Mixed Topics

In June 2023, a multisociety group agreed to change the name of the disease formerly known as nonalcoholic fatty liver disease (NAFLD) to metabolic dysfunction–associated steatotic liver disease (MASLD).

In the week leading up to this, Intercept Pharmaceuticals announced that their program to develop obeticholic acid (OCA) as a first-to-market, long-awaited potential drug therapy for metabolic dysfunction–associated steatohepatitis (MASH), the more pathogenic form of this disease, was being abandoned after the Food and Drug Administration Gastrointestinal Drugs Advisory Committee voted against accelerated approval of the drug. This decision was made in large part owing to data showing modest efficacy coupled with multiple drug-related side effects, including worsening metabolic dysfunction.

The juxtaposition of these two events highlights what could be a fundamental change in perspective when it comes to the management of patients with MASLD and the development of therapies for this disease.
 

A more precise nomenclature for a broad-spectrum disease

The updating of the NAFLD nomenclature to MASLD represents an important change in the way that the medical community is being asked to view and approach the disease of “fatty liver.”

The previous nomenclature clarified that pathogenic liver steatosis can exist in the absence of alcohol. However, it failed to define the primary drivers of the most common form of NAFLD: that is, metabolic syndrome diseases. The new nomenclature not only better defines the broad spectrum of steatotic liver diseases (alcohol, metabolic, drug/genetic, cryptogenic) but also refocuses the attention of providers on the fundamental basis of MASLD as a critical member of the metabolic syndrome spectrum of diseases.

This is in line with the recently updated American Association for the Study of Liver Disease Practice Guidelines for NAFLD (now MASLD), which focus on active screening to identify patients at risk for advanced MASLD, in particular those with medically complicated obesity or high-risk metabolic characteristics such as diabetes. This is a change from previous versions of the guidelines that were cautious to recommend broad screening guidelines in part owing to the lack of “available therapies.”

The increasing clinical burden of MASH has led to the recognition that patients do not have the luxury of waiting for “anticipated therapies” that have frequently shown only marginal or insignificant efficacy. As a result, some providers have refocused their efforts on the development of care pathways that can efficiently provide comprehensive lifestyle interventions to treat MASH and related metabolic comorbidities within hepatology or other subspecialty clinics.
 

Learning from OCA’s limitations

The approach to drug development for MASH seems to be shifting in a similar, metabolic syndrome–focused way.

The risk-benefit analysis from the FDA advisory committee evaluating OCA noted that the drug provided only modest (albeit statistically significant) benefits over placebo in achieving one of two primary clinical endpoints (improvement in fibrosis by one stage without worsening of NASH), but was associated with toxicity as well as significant drug-related side effects, including new or worsening dyslipidemia, accelerated progression to prediabetes or diabetes, and worsening glycemic control in patients with diabetes.

Worsening clinical markers of metabolic health were an important factor in the advisory committee’s decision to not provide accelerated approval of OCA. This informs the criteria upon which future MASH therapies will be evaluated for approval: that an ideal agent for MASH not only will have a significant impact on MASH pathophysiology but will also provide benefit for (or at least not worsen) the metabolic comorbidities associated with MASH.
 

New treatments on the horizon

Fortunately, several new MASH therapeutics in development seem to have promising metabolic profiles.

In the phase 3 MAESTRO-NASH biopsy trial, treatment with resmetirom, a thyroid hormone receptor–beta selective agonist versus placebo resulted in a clinically significant improvement in liver fibrosis by one stage or more (26% vs. 14%) and NASH resolution (30% vs. 10%). Unlike OCA, resmetirom was associated with a clinically significant reduction in LDL cholesterol (–16% compared with placebo).

Resmetirom has received a breakthrough therapy designation, and Madrigal Pharmaceuticals recently completed submission of a new drug application for accelerated approval of this agent to the FDA.

Semaglutide is a glucagonlike peptide–1 receptor agonist that is already FDA approved for treatment of diabetes and obesity and is being studied in a phase 3 analysis for NASH.

In a phase 2 trial, daily dosing of semaglutide vs placebo led to clinically significant improvement in NASH resolution (59% vs. 17%) but not significant improvement in fibrosis (43% vs 33%). Although it is impossible to make a meaningful comparison in outcomes between clinical trials, it should be noted that the absolute rate of response in this trial was higher than is routinely seen in other NASH trials and that the placebo rate for improvement in fibrosis was higher than expected, a common problem with NASH trials.

As expected, treatment with semaglutide was associated with dose-dependent reduction in body weight and hemoglobin A1c, highlighting the global metabolic benefit of this agent.

Another major class of agents being studied for NASH treatment are the fibroblast growth factor (FGF) 21 analogs.

In the recently published phase 2b ENLIVEN trial, treatment with the FGF21 analog pegozafermin versus placebo led to a statistically significant improvement in liver fibrosis by one stage (27% vs. 7%) and a numerical improvement in NASH resolution (26% vs. 2%).

In addition to its effects directly in the liver, FGF21 has been associated with promoting positive global metabolic effects, including improved peripheral insulin sensitivity and amelioration of dyslipidemia. Consistent with this, treatment with pegozafermin resulted in a decrease in serum triglycerides and an increase in serum HDL cholesterol and adiponectin levels.

Ultimately, the best therapeutic strategy for MASH may be one that uses combination therapy to maximize liver-directed effects and also ameliorate concomitant or contributing metabolic dysfunction. This approach is already being investigated. What seems clear, however, is that MASH therapy without concurrent treatment of metabolic comorbidities is probably destined to be ineffective, if not counterproductive.

So, what’s in a name? When it comes to MASLD, it seems quite a bit.
 

Dr. Janardhan is an assistant professor, department of internal medicine, at Rush University Medical Center, Chicago. Dr. Reau is a professor, department of internal medicine, Rush University. Dr. Janardhan reported conflicts of interest with Target RWE, Novo Nordisk, Intercept, and Enanta. Dr. Reau reported conflicts of interest with AbbVie, Gilead, and AASLD.

A version of this article appeared on Medscape.com.

In June 2023, a multisociety group agreed to change the name of the disease formerly known as nonalcoholic fatty liver disease (NAFLD) to metabolic dysfunction–associated steatotic liver disease (MASLD).

In the week leading up to this, Intercept Pharmaceuticals announced that their program to develop obeticholic acid (OCA) as a first-to-market, long-awaited potential drug therapy for metabolic dysfunction–associated steatohepatitis (MASH), the more pathogenic form of this disease, was being abandoned after the Food and Drug Administration Gastrointestinal Drugs Advisory Committee voted against accelerated approval of the drug. This decision was made in large part owing to data showing modest efficacy coupled with multiple drug-related side effects, including worsening metabolic dysfunction.

The juxtaposition of these two events highlights what could be a fundamental change in perspective when it comes to the management of patients with MASLD and the development of therapies for this disease.
 

A more precise nomenclature for a broad-spectrum disease

The updating of the NAFLD nomenclature to MASLD represents an important change in the way that the medical community is being asked to view and approach the disease of “fatty liver.”

The previous nomenclature clarified that pathogenic liver steatosis can exist in the absence of alcohol. However, it failed to define the primary drivers of the most common form of NAFLD: that is, metabolic syndrome diseases. The new nomenclature not only better defines the broad spectrum of steatotic liver diseases (alcohol, metabolic, drug/genetic, cryptogenic) but also refocuses the attention of providers on the fundamental basis of MASLD as a critical member of the metabolic syndrome spectrum of diseases.

This is in line with the recently updated American Association for the Study of Liver Disease Practice Guidelines for NAFLD (now MASLD), which focus on active screening to identify patients at risk for advanced MASLD, in particular those with medically complicated obesity or high-risk metabolic characteristics such as diabetes. This is a change from previous versions of the guidelines that were cautious to recommend broad screening guidelines in part owing to the lack of “available therapies.”

The increasing clinical burden of MASH has led to the recognition that patients do not have the luxury of waiting for “anticipated therapies” that have frequently shown only marginal or insignificant efficacy. As a result, some providers have refocused their efforts on the development of care pathways that can efficiently provide comprehensive lifestyle interventions to treat MASH and related metabolic comorbidities within hepatology or other subspecialty clinics.
 

Learning from OCA’s limitations

The approach to drug development for MASH seems to be shifting in a similar, metabolic syndrome–focused way.

The risk-benefit analysis from the FDA advisory committee evaluating OCA noted that the drug provided only modest (albeit statistically significant) benefits over placebo in achieving one of two primary clinical endpoints (improvement in fibrosis by one stage without worsening of NASH), but was associated with toxicity as well as significant drug-related side effects, including new or worsening dyslipidemia, accelerated progression to prediabetes or diabetes, and worsening glycemic control in patients with diabetes.

Worsening clinical markers of metabolic health were an important factor in the advisory committee’s decision to not provide accelerated approval of OCA. This informs the criteria upon which future MASH therapies will be evaluated for approval: that an ideal agent for MASH not only will have a significant impact on MASH pathophysiology but will also provide benefit for (or at least not worsen) the metabolic comorbidities associated with MASH.
 

New treatments on the horizon

Fortunately, several new MASH therapeutics in development seem to have promising metabolic profiles.

In the phase 3 MAESTRO-NASH biopsy trial, treatment with resmetirom, a thyroid hormone receptor–beta selective agonist versus placebo resulted in a clinically significant improvement in liver fibrosis by one stage or more (26% vs. 14%) and NASH resolution (30% vs. 10%). Unlike OCA, resmetirom was associated with a clinically significant reduction in LDL cholesterol (–16% compared with placebo).

Resmetirom has received a breakthrough therapy designation, and Madrigal Pharmaceuticals recently completed submission of a new drug application for accelerated approval of this agent to the FDA.

Semaglutide is a glucagonlike peptide–1 receptor agonist that is already FDA approved for treatment of diabetes and obesity and is being studied in a phase 3 analysis for NASH.

In a phase 2 trial, daily dosing of semaglutide vs placebo led to clinically significant improvement in NASH resolution (59% vs. 17%) but not significant improvement in fibrosis (43% vs 33%). Although it is impossible to make a meaningful comparison in outcomes between clinical trials, it should be noted that the absolute rate of response in this trial was higher than is routinely seen in other NASH trials and that the placebo rate for improvement in fibrosis was higher than expected, a common problem with NASH trials.

