the youngest and those with a prior gonococcal infection,” wrote Elena Bruzzesi, MD, of Vita-Salute San Raffaele University, and her coauthors.
To determine prevalence of HPV genotypes at anal sites and risk factors, the authors conducted a time-trend, monocentric study on participants who self-identified as MSM who engaged in anal intercourse. The participants underwent one or more anoscopies for HPV genotyping at one academic hospital in Milan between 2015 and 2019.
Swab specimens were collected from the anal canal mucosa, then soaked in thin-layer liquid medium, and sent for molecular analysis.
For detection of HPV phenotypes, the specimens were processed by multiplex real-time polymerase chain reaction.
Findings showed that:
- The overall prevalence of MSM with at least one anal HPV genotype was 88%, with prevalence ranging from 77% to 84%, and no trend difference over the 5-year period.
- Seventy-nine percent of participants were exposed to at least one high-risk (HR)-HPV genotype, and 67.4% by at least one low-risk (LR)-HPV genotype.
- HPV-53, in 27%, was the most prevalent genotype. HPV-6, 11, 16, and 18 prevalence was 22%, 13%, 23%, and 11%, respectively. Of the HR genotypes, HPV-16 and HPV-18 are most often linked with squamous cell cancers and adenocarcinomas, and in the study, prevalence did not change over time.
- Seventy-one percent of participants carried at least one genotype covered by the vaccine, with no change over time.
- On multivariable analysis, the risk of carrying at least one high-risk HPV genotype was linked with younger age (adjusted odds ratio [aOR] for 30 years or younger compared with older than 45 years 2.714; 95% confidence interval [CI], 1.484-4.961), and with having had gonorrhea (aOR, 2.118; 95% CI, 1.100-4.078).
- Also on multivariable analysis, the risk of having one or more genotypes targeted by the 9-valent vaccine was linked with younger age (aOR, 1.868; 95% CI, 1.141-3.060) and with having had gonorrhea (aOR, 1.785; 95% CI, 1.056-3.018).
Mehri S. McKellar, MD, an infectious disease specialist at Duke Health in Durham, N.C., told this news organization.
“This powerful study provides important data on HPV genotype prevalence in the MSM HIV+ population, validating that Gardasil 9 will greatly help these individuals,” said Dr. McKellar, who was not involved in the study.
Robert Salata, MD, infectious disease specialist and professor at Case Western Reserve University, Cleveland, also encourages MSM to get the vaccine.
“It is important to understand that the prevalence of anal HPV in men who have sex with men is very high, that the prevalence, including high-risk genotypes, has remained stable, and that the 9-valent vaccine is clearly indicated, especially in younger men and those with known gonorrhea and other STDs,” Dr. Salata (who was also not involved in the study) told this news organization.
“This is an important reminder for us to continue promoting and providing the vaccine to our patients, especially to HIV+ men who have sex with men, who have the highest rates of anal infection with HPV,” Dr. McKellar advised.
The authors, Dr. McKellar, and Dr. Salata report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Men who have sex with men (MSM) living with HIV, especially those who are young or who’ve had gonorrhea, should get the human papillomavirus (HPV) 9-valent vaccine (Gardasil 9), findings of a newly published study in the Journal of Acquired Immune Deficiency Syndromes suggest.
According to the World Health Organization, only 30% of the target population worldwide has received the HPV vaccine. Despite increased risk for HPV anal infection (an estimated three out of four MSM develop an anal infection from any HPV genotype in their lifetime, epidemiological studies in MSM have been lacking, leaving gaps in data in terms of prevalence rates and prevention.
To help characterize which MSM subgroups benefit the most from early 9-valent HPV vaccination, researchers from Vita-Salute San Raffaele University in Milan determined the prevalence of anal HPV genotypes in MSM who’d been living with HIV for 5 years, and they analyzed the risk factors for HPV anal infection.
Of the 1,352 study participants, 12% were not infected by any HPV genotypes, and the maximum number of genotypes infecting one person (six) was detected in 0.4% (six) people. The prevalence of HR-HPV genotypes or those present in the vaccine remained stable over time.
“Our findings suggest ... that all MSM with HIV would benefit from Gardasil 9 immunization, particularly the youngest and those with a prior gonococcal infection,” wrote Elena Bruzzesi, MD, of Vita-Salute San Raffaele University, and her coauthors.
To determine prevalence of HPV genotypes at anal sites and risk factors, the authors conducted a time-trend, monocentric study on participants who self-identified as MSM who engaged in anal intercourse. The participants underwent one or more anoscopies for HPV genotyping at one academic hospital in Milan between 2015 and 2019.
Swab specimens were collected from the anal canal mucosa, then soaked in thin-layer liquid medium, and sent for molecular analysis.
For detection of HPV phenotypes, the specimens were processed by multiplex real-time polymerase chain reaction.
Findings showed that:
- The overall prevalence of MSM with at least one anal HPV genotype was 88%, with prevalence ranging from 77% to 84%, and no trend difference over the 5-year period.
- Seventy-nine percent of participants were exposed to at least one high-risk (HR)-HPV genotype, and 67.4% by at least one low-risk (LR)-HPV genotype.
- HPV-53, in 27%, was the most prevalent genotype. HPV-6, 11, 16, and 18 prevalence was 22%, 13%, 23%, and 11%, respectively. Of the HR genotypes, HPV-16 and HPV-18 are most often linked with squamous cell cancers and adenocarcinomas, and in the study, prevalence did not change over time.
- Seventy-one percent of participants carried at least one genotype covered by the vaccine, with no change over time.
- On multivariable analysis, the risk of carrying at least one high-risk HPV genotype was linked with younger age (adjusted odds ratio [aOR] for 30 years or younger compared with older than 45 years 2.714; 95% confidence interval [CI], 1.484-4.961), and with having had gonorrhea (aOR, 2.118; 95% CI, 1.100-4.078).
- Also on multivariable analysis, the risk of having one or more genotypes targeted by the 9-valent vaccine was linked with younger age (aOR, 1.868; 95% CI, 1.141-3.060) and with having had gonorrhea (aOR, 1.785; 95% CI, 1.056-3.018).
Mehri S. McKellar, MD, an infectious disease specialist at Duke Health in Durham, N.C., told this news organization.
“This powerful study provides important data on HPV genotype prevalence in the MSM HIV+ population, validating that Gardasil 9 will greatly help these individuals,” said Dr. McKellar, who was not involved in the study.
Robert Salata, MD, infectious disease specialist and professor at Case Western Reserve University, Cleveland, also encourages MSM to get the vaccine.
“It is important to understand that the prevalence of anal HPV in men who have sex with men is very high, that the prevalence, including high-risk genotypes, has remained stable, and that the 9-valent vaccine is clearly indicated, especially in younger men and those with known gonorrhea and other STDs,” Dr. Salata (who was also not involved in the study) told this news organization.
“This is an important reminder for us to continue promoting and providing the vaccine to our patients, especially to HIV+ men who have sex with men, who have the highest rates of anal infection with HPV,” Dr. McKellar advised.
The authors, Dr. McKellar, and Dr. Salata report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES
FDA approves HIV-1 treatment ibalizumab for 30-second IV push
The Food and Drug Administration has approved the HIV-1 medication ibalizumab-uiyk (Trogarzo, Theratechnologies) for administration by intravenous push.
Ibalizumab-uiyk, a long-acting monoclonal antibody, was first approved by the FDA in 2018 for the treatment of adults with multidrug-resistant HIV-1. It is used in combination with other antiretroviral drugs.
Prior to this approval, the drug was administered intravenously as a single 2,000-mg loading dose, followed by an 800-mg maintenance dose every 2 weeks by a trained medical professional. The intravenous infusion is given over 15-30 minutes, according to the Trogarzo website. Now, the maintenance dose can be administered by intravenous push, a method where the undiluted medication is delivered intravenously by injection, in just 30 seconds.
for patients and their health care providers, possibly allowing for more clinics to administer this treatment,” said Christian Marsolais, PhD, the chief medical officer of Theratechnologies, in an Oct. 3 press release.
The FDA approval of the intravenous push method was based on a clinical study which found that ibalizumab administered via intravenous push had similar safety and pharmacokinetic profiles as the intravenous infusion method. So far, 350 individuals have received ibalizumab as a part of the clinical development program, including 19 people who received the medication via intravenous push. The medication is also being studied for administration via intramuscular injection, the press release said.
The most common side effects of ibalizumab include diarrhea, dizziness, nausea, and rash. Severe adverse events have been reported in two patients: one who developed immune reconstitution inflammatory syndrome and another who reported a severe rash.
While multidrug-resistant HIV that would require ibalizumab is not very common – one study found it occurred in fewer than 2% of people with HIV in Western Europe – it is a “very difficult problem because we need to treat these patients to try to achieve virologic suppression,” Monica Gandhi, MD, MPH, associate chief of the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco, noted in an email. While providers generally try to use nonintravenous medications when possible, ibalizumab is an important medication for people with multidrug-resistant HIV and limited treatment options.
“One barrier to administration was the need for IV infusion over 15-30 minutes,” Dr. Gandhi added. “The ability to give this medication as an IV push is an important breakthrough, as we could give this medication more readily for the relatively low number of individuals who will need it.”
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved the HIV-1 medication ibalizumab-uiyk (Trogarzo, Theratechnologies) for administration by intravenous push.
Ibalizumab-uiyk, a long-acting monoclonal antibody, was first approved by the FDA in 2018 for the treatment of adults with multidrug-resistant HIV-1. It is used in combination with other antiretroviral drugs.
Prior to this approval, the drug was administered intravenously as a single 2,000-mg loading dose, followed by an 800-mg maintenance dose every 2 weeks by a trained medical professional. The intravenous infusion is given over 15-30 minutes, according to the Trogarzo website. Now, the maintenance dose can be administered by intravenous push, a method where the undiluted medication is delivered intravenously by injection, in just 30 seconds.
for patients and their health care providers, possibly allowing for more clinics to administer this treatment,” said Christian Marsolais, PhD, the chief medical officer of Theratechnologies, in an Oct. 3 press release.
The FDA approval of the intravenous push method was based on a clinical study which found that ibalizumab administered via intravenous push had similar safety and pharmacokinetic profiles as the intravenous infusion method. So far, 350 individuals have received ibalizumab as a part of the clinical development program, including 19 people who received the medication via intravenous push. The medication is also being studied for administration via intramuscular injection, the press release said.
The most common side effects of ibalizumab include diarrhea, dizziness, nausea, and rash. Severe adverse events have been reported in two patients: one who developed immune reconstitution inflammatory syndrome and another who reported a severe rash.
While multidrug-resistant HIV that would require ibalizumab is not very common – one study found it occurred in fewer than 2% of people with HIV in Western Europe – it is a “very difficult problem because we need to treat these patients to try to achieve virologic suppression,” Monica Gandhi, MD, MPH, associate chief of the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco, noted in an email. While providers generally try to use nonintravenous medications when possible, ibalizumab is an important medication for people with multidrug-resistant HIV and limited treatment options.
“One barrier to administration was the need for IV infusion over 15-30 minutes,” Dr. Gandhi added. “The ability to give this medication as an IV push is an important breakthrough, as we could give this medication more readily for the relatively low number of individuals who will need it.”
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved the HIV-1 medication ibalizumab-uiyk (Trogarzo, Theratechnologies) for administration by intravenous push.
Ibalizumab-uiyk, a long-acting monoclonal antibody, was first approved by the FDA in 2018 for the treatment of adults with multidrug-resistant HIV-1. It is used in combination with other antiretroviral drugs.
Prior to this approval, the drug was administered intravenously as a single 2,000-mg loading dose, followed by an 800-mg maintenance dose every 2 weeks by a trained medical professional. The intravenous infusion is given over 15-30 minutes, according to the Trogarzo website. Now, the maintenance dose can be administered by intravenous push, a method where the undiluted medication is delivered intravenously by injection, in just 30 seconds.
for patients and their health care providers, possibly allowing for more clinics to administer this treatment,” said Christian Marsolais, PhD, the chief medical officer of Theratechnologies, in an Oct. 3 press release.
The FDA approval of the intravenous push method was based on a clinical study which found that ibalizumab administered via intravenous push had similar safety and pharmacokinetic profiles as the intravenous infusion method. So far, 350 individuals have received ibalizumab as a part of the clinical development program, including 19 people who received the medication via intravenous push. The medication is also being studied for administration via intramuscular injection, the press release said.
The most common side effects of ibalizumab include diarrhea, dizziness, nausea, and rash. Severe adverse events have been reported in two patients: one who developed immune reconstitution inflammatory syndrome and another who reported a severe rash.
While multidrug-resistant HIV that would require ibalizumab is not very common – one study found it occurred in fewer than 2% of people with HIV in Western Europe – it is a “very difficult problem because we need to treat these patients to try to achieve virologic suppression,” Monica Gandhi, MD, MPH, associate chief of the division of HIV, infectious diseases, and global medicine at the University of California, San Francisco, noted in an email. While providers generally try to use nonintravenous medications when possible, ibalizumab is an important medication for people with multidrug-resistant HIV and limited treatment options.
“One barrier to administration was the need for IV infusion over 15-30 minutes,” Dr. Gandhi added. “The ability to give this medication as an IV push is an important breakthrough, as we could give this medication more readily for the relatively low number of individuals who will need it.”
A version of this article first appeared on Medscape.com.
52-week data show lebrikizumab atopic dermatitis effects maintained
from the phase 3 ADvocate1 and ADvocate2 trials.
“We’re focused on the responders,” said Andrew Blauvelt, MD, MBA, as he presented the positive findings at the annual congress of the European Academy of Dermatology and Venereology.
Responders were the 291 people whose atopic dermatitis greatly improved after an initial 16 weeks’ treatment with lebrikizumab in both trials and who were then randomly allocated to receive injections every 2 weeks (Q2W, n = 113) or every 4 weeks (Q4W, n = 118), or to receive placebo injections Q2W (n = 60).
“Very interestingly, for me, the Q4W maintenance dosing was just as good as the Q2W maintenance dosing,” said Dr. Blauvelt, president of Oregon Medical Research Center, Portland.
“Another highlight of these data is that the patients who went on to placebo, about 50% of the patients maintained good responses, despite no treatment from week 16 to week 52,” he added.
Most patients did not require topical steroids, and “there were no surprises here” in terms of the safety profile. Lebrikizumab, a monoclonal antibody, binds to soluble interleukin-13 and blocks IL-13 signaling.
“So, the study really shows that specific targeting of IL-13 with lebrikizumab, either Q2W or Q4W, has high maintenance of efficacy and is reasonably tolerated and safe in adolescents and adults with atopic dermatitis,” Dr. Blauvelt concluded.
“We know now that IL-13 is a critical cytokine in AD [atopic dermatitis] pathogenesis. The unique features of this drug I want to highlight is that it has high binding affinity for IL-13,” he said.
“It has a slow dissociation off rate, meaning it binds IL-13 tightly, very potently, and stays blocking and stays hold of IL-13 in a strong manner,” he added. The drug has a half-life of 25 days.
These features could be very important for long-term dosing of the drug, he argued.
Lebrikizumab phase 3 trials
ADvocate1 and ADvocate2 are two of several phase 3 trials evaluating the efficacy and safety of lebrikizumab for the treatment of atopic dermatitis.
These include the completed ADhere study, in which lebrikizumab was used in combination with topical steroids and showed positive results in skin improvement and relief of pruritus.
The ADore study, an open-label trial in adolescents, is yet to report. The ongoing ADjoin study, a long-term extension study, is actively recruiting.
ADvocate1 and ADvocate2 are two identically designed – multicenter, randomized, double-blind, placebo-controlled, parallel-group – monotherapy trials that initially pitched two dosing regimens of lebrikizumab (250 mg) against placebo with a double loading dose at baseline and week 2 and then one dose every 2 weeks. The pair of trials enrolled a total of 869 adolescents and adults.
After the 16-week induction period, all patients in the lebrikizumab arm who had responded to treatment were rerandomly assigned to receive lebrikizumab 250 mg Q2W or Q4W, or placebo Q2W during a 36-week long-term maintenance treatment period.
This brought the total treatment time to 52 weeks for those whose atopic dermatitis had initially responded to lebrikizumab, explained Blauvelt.
Responders were those who, at 16 weeks, had an Investigator’s Global Assessment score of 0 or 1 (IGA 0/1) with a 2-point improvement or who had a 75% improvement in the Eczema Area and Severity Index score (EASI 75) without the need for rescue medication, compared with baseline values.
Induction and maintenance phase results
At the end of the 16-week induction period, a greater proportion of patients who had been treated with lebrikizumab than placebo met a primary outcome of IGA 0/1 in each trial (43.1% vs. 12.7% in ADvocate1 and 33.2% vs. 10.8% in ADvocate2).
