Marcia Frellick

Current efforts to control high blood pressure (BP) are failing in the United States and globally.

The first World Health Organization (WHO) global report on hypertension found that only 54% of adults with hypertension are diagnosed, 42% get treatment, and just 21% have their hypertension controlled.

In the United States, almost half (48%) of adults have high BP, defined as a systolic BP > 130 mm Hg, or a diastolic BP > 80 mm Hg, or are taking medication for high BP, according to the Centers for Disease Control and Prevention. Only about one in four adults (22.5%) with high BP have their BP under control.

High BP is a major risk factor for coronary heart disease, heart failure, and stroke, and the problem of controlling it is only getting worse. In 2024, the American Heart Association estimates that, “among adults, prevalence of hypertension will increase from 51.2% in 2020 to 61.0% in 2050.”
 

Pharmacists Most Effective

Though many factors contribute to hypertension, researchers have found that the kind of specialist leading the hypertension team may play a role in success. Currently, most BP control teams are led by physicians in primary care.

In a recent meta-analysis involving 100 randomized controlled trials and more than 90,000 patients in Circulation, Katherine T. Mills, PhD, School of Public Health, Tulane University, New Orleans, Louisiana, and colleagues found that, while all the groups studied who led BP control efforts were successful in reducing BP, pharmacist- and community health worker–led teams saw the biggest reductions.

Those groups’ efforts resulted in the greatest systolic BP drops: −7.3 mm Hg (pharmacists) and −7.1 mm Hg (community health workers). Groups led by nurses and physicians saw systolic changes of −3 and −2.4 mm Hg, respectively.

Similarly, pharmacist- and community health worker–led efforts saw the greatest diastolic BP reductions (−3.8 and −3.1 mm Hg), compared with nurse-led (−1.6) and physician-led (−1.2) efforts.
 

Reductions Enough to Cut Cardiovascular Disease Risk

The reduction numbers for pharmacists are clinically meaningful, Mills said in an interview. “It’s greater than a lot of what we see from individual lifestyle changes,” such as reducing sodium intake or increasing physical activity.

“It’s a big enough blood pressure change to have meaningful reduction in risk of cardiovascular disease,” she said.

This evidence that the leader of the team matters is particularly important because the treatment of hypertension is not in doubt. Something else is not working the way it should.

“We have basically all the scientific evidence we need in terms of what interventions work. But there’s a big gap between that and what’s actually being done in the real world,” she said.

Mills said she was not surprised that pharmacists got the best results “because so much of it has to do with titrating medications and finding the right kind of medications for each patient.”

Additionally, BP management and control falls right into pharmacists’ wheelhouse, Mills noted, including evaluating medication side effects and talking to patients about medication adherence.
 

Why Pharmacists May Be More Successful

In an accompanying editorial, Ross T. Tsuyuki, PharmD, with the EPICORE Centre, Division of Cardiology, University of Alberta in Edmonton, Canada, and coauthors said the Mills study provides further data to support pharmacists leading BP control efforts, but it’s not the data that have been keeping the model from changing. The barriers include turf wars and lack of legislative change.

The editorialists also said having pharmacist-led BP teams is only the first step. “We need pharmacists to independently prescribe,” they wrote.

“Since individual states govern the scope of practice of pharmacists,” the editorialists wrote, “we have the enormous task of changing regulations to allow pharmacists to independently prescribe for hypertension. But it can be done. The Canadian province of Alberta allows pharmacists to prescribe. And more recently, Idaho. While most states allow some sort of collaborative (dependent) prescribing, that is only a first step.”

Allowing pharmacists to independently prescribe will help populations who do not have a physician or can’t get access to a physician, the editorialists wrote. But changing state legislation would be a lengthy and complex effort.
 

Physician-Led BP Control Model ‘Seems to Fail Miserably’

Coauthor of the editorial, Florian Rader, MD, MSc, medical director of the Hypertension Center of Excellence at Cedars-Sinai Medical Center in Los Angeles, California, said in an interview that, currently, physician-led teams are the norm, “and that model seems to fail miserably.”

He offered several key reasons for that. In primary care, patients with hypertension often have other problems — they may have high cholesterol or diabetes. “They may have acute illnesses that bother them as well as hypertension that doesn’t bother them,” he said.

Physicians tend to find excuses not to increase or add BP medications, Rader said. “We tend then to blame ‘white coat effect’ or say ‘you’re just nervous today.’ ”

Pharmacists, comparatively, are more protocol driven, he said. “They essentially look at blood pressure and they have an algorithm in their mind. If the blood pressure hits the guideline-stated bar, start this medication. If it hits another bar, increase or add another medication.”