As expected, treatment with semaglutide was associated with dose-dependent reduction in body weight and hemoglobin A1c, highlighting the global metabolic benefit of this agent.

Another major class of agents being studied for NASH treatment are the fibroblast growth factor (FGF) 21 analogs.

In the recently published phase 2b ENLIVEN trial, treatment with the FGF21 analog pegozafermin versus placebo led to a statistically significant improvement in liver fibrosis by one stage (27% vs. 7%) and a numerical improvement in NASH resolution (26% vs. 2%).

In addition to its effects directly in the liver, FGF21 has been associated with promoting positive global metabolic effects, including improved peripheral insulin sensitivity and amelioration of dyslipidemia. Consistent with this, treatment with pegozafermin resulted in a decrease in serum triglycerides and an increase in serum HDL cholesterol and adiponectin levels.

Ultimately, the best therapeutic strategy for MASH may be one that uses combination therapy to maximize liver-directed effects and also ameliorate concomitant or contributing metabolic dysfunction. This approach is already being investigated. What seems clear, however, is that MASH therapy without concurrent treatment of metabolic comorbidities is probably destined to be ineffective, if not counterproductive.

So, what’s in a name? When it comes to MASLD, it seems quite a bit.
 

Dr. Janardhan is an assistant professor, department of internal medicine, at Rush University Medical Center, Chicago. Dr. Reau is a professor, department of internal medicine, Rush University. Dr. Janardhan reported conflicts of interest with Target RWE, Novo Nordisk, Intercept, and Enanta. Dr. Reau reported conflicts of interest with AbbVie, Gilead, and AASLD.

A version of this article appeared on Medscape.com.

In June 2023, a multisociety group agreed to change the name of the disease formerly known as nonalcoholic fatty liver disease (NAFLD) to metabolic dysfunction–associated steatotic liver disease (MASLD).

In the week leading up to this, Intercept Pharmaceuticals announced that their program to develop obeticholic acid (OCA) as a first-to-market, long-awaited potential drug therapy for metabolic dysfunction–associated steatohepatitis (MASH), the more pathogenic form of this disease, was being abandoned after the Food and Drug Administration Gastrointestinal Drugs Advisory Committee voted against accelerated approval of the drug. This decision was made in large part owing to data showing modest efficacy coupled with multiple drug-related side effects, including worsening metabolic dysfunction.

The juxtaposition of these two events highlights what could be a fundamental change in perspective when it comes to the management of patients with MASLD and the development of therapies for this disease.
 

A more precise nomenclature for a broad-spectrum disease

The updating of the NAFLD nomenclature to MASLD represents an important change in the way that the medical community is being asked to view and approach the disease of “fatty liver.”

The previous nomenclature clarified that pathogenic liver steatosis can exist in the absence of alcohol. However, it failed to define the primary drivers of the most common form of NAFLD: that is, metabolic syndrome diseases. The new nomenclature not only better defines the broad spectrum of steatotic liver diseases (alcohol, metabolic, drug/genetic, cryptogenic) but also refocuses the attention of providers on the fundamental basis of MASLD as a critical member of the metabolic syndrome spectrum of diseases.

This is in line with the recently updated American Association for the Study of Liver Disease Practice Guidelines for NAFLD (now MASLD), which focus on active screening to identify patients at risk for advanced MASLD, in particular those with medically complicated obesity or high-risk metabolic characteristics such as diabetes. This is a change from previous versions of the guidelines that were cautious to recommend broad screening guidelines in part owing to the lack of “available therapies.”

The increasing clinical burden of MASH has led to the recognition that patients do not have the luxury of waiting for “anticipated therapies” that have frequently shown only marginal or insignificant efficacy. As a result, some providers have refocused their efforts on the development of care pathways that can efficiently provide comprehensive lifestyle interventions to treat MASH and related metabolic comorbidities within hepatology or other subspecialty clinics.
 

Learning from OCA’s limitations

The approach to drug development for MASH seems to be shifting in a similar, metabolic syndrome–focused way.

The risk-benefit analysis from the FDA advisory committee evaluating OCA noted that the drug provided only modest (albeit statistically significant) benefits over placebo in achieving one of two primary clinical endpoints (improvement in fibrosis by one stage without worsening of NASH), but was associated with toxicity as well as significant drug-related side effects, including new or worsening dyslipidemia, accelerated progression to prediabetes or diabetes, and worsening glycemic control in patients with diabetes.

Worsening clinical markers of metabolic health were an important factor in the advisory committee’s decision to not provide accelerated approval of OCA. This informs the criteria upon which future MASH therapies will be evaluated for approval: that an ideal agent for MASH not only will have a significant impact on MASH pathophysiology but will also provide benefit for (or at least not worsen) the metabolic comorbidities associated with MASH.
 

New treatments on the horizon

Fortunately, several new MASH therapeutics in development seem to have promising metabolic profiles.

In the phase 3 MAESTRO-NASH biopsy trial, treatment with resmetirom, a thyroid hormone receptor–beta selective agonist versus placebo resulted in a clinically significant improvement in liver fibrosis by one stage or more (26% vs. 14%) and NASH resolution (30% vs. 10%). Unlike OCA, resmetirom was associated with a clinically significant reduction in LDL cholesterol (–16% compared with placebo).

Resmetirom has received a breakthrough therapy designation, and Madrigal Pharmaceuticals recently completed submission of a new drug application for accelerated approval of this agent to the FDA.

Semaglutide is a glucagonlike peptide–1 receptor agonist that is already FDA approved for treatment of diabetes and obesity and is being studied in a phase 3 analysis for NASH.

In a phase 2 trial, daily dosing of semaglutide vs placebo led to clinically significant improvement in NASH resolution (59% vs. 17%) but not significant improvement in fibrosis (43% vs 33%). Although it is impossible to make a meaningful comparison in outcomes between clinical trials, it should be noted that the absolute rate of response in this trial was higher than is routinely seen in other NASH trials and that the placebo rate for improvement in fibrosis was higher than expected, a common problem with NASH trials.

As expected, treatment with semaglutide was associated with dose-dependent reduction in body weight and hemoglobin A1c, highlighting the global metabolic benefit of this agent.

Another major class of agents being studied for NASH treatment are the fibroblast growth factor (FGF) 21 analogs.

In the recently published phase 2b ENLIVEN trial, treatment with the FGF21 analog pegozafermin versus placebo led to a statistically significant improvement in liver fibrosis by one stage (27% vs. 7%) and a numerical improvement in NASH resolution (26% vs. 2%).

In addition to its effects directly in the liver, FGF21 has been associated with promoting positive global metabolic effects, including improved peripheral insulin sensitivity and amelioration of dyslipidemia. Consistent with this, treatment with pegozafermin resulted in a decrease in serum triglycerides and an increase in serum HDL cholesterol and adiponectin levels.

Ultimately, the best therapeutic strategy for MASH may be one that uses combination therapy to maximize liver-directed effects and also ameliorate concomitant or contributing metabolic dysfunction. This approach is already being investigated. What seems clear, however, is that MASH therapy without concurrent treatment of metabolic comorbidities is probably destined to be ineffective, if not counterproductive.

So, what’s in a name? When it comes to MASLD, it seems quite a bit.
 

Dr. Janardhan is an assistant professor, department of internal medicine, at Rush University Medical Center, Chicago. Dr. Reau is a professor, department of internal medicine, Rush University. Dr. Janardhan reported conflicts of interest with Target RWE, Novo Nordisk, Intercept, and Enanta. Dr. Reau reported conflicts of interest with AbbVie, Gilead, and AASLD.

A version of this article appeared on Medscape.com.

Fear and a lack of health-related knowledge pose significant barriers to preventative cancer care access and effectiveness, recent survey data from The Harris Poll suggests.

The survey, commissioned by Bayer U.S. to identify patient behaviors and care barriers, indicates that more than one in four adults in the United States (27%) would rather not know if they have cancer, and nearly a third (31%) – particularly younger patients aged 18-44 years – avoid going to the doctor because they are afraid of what they might learn.

Similarly, 26% of 2,079 respondents said that fear and anxiety are the main reasons why they don’t make or keep doctor appointments. Those with lower household income and education levels, those with children under age 18 years, and Hispanic adults were most likely to cite this reason.

Almost half (up to 49%) lacked knowledge about certain cancers and risk factors.

For example, 48% of respondents were unaware that breast density affects breast cancer risk and diagnosis, and 38% said they were not very knowledgeable about breast cancer.

Regarding prostate cancer, 49% were unaware that race impacts risk and 49% said they were not knowledgeable about the disease.

The survey highlighted a lack of trust in treatments and health care processes among most adults, especially those with lower income and education levels. Overall, 53% said they have little or no trust in treatments developed by pharmaceutical companies, and 31% said they have little or no trust in medical tests, test results, and other medical processes.

The findings of the survey, which was conducted online June 6-8, 2023, among U.S. adults aged 18 years and older, underscore the need to better educate individuals about cancer risk factors and the benefits of preventative care.

“The increase of fear and anxiety, heightened by a lack of education and in some cases trust barriers, creates an environment where people may not access basic preventative care to ensure early diagnosis,” Sebastian Guth, president of Bayer U.S. and Pharmaceuticals North America, stated in a press release. “This is compounded by the fact that around 27.4 million people of all ages (8.3%) don’t have access to health insurance.

“Companies like Bayer have a responsibility to provide resources that increase health education on the importance of understanding disease risks, early disease screenings, and preventative health care,” Mr. Guth added, noting that the company is partnering with multiple patient advocacy groups to increase trust, awareness, and knowledge “to help individuals understand the resources available to them and their risks for a specific disease.”

Public health initiatives have had mixed results with respect to changing patient behaviors over time, but Breast Cancer Awareness Month (BCAM) in October of each year is a stand-out initiative that could serve as a model for other patient education initiatives, according to a 2022 study.

The Google trends analysis showed that from 2012 to 2021, BCAM was associated with improved public awareness of breast cancer, whereas Lung Cancer Awareness Month and Prostate Cancer Awareness Month had no impact on lung and prostate cancer awareness, respectively, over time, reported Yoshita Nishimura, MD, of Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences in Japan, and Jared D. Acoba, MD, of the University of Hawaii, Honolulu.