A similar result was seen for another primary outcome, EASI 75 (58.8% vs. 16.2% and 52.1% vs. 18.1%) and for a secondary outcome, improvement in pruritus using a numerical rating scale (45.9% vs. 13.0% and 39.8% vs. 11.5%).
In the maintenance phase, with respect to responders, Dr. Blauvelt reported “very similar results” between the QW2 and Q4W maintenance dosing, “and still a quite high response in [half] the patients who were randomized to placebo at week 16.”
In the ADvocate1 and ADvocate2 trials, respectively, an IGA 0/1 with at least a 2-point improvement was maintained at week 52 in 75.8% and 64.6% of patients treated with the Q2W lebrikizumab dose, 74.2% and 80.6% of those treated with the Q4W dose, and 46.5% and 49.8% of those given placebo.
EASI 75 was maintained at week 52 in a respective 79.2% and 77.4% of patients treated with the Q2W dose, 79.2% and 84.7% with the Q4W dose, and 61.3% and 72.0% with placebo.
As for maintenance of at least a 4-point improvement in pruritus score, results at 52 weeks were 81.2% and 90.3% for the 2-week dose, 80.4% and 88.1% for the 4-week dose, and 65.4% and 67.6% for placebo.
Although topical corticosteroid treatment was allowed during the maintenance phase, only about 15% of patients needed this, Dr. Blauvelt said.
Different dosing results questioned
During the discussion period, one delegate highlighted that the twice-weekly maintenance dosing schedule seemed to “do worse a little bit” than the 4-week dosing, with both “close to placebo,” although “the long-term effect is already very impressive.”
Dr. Blauvelt noted that a pooled analysis had been done and that “it’s very clear that being on lebrikizumab works better than not being on lebrikizumab.
“Now, Q2W versus Q4W. We believe that this may be due to the long half-life of the drug possibly. It could be due to the slow disassociation rate, it’s binding tightly,” he suggested.
“We also could talk about disease modification, right. So, it opens up the concept of hit hard, hit early for 16 weeks, and then maybe you can modify disease over time,” Dr. Blauvelt said.
He added: “That’s highly speculative, of course.”
Short-term safety data
The 52-week safety profile of lebrikizumab is consistent with previously published data at 16 weeks, Dr. Blauvelt said. The most common adverse events during the studies included atopic dermatitis, nasopharyngitis, conjunctivitis, conjunctivitis allergic, headache, and COVID-19.
“This drug has comparable efficacy with dupilumab and tralokinumab,” said Jashin J. Wu, MD, from the Dermatology Research and Education Foundation in Irvine, Calif., in an interview. He was not involved in the study.
“As it does not have any significant advantages with less long-term safety data, I do not see a place for it in my practice,” Dr. Wu said.
Dupilumab (Dupixent) and tralokinumab (Adbry) are monoclonal antibodies that also block IL-13. Both are already licensed for treating atopic dermatitis. Dupilumab was approved by the Food and Drug Administration in 2017, and tralokinumab was approved in 2021.
The study was funded by Dermira, a wholly owned subsidiary of Eli Lilly. Eli Lilly has exclusive rights for the development and commercialization of lebrikizumab in the United States and all countries outside Europe; European rights belong to Almirall for all dermatology indications, including atopic dermatitis. Dr. Blauvelt acts as an investigator and adviser to these companies as well as many other pharmaceutical companies that are involved in developing new dermatologic treatments. Dr. Wu has been an investigator, consultant, or speaker for multiple pharmaceutical companies.
A version of this article first appeared on Medscape.com.
from the phase 3 ADvocate1 and ADvocate2 trials.
“We’re focused on the responders,” said Andrew Blauvelt, MD, MBA, as he presented the positive findings at the annual congress of the European Academy of Dermatology and Venereology.
Responders were the 291 people whose atopic dermatitis greatly improved after an initial 16 weeks’ treatment with lebrikizumab in both trials and who were then randomly allocated to receive injections every 2 weeks (Q2W, n = 113) or every 4 weeks (Q4W, n = 118), or to receive placebo injections Q2W (n = 60).
“Very interestingly, for me, the Q4W maintenance dosing was just as good as the Q2W maintenance dosing,” said Dr. Blauvelt, president of Oregon Medical Research Center, Portland.
“Another highlight of these data is that the patients who went on to placebo, about 50% of the patients maintained good responses, despite no treatment from week 16 to week 52,” he added.
Most patients did not require topical steroids, and “there were no surprises here” in terms of the safety profile. Lebrikizumab, a monoclonal antibody, binds to soluble interleukin-13 and blocks IL-13 signaling.
“So, the study really shows that specific targeting of IL-13 with lebrikizumab, either Q2W or Q4W, has high maintenance of efficacy and is reasonably tolerated and safe in adolescents and adults with atopic dermatitis,” Dr. Blauvelt concluded.
“We know now that IL-13 is a critical cytokine in AD [atopic dermatitis] pathogenesis. The unique features of this drug I want to highlight is that it has high binding affinity for IL-13,” he said.
“It has a slow dissociation off rate, meaning it binds IL-13 tightly, very potently, and stays blocking and stays hold of IL-13 in a strong manner,” he added. The drug has a half-life of 25 days.
These features could be very important for long-term dosing of the drug, he argued.
Lebrikizumab phase 3 trials
ADvocate1 and ADvocate2 are two of several phase 3 trials evaluating the efficacy and safety of lebrikizumab for the treatment of atopic dermatitis.
These include the completed ADhere study, in which lebrikizumab was used in combination with topical steroids and showed positive results in skin improvement and relief of pruritus.
The ADore study, an open-label trial in adolescents, is yet to report. The ongoing ADjoin study, a long-term extension study, is actively recruiting.
ADvocate1 and ADvocate2 are two identically designed – multicenter, randomized, double-blind, placebo-controlled, parallel-group – monotherapy trials that initially pitched two dosing regimens of lebrikizumab (250 mg) against placebo with a double loading dose at baseline and week 2 and then one dose every 2 weeks. The pair of trials enrolled a total of 869 adolescents and adults.
After the 16-week induction period, all patients in the lebrikizumab arm who had responded to treatment were rerandomly assigned to receive lebrikizumab 250 mg Q2W or Q4W, or placebo Q2W during a 36-week long-term maintenance treatment period.
This brought the total treatment time to 52 weeks for those whose atopic dermatitis had initially responded to lebrikizumab, explained Blauvelt.
Responders were those who, at 16 weeks, had an Investigator’s Global Assessment score of 0 or 1 (IGA 0/1) with a 2-point improvement or who had a 75% improvement in the Eczema Area and Severity Index score (EASI 75) without the need for rescue medication, compared with baseline values.
Induction and maintenance phase results
At the end of the 16-week induction period, a greater proportion of patients who had been treated with lebrikizumab than placebo met a primary outcome of IGA 0/1 in each trial (43.1% vs. 12.7% in ADvocate1 and 33.2% vs. 10.8% in ADvocate2).
A similar result was seen for another primary outcome, EASI 75 (58.8% vs. 16.2% and 52.1% vs. 18.1%) and for a secondary outcome, improvement in pruritus using a numerical rating scale (45.9% vs. 13.0% and 39.8% vs. 11.5%).
In the maintenance phase, with respect to responders, Dr. Blauvelt reported “very similar results” between the QW2 and Q4W maintenance dosing, “and still a quite high response in [half] the patients who were randomized to placebo at week 16.”
In the ADvocate1 and ADvocate2 trials, respectively, an IGA 0/1 with at least a 2-point improvement was maintained at week 52 in 75.8% and 64.6% of patients treated with the Q2W lebrikizumab dose, 74.2% and 80.6% of those treated with the Q4W dose, and 46.5% and 49.8% of those given placebo.
EASI 75 was maintained at week 52 in a respective 79.2% and 77.4% of patients treated with the Q2W dose, 79.2% and 84.7% with the Q4W dose, and 61.3% and 72.0% with placebo.
As for maintenance of at least a 4-point improvement in pruritus score, results at 52 weeks were 81.2% and 90.3% for the 2-week dose, 80.4% and 88.1% for the 4-week dose, and 65.4% and 67.6% for placebo.
Although topical corticosteroid treatment was allowed during the maintenance phase, only about 15% of patients needed this, Dr. Blauvelt said.
Different dosing results questioned
During the discussion period, one delegate highlighted that the twice-weekly maintenance dosing schedule seemed to “do worse a little bit” than the 4-week dosing, with both “close to placebo,” although “the long-term effect is already very impressive.”
Dr. Blauvelt noted that a pooled analysis had been done and that “it’s very clear that being on lebrikizumab works better than not being on lebrikizumab.
“Now, Q2W versus Q4W. We believe that this may be due to the long half-life of the drug possibly. It could be due to the slow disassociation rate, it’s binding tightly,” he suggested.
“We also could talk about disease modification, right. So, it opens up the concept of hit hard, hit early for 16 weeks, and then maybe you can modify disease over time,” Dr. Blauvelt said.
He added: “That’s highly speculative, of course.”
Short-term safety data
The 52-week safety profile of lebrikizumab is consistent with previously published data at 16 weeks, Dr. Blauvelt said. The most common adverse events during the studies included atopic dermatitis, nasopharyngitis, conjunctivitis, conjunctivitis allergic, headache, and COVID-19.
“This drug has comparable efficacy with dupilumab and tralokinumab,” said Jashin J. Wu, MD, from the Dermatology Research and Education Foundation in Irvine, Calif., in an interview. He was not involved in the study.
“As it does not have any significant advantages with less long-term safety data, I do not see a place for it in my practice,” Dr. Wu said.
Dupilumab (Dupixent) and tralokinumab (Adbry) are monoclonal antibodies that also block IL-13. Both are already licensed for treating atopic dermatitis. Dupilumab was approved by the Food and Drug Administration in 2017, and tralokinumab was approved in 2021.
The study was funded by Dermira, a wholly owned subsidiary of Eli Lilly. Eli Lilly has exclusive rights for the development and commercialization of lebrikizumab in the United States and all countries outside Europe; European rights belong to Almirall for all dermatology indications, including atopic dermatitis. Dr. Blauvelt acts as an investigator and adviser to these companies as well as many other pharmaceutical companies that are involved in developing new dermatologic treatments. Dr. Wu has been an investigator, consultant, or speaker for multiple pharmaceutical companies.
A version of this article first appeared on Medscape.com.
from the phase 3 ADvocate1 and ADvocate2 trials.
“We’re focused on the responders,” said Andrew Blauvelt, MD, MBA, as he presented the positive findings at the annual congress of the European Academy of Dermatology and Venereology.
Responders were the 291 people whose atopic dermatitis greatly improved after an initial 16 weeks’ treatment with lebrikizumab in both trials and who were then randomly allocated to receive injections every 2 weeks (Q2W, n = 113) or every 4 weeks (Q4W, n = 118), or to receive placebo injections Q2W (n = 60).
“Very interestingly, for me, the Q4W maintenance dosing was just as good as the Q2W maintenance dosing,” said Dr. Blauvelt, president of Oregon Medical Research Center, Portland.
“Another highlight of these data is that the patients who went on to placebo, about 50% of the patients maintained good responses, despite no treatment from week 16 to week 52,” he added.
Most patients did not require topical steroids, and “there were no surprises here” in terms of the safety profile. Lebrikizumab, a monoclonal antibody, binds to soluble interleukin-13 and blocks IL-13 signaling.
“So, the study really shows that specific targeting of IL-13 with lebrikizumab, either Q2W or Q4W, has high maintenance of efficacy and is reasonably tolerated and safe in adolescents and adults with atopic dermatitis,” Dr. Blauvelt concluded.
“We know now that IL-13 is a critical cytokine in AD [atopic dermatitis] pathogenesis. The unique features of this drug I want to highlight is that it has high binding affinity for IL-13,” he said.
“It has a slow dissociation off rate, meaning it binds IL-13 tightly, very potently, and stays blocking and stays hold of IL-13 in a strong manner,” he added. The drug has a half-life of 25 days.
These features could be very important for long-term dosing of the drug, he argued.
Lebrikizumab phase 3 trials
ADvocate1 and ADvocate2 are two of several phase 3 trials evaluating the efficacy and safety of lebrikizumab for the treatment of atopic dermatitis.
These include the completed ADhere study, in which lebrikizumab was used in combination with topical steroids and showed positive results in skin improvement and relief of pruritus.
The ADore study, an open-label trial in adolescents, is yet to report. The ongoing ADjoin study, a long-term extension study, is actively recruiting.
ADvocate1 and ADvocate2 are two identically designed – multicenter, randomized, double-blind, placebo-controlled, parallel-group – monotherapy trials that initially pitched two dosing regimens of lebrikizumab (250 mg) against placebo with a double loading dose at baseline and week 2 and then one dose every 2 weeks. The pair of trials enrolled a total of 869 adolescents and adults.
After the 16-week induction period, all patients in the lebrikizumab arm who had responded to treatment were rerandomly assigned to receive lebrikizumab 250 mg Q2W or Q4W, or placebo Q2W during a 36-week long-term maintenance treatment period.
This brought the total treatment time to 52 weeks for those whose atopic dermatitis had initially responded to lebrikizumab, explained Blauvelt.
Responders were those who, at 16 weeks, had an Investigator’s Global Assessment score of 0 or 1 (IGA 0/1) with a 2-point improvement or who had a 75% improvement in the Eczema Area and Severity Index score (EASI 75) without the need for rescue medication, compared with baseline values.
Induction and maintenance phase results
At the end of the 16-week induction period, a greater proportion of patients who had been treated with lebrikizumab than placebo met a primary outcome of IGA 0/1 in each trial (43.1% vs. 12.7% in ADvocate1 and 33.2% vs. 10.8% in ADvocate2).
A similar result was seen for another primary outcome, EASI 75 (58.8% vs. 16.2% and 52.1% vs. 18.1%) and for a secondary outcome, improvement in pruritus using a numerical rating scale (45.9% vs. 13.0% and 39.8% vs. 11.5%).
In the maintenance phase, with respect to responders, Dr. Blauvelt reported “very similar results” between the QW2 and Q4W maintenance dosing, “and still a quite high response in [half] the patients who were randomized to placebo at week 16.”
In the ADvocate1 and ADvocate2 trials, respectively, an IGA 0/1 with at least a 2-point improvement was maintained at week 52 in 75.8% and 64.6% of patients treated with the Q2W lebrikizumab dose, 74.2% and 80.6% of those treated with the Q4W dose, and 46.5% and 49.8% of those given placebo.
EASI 75 was maintained at week 52 in a respective 79.2% and 77.4% of patients treated with the Q2W dose, 79.2% and 84.7% with the Q4W dose, and 61.3% and 72.0% with placebo.
As for maintenance of at least a 4-point improvement in pruritus score, results at 52 weeks were 81.2% and 90.3% for the 2-week dose, 80.4% and 88.1% for the 4-week dose, and 65.4% and 67.6% for placebo.
Although topical corticosteroid treatment was allowed during the maintenance phase, only about 15% of patients needed this, Dr. Blauvelt said.
Different dosing results questioned
During the discussion period, one delegate highlighted that the twice-weekly maintenance dosing schedule seemed to “do worse a little bit” than the 4-week dosing, with both “close to placebo,” although “the long-term effect is already very impressive.”
Dr. Blauvelt noted that a pooled analysis had been done and that “it’s very clear that being on lebrikizumab works better than not being on lebrikizumab.
“Now, Q2W versus Q4W. We believe that this may be due to the long half-life of the drug possibly. It could be due to the slow disassociation rate, it’s binding tightly,” he suggested.
“We also could talk about disease modification, right. So, it opens up the concept of hit hard, hit early for 16 weeks, and then maybe you can modify disease over time,” Dr. Blauvelt said.
He added: “That’s highly speculative, of course.”
Short-term safety data
The 52-week safety profile of lebrikizumab is consistent with previously published data at 16 weeks, Dr. Blauvelt said. The most common adverse events during the studies included atopic dermatitis, nasopharyngitis, conjunctivitis, conjunctivitis allergic, headache, and COVID-19.
“This drug has comparable efficacy with dupilumab and tralokinumab,” said Jashin J. Wu, MD, from the Dermatology Research and Education Foundation in Irvine, Calif., in an interview. He was not involved in the study.
“As it does not have any significant advantages with less long-term safety data, I do not see a place for it in my practice,” Dr. Wu said.
Dupilumab (Dupixent) and tralokinumab (Adbry) are monoclonal antibodies that also block IL-13. Both are already licensed for treating atopic dermatitis. Dupilumab was approved by the Food and Drug Administration in 2017, and tralokinumab was approved in 2021.
The study was funded by Dermira, a wholly owned subsidiary of Eli Lilly. Eli Lilly has exclusive rights for the development and commercialization of lebrikizumab in the United States and all countries outside Europe; European rights belong to Almirall for all dermatology indications, including atopic dermatitis. Dr. Blauvelt acts as an investigator and adviser to these companies as well as many other pharmaceutical companies that are involved in developing new dermatologic treatments. Dr. Wu has been an investigator, consultant, or speaker for multiple pharmaceutical companies.