Rader said turf wars are also keeping physician-led teams from changing, fueled by fears that patients will seek care from pharmacists instead of physicians.

“I don’t think the pharmacists will steal a single patient,” Rader said. “If a physician had a healthcare partner like a pharmacist to optimize blood pressure, then [patients] come back to the physician with normalized BP on the right medications. I think it’s a total win-win. I think we just have to get over that.”

Pharmacist-led warfarin clinics are very well established, Rader said, “but for whatever reason, when it comes to blood pressure, physicians are a little bit more hesitant.”
 

Collaboration Yes, Independent No

Hypertension expert Donald J. DiPette, MD, Health Sciences Distinguished Professor in the Department of Internal Medicine at University of South Carolina, Columbia, said he completely agrees with Mills and colleagues’ conclusion. “Pharmacists and community health workers are most effective at leading BP intervention implementation and should be prioritized in future hypertension control efforts.”

The conclusion “is in line with the thinking of major organizations,” said DiPette, who helped develop the WHO’s most recent pharmacological treatment of hypertension guidelines. “WHO suggests that pharmacological treatment of hypertension can be provided by nonphysician professionals such as pharmacists and nurses as long as the following conditions are met: Proper training, prescribing authority, specific management protocols, and physician oversight.”

DiPette strongly believes BP control efforts should be supervised by a physician, but that could come in different ways. He suggested a collaborative but physician-supervised development of a protocol. Everyone contributes, but the physician signs off on it.

As for the Idaho example of independent practice for pharmacists, DiPette said he doesn’t think that will make a big difference in control rates. “That’s still not team-based care.”
 

Community Health Workers Key

He said he was also glad to see community healthcare workers emerge as the next-most-effective group after pharmacists to lead BP control teams. This is particularly important as BP control efforts globally need to consider the cultural experience of individual communities. “The community worker is on the ground, and can help overcome some of the cultural barriers,” he said.

“The key is to focus on team-based care and moving away from silo practice,” DiPette said.

Physicians, he said, often fall into “clinical or therapeutic inertia,” where BP is concerned. “We fail to titrate or add additional hypertensive medications even when they’re clearly indicated by the blood pressure. This is a problem not with the individual patient or the healthcare system, this is on us as physicians.”

Nonphysicians are more aligned with following protocols and guidelines, irrespective of the dynamics of what’s going on, he said.

And following protocols rigidly is a good thing for hypertension. “We’re not overtreating hypertension,” he emphasized. “We’re undertreating it.”

Reversing the trend on hypertension will take a sea change in medicine — changing institutions, systems, and individuals who have been doing things the same way for decades, he said.

“Our hypertension control rates are dismal,” DiPette said. “What’s more alarming is they’re going down. That’s the urgency. That’s the burning platform. We must strongly consider doing something different.”

Tsuyuki has received investigator-initiated arm’s length research grants from Merck, Pfizer, AstraZeneca, and Sanofi. He has been a speaker/consultant for Merck, Emergent BioSolutions, and Shoppers Drug Mart/Loblaw Companies Limited. Rader has been a consultant for Bristol Meyers Squibb, Cytokinetics, Idorsia, Medtronic, and ReCor Medical. Mills and coauthors reported no relevant financial relationships. DiPette declared no relevant financial relationships. He was part of a leadership team that developed WHO guidelines on hypertension.

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

Current efforts to control high blood pressure (BP) are failing in the United States and globally.

The first World Health Organization (WHO) global report on hypertension found that only 54% of adults with hypertension are diagnosed, 42% get treatment, and just 21% have their hypertension controlled.

In the United States, almost half (48%) of adults have high BP, defined as a systolic BP > 130 mm Hg, or a diastolic BP > 80 mm Hg, or are taking medication for high BP, according to the Centers for Disease Control and Prevention. Only about one in four adults (22.5%) with high BP have their BP under control.

High BP is a major risk factor for coronary heart disease, heart failure, and stroke, and the problem of controlling it is only getting worse. In 2024, the American Heart Association estimates that, “among adults, prevalence of hypertension will increase from 51.2% in 2020 to 61.0% in 2050.”
 

Pharmacists Most Effective

Though many factors contribute to hypertension, researchers have found that the kind of specialist leading the hypertension team may play a role in success. Currently, most BP control teams are led by physicians in primary care.