Dr. Nishimura and Dr. Acoba concluded that the success of BCAM, which was launched in 1985 and is now led by the National Breast Cancer Foundation, is likely a result of “the effective involvement of non-medical industries, influencers affected by breast cancer, and an awareness symbol.”

As for the role of physicians in raising awareness and increasing knowledge at the patient level, various guidelines focus on assessing patient needs and readiness to learn, communicating clearly, and identifying barriers, such as a lack of support and low health literacy.

An American Society of Clinical Oncology consensus guideline for physician-patient communication, for example, provides guidance on core communication skills that apply across the continuum of care, as well as specific topics to address, such as patient goals, treatment options, and support systems – all with an eye toward using “effective communication to optimize the patient-clinician relationship, patient and clinician well-being and family well-being.”

Fear and a lack of health-related knowledge pose significant barriers to preventative cancer care access and effectiveness, recent survey data from The Harris Poll suggests.

The survey, commissioned by Bayer U.S. to identify patient behaviors and care barriers, indicates that more than one in four adults in the United States (27%) would rather not know if they have cancer, and nearly a third (31%) – particularly younger patients aged 18-44 years – avoid going to the doctor because they are afraid of what they might learn.

Similarly, 26% of 2,079 respondents said that fear and anxiety are the main reasons why they don’t make or keep doctor appointments. Those with lower household income and education levels, those with children under age 18 years, and Hispanic adults were most likely to cite this reason.

Almost half (up to 49%) lacked knowledge about certain cancers and risk factors.

For example, 48% of respondents were unaware that breast density affects breast cancer risk and diagnosis, and 38% said they were not very knowledgeable about breast cancer.

Regarding prostate cancer, 49% were unaware that race impacts risk and 49% said they were not knowledgeable about the disease.

The survey highlighted a lack of trust in treatments and health care processes among most adults, especially those with lower income and education levels. Overall, 53% said they have little or no trust in treatments developed by pharmaceutical companies, and 31% said they have little or no trust in medical tests, test results, and other medical processes.

The findings of the survey, which was conducted online June 6-8, 2023, among U.S. adults aged 18 years and older, underscore the need to better educate individuals about cancer risk factors and the benefits of preventative care.

“The increase of fear and anxiety, heightened by a lack of education and in some cases trust barriers, creates an environment where people may not access basic preventative care to ensure early diagnosis,” Sebastian Guth, president of Bayer U.S. and Pharmaceuticals North America, stated in a press release. “This is compounded by the fact that around 27.4 million people of all ages (8.3%) don’t have access to health insurance.

“Companies like Bayer have a responsibility to provide resources that increase health education on the importance of understanding disease risks, early disease screenings, and preventative health care,” Mr. Guth added, noting that the company is partnering with multiple patient advocacy groups to increase trust, awareness, and knowledge “to help individuals understand the resources available to them and their risks for a specific disease.”

Public health initiatives have had mixed results with respect to changing patient behaviors over time, but Breast Cancer Awareness Month (BCAM) in October of each year is a stand-out initiative that could serve as a model for other patient education initiatives, according to a 2022 study.

The Google trends analysis showed that from 2012 to 2021, BCAM was associated with improved public awareness of breast cancer, whereas Lung Cancer Awareness Month and Prostate Cancer Awareness Month had no impact on lung and prostate cancer awareness, respectively, over time, reported Yoshita Nishimura, MD, of Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences in Japan, and Jared D. Acoba, MD, of the University of Hawaii, Honolulu.

Dr. Nishimura and Dr. Acoba concluded that the success of BCAM, which was launched in 1985 and is now led by the National Breast Cancer Foundation, is likely a result of “the effective involvement of non-medical industries, influencers affected by breast cancer, and an awareness symbol.”

As for the role of physicians in raising awareness and increasing knowledge at the patient level, various guidelines focus on assessing patient needs and readiness to learn, communicating clearly, and identifying barriers, such as a lack of support and low health literacy.

An American Society of Clinical Oncology consensus guideline for physician-patient communication, for example, provides guidance on core communication skills that apply across the continuum of care, as well as specific topics to address, such as patient goals, treatment options, and support systems – all with an eye toward using “effective communication to optimize the patient-clinician relationship, patient and clinician well-being and family well-being.”

Fear and a lack of health-related knowledge pose significant barriers to preventative cancer care access and effectiveness, recent survey data from The Harris Poll suggests.

The survey, commissioned by Bayer U.S. to identify patient behaviors and care barriers, indicates that more than one in four adults in the United States (27%) would rather not know if they have cancer, and nearly a third (31%) – particularly younger patients aged 18-44 years – avoid going to the doctor because they are afraid of what they might learn.

Similarly, 26% of 2,079 respondents said that fear and anxiety are the main reasons why they don’t make or keep doctor appointments. Those with lower household income and education levels, those with children under age 18 years, and Hispanic adults were most likely to cite this reason.

Almost half (up to 49%) lacked knowledge about certain cancers and risk factors.

For example, 48% of respondents were unaware that breast density affects breast cancer risk and diagnosis, and 38% said they were not very knowledgeable about breast cancer.

Regarding prostate cancer, 49% were unaware that race impacts risk and 49% said they were not knowledgeable about the disease.

The survey highlighted a lack of trust in treatments and health care processes among most adults, especially those with lower income and education levels. Overall, 53% said they have little or no trust in treatments developed by pharmaceutical companies, and 31% said they have little or no trust in medical tests, test results, and other medical processes.

The findings of the survey, which was conducted online June 6-8, 2023, among U.S. adults aged 18 years and older, underscore the need to better educate individuals about cancer risk factors and the benefits of preventative care.

“The increase of fear and anxiety, heightened by a lack of education and in some cases trust barriers, creates an environment where people may not access basic preventative care to ensure early diagnosis,” Sebastian Guth, president of Bayer U.S. and Pharmaceuticals North America, stated in a press release. “This is compounded by the fact that around 27.4 million people of all ages (8.3%) don’t have access to health insurance.

“Companies like Bayer have a responsibility to provide resources that increase health education on the importance of understanding disease risks, early disease screenings, and preventative health care,” Mr. Guth added, noting that the company is partnering with multiple patient advocacy groups to increase trust, awareness, and knowledge “to help individuals understand the resources available to them and their risks for a specific disease.”

Public health initiatives have had mixed results with respect to changing patient behaviors over time, but Breast Cancer Awareness Month (BCAM) in October of each year is a stand-out initiative that could serve as a model for other patient education initiatives, according to a 2022 study.

The Google trends analysis showed that from 2012 to 2021, BCAM was associated with improved public awareness of breast cancer, whereas Lung Cancer Awareness Month and Prostate Cancer Awareness Month had no impact on lung and prostate cancer awareness, respectively, over time, reported Yoshita Nishimura, MD, of Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences in Japan, and Jared D. Acoba, MD, of the University of Hawaii, Honolulu.

Dr. Nishimura and Dr. Acoba concluded that the success of BCAM, which was launched in 1985 and is now led by the National Breast Cancer Foundation, is likely a result of “the effective involvement of non-medical industries, influencers affected by breast cancer, and an awareness symbol.”

As for the role of physicians in raising awareness and increasing knowledge at the patient level, various guidelines focus on assessing patient needs and readiness to learn, communicating clearly, and identifying barriers, such as a lack of support and low health literacy.

An American Society of Clinical Oncology consensus guideline for physician-patient communication, for example, provides guidance on core communication skills that apply across the continuum of care, as well as specific topics to address, such as patient goals, treatment options, and support systems – all with an eye toward using “effective communication to optimize the patient-clinician relationship, patient and clinician well-being and family well-being.”

The RNA interference therapeutic patisiran (Onpattro) is one step closer to being approved in the United States for treatment of transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy.

The Cardiovascular and Renal Drugs Advisory Committee of the Food and Drug Administration has voted 9 to 3 that the benefits of patisiran outweigh the risks for the treatment of ATTR amyloidosis cardiomyopathy – although many panel members questioned whether the benefits are clinically meaningful.

ATTR amyloidosis is an underdiagnosed, rapidly progressive, debilitating, and fatal disease caused by misfolded TTR proteins, which accumulate as amyloid deposits in various parts of the body, including the heart.

Intravenously administered patisiran is already approved in the United States and Canada for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults.

In the APOLLO-B trial, patisiran showed a statistically significant and clinically meaningful benefit on functional capacity, as measured by the 6-minute walk test, compared with placebo, in patients with ATTR amyloidosis with cardiomyopathy.

The study also met its first secondary endpoint, demonstrating a statistically significant and clinically meaningful benefit on health status and quality of life.

But in explaining her “no” vote, committee member C. Noel Bairey Merz, MD, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, said she “did not feel like there was benefit” using existing clinically relevant thresholds typically used in cardiology.

Committee chair Javed Butler, MD, MPH, Baylor Scott & White Research Institute, Dallas, who also voted no, said he “struggled” with this vote and emphasized that it “absolutely does not reflect that there is not a potential with the therapy.”

Dr. Butler said he voted no largely because he wasn’t sure whether the benefits are clinically meaningful in the context of the study design and how it was conducted. He did not have any safety concerns, which was the general feeling of the committee.

Edward Kasper, MD, Johns Hopkins University, Baltimore, who voted in favor of patisiran for ATTR amyloidosis with cardiomyopathy, said there is a “light wind for benefit and no wind for risk. So, if you’re asking do benefits outweigh the risks, the answer is yes.”

But Dr. Kasper also noted: “It would have been a more difficult question to answer: Is there clinically meaningful benefit versus risk? But that’s not what the question asked.”

In explaining his “yes” vote, Ravi Thadhani, MD, MPH, Emory University, Atlanta, said: “We’re dealing with a rare disease with few options and devastating consequences. We heard from clinicians loud and clear, and from patients for that matter, that options and alternatives are critical, and that there is a continuous decline of cardiac function and worsening of disease in a number of patients that have received the current standard of care. For me, the benefits outweigh the risks.”

Dr. Thadhani also noted that from the data provided, no benefit was shown – ”disappointingly” he lamented – for women, for Black persons, and among individuals who were receiving tafamidis, and he urged the FDA and sponsor to consider this.

The FDA has set a target action date for patisiran for ATTR amyloidosis cardiomyopathy of Oct. 8.