A version of this article first appeared on Medscape.com.
FROM THE EADV CONGRESS
Ruxolitinib repigments many vitiligo-affected body areas
.
Those difficult areas include the hands and feet, said Thierry Passeron, MD, PhD, of Université Côte d’Azur and Centre Hospitalier Universitaire de Nice (France).
Indeed, a 50% or greater improvement in the Vitiligo Area Scoring Index (VASI-50) of the hands and feet was achieved with ruxolitinib cream (Opzelura) in around one-third of patients after 52 weeks’ treatment, and more than half of patients showed improvement in the upper and lower extremities.
During one of the late-breaking news sessions, Dr. Passeron presented a pooled analysis of the Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1) and Study 2 (TruE-V2), which assessed VASI-50 data by body regions.
Similarly positive results were seen on the head and neck and the trunk, with VASI-50 being reached in a respective 68% and 48% of patients after a full year of treatment.
“VASI-50 response rates rose steadily through 52 weeks for both the head and trunk,” said Dr. Passeron. He noted that the trials were initially double-blinded for 24 weeks and that there was a further open-label extension phase through week 52.
In the latter phase, all patients were treated with ruxolitinib; those who originally received a vehicle agent as placebo crossed over to the active treatment.
First FDA-approved treatment for adults and adolescents with vitiligo
Ruxolitinib is a Janus kinase 1/2 inhibitor that has been available for the treatment for atopic dermatitis for more than a year. It was recently approved by the U.S. Food and Drug Administration for the treatment of vitiligo in adults and pediatric patients aged 12 years and older.
This approval was based on the positive findings of the TRuE-V1 and TRuE-V2 studies, which showed that after 24 weeks, 30% of patients treated with ruxolitinib had at least 75% improvement in the facial VASI, compared with 10% of placebo-treated patients.
“These studies demonstrated very nice results, especially on the face, which is the easiest part to repigment in vitiligo,” Dr. Passeron said.
“We know that the location is very important when it comes to repigmentation of vitiligo,” he added. He noted that other body areas, “the extremities, for example, are much more difficult.”
The analysis he presented specifically assessed the effect of ruxolitinib cream on repigmentation in other areas.
Pooled analysis performed
Data from the two TRuE-V trials were pooled. The new analysis included a total of 661 individuals; of those patients, 443 had been treated with topical ruxolitinib, and 218 had received a vehicle cream as a placebo.
For the first 24 weeks, patients received twice-daily 1.5% ruxolitinib cream or vehicle cream. This was followed by a 28-week extension phase in which everyone was treated with ruxolitinib cream, after which there was a 30-day final follow-up period.
Dr. Passeron reported data by body region for weeks 12, 24, and 52, which showed an increasing percentage of patients with VASI-50.
“We didn’t look at the face; that we know well, that is a very good result,” he said.
The best results were seen for the head and neck. VASI-50 was reached by 28.3%, 45.3%, and 68.1% of patients treated with ruxolitinib cream at weeks 12, 24, and 52, respectively. Corresponding rates for the placebo-crossover group were 19.8%, 23.8%, and 51%.
Repigmentation rates of the hand, upper extremities, trunk, lower extremities, and feet were about 9%-15% for both ruxolitinib and placebo at 12 weeks, but by 24 weeks, there was a clear increase in repigmentation rates in the ruxolitinib group for all body areas.
The 24-week VASI-50 rates for hand repigmentation were 24.9% for ruxolitinib cream and 14.4% for placebo. Corresponding rates for upper extremity repigmentation were 33.2% and 8.2%; for the trunk, 26.4% and 12.2%; for the lower extremities, 29.5% and 12.2%; and for the feet, 18.5% and 12.5%.
“The results are quite poor at 12 weeks,” Dr. Passeron said. “It’s very important to keep this in mind; it takes time to repigment vitiligo, it takes to 6-24 months. We have to explain to our patients that they will have to wait to see the results.”
Steady improvements, no new safety concerns
Regarding VASI-50 over time, there was a steady increase in total body scores; 47.7% of patients who received ruxolitinib and 23.3% of placebo-treated patients hit this target at 52 weeks.
“And what is also very important to see is that we didn’t reach the plateau,” Dr. Passeron reported.
Similar patterns were seen for all the other body areas. Again there was a suggestion that rates may continue to rise with continued long-term treatment.
“About one-third of the patients reached at least 50% repigmentation after 1 year of treatment in the hands and feet,” Dr. Passeron said. He noted that certain areas, such as the back of the hand or tips of the fingers, may be unresponsive.
“So, we have to also to warn the patient that probably on these areas we have to combine it with other treatment because it remains very, very difficult to treat.”
There were no new safety concerns regarding treatment-emergent adverse events, which were reported in 52% of patients who received ruxolitinib and in 36% of placebo-treated patients.
The most common adverse reactions included COVID-19 (6.1% vs. 3.1%), acne at the application site (5.3% vs. 1.3%), and pruritus at the application site (3.9% vs. 2.7%), although cases were “mild or moderate,” said Dr. Passeron.
An expert’s take-home
“The results of TRuE-V phase 3 studies are encouraging and exciting,” Viktoria Eleftheriadou, MD, MRCP(UK), SCE(Derm), PhD, said in providing an independent comment for this news organization.
“Although ruxolitinib cream is applied on the skin, this novel treatment for vitiligo is not without risks; therefore, careful monitoring of patients who are started on this topical treatment would be prudent,” said Dr. Eleftheriadou, who is a consultant dermatologist for Walsall Healthcare NHS Trust and the Royal Wolverhampton NHS Trust, Birmingham, United Kingdom.
“I would like to see how many patients achieved VASI-75 or VASI-80 score, which from patients’ perspectives is a more meaningful outcome, as well as how long these results will last for,” she added.
The study was funded by Incyte Corporation. Dr. Passeron has received grants, honoraria, or both from AbbVie, ACM Pharma, Almirall, Amgen, Astellas, Bristol-Myers Squibb, Celgene, Galderma, Genzyme/Sanofi, GlaxoSmithKline, Incyte Corporation, Janssen, LEO Pharma, Eli Lilly, Novartis, Pfizer, Sun Pharmaceuticals, and UCB. Dr. Passeron is the cofounder of YUKIN Therapeutics and has patents on WNT agonists or GSK2b antagonist for repigmentation of vitiligo and on the use of CXCR3B blockers in vitiligo. Dr. Eleftheriadou is an investigator and trial development group member on the HI-Light Vitiligo Trial (specific), a lead investigator on the pilot HI-Light Vitiligo Trial, and a medical advisory panel member of the Vitiligo Society UK. Dr. Eleftheriadou also provides consultancy services to Incyte and Pfizer.
A version of this article first appeared on Medscape.com.
.
Those difficult areas include the hands and feet, said Thierry Passeron, MD, PhD, of Université Côte d’Azur and Centre Hospitalier Universitaire de Nice (France).
Indeed, a 50% or greater improvement in the Vitiligo Area Scoring Index (VASI-50) of the hands and feet was achieved with ruxolitinib cream (Opzelura) in around one-third of patients after 52 weeks’ treatment, and more than half of patients showed improvement in the upper and lower extremities.
During one of the late-breaking news sessions, Dr. Passeron presented a pooled analysis of the Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1) and Study 2 (TruE-V2), which assessed VASI-50 data by body regions.
Similarly positive results were seen on the head and neck and the trunk, with VASI-50 being reached in a respective 68% and 48% of patients after a full year of treatment.
“VASI-50 response rates rose steadily through 52 weeks for both the head and trunk,” said Dr. Passeron. He noted that the trials were initially double-blinded for 24 weeks and that there was a further open-label extension phase through week 52.
In the latter phase, all patients were treated with ruxolitinib; those who originally received a vehicle agent as placebo crossed over to the active treatment.
First FDA-approved treatment for adults and adolescents with vitiligo
Ruxolitinib is a Janus kinase 1/2 inhibitor that has been available for the treatment for atopic dermatitis for more than a year. It was recently approved by the U.S. Food and Drug Administration for the treatment of vitiligo in adults and pediatric patients aged 12 years and older.
This approval was based on the positive findings of the TRuE-V1 and TRuE-V2 studies, which showed that after 24 weeks, 30% of patients treated with ruxolitinib had at least 75% improvement in the facial VASI, compared with 10% of placebo-treated patients.
“These studies demonstrated very nice results, especially on the face, which is the easiest part to repigment in vitiligo,” Dr. Passeron said.
“We know that the location is very important when it comes to repigmentation of vitiligo,” he added. He noted that other body areas, “the extremities, for example, are much more difficult.”
The analysis he presented specifically assessed the effect of ruxolitinib cream on repigmentation in other areas.
Pooled analysis performed
Data from the two TRuE-V trials were pooled. The new analysis included a total of 661 individuals; of those patients, 443 had been treated with topical ruxolitinib, and 218 had received a vehicle cream as a placebo.
For the first 24 weeks, patients received twice-daily 1.5% ruxolitinib cream or vehicle cream. This was followed by a 28-week extension phase in which everyone was treated with ruxolitinib cream, after which there was a 30-day final follow-up period.
Dr. Passeron reported data by body region for weeks 12, 24, and 52, which showed an increasing percentage of patients with VASI-50.
“We didn’t look at the face; that we know well, that is a very good result,” he said.
The best results were seen for the head and neck. VASI-50 was reached by 28.3%, 45.3%, and 68.1% of patients treated with ruxolitinib cream at weeks 12, 24, and 52, respectively. Corresponding rates for the placebo-crossover group were 19.8%, 23.8%, and 51%.
Repigmentation rates of the hand, upper extremities, trunk, lower extremities, and feet were about 9%-15% for both ruxolitinib and placebo at 12 weeks, but by 24 weeks, there was a clear increase in repigmentation rates in the ruxolitinib group for all body areas.
The 24-week VASI-50 rates for hand repigmentation were 24.9% for ruxolitinib cream and 14.4% for placebo. Corresponding rates for upper extremity repigmentation were 33.2% and 8.2%; for the trunk, 26.4% and 12.2%; for the lower extremities, 29.5% and 12.2%; and for the feet, 18.5% and 12.5%.
“The results are quite poor at 12 weeks,” Dr. Passeron said. “It’s very important to keep this in mind; it takes time to repigment vitiligo, it takes to 6-24 months. We have to explain to our patients that they will have to wait to see the results.”
Steady improvements, no new safety concerns
Regarding VASI-50 over time, there was a steady increase in total body scores; 47.7% of patients who received ruxolitinib and 23.3% of placebo-treated patients hit this target at 52 weeks.
“And what is also very important to see is that we didn’t reach the plateau,” Dr. Passeron reported.
Similar patterns were seen for all the other body areas. Again there was a suggestion that rates may continue to rise with continued long-term treatment.
“About one-third of the patients reached at least 50% repigmentation after 1 year of treatment in the hands and feet,” Dr. Passeron said. He noted that certain areas, such as the back of the hand or tips of the fingers, may be unresponsive.
“So, we have to also to warn the patient that probably on these areas we have to combine it with other treatment because it remains very, very difficult to treat.”
There were no new safety concerns regarding treatment-emergent adverse events, which were reported in 52% of patients who received ruxolitinib and in 36% of placebo-treated patients.
The most common adverse reactions included COVID-19 (6.1% vs. 3.1%), acne at the application site (5.3% vs. 1.3%), and pruritus at the application site (3.9% vs. 2.7%), although cases were “mild or moderate,” said Dr. Passeron.
An expert’s take-home
“The results of TRuE-V phase 3 studies are encouraging and exciting,” Viktoria Eleftheriadou, MD, MRCP(UK), SCE(Derm), PhD, said in providing an independent comment for this news organization.
“Although ruxolitinib cream is applied on the skin, this novel treatment for vitiligo is not without risks; therefore, careful monitoring of patients who are started on this topical treatment would be prudent,” said Dr. Eleftheriadou, who is a consultant dermatologist for Walsall Healthcare NHS Trust and the Royal Wolverhampton NHS Trust, Birmingham, United Kingdom.
“I would like to see how many patients achieved VASI-75 or VASI-80 score, which from patients’ perspectives is a more meaningful outcome, as well as how long these results will last for,” she added.
The study was funded by Incyte Corporation. Dr. Passeron has received grants, honoraria, or both from AbbVie, ACM Pharma, Almirall, Amgen, Astellas, Bristol-Myers Squibb, Celgene, Galderma, Genzyme/Sanofi, GlaxoSmithKline, Incyte Corporation, Janssen, LEO Pharma, Eli Lilly, Novartis, Pfizer, Sun Pharmaceuticals, and UCB. Dr. Passeron is the cofounder of YUKIN Therapeutics and has patents on WNT agonists or GSK2b antagonist for repigmentation of vitiligo and on the use of CXCR3B blockers in vitiligo. Dr. Eleftheriadou is an investigator and trial development group member on the HI-Light Vitiligo Trial (specific), a lead investigator on the pilot HI-Light Vitiligo Trial, and a medical advisory panel member of the Vitiligo Society UK. Dr. Eleftheriadou also provides consultancy services to Incyte and Pfizer.
A version of this article first appeared on Medscape.com.
.
Those difficult areas include the hands and feet, said Thierry Passeron, MD, PhD, of Université Côte d’Azur and Centre Hospitalier Universitaire de Nice (France).
Indeed, a 50% or greater improvement in the Vitiligo Area Scoring Index (VASI-50) of the hands and feet was achieved with ruxolitinib cream (Opzelura) in around one-third of patients after 52 weeks’ treatment, and more than half of patients showed improvement in the upper and lower extremities.
During one of the late-breaking news sessions, Dr. Passeron presented a pooled analysis of the Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1) and Study 2 (TruE-V2), which assessed VASI-50 data by body regions.
Similarly positive results were seen on the head and neck and the trunk, with VASI-50 being reached in a respective 68% and 48% of patients after a full year of treatment.
“VASI-50 response rates rose steadily through 52 weeks for both the head and trunk,” said Dr. Passeron. He noted that the trials were initially double-blinded for 24 weeks and that there was a further open-label extension phase through week 52.
In the latter phase, all patients were treated with ruxolitinib; those who originally received a vehicle agent as placebo crossed over to the active treatment.
First FDA-approved treatment for adults and adolescents with vitiligo
Ruxolitinib is a Janus kinase 1/2 inhibitor that has been available for the treatment for atopic dermatitis for more than a year. It was recently approved by the U.S. Food and Drug Administration for the treatment of vitiligo in adults and pediatric patients aged 12 years and older.
This approval was based on the positive findings of the TRuE-V1 and TRuE-V2 studies, which showed that after 24 weeks, 30% of patients treated with ruxolitinib had at least 75% improvement in the facial VASI, compared with 10% of placebo-treated patients.
“These studies demonstrated very nice results, especially on the face, which is the easiest part to repigment in vitiligo,” Dr. Passeron said.
“We know that the location is very important when it comes to repigmentation of vitiligo,” he added. He noted that other body areas, “the extremities, for example, are much more difficult.”
The analysis he presented specifically assessed the effect of ruxolitinib cream on repigmentation in other areas.
Pooled analysis performed
Data from the two TRuE-V trials were pooled. The new analysis included a total of 661 individuals; of those patients, 443 had been treated with topical ruxolitinib, and 218 had received a vehicle cream as a placebo.
For the first 24 weeks, patients received twice-daily 1.5% ruxolitinib cream or vehicle cream. This was followed by a 28-week extension phase in which everyone was treated with ruxolitinib cream, after which there was a 30-day final follow-up period.
Dr. Passeron reported data by body region for weeks 12, 24, and 52, which showed an increasing percentage of patients with VASI-50.
“We didn’t look at the face; that we know well, that is a very good result,” he said.
The best results were seen for the head and neck. VASI-50 was reached by 28.3%, 45.3%, and 68.1% of patients treated with ruxolitinib cream at weeks 12, 24, and 52, respectively. Corresponding rates for the placebo-crossover group were 19.8%, 23.8%, and 51%.
Repigmentation rates of the hand, upper extremities, trunk, lower extremities, and feet were about 9%-15% for both ruxolitinib and placebo at 12 weeks, but by 24 weeks, there was a clear increase in repigmentation rates in the ruxolitinib group for all body areas.
The 24-week VASI-50 rates for hand repigmentation were 24.9% for ruxolitinib cream and 14.4% for placebo. Corresponding rates for upper extremity repigmentation were 33.2% and 8.2%; for the trunk, 26.4% and 12.2%; for the lower extremities, 29.5% and 12.2%; and for the feet, 18.5% and 12.5%.
“The results are quite poor at 12 weeks,” Dr. Passeron said. “It’s very important to keep this in mind; it takes time to repigment vitiligo, it takes to 6-24 months. We have to explain to our patients that they will have to wait to see the results.”