In a recent meta-analysis involving 100 randomized controlled trials and more than 90,000 patients in Circulation, Katherine T. Mills, PhD, School of Public Health, Tulane University, New Orleans, Louisiana, and colleagues found that, while all the groups studied who led BP control efforts were successful in reducing BP, pharmacist- and community health worker–led teams saw the biggest reductions.

Those groups’ efforts resulted in the greatest systolic BP drops: −7.3 mm Hg (pharmacists) and −7.1 mm Hg (community health workers). Groups led by nurses and physicians saw systolic changes of −3 and −2.4 mm Hg, respectively.

Similarly, pharmacist- and community health worker–led efforts saw the greatest diastolic BP reductions (−3.8 and −3.1 mm Hg), compared with nurse-led (−1.6) and physician-led (−1.2) efforts.
 

Reductions Enough to Cut Cardiovascular Disease Risk

The reduction numbers for pharmacists are clinically meaningful, Mills said in an interview. “It’s greater than a lot of what we see from individual lifestyle changes,” such as reducing sodium intake or increasing physical activity.

“It’s a big enough blood pressure change to have meaningful reduction in risk of cardiovascular disease,” she said.

This evidence that the leader of the team matters is particularly important because the treatment of hypertension is not in doubt. Something else is not working the way it should.

“We have basically all the scientific evidence we need in terms of what interventions work. But there’s a big gap between that and what’s actually being done in the real world,” she said.

Mills said she was not surprised that pharmacists got the best results “because so much of it has to do with titrating medications and finding the right kind of medications for each patient.”

Additionally, BP management and control falls right into pharmacists’ wheelhouse, Mills noted, including evaluating medication side effects and talking to patients about medication adherence.
 

Why Pharmacists May Be More Successful

In an accompanying editorial, Ross T. Tsuyuki, PharmD, with the EPICORE Centre, Division of Cardiology, University of Alberta in Edmonton, Canada, and coauthors said the Mills study provides further data to support pharmacists leading BP control efforts, but it’s not the data that have been keeping the model from changing. The barriers include turf wars and lack of legislative change.

The editorialists also said having pharmacist-led BP teams is only the first step. “We need pharmacists to independently prescribe,” they wrote.

“Since individual states govern the scope of practice of pharmacists,” the editorialists wrote, “we have the enormous task of changing regulations to allow pharmacists to independently prescribe for hypertension. But it can be done. The Canadian province of Alberta allows pharmacists to prescribe. And more recently, Idaho. While most states allow some sort of collaborative (dependent) prescribing, that is only a first step.”

Allowing pharmacists to independently prescribe will help populations who do not have a physician or can’t get access to a physician, the editorialists wrote. But changing state legislation would be a lengthy and complex effort.
 

Physician-Led BP Control Model ‘Seems to Fail Miserably’

Coauthor of the editorial, Florian Rader, MD, MSc, medical director of the Hypertension Center of Excellence at Cedars-Sinai Medical Center in Los Angeles, California, said in an interview that, currently, physician-led teams are the norm, “and that model seems to fail miserably.”

He offered several key reasons for that. In primary care, patients with hypertension often have other problems — they may have high cholesterol or diabetes. “They may have acute illnesses that bother them as well as hypertension that doesn’t bother them,” he said.

Physicians tend to find excuses not to increase or add BP medications, Rader said. “We tend then to blame ‘white coat effect’ or say ‘you’re just nervous today.’ ”

Pharmacists, comparatively, are more protocol driven, he said. “They essentially look at blood pressure and they have an algorithm in their mind. If the blood pressure hits the guideline-stated bar, start this medication. If it hits another bar, increase or add another medication.”

Rader said turf wars are also keeping physician-led teams from changing, fueled by fears that patients will seek care from pharmacists instead of physicians.

“I don’t think the pharmacists will steal a single patient,” Rader said. “If a physician had a healthcare partner like a pharmacist to optimize blood pressure, then [patients] come back to the physician with normalized BP on the right medications. I think it’s a total win-win. I think we just have to get over that.”

Pharmacist-led warfarin clinics are very well established, Rader said, “but for whatever reason, when it comes to blood pressure, physicians are a little bit more hesitant.”
 

Collaboration Yes, Independent No

Hypertension expert Donald J. DiPette, MD, Health Sciences Distinguished Professor in the Department of Internal Medicine at University of South Carolina, Columbia, said he completely agrees with Mills and colleagues’ conclusion. “Pharmacists and community health workers are most effective at leading BP intervention implementation and should be prioritized in future hypertension control efforts.”