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

The RNA interference therapeutic patisiran (Onpattro) is one step closer to being approved in the United States for treatment of transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy.

The Cardiovascular and Renal Drugs Advisory Committee of the Food and Drug Administration has voted 9 to 3 that the benefits of patisiran outweigh the risks for the treatment of ATTR amyloidosis cardiomyopathy – although many panel members questioned whether the benefits are clinically meaningful.

ATTR amyloidosis is an underdiagnosed, rapidly progressive, debilitating, and fatal disease caused by misfolded TTR proteins, which accumulate as amyloid deposits in various parts of the body, including the heart.

Intravenously administered patisiran is already approved in the United States and Canada for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults.

In the APOLLO-B trial, patisiran showed a statistically significant and clinically meaningful benefit on functional capacity, as measured by the 6-minute walk test, compared with placebo, in patients with ATTR amyloidosis with cardiomyopathy.

The study also met its first secondary endpoint, demonstrating a statistically significant and clinically meaningful benefit on health status and quality of life.

But in explaining her “no” vote, committee member C. Noel Bairey Merz, MD, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, said she “did not feel like there was benefit” using existing clinically relevant thresholds typically used in cardiology.

Committee chair Javed Butler, MD, MPH, Baylor Scott & White Research Institute, Dallas, who also voted no, said he “struggled” with this vote and emphasized that it “absolutely does not reflect that there is not a potential with the therapy.”

Dr. Butler said he voted no largely because he wasn’t sure whether the benefits are clinically meaningful in the context of the study design and how it was conducted. He did not have any safety concerns, which was the general feeling of the committee.

Edward Kasper, MD, Johns Hopkins University, Baltimore, who voted in favor of patisiran for ATTR amyloidosis with cardiomyopathy, said there is a “light wind for benefit and no wind for risk. So, if you’re asking do benefits outweigh the risks, the answer is yes.”

But Dr. Kasper also noted: “It would have been a more difficult question to answer: Is there clinically meaningful benefit versus risk? But that’s not what the question asked.”

In explaining his “yes” vote, Ravi Thadhani, MD, MPH, Emory University, Atlanta, said: “We’re dealing with a rare disease with few options and devastating consequences. We heard from clinicians loud and clear, and from patients for that matter, that options and alternatives are critical, and that there is a continuous decline of cardiac function and worsening of disease in a number of patients that have received the current standard of care. For me, the benefits outweigh the risks.”

Dr. Thadhani also noted that from the data provided, no benefit was shown – ”disappointingly” he lamented – for women, for Black persons, and among individuals who were receiving tafamidis, and he urged the FDA and sponsor to consider this.

The FDA has set a target action date for patisiran for ATTR amyloidosis cardiomyopathy of Oct. 8.

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

The RNA interference therapeutic patisiran (Onpattro) is one step closer to being approved in the United States for treatment of transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy.

The Cardiovascular and Renal Drugs Advisory Committee of the Food and Drug Administration has voted 9 to 3 that the benefits of patisiran outweigh the risks for the treatment of ATTR amyloidosis cardiomyopathy – although many panel members questioned whether the benefits are clinically meaningful.

ATTR amyloidosis is an underdiagnosed, rapidly progressive, debilitating, and fatal disease caused by misfolded TTR proteins, which accumulate as amyloid deposits in various parts of the body, including the heart.

Intravenously administered patisiran is already approved in the United States and Canada for the treatment of the polyneuropathy of hereditary ATTR amyloidosis in adults.

In the APOLLO-B trial, patisiran showed a statistically significant and clinically meaningful benefit on functional capacity, as measured by the 6-minute walk test, compared with placebo, in patients with ATTR amyloidosis with cardiomyopathy.

The study also met its first secondary endpoint, demonstrating a statistically significant and clinically meaningful benefit on health status and quality of life.

But in explaining her “no” vote, committee member C. Noel Bairey Merz, MD, Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, said she “did not feel like there was benefit” using existing clinically relevant thresholds typically used in cardiology.

Committee chair Javed Butler, MD, MPH, Baylor Scott & White Research Institute, Dallas, who also voted no, said he “struggled” with this vote and emphasized that it “absolutely does not reflect that there is not a potential with the therapy.”

Dr. Butler said he voted no largely because he wasn’t sure whether the benefits are clinically meaningful in the context of the study design and how it was conducted. He did not have any safety concerns, which was the general feeling of the committee.

Edward Kasper, MD, Johns Hopkins University, Baltimore, who voted in favor of patisiran for ATTR amyloidosis with cardiomyopathy, said there is a “light wind for benefit and no wind for risk. So, if you’re asking do benefits outweigh the risks, the answer is yes.”

But Dr. Kasper also noted: “It would have been a more difficult question to answer: Is there clinically meaningful benefit versus risk? But that’s not what the question asked.”

In explaining his “yes” vote, Ravi Thadhani, MD, MPH, Emory University, Atlanta, said: “We’re dealing with a rare disease with few options and devastating consequences. We heard from clinicians loud and clear, and from patients for that matter, that options and alternatives are critical, and that there is a continuous decline of cardiac function and worsening of disease in a number of patients that have received the current standard of care. For me, the benefits outweigh the risks.”

Dr. Thadhani also noted that from the data provided, no benefit was shown – ”disappointingly” he lamented – for women, for Black persons, and among individuals who were receiving tafamidis, and he urged the FDA and sponsor to consider this.

The FDA has set a target action date for patisiran for ATTR amyloidosis cardiomyopathy of Oct. 8.

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

Recently, my office received several phone calls from patients asking if I perform “trap tox.” Having not been on social media around that time, I assumed the term had something to do with botulinum toxin and the trapezius muscle, but I had never heard it before. Not too long afterwards, patients were asking me about it in the office, using the same terminology, and I had several calls about it in one day. When I asked one trusted patient where she’d heard this term, which seemed to be trending, she told me that she had seen it on Instagram, as an ad or a “suggested for you” post.

Whether it’s a different name or term for a cosmetic procedure or laser we use that I’ve never heard before – such as “lip flip” or trap tox (also known as “Barbie Botox”) – many of these trendy terms spread like wildfire on social media. Some of the terms may be marketing tools started and spread by doctors who perform aesthetic procedures, something I don’t recommend as it only creates confusion for patients and practitioners, similar to the confusion consumers face regarding the plethora of over-the-counter skin care options and the marketing terms used for them. Other terms and trends are also started by nonphysician or non–professionally trained providers, sometimes leading to an unsafe or misleading term for an aesthetic procedure.

Over the past few years, several articles about the impact of social media in aesthetics have been published. In one recent paper, published in 2022, Boen and Jerdan noted that 72% of people in the United States use social media, up from 5% of American adults in 2005. In the United States, they note, “YouTube is the most popular platform with 73% of adult users, followed by Facebook (69%), Instagram (37%), SnapChat (24%), and Twitter (22%). Of the sites used daily, Facebook has the most activity (74%), followed by Instagram (64%), SnapChat (63%), YouTube (51%), and Twitter (42%).” They argue that the pros of social media in aesthetic medicine include its use as an educational tool by medical professionals to educate and provide accurate information about cosmetic procedures, and that “providing factual and evidence-based medical information to the public can help to counteract the abundant misinformation that is out there.” The cons include misinformation, no credentialing verification of the provider of the information – essentially anyone can be an “influencer” – as well as the addictive nature of social media for the consumer.

Along the same lines, younger patients tend to rely more on social media in choosing treatments and providers, further perpetuating any anxiety created from misinformation and unrealistic expectations from nonmedical influencers regarding procedures, filters used on photographs, photo editing, etc., in achieving an aesthetic result.

Physicians, particularly fellowship-trained aesthetic and surgical dermatologists, plastic and reconstructive surgeons, oculoplastic surgeons, and ENT facial plastic surgeons, who have the most training, knowledge, and expertise about aesthetic procedures, often have the least amount of time to devote to education via social media, compared with nonmedical influencers. Unless sponsored, they are also not being compensated for using it as an educational tool, except for potential indirect compensation from using it as a marketing tool for themselves and their practices. In contrast, nonmedical influencers often have many followers and time to create content, and in some cases, this is their full-time job.

All in all, most authors agree that social media has been associated with an increased acceptance of cosmetic surgery and procedures. Whether it be a trend seen on social media, or viewing one’s appearance in a filtered or photoediting app, or seeing an image of how another person looks (similar to how people in magazines, films and on television, were viewed in the past), social media has piqued people’s interest in aesthetics. It remains a balance for interested physicians to help keep information about cosmetic procedures presented in a healthy, interesting, professional, and accurate manner, and in a non–time-consuming way.

Dr. Wesley practices dermatology in Beverly Hills, Calif. Write to her at dermnews@mdedge.com. She had no relevant disclosures.
 

References

Boen M and Jerdan K. Clin Dermatol. 2022 Jan-Feb;40(1):45-8.

Chen J et al. JAMA Facial Plast Surg. 2019 Sep 1;21(5):361-7.

Chopan M et al. Plast Reconstr Surg. 2019 Apr;143(4):1259-65.

Recently, my office received several phone calls from patients asking if I perform “trap tox.” Having not been on social media around that time, I assumed the term had something to do with botulinum toxin and the trapezius muscle, but I had never heard it before. Not too long afterwards, patients were asking me about it in the office, using the same terminology, and I had several calls about it in one day. When I asked one trusted patient where she’d heard this term, which seemed to be trending, she told me that she had seen it on Instagram, as an ad or a “suggested for you” post.

Whether it’s a different name or term for a cosmetic procedure or laser we use that I’ve never heard before – such as “lip flip” or trap tox (also known as “Barbie Botox”) – many of these trendy terms spread like wildfire on social media. Some of the terms may be marketing tools started and spread by doctors who perform aesthetic procedures, something I don’t recommend as it only creates confusion for patients and practitioners, similar to the confusion consumers face regarding the plethora of over-the-counter skin care options and the marketing terms used for them. Other terms and trends are also started by nonphysician or non–professionally trained providers, sometimes leading to an unsafe or misleading term for an aesthetic procedure.