Steady improvements, no new safety concerns
Regarding VASI-50 over time, there was a steady increase in total body scores; 47.7% of patients who received ruxolitinib and 23.3% of placebo-treated patients hit this target at 52 weeks.
“And what is also very important to see is that we didn’t reach the plateau,” Dr. Passeron reported.
Similar patterns were seen for all the other body areas. Again there was a suggestion that rates may continue to rise with continued long-term treatment.
“About one-third of the patients reached at least 50% repigmentation after 1 year of treatment in the hands and feet,” Dr. Passeron said. He noted that certain areas, such as the back of the hand or tips of the fingers, may be unresponsive.
“So, we have to also to warn the patient that probably on these areas we have to combine it with other treatment because it remains very, very difficult to treat.”
There were no new safety concerns regarding treatment-emergent adverse events, which were reported in 52% of patients who received ruxolitinib and in 36% of placebo-treated patients.
The most common adverse reactions included COVID-19 (6.1% vs. 3.1%), acne at the application site (5.3% vs. 1.3%), and pruritus at the application site (3.9% vs. 2.7%), although cases were “mild or moderate,” said Dr. Passeron.
An expert’s take-home
“The results of TRuE-V phase 3 studies are encouraging and exciting,” Viktoria Eleftheriadou, MD, MRCP(UK), SCE(Derm), PhD, said in providing an independent comment for this news organization.
“Although ruxolitinib cream is applied on the skin, this novel treatment for vitiligo is not without risks; therefore, careful monitoring of patients who are started on this topical treatment would be prudent,” said Dr. Eleftheriadou, who is a consultant dermatologist for Walsall Healthcare NHS Trust and the Royal Wolverhampton NHS Trust, Birmingham, United Kingdom.
“I would like to see how many patients achieved VASI-75 or VASI-80 score, which from patients’ perspectives is a more meaningful outcome, as well as how long these results will last for,” she added.
The study was funded by Incyte Corporation. Dr. Passeron has received grants, honoraria, or both from AbbVie, ACM Pharma, Almirall, Amgen, Astellas, Bristol-Myers Squibb, Celgene, Galderma, Genzyme/Sanofi, GlaxoSmithKline, Incyte Corporation, Janssen, LEO Pharma, Eli Lilly, Novartis, Pfizer, Sun Pharmaceuticals, and UCB. Dr. Passeron is the cofounder of YUKIN Therapeutics and has patents on WNT agonists or GSK2b antagonist for repigmentation of vitiligo and on the use of CXCR3B blockers in vitiligo. Dr. Eleftheriadou is an investigator and trial development group member on the HI-Light Vitiligo Trial (specific), a lead investigator on the pilot HI-Light Vitiligo Trial, and a medical advisory panel member of the Vitiligo Society UK. Dr. Eleftheriadou also provides consultancy services to Incyte and Pfizer.
A version of this article first appeared on Medscape.com.
FROM THE EADV CONGRESS
Bariatric surgery may up risk for epilepsy
Analyzing health records, investigators compared almost 17,000 patients who had undergone bariatric surgery with more than 620,000 individuals with obesity who had not undergone the surgery.
During a minimum 3-year follow-up period, the surgery group had a 45% higher risk of developing epilepsy than the nonsurgery group. Moreover, patients who had a stroke after their bariatric surgery were 14 times more likely to develop epilepsy than those who did not have a stroke.
“When considering having bariatric surgery, people should talk to their doctors about the benefits and risks,” senior investigator Jorge Burneo, MD, professor of neurology, biostatistics, and epidemiology and endowed chair in epilepsy at Western University, London, told this news organization.
“While there are many health benefits of weight loss, our findings suggest that epilepsy is a long-term risk of bariatric surgery for weight loss,” Dr. Burneo said.
The findings were published online in Neurology.
Unrecognized risk factor?
Bariatric surgery has become more common as global rates of obesity have increased. The surgery has been shown to reduce the risk for serious obesity-related conditions, the researchers note.
However, “in addition to the positive outcomes of bariatric surgery, several long-term neurological complications have also been identified,” they write.
One previous study reported increased epilepsy risk following gastric bypass. Those findings “suggest that bariatric surgery may be an unrecognized epilepsy risk factor; however, this possible association has not been thoroughly explored,” write the investigators.
Dr. Burneo said he conducted the study because he has seen patients with epilepsy in his clinic who were “without risk factors, with normal MRIs, who shared the history of having bariatric surgery before the development of epilepsy.”
The researchers’ primary objective was to “assess whether epilepsy risk is elevated following bariatric surgery for weight loss relative to a nonsurgical cohort of patients who are obese,” he noted.
The study used linked administrative health databases in Ontario, Canada. Patients were accrued from July 1, 2010, to Dec. 31, 2016, and were followed until Dec. 31, 2019. The analysis included 639,472 participants, 2.7% of whom had undergone bariatric surgery.
The “exposed” cohort consisted of all Ontario residents aged 18 years or older who had undergone bariatric surgery during the 6-year period (n = 16,958; 65.1% women; mean age, 47.4 years), while the “unexposed” cohort consisted of patients hospitalized with a diagnosis of obesity who had not undergone bariatric surgery (n = 622,514; 62.8% women; mean age, 47.6 years).
Patients with a history of seizures, epilepsy, epilepsy risk factors, prior brain surgery, psychiatric disorders, or drug or alcohol abuse/dependence were excluded from the analysis.
The researchers collected data on patients’ sociodemographic characteristics at the index date, as well as Charlson Comorbidity Index scores during the 2 years prior to index, and data regarding several specific comorbidities, such as diabetes mellitus, hypertension, sleep apnea, depression/anxiety, and cardiovascular factors.
The exposed and unexposed cohorts were followed for a median period of 5.8 and 5.9 person-years, respectively.
‘Unclear’ mechanisms
Before weighting, 0.4% of participants in the exposed cohort (n = 73) developed epilepsy, versus 0.2% of participants in the unexposed cohort (n = 1,260) by the end of the follow-up period.
In the weighted cohorts, there were 50.1 epilepsy diagnoses per 100,000 person-years, versus 34.1 per 100,000 person-years (rate difference, 16 per 100,000 person-years).
The multivariable analysis of the weighted cohort showed the hazard ratio for epilepsy cases that were associated with bariatric surgery was 1.45 (95% confidence interval, 1.35-1.56), after adjusting for sleep apnea and including stroke as a time-varying covariate.
Having a stroke during the follow-up period increased epilepsy 14-fold in the exposed cohort (HR, 14.03; 95% CI, 4.25-46.25).
The investigators note that they were unable to measure obesity status or body mass index throughout the study and that some obesity-related comorbidities “may affect epilepsy risk.”
In addition, Dr. Burneo reported that the study did not investigate potential causes and mechanisms of the association between bariatric surgery and epilepsy risk.
Hypotheses “include potential nutritional deficiencies, receipt of general anesthesia, or other unclear causes,” he said.
“Future research should investigate epilepsy as a potential long-term complication of bariatric surgery, exploring the possible effects of this procedure,” Dr. Burneo added.
Risk-benefit discussion
In a comment, Jacqueline French, MD, professor of neurology at NYU Grossman School of Medicine, and director of NYU’s Epilepsy Study Consortium, said she was “not 100% surprised by the findings” because she has seen in her clinical practice “a number of patients who developed epilepsy after bariatric surgery or had a history of bariatric surgery at the time they developed epilepsy.”
On the other hand, she has also seen patients who did not have a history of bariatric surgery and who developed epilepsy.
“I’m unable to tell if there is an association, although I’ve had it at the back of my head as a thought and wondered about it,” said Dr. French, who is also the chief medical and innovation officer at the Epilepsy Foundation. She was not involved with the study.
She noted that possible mechanisms underlying the association are that gastric bypass surgery leads to a “significant alteration” in nutrient absorption. Moreover, “we now know that the microbiome is associated with epilepsy” and that changes occur in the gut microbiome after bariatric surgery, Dr. French said.
There are two take-home messages for practicing clinicians, she added.
“Although the risk [of developing epilepsy] is very low, it should be presented as part of the risks and benefits to patients considering bariatric surgery,” she said.
“It’s equally important to follow up on the potential differences in these patients who go on to develop epilepsy following bariatric surgery,” said Dr. French. “Is there a certain metabolic profile or some nutrient previously absorbed that now is not absorbed that might predispose people to risk?”
This would be “enormously important to know because it might not just pertain to these people but to a whole other cohort of people who develop epilepsy,” Dr. French concluded.
The study was funded by the Ontario Ministry of Health and Ministry of Long-Term Care and by the Jack Cowin Endowed Chair in Epilepsy Research at Western University. Dr. Burneo holds the Jack Cowin Endowed Chair in Epilepsy Research at Western University. The other investigators and Dr. French have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Analyzing health records, investigators compared almost 17,000 patients who had undergone bariatric surgery with more than 620,000 individuals with obesity who had not undergone the surgery.
During a minimum 3-year follow-up period, the surgery group had a 45% higher risk of developing epilepsy than the nonsurgery group. Moreover, patients who had a stroke after their bariatric surgery were 14 times more likely to develop epilepsy than those who did not have a stroke.
“When considering having bariatric surgery, people should talk to their doctors about the benefits and risks,” senior investigator Jorge Burneo, MD, professor of neurology, biostatistics, and epidemiology and endowed chair in epilepsy at Western University, London, told this news organization.
“While there are many health benefits of weight loss, our findings suggest that epilepsy is a long-term risk of bariatric surgery for weight loss,” Dr. Burneo said.
The findings were published online in Neurology.
Unrecognized risk factor?
Bariatric surgery has become more common as global rates of obesity have increased. The surgery has been shown to reduce the risk for serious obesity-related conditions, the researchers note.
However, “in addition to the positive outcomes of bariatric surgery, several long-term neurological complications have also been identified,” they write.
One previous study reported increased epilepsy risk following gastric bypass. Those findings “suggest that bariatric surgery may be an unrecognized epilepsy risk factor; however, this possible association has not been thoroughly explored,” write the investigators.
Dr. Burneo said he conducted the study because he has seen patients with epilepsy in his clinic who were “without risk factors, with normal MRIs, who shared the history of having bariatric surgery before the development of epilepsy.”
The researchers’ primary objective was to “assess whether epilepsy risk is elevated following bariatric surgery for weight loss relative to a nonsurgical cohort of patients who are obese,” he noted.
The study used linked administrative health databases in Ontario, Canada. Patients were accrued from July 1, 2010, to Dec. 31, 2016, and were followed until Dec. 31, 2019. The analysis included 639,472 participants, 2.7% of whom had undergone bariatric surgery.
The “exposed” cohort consisted of all Ontario residents aged 18 years or older who had undergone bariatric surgery during the 6-year period (n = 16,958; 65.1% women; mean age, 47.4 years), while the “unexposed” cohort consisted of patients hospitalized with a diagnosis of obesity who had not undergone bariatric surgery (n = 622,514; 62.8% women; mean age, 47.6 years).
Patients with a history of seizures, epilepsy, epilepsy risk factors, prior brain surgery, psychiatric disorders, or drug or alcohol abuse/dependence were excluded from the analysis.
The researchers collected data on patients’ sociodemographic characteristics at the index date, as well as Charlson Comorbidity Index scores during the 2 years prior to index, and data regarding several specific comorbidities, such as diabetes mellitus, hypertension, sleep apnea, depression/anxiety, and cardiovascular factors.
The exposed and unexposed cohorts were followed for a median period of 5.8 and 5.9 person-years, respectively.
‘Unclear’ mechanisms
Before weighting, 0.4% of participants in the exposed cohort (n = 73) developed epilepsy, versus 0.2% of participants in the unexposed cohort (n = 1,260) by the end of the follow-up period.
In the weighted cohorts, there were 50.1 epilepsy diagnoses per 100,000 person-years, versus 34.1 per 100,000 person-years (rate difference, 16 per 100,000 person-years).
The multivariable analysis of the weighted cohort showed the hazard ratio for epilepsy cases that were associated with bariatric surgery was 1.45 (95% confidence interval, 1.35-1.56), after adjusting for sleep apnea and including stroke as a time-varying covariate.
Having a stroke during the follow-up period increased epilepsy 14-fold in the exposed cohort (HR, 14.03; 95% CI, 4.25-46.25).
The investigators note that they were unable to measure obesity status or body mass index throughout the study and that some obesity-related comorbidities “may affect epilepsy risk.”
In addition, Dr. Burneo reported that the study did not investigate potential causes and mechanisms of the association between bariatric surgery and epilepsy risk.
Hypotheses “include potential nutritional deficiencies, receipt of general anesthesia, or other unclear causes,” he said.
“Future research should investigate epilepsy as a potential long-term complication of bariatric surgery, exploring the possible effects of this procedure,” Dr. Burneo added.
Risk-benefit discussion
In a comment, Jacqueline French, MD, professor of neurology at NYU Grossman School of Medicine, and director of NYU’s Epilepsy Study Consortium, said she was “not 100% surprised by the findings” because she has seen in her clinical practice “a number of patients who developed epilepsy after bariatric surgery or had a history of bariatric surgery at the time they developed epilepsy.”
On the other hand, she has also seen patients who did not have a history of bariatric surgery and who developed epilepsy.
“I’m unable to tell if there is an association, although I’ve had it at the back of my head as a thought and wondered about it,” said Dr. French, who is also the chief medical and innovation officer at the Epilepsy Foundation. She was not involved with the study.
She noted that possible mechanisms underlying the association are that gastric bypass surgery leads to a “significant alteration” in nutrient absorption. Moreover, “we now know that the microbiome is associated with epilepsy” and that changes occur in the gut microbiome after bariatric surgery, Dr. French said.
There are two take-home messages for practicing clinicians, she added.
“Although the risk [of developing epilepsy] is very low, it should be presented as part of the risks and benefits to patients considering bariatric surgery,” she said.
“It’s equally important to follow up on the potential differences in these patients who go on to develop epilepsy following bariatric surgery,” said Dr. French. “Is there a certain metabolic profile or some nutrient previously absorbed that now is not absorbed that might predispose people to risk?”
This would be “enormously important to know because it might not just pertain to these people but to a whole other cohort of people who develop epilepsy,” Dr. French concluded.
The study was funded by the Ontario Ministry of Health and Ministry of Long-Term Care and by the Jack Cowin Endowed Chair in Epilepsy Research at Western University. Dr. Burneo holds the Jack Cowin Endowed Chair in Epilepsy Research at Western University. The other investigators and Dr. French have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Analyzing health records, investigators compared almost 17,000 patients who had undergone bariatric surgery with more than 620,000 individuals with obesity who had not undergone the surgery.
During a minimum 3-year follow-up period, the surgery group had a 45% higher risk of developing epilepsy than the nonsurgery group. Moreover, patients who had a stroke after their bariatric surgery were 14 times more likely to develop epilepsy than those who did not have a stroke.
“When considering having bariatric surgery, people should talk to their doctors about the benefits and risks,” senior investigator Jorge Burneo, MD, professor of neurology, biostatistics, and epidemiology and endowed chair in epilepsy at Western University, London, told this news organization.
“While there are many health benefits of weight loss, our findings suggest that epilepsy is a long-term risk of bariatric surgery for weight loss,” Dr. Burneo said.
The findings were published online in Neurology.
Unrecognized risk factor?
Bariatric surgery has become more common as global rates of obesity have increased. The surgery has been shown to reduce the risk for serious obesity-related conditions, the researchers note.
However, “in addition to the positive outcomes of bariatric surgery, several long-term neurological complications have also been identified,” they write.
One previous study reported increased epilepsy risk following gastric bypass. Those findings “suggest that bariatric surgery may be an unrecognized epilepsy risk factor; however, this possible association has not been thoroughly explored,” write the investigators.
Dr. Burneo said he conducted the study because he has seen patients with epilepsy in his clinic who were “without risk factors, with normal MRIs, who shared the history of having bariatric surgery before the development of epilepsy.”
The researchers’ primary objective was to “assess whether epilepsy risk is elevated following bariatric surgery for weight loss relative to a nonsurgical cohort of patients who are obese,” he noted.
The study used linked administrative health databases in Ontario, Canada. Patients were accrued from July 1, 2010, to Dec. 31, 2016, and were followed until Dec. 31, 2019. The analysis included 639,472 participants, 2.7% of whom had undergone bariatric surgery.
The “exposed” cohort consisted of all Ontario residents aged 18 years or older who had undergone bariatric surgery during the 6-year period (n = 16,958; 65.1% women; mean age, 47.4 years), while the “unexposed” cohort consisted of patients hospitalized with a diagnosis of obesity who had not undergone bariatric surgery (n = 622,514; 62.8% women; mean age, 47.6 years).
Patients with a history of seizures, epilepsy, epilepsy risk factors, prior brain surgery, psychiatric disorders, or drug or alcohol abuse/dependence were excluded from the analysis.
The researchers collected data on patients’ sociodemographic characteristics at the index date, as well as Charlson Comorbidity Index scores during the 2 years prior to index, and data regarding several specific comorbidities, such as diabetes mellitus, hypertension, sleep apnea, depression/anxiety, and cardiovascular factors.
The exposed and unexposed cohorts were followed for a median period of 5.8 and 5.9 person-years, respectively.
‘Unclear’ mechanisms
Before weighting, 0.4% of participants in the exposed cohort (n = 73) developed epilepsy, versus 0.2% of participants in the unexposed cohort (n = 1,260) by the end of the follow-up period.
In the weighted cohorts, there were 50.1 epilepsy diagnoses per 100,000 person-years, versus 34.1 per 100,000 person-years (rate difference, 16 per 100,000 person-years).
The multivariable analysis of the weighted cohort showed the hazard ratio for epilepsy cases that were associated with bariatric surgery was 1.45 (95% confidence interval, 1.35-1.56), after adjusting for sleep apnea and including stroke as a time-varying covariate.
Having a stroke during the follow-up period increased epilepsy 14-fold in the exposed cohort (HR, 14.03; 95% CI, 4.25-46.25).
The investigators note that they were unable to measure obesity status or body mass index throughout the study and that some obesity-related comorbidities “may affect epilepsy risk.”
In addition, Dr. Burneo reported that the study did not investigate potential causes and mechanisms of the association between bariatric surgery and epilepsy risk.
Hypotheses “include potential nutritional deficiencies, receipt of general anesthesia, or other unclear causes,” he said.
“Future research should investigate epilepsy as a potential long-term complication of bariatric surgery, exploring the possible effects of this procedure,” Dr. Burneo added.
Risk-benefit discussion
In a comment, Jacqueline French, MD, professor of neurology at NYU Grossman School of Medicine, and director of NYU’s Epilepsy Study Consortium, said she was “not 100% surprised by the findings” because she has seen in her clinical practice “a number of patients who developed epilepsy after bariatric surgery or had a history of bariatric surgery at the time they developed epilepsy.”
On the other hand, she has also seen patients who did not have a history of bariatric surgery and who developed epilepsy.
“I’m unable to tell if there is an association, although I’ve had it at the back of my head as a thought and wondered about it,” said Dr. French, who is also the chief medical and innovation officer at the Epilepsy Foundation. She was not involved with the study.
She noted that possible mechanisms underlying the association are that gastric bypass surgery leads to a “significant alteration” in nutrient absorption. Moreover, “we now know that the microbiome is associated with epilepsy” and that changes occur in the gut microbiome after bariatric surgery, Dr. French said.
There are two take-home messages for practicing clinicians, she added.
“Although the risk [of developing epilepsy] is very low, it should be presented as part of the risks and benefits to patients considering bariatric surgery,” she said.
“It’s equally important to follow up on the potential differences in these patients who go on to develop epilepsy following bariatric surgery,” said Dr. French. “Is there a certain metabolic profile or some nutrient previously absorbed that now is not absorbed that might predispose people to risk?”
This would be “enormously important to know because it might not just pertain to these people but to a whole other cohort of people who develop epilepsy,” Dr. French concluded.
The study was funded by the Ontario Ministry of Health and Ministry of Long-Term Care and by the Jack Cowin Endowed Chair in Epilepsy Research at Western University. Dr. Burneo holds the Jack Cowin Endowed Chair in Epilepsy Research at Western University. The other investigators and Dr. French have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM NEUROLOGY
Breakthrough COVID studies lend support to use of new boosters in immunosuppressed patients
People with immune-mediated inflammatory diseases who are taking immunosuppressants don’t mount as strong of an immune defense against the Omicron variant as they did against the original SARS-CoV-2 wild-type virus, according to two studies published in Annals of the Rheumatic Diseases. One of the studies further showed that vaccinated individuals taking immunosuppressants have poorer cross-neutralizing responses to Omicron than do healthy vaccinated individuals, even after three doses of the COVID-19 mRNA vaccines.
“We carefully suggest that if Omicron-specific vaccination can be administered, it may be an effective way to reduce the risk of breakthrough infections in patients with autoimmune rheumatic disease,” Sang Tae Choi, MD, PhD, of the University College of Medicine, Seoul, Korea, and one of the authors of the study on cross-neutralizing protection, told this news organization. “However, further research is needed on Omicron-specific vaccine effectiveness in patients with immune dysfunctions. We believe that these study results can be of great benefit in determining the strategy of vaccination in the future.”
The earlier study, published in July, examined the ability of COVID-19 vaccines to induce cross-reactive antibody responses against Omicron infections in patients with autoimmune rheumatic diseases (ARDs). The observational study involved 149 patients with ARDs and 94 health care workers as controls, all of whom provided blood samples a median 15 weeks after their second COVID vaccine dose or a median 8 weeks after their third dose. A little more than two-thirds of the patients (68.5%) had received a third mRNA vaccine dose. None of the participants previously had COVID-19.
The researchers compared the rate of breakthrough infections with the Omicron variant to the neutralizing responses in patients’ blood, specifically the cross-neutralizing antibody responses because the original mRNA vaccines targeted a different variant than Omicron. Breakthrough infections were assessed by survey questions.
“Our findings suggested that neither primary series vaccinations nor booster doses are sufficient to induce Omicron-neutralizing responses above the threshold in patients with ARDs, although responses were noticeably increased following the third dose of an mRNA vaccine,” write Woo-Joong Kim, of the Chung-Ang University College of Medicine, Seoul, Korea, and his colleagues. “This impairment of cross-neutralization responses across most of our patients contrasts starkly with a potent elicitation of the Omicron-neutralizing responses after the third vaccination in healthy recipients.”
The average neutralizing responses against the original SARS-CoV-2 strain were similar in both groups: 76% in patients with ARDs and 72% in health care workers after the second dose. The mean response after a third dose was 97% in health care workers and 88% in patients.
The average cross-neutralizing response against the Omicron variant was far lower, particularly in those with rheumatic disease: only 11.5%, which rose to 27% after the third dose. Only 39% of the patient sera showed neutralization of Omicron, even after the third dose. Meanwhile, the mean cross-neutralizing response in health care workers was 18% after the second dose and 50% after the third.
When the researchers compared seropositivity rates against the original virus to neutralizing responses against Omicron, the association between these was stronger in health care workers than in those with ARDs. In fact, among patients with ARDs who seroconverted, only 41% showed any response against Omicron. Among all the patients, most of those who didn’t respond to Omicron (93.5%) had initially seroconverted.
The researchers also looked at the ability to neutralize Omicron on the basis of disease in those who received three doses of the vaccine. About half of those with lupus (52%) showed any neutralization against Omicron, compared with 25% of those with rheumatoid arthritis, 37.5% of those with ankylosing spondylitis, 33% of those with Behçet snydrome, and all of those with adult-onset Still’s disease.
The rate of breakthrough infections was lower in patients (19%) than in health care workers (33%). A similar pattern was seen in the more recent study published Sept. 5. Researchers used data from a prospective cohort study in the Netherlands to examine incidence and severity of Omicron breakthrough infections in patients with immune-mediated inflammatory diseases. The researchers compared infection rates and severity among 1,593 vaccinated patients with inflammatory disease who were taking immunosuppressants and 579 vaccinated controls (418 patients with inflammatory disease not on immunosuppressants and 161 healthy controls).
One in five patients with inflammatory disease (21%) were taking immunosuppressants that substantially impair antibodies, such as anti-CD20 therapy, S1P modulators, or mycophenolate mofetil combination therapy, and 48% of these patients seroconverted after primary vaccination, compared with 96% of patients taking other immunosuppressants and 98% of controls.
Breakthrough infection rates were similar between the control group (31%) and those taking immunosuppressants (30%). Only three participants had severe disease requiring hospitalization: one control and two patients taking immunosuppressants.
“In both studies, the controls had similar or higher rates of breakthrough infections, compared with the immunosuppressed,” noted Alfred Kim, MD, an assistant professor of medicine at Washington University, St Louis, but he added, “one has to consider differences in mitigation strategies, such as masking, that may explain these findings.” That is, patients taking immunosuppressants may be taking fewer risks in the community or have fewer potential exposures, especially in the Korean study, wherein the controls were health care workers.
A greater disparity in infections occurred when considering seroconversion rates. Breakthrough incidence was 38% among those taking immunosuppressants who did not seroconvert, compared with 29% among those who did. A similar trend was seen in breakthrough incidence between those taking strongly antibody-impairing immunosuppressants (36% breakthrough rate) and those taking other immunosuppressants (28%).
Among those taking immunosuppressants who seroconverted, a primary series of vaccination reduced the risk of a breakthrough infection by 29%. Protection became more robust with a booster or prior infection, both of which reduced breakthrough infection risk by 39% in those taking immunosuppressants who seroconverted.
“We demonstrate in patients with immune-mediated inflammatory diseases on immunosuppressants that additional vaccinations are associated with decreased risk of SARS-CoV-2 Omicron breakthrough infections,” wrote Eileen W. Stalman, MD, PhD, of Amsterdam UMC in the Netherlands, and her colleagues.
Though neither study broke down immune response or breakthrough infection based on individual medications, Kim said that previous research allows one to extrapolate “that prior culprits of poor vaccine responses [such as B-cell depleting drugs, mycophenolate, and TNF [tumor necrosis factor] inhibitors will continue to bear the greatest burden in breakthrough infection, including Omicron.”
Overall, he found the data from both studies relatively consistent with one another.
“Those on immunosuppression, particularly mechanisms that have been established as risk factors for poor vaccine responses, are at risk of breakthrough infection during the era of Omicron,” Dr. Kim said.
The earlier study from Korea also found that “the median time between the third-dose vaccination and the date of confirmed breakthrough infection in patients with ARDs was significantly shorter, compared with that in health care workers” at just 93 days in patients versus 122 days in health care workers. They postulated that this population’s limited neutralization of Omicron explained this short-lived protection.
Most of the patients with breakthrough infections (74%) in that study showed no neutralization against Omicron, including the only two hospitalized patients, both of whom had strong responses against the original SARS-CoV-2 strain. The significant decline over time of neutralization against Omicron suggested “the potential for a substantial loss of the protection from breakthrough infection,” the authors write.
“The third dose of an mRNA vaccine could improve the cross-neutralization of the SARS-CoV-2 Omicron variant in patients with autoimmune rheumatic disease [although] more than half of the patients failed to generate Omicron-neutralizing antibodies,” Tae Choi said in an interview. “Our study sheds light on the relative deficiency of the Omicron-specific neutralizing responses in patients with autoimmune rheumatic disease and their anticipated vulnerability to breakthrough infection.”
The message for clinicians, Dr. Kim said, is to “continue to urge our patients to maintain additional and boosting doses per guidance, use pre-exposure prophylaxis such as Evusheld, and continue other mitigation strategies as they have done.”
The Dutch study was funded by The Netherlands Organization for Health Research and Development; the Korean study used no external funding.
The authors of the Korean study had no disclosures. The Dutch study’s authors reported a wide range of disclosures involving more than a dozen pharmaceutical companies but not including Pfizer or Moderna. Dr. Kim’s industry disclosures include Alexion, ANI, AstraZeneca, Aurinia, Exagen, Foghorn Therapeutics, GlaxoSmithKline, Kypha, and Pfizer.
A version of this article first appeared on Medscape.com.
People with immune-mediated inflammatory diseases who are taking immunosuppressants don’t mount as strong of an immune defense against the Omicron variant as they did against the original SARS-CoV-2 wild-type virus, according to two studies published in Annals of the Rheumatic Diseases. One of the studies further showed that vaccinated individuals taking immunosuppressants have poorer cross-neutralizing responses to Omicron than do healthy vaccinated individuals, even after three doses of the COVID-19 mRNA vaccines.
“We carefully suggest that if Omicron-specific vaccination can be administered, it may be an effective way to reduce the risk of breakthrough infections in patients with autoimmune rheumatic disease,” Sang Tae Choi, MD, PhD, of the University College of Medicine, Seoul, Korea, and one of the authors of the study on cross-neutralizing protection, told this news organization. “However, further research is needed on Omicron-specific vaccine effectiveness in patients with immune dysfunctions. We believe that these study results can be of great benefit in determining the strategy of vaccination in the future.”
The earlier study, published in July, examined the ability of COVID-19 vaccines to induce cross-reactive antibody responses against Omicron infections in patients with autoimmune rheumatic diseases (ARDs). The observational study involved 149 patients with ARDs and 94 health care workers as controls, all of whom provided blood samples a median 15 weeks after their second COVID vaccine dose or a median 8 weeks after their third dose. A little more than two-thirds of the patients (68.5%) had received a third mRNA vaccine dose. None of the participants previously had COVID-19.
The researchers compared the rate of breakthrough infections with the Omicron variant to the neutralizing responses in patients’ blood, specifically the cross-neutralizing antibody responses because the original mRNA vaccines targeted a different variant than Omicron. Breakthrough infections were assessed by survey questions.
“Our findings suggested that neither primary series vaccinations nor booster doses are sufficient to induce Omicron-neutralizing responses above the threshold in patients with ARDs, although responses were noticeably increased following the third dose of an mRNA vaccine,” write Woo-Joong Kim, of the Chung-Ang University College of Medicine, Seoul, Korea, and his colleagues. “This impairment of cross-neutralization responses across most of our patients contrasts starkly with a potent elicitation of the Omicron-neutralizing responses after the third vaccination in healthy recipients.”
The average neutralizing responses against the original SARS-CoV-2 strain were similar in both groups: 76% in patients with ARDs and 72% in health care workers after the second dose. The mean response after a third dose was 97% in health care workers and 88% in patients.
The average cross-neutralizing response against the Omicron variant was far lower, particularly in those with rheumatic disease: only 11.5%, which rose to 27% after the third dose. Only 39% of the patient sera showed neutralization of Omicron, even after the third dose. Meanwhile, the mean cross-neutralizing response in health care workers was 18% after the second dose and 50% after the third.
When the researchers compared seropositivity rates against the original virus to neutralizing responses against Omicron, the association between these was stronger in health care workers than in those with ARDs. In fact, among patients with ARDs who seroconverted, only 41% showed any response against Omicron. Among all the patients, most of those who didn’t respond to Omicron (93.5%) had initially seroconverted.
The researchers also looked at the ability to neutralize Omicron on the basis of disease in those who received three doses of the vaccine. About half of those with lupus (52%) showed any neutralization against Omicron, compared with 25% of those with rheumatoid arthritis, 37.5% of those with ankylosing spondylitis, 33% of those with Behçet snydrome, and all of those with adult-onset Still’s disease.
The rate of breakthrough infections was lower in patients (19%) than in health care workers (33%). A similar pattern was seen in the more recent study published Sept. 5. Researchers used data from a prospective cohort study in the Netherlands to examine incidence and severity of Omicron breakthrough infections in patients with immune-mediated inflammatory diseases. The researchers compared infection rates and severity among 1,593 vaccinated patients with inflammatory disease who were taking immunosuppressants and 579 vaccinated controls (418 patients with inflammatory disease not on immunosuppressants and 161 healthy controls).
One in five patients with inflammatory disease (21%) were taking immunosuppressants that substantially impair antibodies, such as anti-CD20 therapy, S1P modulators, or mycophenolate mofetil combination therapy, and 48% of these patients seroconverted after primary vaccination, compared with 96% of patients taking other immunosuppressants and 98% of controls.
Breakthrough infection rates were similar between the control group (31%) and those taking immunosuppressants (30%). Only three participants had severe disease requiring hospitalization: one control and two patients taking immunosuppressants.
“In both studies, the controls had similar or higher rates of breakthrough infections, compared with the immunosuppressed,” noted Alfred Kim, MD, an assistant professor of medicine at Washington University, St Louis, but he added, “one has to consider differences in mitigation strategies, such as masking, that may explain these findings.” That is, patients taking immunosuppressants may be taking fewer risks in the community or have fewer potential exposures, especially in the Korean study, wherein the controls were health care workers.
A greater disparity in infections occurred when considering seroconversion rates. Breakthrough incidence was 38% among those taking immunosuppressants who did not seroconvert, compared with 29% among those who did. A similar trend was seen in breakthrough incidence between those taking strongly antibody-impairing immunosuppressants (36% breakthrough rate) and those taking other immunosuppressants (28%).
Among those taking immunosuppressants who seroconverted, a primary series of vaccination reduced the risk of a breakthrough infection by 29%. Protection became more robust with a booster or prior infection, both of which reduced breakthrough infection risk by 39% in those taking immunosuppressants who seroconverted.
“We demonstrate in patients with immune-mediated inflammatory diseases on immunosuppressants that additional vaccinations are associated with decreased risk of SARS-CoV-2 Omicron breakthrough infections,” wrote Eileen W. Stalman, MD, PhD, of Amsterdam UMC in the Netherlands, and her colleagues.