Over the past few years, several articles about the impact of social media in aesthetics have been published. In one recent paper, published in 2022, Boen and Jerdan noted that 72% of people in the United States use social media, up from 5% of American adults in 2005. In the United States, they note, “YouTube is the most popular platform with 73% of adult users, followed by Facebook (69%), Instagram (37%), SnapChat (24%), and Twitter (22%). Of the sites used daily, Facebook has the most activity (74%), followed by Instagram (64%), SnapChat (63%), YouTube (51%), and Twitter (42%).” They argue that the pros of social media in aesthetic medicine include its use as an educational tool by medical professionals to educate and provide accurate information about cosmetic procedures, and that “providing factual and evidence-based medical information to the public can help to counteract the abundant misinformation that is out there.” The cons include misinformation, no credentialing verification of the provider of the information – essentially anyone can be an “influencer” – as well as the addictive nature of social media for the consumer.

Along the same lines, younger patients tend to rely more on social media in choosing treatments and providers, further perpetuating any anxiety created from misinformation and unrealistic expectations from nonmedical influencers regarding procedures, filters used on photographs, photo editing, etc., in achieving an aesthetic result.

Physicians, particularly fellowship-trained aesthetic and surgical dermatologists, plastic and reconstructive surgeons, oculoplastic surgeons, and ENT facial plastic surgeons, who have the most training, knowledge, and expertise about aesthetic procedures, often have the least amount of time to devote to education via social media, compared with nonmedical influencers. Unless sponsored, they are also not being compensated for using it as an educational tool, except for potential indirect compensation from using it as a marketing tool for themselves and their practices. In contrast, nonmedical influencers often have many followers and time to create content, and in some cases, this is their full-time job.

All in all, most authors agree that social media has been associated with an increased acceptance of cosmetic surgery and procedures. Whether it be a trend seen on social media, or viewing one’s appearance in a filtered or photoediting app, or seeing an image of how another person looks (similar to how people in magazines, films and on television, were viewed in the past), social media has piqued people’s interest in aesthetics. It remains a balance for interested physicians to help keep information about cosmetic procedures presented in a healthy, interesting, professional, and accurate manner, and in a non–time-consuming way.

Dr. Wesley practices dermatology in Beverly Hills, Calif. Write to her at dermnews@mdedge.com. She had no relevant disclosures.
 

References

Boen M and Jerdan K. Clin Dermatol. 2022 Jan-Feb;40(1):45-8.

Chen J et al. JAMA Facial Plast Surg. 2019 Sep 1;21(5):361-7.

Chopan M et al. Plast Reconstr Surg. 2019 Apr;143(4):1259-65.

Recently, my office received several phone calls from patients asking if I perform “trap tox.” Having not been on social media around that time, I assumed the term had something to do with botulinum toxin and the trapezius muscle, but I had never heard it before. Not too long afterwards, patients were asking me about it in the office, using the same terminology, and I had several calls about it in one day. When I asked one trusted patient where she’d heard this term, which seemed to be trending, she told me that she had seen it on Instagram, as an ad or a “suggested for you” post.

Whether it’s a different name or term for a cosmetic procedure or laser we use that I’ve never heard before – such as “lip flip” or trap tox (also known as “Barbie Botox”) – many of these trendy terms spread like wildfire on social media. Some of the terms may be marketing tools started and spread by doctors who perform aesthetic procedures, something I don’t recommend as it only creates confusion for patients and practitioners, similar to the confusion consumers face regarding the plethora of over-the-counter skin care options and the marketing terms used for them. Other terms and trends are also started by nonphysician or non–professionally trained providers, sometimes leading to an unsafe or misleading term for an aesthetic procedure.

Over the past few years, several articles about the impact of social media in aesthetics have been published. In one recent paper, published in 2022, Boen and Jerdan noted that 72% of people in the United States use social media, up from 5% of American adults in 2005. In the United States, they note, “YouTube is the most popular platform with 73% of adult users, followed by Facebook (69%), Instagram (37%), SnapChat (24%), and Twitter (22%). Of the sites used daily, Facebook has the most activity (74%), followed by Instagram (64%), SnapChat (63%), YouTube (51%), and Twitter (42%).” They argue that the pros of social media in aesthetic medicine include its use as an educational tool by medical professionals to educate and provide accurate information about cosmetic procedures, and that “providing factual and evidence-based medical information to the public can help to counteract the abundant misinformation that is out there.” The cons include misinformation, no credentialing verification of the provider of the information – essentially anyone can be an “influencer” – as well as the addictive nature of social media for the consumer.

Along the same lines, younger patients tend to rely more on social media in choosing treatments and providers, further perpetuating any anxiety created from misinformation and unrealistic expectations from nonmedical influencers regarding procedures, filters used on photographs, photo editing, etc., in achieving an aesthetic result.

Physicians, particularly fellowship-trained aesthetic and surgical dermatologists, plastic and reconstructive surgeons, oculoplastic surgeons, and ENT facial plastic surgeons, who have the most training, knowledge, and expertise about aesthetic procedures, often have the least amount of time to devote to education via social media, compared with nonmedical influencers. Unless sponsored, they are also not being compensated for using it as an educational tool, except for potential indirect compensation from using it as a marketing tool for themselves and their practices. In contrast, nonmedical influencers often have many followers and time to create content, and in some cases, this is their full-time job.

All in all, most authors agree that social media has been associated with an increased acceptance of cosmetic surgery and procedures. Whether it be a trend seen on social media, or viewing one’s appearance in a filtered or photoediting app, or seeing an image of how another person looks (similar to how people in magazines, films and on television, were viewed in the past), social media has piqued people’s interest in aesthetics. It remains a balance for interested physicians to help keep information about cosmetic procedures presented in a healthy, interesting, professional, and accurate manner, and in a non–time-consuming way.

Dr. Wesley practices dermatology in Beverly Hills, Calif. Write to her at dermnews@mdedge.com. She had no relevant disclosures.
 

References

Boen M and Jerdan K. Clin Dermatol. 2022 Jan-Feb;40(1):45-8.

Chen J et al. JAMA Facial Plast Surg. 2019 Sep 1;21(5):361-7.

Chopan M et al. Plast Reconstr Surg. 2019 Apr;143(4):1259-65.

SINGAPORE – Can the prolonged use of skin-lightening products, such as hydroquinone, lead to skin cancer?

This question was posed by Ousmane Faye, MD, PhD, director general of Mali’s Bamako Dermatology Hospital, at the World Congress of Dermatology. 

Dr. Faye explored the issue during a hot topics session at the meeting, prefacing that it was an important question to ask because “in West Africa, skin bleaching is very common.”

“There are many local names” for skin bleaching, he said. “For example, in Senegal, it’s called xessal; in Mali and Ivory Coast, its name is caco; in South Africa, there are many names, like ukutsheyisa.”

Skin bleaching refers to the cosmetic misuse of topical agents to change one’s natural skin color. It’s a centuries-old practice that people, mainly women, adopt “to increase attractiveness and self-esteem,” explained Dr. Faye.

To demonstrate how pervasive skin bleaching is on the continent, he presented a slide that summarized figures from six studies spanning the past 2 decades. Prevalence ranged from 25% in Mali (based on a 1993 survey of 210 women) to a high of 79.25% in Benin (from a sample size of 511 women in 2019). In other studies of women in Burkina Faso and Togo, the figures were 44.3% and 58.9%, respectively. The most recently conducted study, which involved 2,689 Senegalese women and was published in 2022, found that nearly 6 in 10 (59.2%) respondents used skin-lightening products.

But skin bleaching isn’t just limited to Africa, said session moderator Omar Lupi, MD, PhD, associate professor of dermatology at the Federal University of the State of Rio de Janeiro, when approached for an independent comment. “It’s a traditional practice around the world. Maybe not in the developed countries, but it’s quite common in Africa, in South America, and in Asia.”

His sentiments are echoed in a meta-analysis that was published in the International Journal of Dermatology in 2019. The work examined 68 studies involving more than 67,000 people across Africa, Asia, Europe, the Middle East, and North America. It found that the pooled lifetime prevalence of skin bleaching was 27.7% (95% confidence interval, 19.6-37.5; P < .01).

“This is an important and interesting topic because our world is shrinking,” Dr. Lupi told this news organization. “Even in countries that don’t have bleaching as a common situation, we now have patients who are migrating from one part [of the world] to another, so bleaching is something that can knock on your door and you need to be prepared.”

Misuse leads to complications

The issue is pertinent to dermatologists because skin bleaching is associated with a wide range of complications. Take, for example, topical steroids, which are the most common products used for bleaching, said Dr. Faye in his talk. 

“Clobetasol can suppress the hypothalamic-pituitary-adrenal (HPA) function,” he said, referring to the body’s main stress response system. “It can also foster skin infection, including bacterial, fungal, viral, and parasitic infection.”

In addition, topical steroids that are misused as skin lighteners have been reported to cause stretch marks, skin atrophy, inflammatory acne, and even metabolic disorders such as diabetes and hypertension, said Dr. Faye.

To further his point, he cited a 2021 prospective case-control study conducted across five sub-Saharan countries, which found that the use of “voluntary cosmetic depigmentation” significantly increased a person’s risk for necrotizing fasciitis of the lower limbs (odds ratio, 2.29; 95% CI, 1.19-3.73; P = .0226).

Similarly, mercury, another substance found in products commonly used to bleach skin, has been associated with problems ranging from rashes to renal toxicity. And because it’s so incredibly harmful, mercury is also known to cause neurologic abnormalities. 

Apart from causing certain conditions, prolonged use of skin-lightening products can change the way existing diseases present themselves as well as their severity, added Dr. Faye. 
 

An increased risk

But what about skin bleaching’s link with cancer? “Skin cancer on Black skin is uncommon, yet it occurs in skin-bleaching women,” said Dr. Faye.

“Since 2000, we have had some cases of skin cancer associated with skin bleaching,” he continued, adding that squamous cell carcinoma (SCC) is the most frequent type of cancer observed. 

If you look at what’s been published on the topic so far, you’ll see that “all the cases of skin cancer are located over the neck or some exposed area when skin bleaching products are used for more than 10 years,” said Dr. Faye. “And most of the time, the age of the patient ranges from 30 to 60 years.”

The first known case in Africa was reported in a 58-year-old woman from Ghana, who had been using skin bleaching products for close to 30 years. The patient presented with tumors on her face, neck, and arms.