Though neither study broke down immune response or breakthrough infection based on individual medications, Kim said that previous research allows one to extrapolate “that prior culprits of poor vaccine responses [such as B-cell depleting drugs, mycophenolate, and TNF [tumor necrosis factor] inhibitors will continue to bear the greatest burden in breakthrough infection, including Omicron.”
Overall, he found the data from both studies relatively consistent with one another.
“Those on immunosuppression, particularly mechanisms that have been established as risk factors for poor vaccine responses, are at risk of breakthrough infection during the era of Omicron,” Dr. Kim said.
The earlier study from Korea also found that “the median time between the third-dose vaccination and the date of confirmed breakthrough infection in patients with ARDs was significantly shorter, compared with that in health care workers” at just 93 days in patients versus 122 days in health care workers. They postulated that this population’s limited neutralization of Omicron explained this short-lived protection.
Most of the patients with breakthrough infections (74%) in that study showed no neutralization against Omicron, including the only two hospitalized patients, both of whom had strong responses against the original SARS-CoV-2 strain. The significant decline over time of neutralization against Omicron suggested “the potential for a substantial loss of the protection from breakthrough infection,” the authors write.
“The third dose of an mRNA vaccine could improve the cross-neutralization of the SARS-CoV-2 Omicron variant in patients with autoimmune rheumatic disease [although] more than half of the patients failed to generate Omicron-neutralizing antibodies,” Tae Choi said in an interview. “Our study sheds light on the relative deficiency of the Omicron-specific neutralizing responses in patients with autoimmune rheumatic disease and their anticipated vulnerability to breakthrough infection.”
The message for clinicians, Dr. Kim said, is to “continue to urge our patients to maintain additional and boosting doses per guidance, use pre-exposure prophylaxis such as Evusheld, and continue other mitigation strategies as they have done.”
The Dutch study was funded by The Netherlands Organization for Health Research and Development; the Korean study used no external funding.
The authors of the Korean study had no disclosures. The Dutch study’s authors reported a wide range of disclosures involving more than a dozen pharmaceutical companies but not including Pfizer or Moderna. Dr. Kim’s industry disclosures include Alexion, ANI, AstraZeneca, Aurinia, Exagen, Foghorn Therapeutics, GlaxoSmithKline, Kypha, and Pfizer.
A version of this article first appeared on Medscape.com.
People with immune-mediated inflammatory diseases who are taking immunosuppressants don’t mount as strong of an immune defense against the Omicron variant as they did against the original SARS-CoV-2 wild-type virus, according to two studies published in Annals of the Rheumatic Diseases. One of the studies further showed that vaccinated individuals taking immunosuppressants have poorer cross-neutralizing responses to Omicron than do healthy vaccinated individuals, even after three doses of the COVID-19 mRNA vaccines.
“We carefully suggest that if Omicron-specific vaccination can be administered, it may be an effective way to reduce the risk of breakthrough infections in patients with autoimmune rheumatic disease,” Sang Tae Choi, MD, PhD, of the University College of Medicine, Seoul, Korea, and one of the authors of the study on cross-neutralizing protection, told this news organization. “However, further research is needed on Omicron-specific vaccine effectiveness in patients with immune dysfunctions. We believe that these study results can be of great benefit in determining the strategy of vaccination in the future.”
The earlier study, published in July, examined the ability of COVID-19 vaccines to induce cross-reactive antibody responses against Omicron infections in patients with autoimmune rheumatic diseases (ARDs). The observational study involved 149 patients with ARDs and 94 health care workers as controls, all of whom provided blood samples a median 15 weeks after their second COVID vaccine dose or a median 8 weeks after their third dose. A little more than two-thirds of the patients (68.5%) had received a third mRNA vaccine dose. None of the participants previously had COVID-19.
The researchers compared the rate of breakthrough infections with the Omicron variant to the neutralizing responses in patients’ blood, specifically the cross-neutralizing antibody responses because the original mRNA vaccines targeted a different variant than Omicron. Breakthrough infections were assessed by survey questions.
“Our findings suggested that neither primary series vaccinations nor booster doses are sufficient to induce Omicron-neutralizing responses above the threshold in patients with ARDs, although responses were noticeably increased following the third dose of an mRNA vaccine,” write Woo-Joong Kim, of the Chung-Ang University College of Medicine, Seoul, Korea, and his colleagues. “This impairment of cross-neutralization responses across most of our patients contrasts starkly with a potent elicitation of the Omicron-neutralizing responses after the third vaccination in healthy recipients.”
The average neutralizing responses against the original SARS-CoV-2 strain were similar in both groups: 76% in patients with ARDs and 72% in health care workers after the second dose. The mean response after a third dose was 97% in health care workers and 88% in patients.
The average cross-neutralizing response against the Omicron variant was far lower, particularly in those with rheumatic disease: only 11.5%, which rose to 27% after the third dose. Only 39% of the patient sera showed neutralization of Omicron, even after the third dose. Meanwhile, the mean cross-neutralizing response in health care workers was 18% after the second dose and 50% after the third.
When the researchers compared seropositivity rates against the original virus to neutralizing responses against Omicron, the association between these was stronger in health care workers than in those with ARDs. In fact, among patients with ARDs who seroconverted, only 41% showed any response against Omicron. Among all the patients, most of those who didn’t respond to Omicron (93.5%) had initially seroconverted.
The researchers also looked at the ability to neutralize Omicron on the basis of disease in those who received three doses of the vaccine. About half of those with lupus (52%) showed any neutralization against Omicron, compared with 25% of those with rheumatoid arthritis, 37.5% of those with ankylosing spondylitis, 33% of those with Behçet snydrome, and all of those with adult-onset Still’s disease.
The rate of breakthrough infections was lower in patients (19%) than in health care workers (33%). A similar pattern was seen in the more recent study published Sept. 5. Researchers used data from a prospective cohort study in the Netherlands to examine incidence and severity of Omicron breakthrough infections in patients with immune-mediated inflammatory diseases. The researchers compared infection rates and severity among 1,593 vaccinated patients with inflammatory disease who were taking immunosuppressants and 579 vaccinated controls (418 patients with inflammatory disease not on immunosuppressants and 161 healthy controls).
One in five patients with inflammatory disease (21%) were taking immunosuppressants that substantially impair antibodies, such as anti-CD20 therapy, S1P modulators, or mycophenolate mofetil combination therapy, and 48% of these patients seroconverted after primary vaccination, compared with 96% of patients taking other immunosuppressants and 98% of controls.
Breakthrough infection rates were similar between the control group (31%) and those taking immunosuppressants (30%). Only three participants had severe disease requiring hospitalization: one control and two patients taking immunosuppressants.
“In both studies, the controls had similar or higher rates of breakthrough infections, compared with the immunosuppressed,” noted Alfred Kim, MD, an assistant professor of medicine at Washington University, St Louis, but he added, “one has to consider differences in mitigation strategies, such as masking, that may explain these findings.” That is, patients taking immunosuppressants may be taking fewer risks in the community or have fewer potential exposures, especially in the Korean study, wherein the controls were health care workers.
A greater disparity in infections occurred when considering seroconversion rates. Breakthrough incidence was 38% among those taking immunosuppressants who did not seroconvert, compared with 29% among those who did. A similar trend was seen in breakthrough incidence between those taking strongly antibody-impairing immunosuppressants (36% breakthrough rate) and those taking other immunosuppressants (28%).
Among those taking immunosuppressants who seroconverted, a primary series of vaccination reduced the risk of a breakthrough infection by 29%. Protection became more robust with a booster or prior infection, both of which reduced breakthrough infection risk by 39% in those taking immunosuppressants who seroconverted.
“We demonstrate in patients with immune-mediated inflammatory diseases on immunosuppressants that additional vaccinations are associated with decreased risk of SARS-CoV-2 Omicron breakthrough infections,” wrote Eileen W. Stalman, MD, PhD, of Amsterdam UMC in the Netherlands, and her colleagues.
Though neither study broke down immune response or breakthrough infection based on individual medications, Kim said that previous research allows one to extrapolate “that prior culprits of poor vaccine responses [such as B-cell depleting drugs, mycophenolate, and TNF [tumor necrosis factor] inhibitors will continue to bear the greatest burden in breakthrough infection, including Omicron.”
Overall, he found the data from both studies relatively consistent with one another.
“Those on immunosuppression, particularly mechanisms that have been established as risk factors for poor vaccine responses, are at risk of breakthrough infection during the era of Omicron,” Dr. Kim said.
The earlier study from Korea also found that “the median time between the third-dose vaccination and the date of confirmed breakthrough infection in patients with ARDs was significantly shorter, compared with that in health care workers” at just 93 days in patients versus 122 days in health care workers. They postulated that this population’s limited neutralization of Omicron explained this short-lived protection.
Most of the patients with breakthrough infections (74%) in that study showed no neutralization against Omicron, including the only two hospitalized patients, both of whom had strong responses against the original SARS-CoV-2 strain. The significant decline over time of neutralization against Omicron suggested “the potential for a substantial loss of the protection from breakthrough infection,” the authors write.
“The third dose of an mRNA vaccine could improve the cross-neutralization of the SARS-CoV-2 Omicron variant in patients with autoimmune rheumatic disease [although] more than half of the patients failed to generate Omicron-neutralizing antibodies,” Tae Choi said in an interview. “Our study sheds light on the relative deficiency of the Omicron-specific neutralizing responses in patients with autoimmune rheumatic disease and their anticipated vulnerability to breakthrough infection.”
The message for clinicians, Dr. Kim said, is to “continue to urge our patients to maintain additional and boosting doses per guidance, use pre-exposure prophylaxis such as Evusheld, and continue other mitigation strategies as they have done.”
The Dutch study was funded by The Netherlands Organization for Health Research and Development; the Korean study used no external funding.
The authors of the Korean study had no disclosures. The Dutch study’s authors reported a wide range of disclosures involving more than a dozen pharmaceutical companies but not including Pfizer or Moderna. Dr. Kim’s industry disclosures include Alexion, ANI, AstraZeneca, Aurinia, Exagen, Foghorn Therapeutics, GlaxoSmithKline, Kypha, and Pfizer.
A version of this article first appeared on Medscape.com.
Don’t make children with head lice leave school, report says
The American Academy of Pediatrics says children with head lice don’t need to be sent home from school.
Head lice infestations aren’t really a health hazard because of low transmission rates, a new report from the academy says, and sending students home “may stigmatize children suspected of having head lice.” The group says schools should instead offer education programs to help families understand how to manage head lice.
“Head lice are an unpleasant part of the human experience, but they can be successfully managed and are no reason for a child to miss school,” Dawn Nolt, MD, lead author of the report on head lice, said in a news release.
The report advises schools to abandon “no-nit” policies, which call for a student to be lice-free before being allowed back in class.
“A child or adolescent should not be restricted from school attendance because of head lice, given the low contagion within classrooms. ‘No-nit’ policies that exclude children or adolescents until all nits are removed may violate a child’s or adolescent’s civil liberties and are best addressed with legal counsel for schools,” the report says.
The report notes that lice almost always spread through head-to-head contact, not by “jumping” from one person to another. It’s possible for lice to spread by touching the belongings of a person with lice, such as combs or sports helmets, but the chances of that happening are very low, the academy said.
“Lice found on combs are likely to be injured or dead, and a louse is not likely to leave a healthy head unless there is a heavy infestation,” the report says.
The report lists new medications for treatment and gives an algorithm for managing head lice cases.
“The ideal treatment of head lice should be safe, free of toxic chemicals, readily available, simple to apply, effective, and inexpensive,” the report says.
This is the first updated guidance on head lice from the American Academy of Pediatrics since 2015. The CDC also says students with head lice don’t need to be sent home.
“Students diagnosed with live head lice do not need to be sent home early from school; they can go home at the end of the day, be treated, and return to class after appropriate treatment has begun. Nits may persist after treatment, but successful treatment should kill crawling lice,” the CDC says.
A version of this article first appeared on WebMD.com.
The American Academy of Pediatrics says children with head lice don’t need to be sent home from school.
Head lice infestations aren’t really a health hazard because of low transmission rates, a new report from the academy says, and sending students home “may stigmatize children suspected of having head lice.” The group says schools should instead offer education programs to help families understand how to manage head lice.
“Head lice are an unpleasant part of the human experience, but they can be successfully managed and are no reason for a child to miss school,” Dawn Nolt, MD, lead author of the report on head lice, said in a news release.
The report advises schools to abandon “no-nit” policies, which call for a student to be lice-free before being allowed back in class.
“A child or adolescent should not be restricted from school attendance because of head lice, given the low contagion within classrooms. ‘No-nit’ policies that exclude children or adolescents until all nits are removed may violate a child’s or adolescent’s civil liberties and are best addressed with legal counsel for schools,” the report says.
The report notes that lice almost always spread through head-to-head contact, not by “jumping” from one person to another. It’s possible for lice to spread by touching the belongings of a person with lice, such as combs or sports helmets, but the chances of that happening are very low, the academy said.
“Lice found on combs are likely to be injured or dead, and a louse is not likely to leave a healthy head unless there is a heavy infestation,” the report says.
The report lists new medications for treatment and gives an algorithm for managing head lice cases.
“The ideal treatment of head lice should be safe, free of toxic chemicals, readily available, simple to apply, effective, and inexpensive,” the report says.
This is the first updated guidance on head lice from the American Academy of Pediatrics since 2015. The CDC also says students with head lice don’t need to be sent home.
“Students diagnosed with live head lice do not need to be sent home early from school; they can go home at the end of the day, be treated, and return to class after appropriate treatment has begun. Nits may persist after treatment, but successful treatment should kill crawling lice,” the CDC says.
A version of this article first appeared on WebMD.com.
The American Academy of Pediatrics says children with head lice don’t need to be sent home from school.
Head lice infestations aren’t really a health hazard because of low transmission rates, a new report from the academy says, and sending students home “may stigmatize children suspected of having head lice.” The group says schools should instead offer education programs to help families understand how to manage head lice.
“Head lice are an unpleasant part of the human experience, but they can be successfully managed and are no reason for a child to miss school,” Dawn Nolt, MD, lead author of the report on head lice, said in a news release.
The report advises schools to abandon “no-nit” policies, which call for a student to be lice-free before being allowed back in class.
“A child or adolescent should not be restricted from school attendance because of head lice, given the low contagion within classrooms. ‘No-nit’ policies that exclude children or adolescents until all nits are removed may violate a child’s or adolescent’s civil liberties and are best addressed with legal counsel for schools,” the report says.
The report notes that lice almost always spread through head-to-head contact, not by “jumping” from one person to another. It’s possible for lice to spread by touching the belongings of a person with lice, such as combs or sports helmets, but the chances of that happening are very low, the academy said.
“Lice found on combs are likely to be injured or dead, and a louse is not likely to leave a healthy head unless there is a heavy infestation,” the report says.
The report lists new medications for treatment and gives an algorithm for managing head lice cases.
“The ideal treatment of head lice should be safe, free of toxic chemicals, readily available, simple to apply, effective, and inexpensive,” the report says.
This is the first updated guidance on head lice from the American Academy of Pediatrics since 2015. The CDC also says students with head lice don’t need to be sent home.
“Students diagnosed with live head lice do not need to be sent home early from school; they can go home at the end of the day, be treated, and return to class after appropriate treatment has begun. Nits may persist after treatment, but successful treatment should kill crawling lice,” the CDC says.
A version of this article first appeared on WebMD.com.
Balanced fat intake links with less type 2 diabetes
Researchers published the study covered in this summary on Preprints with The Lancet as a preprint that has not yet been peer reviewed.
Key takeaways
- Adults in China who consumed a “balanced,” moderate ratio (middle three quintiles) of animal-to-vegetable cooking oil had a lower rate of developing type 2 diabetes during a median follow-up of 8.6 years, compared with those who consumed the lowest ratio (first quintile), after multivariable adjustment using prospectively collected data.
- The results also indicate that increasing animal cooking oil (such as lard, tallow, or butter) and vegetable cooking oil (such as peanut or soybean oil) consumption were each positively associated with a higher rate of developing type 2 diabetes.
- Those who consumed the highest ratio (fifth quintile) of animal-to-vegetable cooking oil had a nonsignificant difference in their rate of developing type 2 diabetes, compared with those in the first quintile.
Why this matters
- The findings suggest that consuming a diet with a “balanced” moderate intake of animal and vegetable oil might lower the risk of type 2 diabetes, which would reduce disease burden and health care expenditures.
- The results imply that using a single source of cooking oil, either animal or vegetable, contributes to the incidence of type 2 diabetes.
- This is the first large epidemiological study showing a relationship between the ratio of animal- and vegetable-derived fats in people’s diets and their risk for incident type 2 diabetes.
Study design
- The researchers used data collected prospectively starting in 2010-2012 from 7,274 adult residents of Guizhou province, China, with follow-up assessment in 2020 after a median of 8.6 years.
- At baseline, participants underwent an oral glucose tolerance test and provided information on demographics, family medical history, and personal medical history, including whether they had been diagnosed with type 2 diabetes or were taking antihyperglycemic medications. The study did not include anyone with a history of diabetes.
- Data on intake of animal and vegetable cooking oil came from a dietary questionnaire.
- The authors calculated hazard ratios for development of type 2 diabetes after adjusting for multiple potential confounders.
Key results
- The study cohort averaged 44 years old, and 53% were women.
- During a median follow-up of 8.6 years, 747 people developed type 2 diabetes.
- Compared with those who had the lowest intake of animal cooking oil (first quintile), those with the highest intake (fifth quintile) had a significant 28% increased relative rate for developing type 2 diabetes after adjustment for several potential confounders.
- Compared with those with the lowest intake of vegetable cooking oil, those with the highest intake had a significant 56% increased rate of developing type 2 diabetes after adjustment.
- Compared with adults with the lowest animal-to-vegetable cooking oil ratio (first quintile), those in the second, third, and fourth quintiles for this ratio had significantly lower adjusted relative rates of developing type 2 diabetes, with adjusted hazard ratios of 0.79, 0.65, and 0.68, respectively. Those in the highest quintile (fifth quintile) did not have a significantly different risk, compared with the first quintile.
- The protective effect of a balanced ratio of animal-to-vegetable cooking oils was stronger in people who lived in rural districts and in those who had obesity.
Limitations
- The dietary information came from participants’ self-reports, which may have produced biased data.
- The study only included information about animal and vegetable cooking oil consumed at home.
- There may have been residual confounding from variables not included in the study.
- The time of diagnosis of type 2 diabetes may have been inaccurate because follow-up occurred only once.
- The study may have underestimated the incidence of type 2 diabetes because of a lack of information about hemoglobin A1c levels at follow-up.
Disclosures
- The study did not receive commercial funding.
- The authors reported no financial disclosures.
This is a summary of a preprint article “The consumption ratio of animal cooking oil to vegetable cooking oil and reduced risk of type 2 diabetes mellitus: A prospective cohort study in Southwest China” written by researchers primarily from Zunyi Medical University, China, on Preprints with The Lancet. This study has not yet been peer reviewed. The full text of the study can be found on papers.ssrn.com.
A version of this article first appeared on Medscape.com.
Researchers published the study covered in this summary on Preprints with The Lancet as a preprint that has not yet been peer reviewed.
Key takeaways
- Adults in China who consumed a “balanced,” moderate ratio (middle three quintiles) of animal-to-vegetable cooking oil had a lower rate of developing type 2 diabetes during a median follow-up of 8.6 years, compared with those who consumed the lowest ratio (first quintile), after multivariable adjustment using prospectively collected data.
- The results also indicate that increasing animal cooking oil (such as lard, tallow, or butter) and vegetable cooking oil (such as peanut or soybean oil) consumption were each positively associated with a higher rate of developing type 2 diabetes.
- Those who consumed the highest ratio (fifth quintile) of animal-to-vegetable cooking oil had a nonsignificant difference in their rate of developing type 2 diabetes, compared with those in the first quintile.
Why this matters
- The findings suggest that consuming a diet with a “balanced” moderate intake of animal and vegetable oil might lower the risk of type 2 diabetes, which would reduce disease burden and health care expenditures.
- The results imply that using a single source of cooking oil, either animal or vegetable, contributes to the incidence of type 2 diabetes.
- This is the first large epidemiological study showing a relationship between the ratio of animal- and vegetable-derived fats in people’s diets and their risk for incident type 2 diabetes.
Study design
- The researchers used data collected prospectively starting in 2010-2012 from 7,274 adult residents of Guizhou province, China, with follow-up assessment in 2020 after a median of 8.6 years.
- At baseline, participants underwent an oral glucose tolerance test and provided information on demographics, family medical history, and personal medical history, including whether they had been diagnosed with type 2 diabetes or were taking antihyperglycemic medications. The study did not include anyone with a history of diabetes.
- Data on intake of animal and vegetable cooking oil came from a dietary questionnaire.
- The authors calculated hazard ratios for development of type 2 diabetes after adjusting for multiple potential confounders.
Key results
- The study cohort averaged 44 years old, and 53% were women.
- During a median follow-up of 8.6 years, 747 people developed type 2 diabetes.
- Compared with those who had the lowest intake of animal cooking oil (first quintile), those with the highest intake (fifth quintile) had a significant 28% increased relative rate for developing type 2 diabetes after adjustment for several potential confounders.
- Compared with those with the lowest intake of vegetable cooking oil, those with the highest intake had a significant 56% increased rate of developing type 2 diabetes after adjustment.
- Compared with adults with the lowest animal-to-vegetable cooking oil ratio (first quintile), those in the second, third, and fourth quintiles for this ratio had significantly lower adjusted relative rates of developing type 2 diabetes, with adjusted hazard ratios of 0.79, 0.65, and 0.68, respectively. Those in the highest quintile (fifth quintile) did not have a significantly different risk, compared with the first quintile.
- The protective effect of a balanced ratio of animal-to-vegetable cooking oils was stronger in people who lived in rural districts and in those who had obesity.
Limitations
- The dietary information came from participants’ self-reports, which may have produced biased data.
- The study only included information about animal and vegetable cooking oil consumed at home.
- There may have been residual confounding from variables not included in the study.
- The time of diagnosis of type 2 diabetes may have been inaccurate because follow-up occurred only once.
- The study may have underestimated the incidence of type 2 diabetes because of a lack of information about hemoglobin A1c levels at follow-up.
Disclosures
- The study did not receive commercial funding.
- The authors reported no financial disclosures.
This is a summary of a preprint article “The consumption ratio of animal cooking oil to vegetable cooking oil and reduced risk of type 2 diabetes mellitus: A prospective cohort study in Southwest China” written by researchers primarily from Zunyi Medical University, China, on Preprints with The Lancet. This study has not yet been peer reviewed. The full text of the study can be found on papers.ssrn.com.
A version of this article first appeared on Medscape.com.
Researchers published the study covered in this summary on Preprints with The Lancet as a preprint that has not yet been peer reviewed.
Key takeaways
- Adults in China who consumed a “balanced,” moderate ratio (middle three quintiles) of animal-to-vegetable cooking oil had a lower rate of developing type 2 diabetes during a median follow-up of 8.6 years, compared with those who consumed the lowest ratio (first quintile), after multivariable adjustment using prospectively collected data.
- The results also indicate that increasing animal cooking oil (such as lard, tallow, or butter) and vegetable cooking oil (such as peanut or soybean oil) consumption were each positively associated with a higher rate of developing type 2 diabetes.
- Those who consumed the highest ratio (fifth quintile) of animal-to-vegetable cooking oil had a nonsignificant difference in their rate of developing type 2 diabetes, compared with those in the first quintile.
Why this matters
- The findings suggest that consuming a diet with a “balanced” moderate intake of animal and vegetable oil might lower the risk of type 2 diabetes, which would reduce disease burden and health care expenditures.
- The results imply that using a single source of cooking oil, either animal or vegetable, contributes to the incidence of type 2 diabetes.
- This is the first large epidemiological study showing a relationship between the ratio of animal- and vegetable-derived fats in people’s diets and their risk for incident type 2 diabetes.
Study design
- The researchers used data collected prospectively starting in 2010-2012 from 7,274 adult residents of Guizhou province, China, with follow-up assessment in 2020 after a median of 8.6 years.
- At baseline, participants underwent an oral glucose tolerance test and provided information on demographics, family medical history, and personal medical history, including whether they had been diagnosed with type 2 diabetes or were taking antihyperglycemic medications. The study did not include anyone with a history of diabetes.
- Data on intake of animal and vegetable cooking oil came from a dietary questionnaire.
- The authors calculated hazard ratios for development of type 2 diabetes after adjusting for multiple potential confounders.
Key results
- The study cohort averaged 44 years old, and 53% were women.
- During a median follow-up of 8.6 years, 747 people developed type 2 diabetes.
- Compared with those who had the lowest intake of animal cooking oil (first quintile), those with the highest intake (fifth quintile) had a significant 28% increased relative rate for developing type 2 diabetes after adjustment for several potential confounders.
- Compared with those with the lowest intake of vegetable cooking oil, those with the highest intake had a significant 56% increased rate of developing type 2 diabetes after adjustment.
- Compared with adults with the lowest animal-to-vegetable cooking oil ratio (first quintile), those in the second, third, and fourth quintiles for this ratio had significantly lower adjusted relative rates of developing type 2 diabetes, with adjusted hazard ratios of 0.79, 0.65, and 0.68, respectively. Those in the highest quintile (fifth quintile) did not have a significantly different risk, compared with the first quintile.
- The protective effect of a balanced ratio of animal-to-vegetable cooking oils was stronger in people who lived in rural districts and in those who had obesity.
Limitations
- The dietary information came from participants’ self-reports, which may have produced biased data.
- The study only included information about animal and vegetable cooking oil consumed at home.
- There may have been residual confounding from variables not included in the study.
- The time of diagnosis of type 2 diabetes may have been inaccurate because follow-up occurred only once.
- The study may have underestimated the incidence of type 2 diabetes because of a lack of information about hemoglobin A1c levels at follow-up.
Disclosures
- The study did not receive commercial funding.
- The authors reported no financial disclosures.
This is a summary of a preprint article “The consumption ratio of animal cooking oil to vegetable cooking oil and reduced risk of type 2 diabetes mellitus: A prospective cohort study in Southwest China” written by researchers primarily from Zunyi Medical University, China, on Preprints with The Lancet. This study has not yet been peer reviewed. The full text of the study can be found on papers.ssrn.com.
A version of this article first appeared on Medscape.com.
Sleep apnea: Is the sleep industry part of the problem? A reporter seeks answers
Editor's Note: We periodically publish patient viewpoints on specific issues of interest to our audience.
I woke up in a strange bedroom with 24 electrodes glued all over my body and a plastic mask attached to a hose covering my face.
The lab technician who watched me all night via video feed told me that I had “wicked sleep apnea” and that it was “central sleep apnea” – a type that originates in the brain and fails to tell the muscles to inhale.
As a journalist– and one terrified by the diagnosis – I set out to do my own research. After a few weeks of sleuthing and interviewing experts, I reached two important conclusions.
First, I had moderate apnea, if that, and it could be treated without the elaborate machines, mouthpieces, or other devices that specialists who had consulted on my care were talking about.
Second, I was on a conveyor belt.
It all began with a desire for answers: I had been feeling drowsy during the day, and my wife told me I snored. Both can mean obstructive sleep apnea. With obstructive sleep apnea, the mouth and throat relax when a person is unconscious, sometimes blocking or narrowing the airway. That interrupts breathing, as well as sleep. Without treatment, the resulting disruption in oxygen flow might increase the risk of developing certain cardiovascular diseases.
So I contacted a sleep-treatment center, and doctors gave me an at-home test ($365). Two weeks later, they told me I had “high-moderate” sleep apnea and needed to acquire a continuous positive airway pressure (CPAP) machine, at a cost of about $600.
Though I had hoped to get the equipment and adjust the settings to see what worked best, my doctors said I had to come to the sleep lab for an overnight test ($1,900) to have them “titrate” the optimal CPAP air pressure.
“How do you treat central sleep apnea?” I worriedly asked the technician after that first overnight stay. She said something about an adaptive servo-ventilation machine ($4,000). And one pricey lab sleepover wasn’t enough, she said. I needed to come back for another.
(Most procedures and devices mentioned in this article were covered or would have been covered by insurance – in my case, Medicare, plus a supplemental plan. Unnecessary care is a big reason Americans’ insurance costs – premiums, copays, and deductibles – tend to rise year after year.)
As a journalist who spent years covering the business of health care, I found there was more motivating my expensive testing cascade than concerns about my health.
The American Academy of Sleep Medicine, a nonprofit based near Chicago, decides what is sleep apnea and how to treat it. Working with sleep societies around the world, it publishes the International Classification of Sleep Disorders, relied on by doctors everywhere to diagnose and categorize disease.
But behind that effort lie considerable conflicts of interest. Like so much of U.S. health care, sleep medicine turns out to be a thriving industry. AASM finances its operations in part with payments from CPAP machine manufacturers and other companies that stand to profit from expensive treatments and expansive definitions of apnea and other sleep disorders.
Zoll Itamar, which makes the at-home testing device I used, as well as implantable nerve-stimulation hardware for central sleep apnea, is a $60,000, “platinum” partner in AASM’s Industry Engagement Program. So is Avadel Pharmaceuticals, which is testing a drug to treat narcolepsy, characterized by intense daytime sleepiness.
Other sponsors include the maker of an anti-insomnia drug; another company with a narcolepsy drug; Fisher & Paykel Healthcare, which makes CPAP machines and masks; and Inspire Medical Systems, maker of a heavily advertised surgical implant, costing tens of thousands of dollars, to treat apnea.
Corporate sponsors for Sleep 2022, a convention AASM put on in Charlotte, N.C., with other professional societies, included many of those companies, plus Philips Respironics and ResMed, two of the biggest CPAP machine makers.
In a statement, AASM spokesperson Jennifer Gibson said a conflict-of-interest policy and a noninterference pledge from industry funders protect the integrity of the academy’s work. Industry donations account for about $170,000 of AASM’s annual revenue of about $15 million. Other revenue comes from educational materials and membership and accreditation fees.
Here’s what else I found. Almost everybody breathes irregularly sometime at night, especially during REM sleep, characterized by rapid eye movement and dreams. Blood oxygen levels also fluctuate slightly.
But recent European studies have shown that standards under the International Classification of Sleep Disorders would doom huge portions of the general population to a sleep apnea diagnosis – whether or not people had complaints of daytime tiredness or other sleep problems.
A study in Lausanne, Switzerland, showed that 50% of local men and 23% of the women 40 or older were positive for sleep apnea under such criteria.
Such rates of disease are “extraordinarily high,” “astronomical,” and “implausible,” Dirk Pevernagie, PhD, a scientist at Ghent (Belgium) University Hospital, wrote with colleagues 2 years ago in a comprehensive study in the Journal of Sleep Research.
“Right now, there is no real evidence for the criteria that have been put forward to diagnose obstructive sleep apnea and rate its severity,” he said in an interview.
Likewise, 19% of middle-aged subjects in a 2016 Icelandic study appeared to have moderate to severe “apnea” under one definition in the International Classification of Sleep Disorders even though many reported no drowsiness.
“Most of them were really surprised,” said Erna Sif Arnardóttir, who led the study and is running a large European program to refine detection and treatment of apnea.
Nevertheless, the official AASM journal recommends extremely broad screening for sleep apnea, looking for patients who have what it defines as illness. Everybody 18 and older should be screened every year for apnea if they have diabetes, obesity, untreated high blood pressure, or heart disease – even if they have never complained about sleep problems, the group says.
AASM “continually evaluates the definitions, criteria and recommendations used in the identification of sleep apnea and other sleep disorders,” Ms. Gibson said in the statement. Meanwhile, routine screening by primary care doctors “is a simple way” of gauging whether a high-risk patient may have obstructive sleep apnea, the statement said.
The U.S. Preventive Services Task Force, an authoritative body that reviews the effectiveness of preventive care, takes a conservative view, more like that of the European researchers, concluding there is “insufficient” evidence to support widespread screening among patients with no symptoms.
Many insurers refuse to pay for CPAP machines and other treatments prescribed for people at the outer edges of the AASM’s apnea definition. But AASM is pressuring them to come around.
After all my reporting, I concluded that my apnea is real, though moderate. My alarming reading in the overnight lab – diagnosed quickly as central sleep apnea – was a byproduct of the testing machinery itself. That’s a well-described phenomenon that occurs in 5% to 15% of patients.
And when I looked closely at the results of my at-home diagnostic test, I had an epiphany: My overall score was 26 breathing interruptions and blood-oxygen level declines, on average, per hour – enough to put me in the “high-moderate” category for apnea. But when I looked at the data sorted according to sleeping positions, I saw that I scored much better when I slept on my side: only 10 interruptions in an hour.
So I did a little experiment: I bought a $25 pulse oximeter with a smartphone app that records oxygen dips and breathing interruptions. When I slept on my side, there were hardly any.
Now I sleep on my side. I snore less. I wake up refreshed. I’m not daytime drowsy.
None of my specialists mentioned turning on to my side – known in medical parlance as “positional therapy” – though the intervention is recognized as effective by many researchers. Sleeping on one’s back contributes to snoring and blockages, especially as people age and the muscles in the throat become looser.
“Positional patients ... can sleep in the lateral position and sleep quite well,” said Arie Oksenberg, PhD, a sleep researcher formerly at Loewenstein Hospital in Ra’anana, Israel.
But it’s not easy to find this in the official AASM treatment guidelines, which instead go right to the money-making options like CPAP machines, surgery, central apnea, and mouth appliances.
Dealing with apnea by shifting slightly in bed gets little more than a couple of paragraphs in AASM’s guideline on “other” treatments and a little box on a long and complex decision chart.