Dr. Faye then proceeded to share more than 10 such carcinoma cases. “These previous reports strongly suggest a relationship between skin bleaching and skin cancers,” said Dr. Faye.

Indeed, there have been reports and publications in the literature that support his observation, including one last year, which found that use of the tyrosinase inhibitor hydroquinone was associated with approximately a threefold increased risk for skin cancer.

For some, including Brazil’s Dr. Lupi, Dr. Faye’s talk was enlightening: “I didn’t know about this relationship [of bleaching] with skin cancer, it was something new for me.”

But the prevalence of SCC is very low, compared with that of skin bleaching, Dr. Faye acknowledged. Moreover, the cancer observed in the cases reported could have resulted from a number of reasons, including exposure to harmful ultraviolet rays from the sun and genetic predisposition in addition to the use of bleaching products such as hydroquinone. “Other causes of skin cancer are not excluded,” he said.

To further explore the link between skin bleaching and cancer, “we need case-control studies to provide more evidence,” he added. Until then, dermatologists “should keep on promoting messages” to prevent SCC from occurring. This includes encouraging the use of proper sun protection in addition to discouraging the practice of skin bleaching, which still persists despite more than 10 African nations banning the use of toxic skin-lightening products.

Dr. Faye and Dr. Lupi report no relevant financial relationships.

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

SINGAPORE – Can the prolonged use of skin-lightening products, such as hydroquinone, lead to skin cancer?

This question was posed by Ousmane Faye, MD, PhD, director general of Mali’s Bamako Dermatology Hospital, at the World Congress of Dermatology. 

Dr. Faye explored the issue during a hot topics session at the meeting, prefacing that it was an important question to ask because “in West Africa, skin bleaching is very common.”

“There are many local names” for skin bleaching, he said. “For example, in Senegal, it’s called xessal; in Mali and Ivory Coast, its name is caco; in South Africa, there are many names, like ukutsheyisa.”

Skin bleaching refers to the cosmetic misuse of topical agents to change one’s natural skin color. It’s a centuries-old practice that people, mainly women, adopt “to increase attractiveness and self-esteem,” explained Dr. Faye.

To demonstrate how pervasive skin bleaching is on the continent, he presented a slide that summarized figures from six studies spanning the past 2 decades. Prevalence ranged from 25% in Mali (based on a 1993 survey of 210 women) to a high of 79.25% in Benin (from a sample size of 511 women in 2019). In other studies of women in Burkina Faso and Togo, the figures were 44.3% and 58.9%, respectively. The most recently conducted study, which involved 2,689 Senegalese women and was published in 2022, found that nearly 6 in 10 (59.2%) respondents used skin-lightening products.

But skin bleaching isn’t just limited to Africa, said session moderator Omar Lupi, MD, PhD, associate professor of dermatology at the Federal University of the State of Rio de Janeiro, when approached for an independent comment. “It’s a traditional practice around the world. Maybe not in the developed countries, but it’s quite common in Africa, in South America, and in Asia.”

His sentiments are echoed in a meta-analysis that was published in the International Journal of Dermatology in 2019. The work examined 68 studies involving more than 67,000 people across Africa, Asia, Europe, the Middle East, and North America. It found that the pooled lifetime prevalence of skin bleaching was 27.7% (95% confidence interval, 19.6-37.5; P < .01).

“This is an important and interesting topic because our world is shrinking,” Dr. Lupi told this news organization. “Even in countries that don’t have bleaching as a common situation, we now have patients who are migrating from one part [of the world] to another, so bleaching is something that can knock on your door and you need to be prepared.”

Misuse leads to complications

The issue is pertinent to dermatologists because skin bleaching is associated with a wide range of complications. Take, for example, topical steroids, which are the most common products used for bleaching, said Dr. Faye in his talk. 

“Clobetasol can suppress the hypothalamic-pituitary-adrenal (HPA) function,” he said, referring to the body’s main stress response system. “It can also foster skin infection, including bacterial, fungal, viral, and parasitic infection.”

In addition, topical steroids that are misused as skin lighteners have been reported to cause stretch marks, skin atrophy, inflammatory acne, and even metabolic disorders such as diabetes and hypertension, said Dr. Faye.

To further his point, he cited a 2021 prospective case-control study conducted across five sub-Saharan countries, which found that the use of “voluntary cosmetic depigmentation” significantly increased a person’s risk for necrotizing fasciitis of the lower limbs (odds ratio, 2.29; 95% CI, 1.19-3.73; P = .0226).

Similarly, mercury, another substance found in products commonly used to bleach skin, has been associated with problems ranging from rashes to renal toxicity. And because it’s so incredibly harmful, mercury is also known to cause neurologic abnormalities. 

Apart from causing certain conditions, prolonged use of skin-lightening products can change the way existing diseases present themselves as well as their severity, added Dr. Faye. 
 

An increased risk

But what about skin bleaching’s link with cancer? “Skin cancer on Black skin is uncommon, yet it occurs in skin-bleaching women,” said Dr. Faye.

“Since 2000, we have had some cases of skin cancer associated with skin bleaching,” he continued, adding that squamous cell carcinoma (SCC) is the most frequent type of cancer observed. 

If you look at what’s been published on the topic so far, you’ll see that “all the cases of skin cancer are located over the neck or some exposed area when skin bleaching products are used for more than 10 years,” said Dr. Faye. “And most of the time, the age of the patient ranges from 30 to 60 years.”

The first known case in Africa was reported in a 58-year-old woman from Ghana, who had been using skin bleaching products for close to 30 years. The patient presented with tumors on her face, neck, and arms.

Dr. Faye then proceeded to share more than 10 such carcinoma cases. “These previous reports strongly suggest a relationship between skin bleaching and skin cancers,” said Dr. Faye.

Indeed, there have been reports and publications in the literature that support his observation, including one last year, which found that use of the tyrosinase inhibitor hydroquinone was associated with approximately a threefold increased risk for skin cancer.

For some, including Brazil’s Dr. Lupi, Dr. Faye’s talk was enlightening: “I didn’t know about this relationship [of bleaching] with skin cancer, it was something new for me.”

But the prevalence of SCC is very low, compared with that of skin bleaching, Dr. Faye acknowledged. Moreover, the cancer observed in the cases reported could have resulted from a number of reasons, including exposure to harmful ultraviolet rays from the sun and genetic predisposition in addition to the use of bleaching products such as hydroquinone. “Other causes of skin cancer are not excluded,” he said.

To further explore the link between skin bleaching and cancer, “we need case-control studies to provide more evidence,” he added. Until then, dermatologists “should keep on promoting messages” to prevent SCC from occurring. This includes encouraging the use of proper sun protection in addition to discouraging the practice of skin bleaching, which still persists despite more than 10 African nations banning the use of toxic skin-lightening products.

Dr. Faye and Dr. Lupi report no relevant financial relationships.

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

SINGAPORE – Can the prolonged use of skin-lightening products, such as hydroquinone, lead to skin cancer?

This question was posed by Ousmane Faye, MD, PhD, director general of Mali’s Bamako Dermatology Hospital, at the World Congress of Dermatology. 

Dr. Faye explored the issue during a hot topics session at the meeting, prefacing that it was an important question to ask because “in West Africa, skin bleaching is very common.”

“There are many local names” for skin bleaching, he said. “For example, in Senegal, it’s called xessal; in Mali and Ivory Coast, its name is caco; in South Africa, there are many names, like ukutsheyisa.”

Skin bleaching refers to the cosmetic misuse of topical agents to change one’s natural skin color. It’s a centuries-old practice that people, mainly women, adopt “to increase attractiveness and self-esteem,” explained Dr. Faye.

To demonstrate how pervasive skin bleaching is on the continent, he presented a slide that summarized figures from six studies spanning the past 2 decades. Prevalence ranged from 25% in Mali (based on a 1993 survey of 210 women) to a high of 79.25% in Benin (from a sample size of 511 women in 2019). In other studies of women in Burkina Faso and Togo, the figures were 44.3% and 58.9%, respectively. The most recently conducted study, which involved 2,689 Senegalese women and was published in 2022, found that nearly 6 in 10 (59.2%) respondents used skin-lightening products.

But skin bleaching isn’t just limited to Africa, said session moderator Omar Lupi, MD, PhD, associate professor of dermatology at the Federal University of the State of Rio de Janeiro, when approached for an independent comment. “It’s a traditional practice around the world. Maybe not in the developed countries, but it’s quite common in Africa, in South America, and in Asia.”

His sentiments are echoed in a meta-analysis that was published in the International Journal of Dermatology in 2019. The work examined 68 studies involving more than 67,000 people across Africa, Asia, Europe, the Middle East, and North America. It found that the pooled lifetime prevalence of skin bleaching was 27.7% (95% confidence interval, 19.6-37.5; P < .01).

“This is an important and interesting topic because our world is shrinking,” Dr. Lupi told this news organization. “Even in countries that don’t have bleaching as a common situation, we now have patients who are migrating from one part [of the world] to another, so bleaching is something that can knock on your door and you need to be prepared.”

Misuse leads to complications

The issue is pertinent to dermatologists because skin bleaching is associated with a wide range of complications. Take, for example, topical steroids, which are the most common products used for bleaching, said Dr. Faye in his talk. 

“Clobetasol can suppress the hypothalamic-pituitary-adrenal (HPA) function,” he said, referring to the body’s main stress response system. “It can also foster skin infection, including bacterial, fungal, viral, and parasitic infection.”

In addition, topical steroids that are misused as skin lighteners have been reported to cause stretch marks, skin atrophy, inflammatory acne, and even metabolic disorders such as diabetes and hypertension, said Dr. Faye.

To further his point, he cited a 2021 prospective case-control study conducted across five sub-Saharan countries, which found that the use of “voluntary cosmetic depigmentation” significantly increased a person’s risk for necrotizing fasciitis of the lower limbs (odds ratio, 2.29; 95% CI, 1.19-3.73; P = .0226).

Similarly, mercury, another substance found in products commonly used to bleach skin, has been associated with problems ranging from rashes to renal toxicity. And because it’s so incredibly harmful, mercury is also known to cause neurologic abnormalities. 

Apart from causing certain conditions, prolonged use of skin-lightening products can change the way existing diseases present themselves as well as their severity, added Dr. Faye. 
 

An increased risk

But what about skin bleaching’s link with cancer? “Skin cancer on Black skin is uncommon, yet it occurs in skin-bleaching women,” said Dr. Faye.

“Since 2000, we have had some cases of skin cancer associated with skin bleaching,” he continued, adding that squamous cell carcinoma (SCC) is the most frequent type of cancer observed. 

If you look at what’s been published on the topic so far, you’ll see that “all the cases of skin cancer are located over the neck or some exposed area when skin bleaching products are used for more than 10 years,” said Dr. Faye. “And most of the time, the age of the patient ranges from 30 to 60 years.”

The first known case in Africa was reported in a 58-year-old woman from Ghana, who had been using skin bleaching products for close to 30 years. The patient presented with tumors on her face, neck, and arms.

Dr. Faye then proceeded to share more than 10 such carcinoma cases. “These previous reports strongly suggest a relationship between skin bleaching and skin cancers,” said Dr. Faye.

Indeed, there have been reports and publications in the literature that support his observation, including one last year, which found that use of the tyrosinase inhibitor hydroquinone was associated with approximately a threefold increased risk for skin cancer.

For some, including Brazil’s Dr. Lupi, Dr. Faye’s talk was enlightening: “I didn’t know about this relationship [of bleaching] with skin cancer, it was something new for me.”

But the prevalence of SCC is very low, compared with that of skin bleaching, Dr. Faye acknowledged. Moreover, the cancer observed in the cases reported could have resulted from a number of reasons, including exposure to harmful ultraviolet rays from the sun and genetic predisposition in addition to the use of bleaching products such as hydroquinone. “Other causes of skin cancer are not excluded,” he said.

To further explore the link between skin bleaching and cancer, “we need case-control studies to provide more evidence,” he added. Until then, dermatologists “should keep on promoting messages” to prevent SCC from occurring. This includes encouraging the use of proper sun protection in addition to discouraging the practice of skin bleaching, which still persists despite more than 10 African nations banning the use of toxic skin-lightening products.

Dr. Faye and Dr. Lupi report no relevant financial relationships.

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

America’s most popular oral nasal decongestant, phenylephrine, was deemed ineffective by a Food and Drug Administration panel in a unanimous vote on Sept. 12.

The Nonprescription Drug Advisory Committee discussed the efficacy and pharmacokinetic data for phenylephrine. The committee’s next move is to determine if the drug’s status as Generally Recognized as Safe and Effective should be revoked. This would mean manufacturers would have to come up with new formulations, or products containing the drug would be removed from store shelves. NDAC did not disclose a timeline for assessing GRASE status.

A version of this article appeared on Medscape.com.

America’s most popular oral nasal decongestant, phenylephrine, was deemed ineffective by a Food and Drug Administration panel in a unanimous vote on Sept. 12.

The Nonprescription Drug Advisory Committee discussed the efficacy and pharmacokinetic data for phenylephrine. The committee’s next move is to determine if the drug’s status as Generally Recognized as Safe and Effective should be revoked. This would mean manufacturers would have to come up with new formulations, or products containing the drug would be removed from store shelves. NDAC did not disclose a timeline for assessing GRASE status.

A version of this article appeared on Medscape.com.

America’s most popular oral nasal decongestant, phenylephrine, was deemed ineffective by a Food and Drug Administration panel in a unanimous vote on Sept. 12.

The Nonprescription Drug Advisory Committee discussed the efficacy and pharmacokinetic data for phenylephrine. The committee’s next move is to determine if the drug’s status as Generally Recognized as Safe and Effective should be revoked. This would mean manufacturers would have to come up with new formulations, or products containing the drug would be removed from store shelves. NDAC did not disclose a timeline for assessing GRASE status.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

How do you tell if a condition is caused by an infection?

It seems like an obvious question, right? In the post–van Leeuwenhoek era we can look at whatever part of the body is diseased under a microscope and see microbes – you know, the usual suspects.

Except when we can’t. And there are plenty of cases where we can’t: where the microbe is too small to be seen without more advanced imaging techniques, like with viruses; or when the pathogen is sparsely populated or hard to culture, like Mycobacterium.

Finding out that a condition is the result of an infection is not only an exercise for 19th century physicians. After all, it was 2008 when Barry Marshall and Robin Warren won their Nobel Prize for proving that stomach ulcers, long thought to be due to “stress,” were actually caused by a tiny microbe called Helicobacter pylori.

And this week, we are looking at a study which, once again, begins to suggest that a condition thought to be more or less random – cerebral amyloid angiopathy – may actually be the result of an infectious disease.

We’re talking about this paper, appearing in JAMA, which is just a great example of old-fashioned shoe-leather epidemiology. But let’s get up to speed on cerebral amyloid angiopathy (CAA) first.

CAA is characterized by the deposition of amyloid protein in the brain. While there are some genetic causes, they are quite rare, and most cases are thought to be idiopathic. Recent analyses suggest that somewhere between 5% and 7% of cognitively normal older adults have CAA, but the rate is much higher among those with intracerebral hemorrhage – brain bleeds. In fact, CAA is the second-most common cause of bleeding in the brain, second only to severe hypertension.

Most of the textbooks continue to describe CAA as a sporadic condition, but there have been some intriguing studies that suggest it may be transmissible. An article in Nature highlights cases that seemed to develop after the administration of cadaveric pituitary hormone.

Other studies have shown potential transmission via dura mater grafts and neurosurgical instruments. But despite those clues, no infectious organism has been identified. Some have suggested that the long latent period and difficulty of finding a responsible microbe points to a prion-like disease not yet known. But these studies are more or less case series. The new JAMA paper gives us, if not a smoking gun, a pretty decent set of fingerprints.

Here’s the idea: If CAA is caused by some infectious agent, it may be transmitted in the blood. We know that a decent percentage of people who have spontaneous brain bleeds have CAA. If those people donated blood in the past, maybe the people who received that blood would be at risk for brain bleeds too.

courtesy Dr. F. Perry Wilson

courtesy Dr. F. Perry Wilson

courtesy Dr. F. Perry Wilson

courtesy JAMA Internal Medicine

Dr. F. Perry Wilson is an associate professor of medicine and public health and director of Yale University’s Clinical and Translational Research Accelerator in New Haven, Conn. He reported no conflicts of interest.
 

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

This transcript has been edited for clarity.

How do you tell if a condition is caused by an infection?

It seems like an obvious question, right? In the post–van Leeuwenhoek era we can look at whatever part of the body is diseased under a microscope and see microbes – you know, the usual suspects.

Except when we can’t. And there are plenty of cases where we can’t: where the microbe is too small to be seen without more advanced imaging techniques, like with viruses; or when the pathogen is sparsely populated or hard to culture, like Mycobacterium.

Finding out that a condition is the result of an infection is not only an exercise for 19th century physicians. After all, it was 2008 when Barry Marshall and Robin Warren won their Nobel Prize for proving that stomach ulcers, long thought to be due to “stress,” were actually caused by a tiny microbe called Helicobacter pylori.

And this week, we are looking at a study which, once again, begins to suggest that a condition thought to be more or less random – cerebral amyloid angiopathy – may actually be the result of an infectious disease.

We’re talking about this paper, appearing in JAMA, which is just a great example of old-fashioned shoe-leather epidemiology. But let’s get up to speed on cerebral amyloid angiopathy (CAA) first.

CAA is characterized by the deposition of amyloid protein in the brain. While there are some genetic causes, they are quite rare, and most cases are thought to be idiopathic. Recent analyses suggest that somewhere between 5% and 7% of cognitively normal older adults have CAA, but the rate is much higher among those with intracerebral hemorrhage – brain bleeds. In fact, CAA is the second-most common cause of bleeding in the brain, second only to severe hypertension.

Most of the textbooks continue to describe CAA as a sporadic condition, but there have been some intriguing studies that suggest it may be transmissible. An article in Nature highlights cases that seemed to develop after the administration of cadaveric pituitary hormone.

Other studies have shown potential transmission via dura mater grafts and neurosurgical instruments. But despite those clues, no infectious organism has been identified. Some have suggested that the long latent period and difficulty of finding a responsible microbe points to a prion-like disease not yet known. But these studies are more or less case series. The new JAMA paper gives us, if not a smoking gun, a pretty decent set of fingerprints.

Here’s the idea: If CAA is caused by some infectious agent, it may be transmitted in the blood. We know that a decent percentage of people who have spontaneous brain bleeds have CAA. If those people donated blood in the past, maybe the people who received that blood would be at risk for brain bleeds too.

courtesy Dr. F. Perry Wilson

courtesy Dr. F. Perry Wilson

courtesy Dr. F. Perry Wilson

courtesy JAMA Internal Medicine

Dr. F. Perry Wilson is an associate professor of medicine and public health and director of Yale University’s Clinical and Translational Research Accelerator in New Haven, Conn. He reported no conflicts of interest.
 

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

This transcript has been edited for clarity.

How do you tell if a condition is caused by an infection?

It seems like an obvious question, right? In the post–van Leeuwenhoek era we can look at whatever part of the body is diseased under a microscope and see microbes – you know, the usual suspects.

Except when we can’t. And there are plenty of cases where we can’t: where the microbe is too small to be seen without more advanced imaging techniques, like with viruses; or when the pathogen is sparsely populated or hard to culture, like Mycobacterium.

Finding out that a condition is the result of an infection is not only an exercise for 19th century physicians. After all, it was 2008 when Barry Marshall and Robin Warren won their Nobel Prize for proving that stomach ulcers, long thought to be due to “stress,” were actually caused by a tiny microbe called Helicobacter pylori.

And this week, we are looking at a study which, once again, begins to suggest that a condition thought to be more or less random – cerebral amyloid angiopathy – may actually be the result of an infectious disease.

We’re talking about this paper, appearing in JAMA, which is just a great example of old-fashioned shoe-leather epidemiology. But let’s get up to speed on cerebral amyloid angiopathy (CAA) first.

CAA is characterized by the deposition of amyloid protein in the brain. While there are some genetic causes, they are quite rare, and most cases are thought to be idiopathic. Recent analyses suggest that somewhere between 5% and 7% of cognitively normal older adults have CAA, but the rate is much higher among those with intracerebral hemorrhage – brain bleeds. In fact, CAA is the second-most common cause of bleeding in the brain, second only to severe hypertension.