A third or more of patients wear CPAPs only a few hours a night or stop using them. It turns out people don’t like machines in their beds.
“Positional therapy is an effective treatment option for some patients,” said Ms. Gibson. But she said there are concerns about whether patients will sleep on their sides long term and whether trying to stay in one position might cause sleep interruptions itself.
It’s true that side-sleeping doesn’t help everybody. And it often takes practice. (Some people tape a tennis ball to their pajamas to keep them off their backs.) Even conservative sleep doctors say CPAP machines are the best solution for many patients.
But there is a largely overlooked alternative.
“Are we missing a simple treatment for most adult sleep apnea patients?” was the name of a 2013 paper that Dr. Oksenberg and a colleague wrote about positional therapy.
In my case, the answer was “yes.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Editor's Note: We periodically publish patient viewpoints on specific issues of interest to our audience.
I woke up in a strange bedroom with 24 electrodes glued all over my body and a plastic mask attached to a hose covering my face.
The lab technician who watched me all night via video feed told me that I had “wicked sleep apnea” and that it was “central sleep apnea” – a type that originates in the brain and fails to tell the muscles to inhale.
As a journalist– and one terrified by the diagnosis – I set out to do my own research. After a few weeks of sleuthing and interviewing experts, I reached two important conclusions.
First, I had moderate apnea, if that, and it could be treated without the elaborate machines, mouthpieces, or other devices that specialists who had consulted on my care were talking about.
Second, I was on a conveyor belt.
It all began with a desire for answers: I had been feeling drowsy during the day, and my wife told me I snored. Both can mean obstructive sleep apnea. With obstructive sleep apnea, the mouth and throat relax when a person is unconscious, sometimes blocking or narrowing the airway. That interrupts breathing, as well as sleep. Without treatment, the resulting disruption in oxygen flow might increase the risk of developing certain cardiovascular diseases.
So I contacted a sleep-treatment center, and doctors gave me an at-home test ($365). Two weeks later, they told me I had “high-moderate” sleep apnea and needed to acquire a continuous positive airway pressure (CPAP) machine, at a cost of about $600.
Though I had hoped to get the equipment and adjust the settings to see what worked best, my doctors said I had to come to the sleep lab for an overnight test ($1,900) to have them “titrate” the optimal CPAP air pressure.
“How do you treat central sleep apnea?” I worriedly asked the technician after that first overnight stay. She said something about an adaptive servo-ventilation machine ($4,000). And one pricey lab sleepover wasn’t enough, she said. I needed to come back for another.
(Most procedures and devices mentioned in this article were covered or would have been covered by insurance – in my case, Medicare, plus a supplemental plan. Unnecessary care is a big reason Americans’ insurance costs – premiums, copays, and deductibles – tend to rise year after year.)
As a journalist who spent years covering the business of health care, I found there was more motivating my expensive testing cascade than concerns about my health.
The American Academy of Sleep Medicine, a nonprofit based near Chicago, decides what is sleep apnea and how to treat it. Working with sleep societies around the world, it publishes the International Classification of Sleep Disorders, relied on by doctors everywhere to diagnose and categorize disease.
But behind that effort lie considerable conflicts of interest. Like so much of U.S. health care, sleep medicine turns out to be a thriving industry. AASM finances its operations in part with payments from CPAP machine manufacturers and other companies that stand to profit from expensive treatments and expansive definitions of apnea and other sleep disorders.
Zoll Itamar, which makes the at-home testing device I used, as well as implantable nerve-stimulation hardware for central sleep apnea, is a $60,000, “platinum” partner in AASM’s Industry Engagement Program. So is Avadel Pharmaceuticals, which is testing a drug to treat narcolepsy, characterized by intense daytime sleepiness.
Other sponsors include the maker of an anti-insomnia drug; another company with a narcolepsy drug; Fisher & Paykel Healthcare, which makes CPAP machines and masks; and Inspire Medical Systems, maker of a heavily advertised surgical implant, costing tens of thousands of dollars, to treat apnea.
Corporate sponsors for Sleep 2022, a convention AASM put on in Charlotte, N.C., with other professional societies, included many of those companies, plus Philips Respironics and ResMed, two of the biggest CPAP machine makers.
In a statement, AASM spokesperson Jennifer Gibson said a conflict-of-interest policy and a noninterference pledge from industry funders protect the integrity of the academy’s work. Industry donations account for about $170,000 of AASM’s annual revenue of about $15 million. Other revenue comes from educational materials and membership and accreditation fees.
Here’s what else I found. Almost everybody breathes irregularly sometime at night, especially during REM sleep, characterized by rapid eye movement and dreams. Blood oxygen levels also fluctuate slightly.
But recent European studies have shown that standards under the International Classification of Sleep Disorders would doom huge portions of the general population to a sleep apnea diagnosis – whether or not people had complaints of daytime tiredness or other sleep problems.
A study in Lausanne, Switzerland, showed that 50% of local men and 23% of the women 40 or older were positive for sleep apnea under such criteria.
Such rates of disease are “extraordinarily high,” “astronomical,” and “implausible,” Dirk Pevernagie, PhD, a scientist at Ghent (Belgium) University Hospital, wrote with colleagues 2 years ago in a comprehensive study in the Journal of Sleep Research.
“Right now, there is no real evidence for the criteria that have been put forward to diagnose obstructive sleep apnea and rate its severity,” he said in an interview.
Likewise, 19% of middle-aged subjects in a 2016 Icelandic study appeared to have moderate to severe “apnea” under one definition in the International Classification of Sleep Disorders even though many reported no drowsiness.
“Most of them were really surprised,” said Erna Sif Arnardóttir, who led the study and is running a large European program to refine detection and treatment of apnea.
Nevertheless, the official AASM journal recommends extremely broad screening for sleep apnea, looking for patients who have what it defines as illness. Everybody 18 and older should be screened every year for apnea if they have diabetes, obesity, untreated high blood pressure, or heart disease – even if they have never complained about sleep problems, the group says.
AASM “continually evaluates the definitions, criteria and recommendations used in the identification of sleep apnea and other sleep disorders,” Ms. Gibson said in the statement. Meanwhile, routine screening by primary care doctors “is a simple way” of gauging whether a high-risk patient may have obstructive sleep apnea, the statement said.
The U.S. Preventive Services Task Force, an authoritative body that reviews the effectiveness of preventive care, takes a conservative view, more like that of the European researchers, concluding there is “insufficient” evidence to support widespread screening among patients with no symptoms.
Many insurers refuse to pay for CPAP machines and other treatments prescribed for people at the outer edges of the AASM’s apnea definition. But AASM is pressuring them to come around.
After all my reporting, I concluded that my apnea is real, though moderate. My alarming reading in the overnight lab – diagnosed quickly as central sleep apnea – was a byproduct of the testing machinery itself. That’s a well-described phenomenon that occurs in 5% to 15% of patients.
And when I looked closely at the results of my at-home diagnostic test, I had an epiphany: My overall score was 26 breathing interruptions and blood-oxygen level declines, on average, per hour – enough to put me in the “high-moderate” category for apnea. But when I looked at the data sorted according to sleeping positions, I saw that I scored much better when I slept on my side: only 10 interruptions in an hour.
So I did a little experiment: I bought a $25 pulse oximeter with a smartphone app that records oxygen dips and breathing interruptions. When I slept on my side, there were hardly any.
Now I sleep on my side. I snore less. I wake up refreshed. I’m not daytime drowsy.
None of my specialists mentioned turning on to my side – known in medical parlance as “positional therapy” – though the intervention is recognized as effective by many researchers. Sleeping on one’s back contributes to snoring and blockages, especially as people age and the muscles in the throat become looser.
“Positional patients ... can sleep in the lateral position and sleep quite well,” said Arie Oksenberg, PhD, a sleep researcher formerly at Loewenstein Hospital in Ra’anana, Israel.
But it’s not easy to find this in the official AASM treatment guidelines, which instead go right to the money-making options like CPAP machines, surgery, central apnea, and mouth appliances.
Dealing with apnea by shifting slightly in bed gets little more than a couple of paragraphs in AASM’s guideline on “other” treatments and a little box on a long and complex decision chart.
A third or more of patients wear CPAPs only a few hours a night or stop using them. It turns out people don’t like machines in their beds.
“Positional therapy is an effective treatment option for some patients,” said Ms. Gibson. But she said there are concerns about whether patients will sleep on their sides long term and whether trying to stay in one position might cause sleep interruptions itself.
It’s true that side-sleeping doesn’t help everybody. And it often takes practice. (Some people tape a tennis ball to their pajamas to keep them off their backs.) Even conservative sleep doctors say CPAP machines are the best solution for many patients.
But there is a largely overlooked alternative.
“Are we missing a simple treatment for most adult sleep apnea patients?” was the name of a 2013 paper that Dr. Oksenberg and a colleague wrote about positional therapy.
In my case, the answer was “yes.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Editor's Note: We periodically publish patient viewpoints on specific issues of interest to our audience.
I woke up in a strange bedroom with 24 electrodes glued all over my body and a plastic mask attached to a hose covering my face.
The lab technician who watched me all night via video feed told me that I had “wicked sleep apnea” and that it was “central sleep apnea” – a type that originates in the brain and fails to tell the muscles to inhale.
As a journalist– and one terrified by the diagnosis – I set out to do my own research. After a few weeks of sleuthing and interviewing experts, I reached two important conclusions.
First, I had moderate apnea, if that, and it could be treated without the elaborate machines, mouthpieces, or other devices that specialists who had consulted on my care were talking about.
Second, I was on a conveyor belt.
It all began with a desire for answers: I had been feeling drowsy during the day, and my wife told me I snored. Both can mean obstructive sleep apnea. With obstructive sleep apnea, the mouth and throat relax when a person is unconscious, sometimes blocking or narrowing the airway. That interrupts breathing, as well as sleep. Without treatment, the resulting disruption in oxygen flow might increase the risk of developing certain cardiovascular diseases.
So I contacted a sleep-treatment center, and doctors gave me an at-home test ($365). Two weeks later, they told me I had “high-moderate” sleep apnea and needed to acquire a continuous positive airway pressure (CPAP) machine, at a cost of about $600.
Though I had hoped to get the equipment and adjust the settings to see what worked best, my doctors said I had to come to the sleep lab for an overnight test ($1,900) to have them “titrate” the optimal CPAP air pressure.
“How do you treat central sleep apnea?” I worriedly asked the technician after that first overnight stay. She said something about an adaptive servo-ventilation machine ($4,000). And one pricey lab sleepover wasn’t enough, she said. I needed to come back for another.
(Most procedures and devices mentioned in this article were covered or would have been covered by insurance – in my case, Medicare, plus a supplemental plan. Unnecessary care is a big reason Americans’ insurance costs – premiums, copays, and deductibles – tend to rise year after year.)
As a journalist who spent years covering the business of health care, I found there was more motivating my expensive testing cascade than concerns about my health.
The American Academy of Sleep Medicine, a nonprofit based near Chicago, decides what is sleep apnea and how to treat it. Working with sleep societies around the world, it publishes the International Classification of Sleep Disorders, relied on by doctors everywhere to diagnose and categorize disease.
But behind that effort lie considerable conflicts of interest. Like so much of U.S. health care, sleep medicine turns out to be a thriving industry. AASM finances its operations in part with payments from CPAP machine manufacturers and other companies that stand to profit from expensive treatments and expansive definitions of apnea and other sleep disorders.
Zoll Itamar, which makes the at-home testing device I used, as well as implantable nerve-stimulation hardware for central sleep apnea, is a $60,000, “platinum” partner in AASM’s Industry Engagement Program. So is Avadel Pharmaceuticals, which is testing a drug to treat narcolepsy, characterized by intense daytime sleepiness.
Other sponsors include the maker of an anti-insomnia drug; another company with a narcolepsy drug; Fisher & Paykel Healthcare, which makes CPAP machines and masks; and Inspire Medical Systems, maker of a heavily advertised surgical implant, costing tens of thousands of dollars, to treat apnea.
Corporate sponsors for Sleep 2022, a convention AASM put on in Charlotte, N.C., with other professional societies, included many of those companies, plus Philips Respironics and ResMed, two of the biggest CPAP machine makers.
In a statement, AASM spokesperson Jennifer Gibson said a conflict-of-interest policy and a noninterference pledge from industry funders protect the integrity of the academy’s work. Industry donations account for about $170,000 of AASM’s annual revenue of about $15 million. Other revenue comes from educational materials and membership and accreditation fees.
Here’s what else I found. Almost everybody breathes irregularly sometime at night, especially during REM sleep, characterized by rapid eye movement and dreams. Blood oxygen levels also fluctuate slightly.
But recent European studies have shown that standards under the International Classification of Sleep Disorders would doom huge portions of the general population to a sleep apnea diagnosis – whether or not people had complaints of daytime tiredness or other sleep problems.
A study in Lausanne, Switzerland, showed that 50% of local men and 23% of the women 40 or older were positive for sleep apnea under such criteria.
Such rates of disease are “extraordinarily high,” “astronomical,” and “implausible,” Dirk Pevernagie, PhD, a scientist at Ghent (Belgium) University Hospital, wrote with colleagues 2 years ago in a comprehensive study in the Journal of Sleep Research.
“Right now, there is no real evidence for the criteria that have been put forward to diagnose obstructive sleep apnea and rate its severity,” he said in an interview.
Likewise, 19% of middle-aged subjects in a 2016 Icelandic study appeared to have moderate to severe “apnea” under one definition in the International Classification of Sleep Disorders even though many reported no drowsiness.
“Most of them were really surprised,” said Erna Sif Arnardóttir, who led the study and is running a large European program to refine detection and treatment of apnea.
Nevertheless, the official AASM journal recommends extremely broad screening for sleep apnea, looking for patients who have what it defines as illness. Everybody 18 and older should be screened every year for apnea if they have diabetes, obesity, untreated high blood pressure, or heart disease – even if they have never complained about sleep problems, the group says.
AASM “continually evaluates the definitions, criteria and recommendations used in the identification of sleep apnea and other sleep disorders,” Ms. Gibson said in the statement. Meanwhile, routine screening by primary care doctors “is a simple way” of gauging whether a high-risk patient may have obstructive sleep apnea, the statement said.
The U.S. Preventive Services Task Force, an authoritative body that reviews the effectiveness of preventive care, takes a conservative view, more like that of the European researchers, concluding there is “insufficient” evidence to support widespread screening among patients with no symptoms.
Many insurers refuse to pay for CPAP machines and other treatments prescribed for people at the outer edges of the AASM’s apnea definition. But AASM is pressuring them to come around.
After all my reporting, I concluded that my apnea is real, though moderate. My alarming reading in the overnight lab – diagnosed quickly as central sleep apnea – was a byproduct of the testing machinery itself. That’s a well-described phenomenon that occurs in 5% to 15% of patients.
And when I looked closely at the results of my at-home diagnostic test, I had an epiphany: My overall score was 26 breathing interruptions and blood-oxygen level declines, on average, per hour – enough to put me in the “high-moderate” category for apnea. But when I looked at the data sorted according to sleeping positions, I saw that I scored much better when I slept on my side: only 10 interruptions in an hour.
So I did a little experiment: I bought a $25 pulse oximeter with a smartphone app that records oxygen dips and breathing interruptions. When I slept on my side, there were hardly any.
Now I sleep on my side. I snore less. I wake up refreshed. I’m not daytime drowsy.
None of my specialists mentioned turning on to my side – known in medical parlance as “positional therapy” – though the intervention is recognized as effective by many researchers. Sleeping on one’s back contributes to snoring and blockages, especially as people age and the muscles in the throat become looser.
“Positional patients ... can sleep in the lateral position and sleep quite well,” said Arie Oksenberg, PhD, a sleep researcher formerly at Loewenstein Hospital in Ra’anana, Israel.
But it’s not easy to find this in the official AASM treatment guidelines, which instead go right to the money-making options like CPAP machines, surgery, central apnea, and mouth appliances.
Dealing with apnea by shifting slightly in bed gets little more than a couple of paragraphs in AASM’s guideline on “other” treatments and a little box on a long and complex decision chart.
A third or more of patients wear CPAPs only a few hours a night or stop using them. It turns out people don’t like machines in their beds.
“Positional therapy is an effective treatment option for some patients,” said Ms. Gibson. But she said there are concerns about whether patients will sleep on their sides long term and whether trying to stay in one position might cause sleep interruptions itself.
It’s true that side-sleeping doesn’t help everybody. And it often takes practice. (Some people tape a tennis ball to their pajamas to keep them off their backs.) Even conservative sleep doctors say CPAP machines are the best solution for many patients.
But there is a largely overlooked alternative.
“Are we missing a simple treatment for most adult sleep apnea patients?” was the name of a 2013 paper that Dr. Oksenberg and a colleague wrote about positional therapy.
In my case, the answer was “yes.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.