Most of the textbooks continue to describe CAA as a sporadic condition, but there have been some intriguing studies that suggest it may be transmissible. An article in Nature highlights cases that seemed to develop after the administration of cadaveric pituitary hormone.

Other studies have shown potential transmission via dura mater grafts and neurosurgical instruments. But despite those clues, no infectious organism has been identified. Some have suggested that the long latent period and difficulty of finding a responsible microbe points to a prion-like disease not yet known. But these studies are more or less case series. The new JAMA paper gives us, if not a smoking gun, a pretty decent set of fingerprints.

Here’s the idea: If CAA is caused by some infectious agent, it may be transmitted in the blood. We know that a decent percentage of people who have spontaneous brain bleeds have CAA. If those people donated blood in the past, maybe the people who received that blood would be at risk for brain bleeds too.

courtesy Dr. F. Perry Wilson

courtesy Dr. F. Perry Wilson

courtesy Dr. F. Perry Wilson

courtesy JAMA Internal Medicine

Dr. F. Perry Wilson is an associate professor of medicine and public health and director of Yale University’s Clinical and Translational Research Accelerator in New Haven, Conn. He reported no conflicts of interest.
 

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

TOPLINE:

Eight psychosocial factors, grouped into two distinct clusters, are significantly associated with risk for atrial fibrillation in postmenopausal women, with insomnia and stressful life events (SLEs) being the most strongly associated with AFib, a large new study has found.

METHODOLOGY:

• In addition to traditional risk factors such as obesity, advanced age, ethnicity, smoking, alcohol, hypertension, diabetes, coronary artery disease, heart failure, and emotional and psychological distress may also affect AFib.
• The study included 83,736 postmenopausal women in the Women’s Health Initiative (mean age, 63.9 years; 88.1% White) who did not have AFib at baseline.
• From questionnaires, researchers collected information on psychosocial stressors and used hierarchical cluster analysis to identify patterns of psychosocial predictors.
• They separated these clusters into quartiles, identified associations between psychosocial exposure variables, and adjusted for traditional risk factors.
• Over an average follow-up of 10.5 years, 23,954 participants (28.6%) developed incident AFib.
•  

TAKEAWAY:

• The analysis generated two clusters of distinct psychosocial variables that were significantly associated with AFib: the Stress Cluster, including SLEs, depressive symptoms, and insomnia; and the Strain Cluster, including three personality traits: optimism, cynical hostility, and emotional expressiveness; and two social measures: social support, and social strain.
• Those in the highest quartiles of both the Stress Cluster and the Strain Cluster had greater rates of AFib, compared with those in the lowest quartiles.
• In a final model, the association between SLEs (hazard ratio, 1.02; 95% confidence interval, 1.01-1.04) and insomnia (HR, 1.04; 95% CI, 1.03-1.06) were most strongly linked to increased incidence of AFib, and a sensitivity analysis using snoring as a surrogate marker for sleep apnea didn’t change this outcome, supporting the independent effect of insomnia on AFib.
• In subgroup analyses, the Stress Cluster had a stronger association with AFib incidence in younger (50-69 years) versus older women (70-79 years), and in non-Hispanic White and Asian women versus Hispanic and non-Hispanic Black women.
•  

IN PRACTICE:

The results support the hypothesis that psychosocial predictors account for additional risk for AFib “above and beyond” traditional risk factors, the authors wrote. Identifying and addressing sex-specific, modifiable risk factors, including insomnia, “may help reduce the burden of AF[ib] in aging women.”

SOURCE:

The study was conducted by Susan X. Zhao, MD, division of cardiology, department of medicine, Santa Clara Valley Medical Center, San Jose, Calif., and colleagues. It was published online in the Journal of the American Heart Association.

LIMITATIONS:

The psychometric questionnaires were administered only at study entry, but psychosocial variables may change over time. Data on sleep apnea and other sleep disorders, which may confound the relationship between insomnia and AFib, were not available, and although the study included a sensitivity analysis controlling for snoring, this is an imperfect surrogate for sleep apnea. Generalizability to other demographic, racial, and ethnic groups is limited.

DISCLOSURES:

The Women’s Health Initiative program is funded by the National Heart, Lung, and Blood Institute; National Institutes of Health; and the Department of Health & Human Services. The authors have no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Eight psychosocial factors, grouped into two distinct clusters, are significantly associated with risk for atrial fibrillation in postmenopausal women, with insomnia and stressful life events (SLEs) being the most strongly associated with AFib, a large new study has found.

METHODOLOGY:

• In addition to traditional risk factors such as obesity, advanced age, ethnicity, smoking, alcohol, hypertension, diabetes, coronary artery disease, heart failure, and emotional and psychological distress may also affect AFib.
• The study included 83,736 postmenopausal women in the Women’s Health Initiative (mean age, 63.9 years; 88.1% White) who did not have AFib at baseline.
• From questionnaires, researchers collected information on psychosocial stressors and used hierarchical cluster analysis to identify patterns of psychosocial predictors.
• They separated these clusters into quartiles, identified associations between psychosocial exposure variables, and adjusted for traditional risk factors.
• Over an average follow-up of 10.5 years, 23,954 participants (28.6%) developed incident AFib.
•  

TAKEAWAY:

• The analysis generated two clusters of distinct psychosocial variables that were significantly associated with AFib: the Stress Cluster, including SLEs, depressive symptoms, and insomnia; and the Strain Cluster, including three personality traits: optimism, cynical hostility, and emotional expressiveness; and two social measures: social support, and social strain.
• Those in the highest quartiles of both the Stress Cluster and the Strain Cluster had greater rates of AFib, compared with those in the lowest quartiles.
• In a final model, the association between SLEs (hazard ratio, 1.02; 95% confidence interval, 1.01-1.04) and insomnia (HR, 1.04; 95% CI, 1.03-1.06) were most strongly linked to increased incidence of AFib, and a sensitivity analysis using snoring as a surrogate marker for sleep apnea didn’t change this outcome, supporting the independent effect of insomnia on AFib.
• In subgroup analyses, the Stress Cluster had a stronger association with AFib incidence in younger (50-69 years) versus older women (70-79 years), and in non-Hispanic White and Asian women versus Hispanic and non-Hispanic Black women.
•  

IN PRACTICE:

The results support the hypothesis that psychosocial predictors account for additional risk for AFib “above and beyond” traditional risk factors, the authors wrote. Identifying and addressing sex-specific, modifiable risk factors, including insomnia, “may help reduce the burden of AF[ib] in aging women.”

SOURCE:

The study was conducted by Susan X. Zhao, MD, division of cardiology, department of medicine, Santa Clara Valley Medical Center, San Jose, Calif., and colleagues. It was published online in the Journal of the American Heart Association.

LIMITATIONS:

The psychometric questionnaires were administered only at study entry, but psychosocial variables may change over time. Data on sleep apnea and other sleep disorders, which may confound the relationship between insomnia and AFib, were not available, and although the study included a sensitivity analysis controlling for snoring, this is an imperfect surrogate for sleep apnea. Generalizability to other demographic, racial, and ethnic groups is limited.

DISCLOSURES:

The Women’s Health Initiative program is funded by the National Heart, Lung, and Blood Institute; National Institutes of Health; and the Department of Health & Human Services. The authors have no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Eight psychosocial factors, grouped into two distinct clusters, are significantly associated with risk for atrial fibrillation in postmenopausal women, with insomnia and stressful life events (SLEs) being the most strongly associated with AFib, a large new study has found.

METHODOLOGY:

• In addition to traditional risk factors such as obesity, advanced age, ethnicity, smoking, alcohol, hypertension, diabetes, coronary artery disease, heart failure, and emotional and psychological distress may also affect AFib.
• The study included 83,736 postmenopausal women in the Women’s Health Initiative (mean age, 63.9 years; 88.1% White) who did not have AFib at baseline.
• From questionnaires, researchers collected information on psychosocial stressors and used hierarchical cluster analysis to identify patterns of psychosocial predictors.
• They separated these clusters into quartiles, identified associations between psychosocial exposure variables, and adjusted for traditional risk factors.
• Over an average follow-up of 10.5 years, 23,954 participants (28.6%) developed incident AFib.
•  

TAKEAWAY:

• The analysis generated two clusters of distinct psychosocial variables that were significantly associated with AFib: the Stress Cluster, including SLEs, depressive symptoms, and insomnia; and the Strain Cluster, including three personality traits: optimism, cynical hostility, and emotional expressiveness; and two social measures: social support, and social strain.
• Those in the highest quartiles of both the Stress Cluster and the Strain Cluster had greater rates of AFib, compared with those in the lowest quartiles.
• In a final model, the association between SLEs (hazard ratio, 1.02; 95% confidence interval, 1.01-1.04) and insomnia (HR, 1.04; 95% CI, 1.03-1.06) were most strongly linked to increased incidence of AFib, and a sensitivity analysis using snoring as a surrogate marker for sleep apnea didn’t change this outcome, supporting the independent effect of insomnia on AFib.
• In subgroup analyses, the Stress Cluster had a stronger association with AFib incidence in younger (50-69 years) versus older women (70-79 years), and in non-Hispanic White and Asian women versus Hispanic and non-Hispanic Black women.
•  

IN PRACTICE:

The results support the hypothesis that psychosocial predictors account for additional risk for AFib “above and beyond” traditional risk factors, the authors wrote. Identifying and addressing sex-specific, modifiable risk factors, including insomnia, “may help reduce the burden of AF[ib] in aging women.”

SOURCE:

The study was conducted by Susan X. Zhao, MD, division of cardiology, department of medicine, Santa Clara Valley Medical Center, San Jose, Calif., and colleagues. It was published online in the Journal of the American Heart Association.

LIMITATIONS:

The psychometric questionnaires were administered only at study entry, but psychosocial variables may change over time. Data on sleep apnea and other sleep disorders, which may confound the relationship between insomnia and AFib, were not available, and although the study included a sensitivity analysis controlling for snoring, this is an imperfect surrogate for sleep apnea. Generalizability to other demographic, racial, and ethnic groups is limited.

DISCLOSURES:

The Women’s Health Initiative program is funded by the National Heart, Lung, and Blood Institute; National Institutes of Health; and the Department of Health & Human Services. The authors have no relevant conflicts of interest.

A version of this article appeared on Medscape.com.