The conclusion “is in line with the thinking of major organizations,” said DiPette, who helped develop the WHO’s most recent pharmacological treatment of hypertension guidelines. “WHO suggests that pharmacological treatment of hypertension can be provided by nonphysician professionals such as pharmacists and nurses as long as the following conditions are met: Proper training, prescribing authority, specific management protocols, and physician oversight.”

DiPette strongly believes BP control efforts should be supervised by a physician, but that could come in different ways. He suggested a collaborative but physician-supervised development of a protocol. Everyone contributes, but the physician signs off on it.

As for the Idaho example of independent practice for pharmacists, DiPette said he doesn’t think that will make a big difference in control rates. “That’s still not team-based care.”
 

Community Health Workers Key

He said he was also glad to see community healthcare workers emerge as the next-most-effective group after pharmacists to lead BP control teams. This is particularly important as BP control efforts globally need to consider the cultural experience of individual communities. “The community worker is on the ground, and can help overcome some of the cultural barriers,” he said.

“The key is to focus on team-based care and moving away from silo practice,” DiPette said.

Physicians, he said, often fall into “clinical or therapeutic inertia,” where BP is concerned. “We fail to titrate or add additional hypertensive medications even when they’re clearly indicated by the blood pressure. This is a problem not with the individual patient or the healthcare system, this is on us as physicians.”

Nonphysicians are more aligned with following protocols and guidelines, irrespective of the dynamics of what’s going on, he said.

And following protocols rigidly is a good thing for hypertension. “We’re not overtreating hypertension,” he emphasized. “We’re undertreating it.”

Reversing the trend on hypertension will take a sea change in medicine — changing institutions, systems, and individuals who have been doing things the same way for decades, he said.

“Our hypertension control rates are dismal,” DiPette said. “What’s more alarming is they’re going down. That’s the urgency. That’s the burning platform. We must strongly consider doing something different.”

Tsuyuki has received investigator-initiated arm’s length research grants from Merck, Pfizer, AstraZeneca, and Sanofi. He has been a speaker/consultant for Merck, Emergent BioSolutions, and Shoppers Drug Mart/Loblaw Companies Limited. Rader has been a consultant for Bristol Meyers Squibb, Cytokinetics, Idorsia, Medtronic, and ReCor Medical. Mills and coauthors reported no relevant financial relationships. DiPette declared no relevant financial relationships. He was part of a leadership team that developed WHO guidelines on hypertension.

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

Current efforts to control high blood pressure (BP) are failing in the United States and globally.

The first World Health Organization (WHO) global report on hypertension found that only 54% of adults with hypertension are diagnosed, 42% get treatment, and just 21% have their hypertension controlled.

In the United States, almost half (48%) of adults have high BP, defined as a systolic BP > 130 mm Hg, or a diastolic BP > 80 mm Hg, or are taking medication for high BP, according to the Centers for Disease Control and Prevention. Only about one in four adults (22.5%) with high BP have their BP under control.

High BP is a major risk factor for coronary heart disease, heart failure, and stroke, and the problem of controlling it is only getting worse. In 2024, the American Heart Association estimates that, “among adults, prevalence of hypertension will increase from 51.2% in 2020 to 61.0% in 2050.”
 

Pharmacists Most Effective

Though many factors contribute to hypertension, researchers have found that the kind of specialist leading the hypertension team may play a role in success. Currently, most BP control teams are led by physicians in primary care.

In a recent meta-analysis involving 100 randomized controlled trials and more than 90,000 patients in Circulation, Katherine T. Mills, PhD, School of Public Health, Tulane University, New Orleans, Louisiana, and colleagues found that, while all the groups studied who led BP control efforts were successful in reducing BP, pharmacist- and community health worker–led teams saw the biggest reductions.

Those groups’ efforts resulted in the greatest systolic BP drops: −7.3 mm Hg (pharmacists) and −7.1 mm Hg (community health workers). Groups led by nurses and physicians saw systolic changes of −3 and −2.4 mm Hg, respectively.

Similarly, pharmacist- and community health worker–led efforts saw the greatest diastolic BP reductions (−3.8 and −3.1 mm Hg), compared with nurse-led (−1.6) and physician-led (−1.2) efforts.
 

Reductions Enough to Cut Cardiovascular Disease Risk

The reduction numbers for pharmacists are clinically meaningful, Mills said in an interview. “It’s greater than a lot of what we see from individual lifestyle changes,” such as reducing sodium intake or increasing physical activity.

“It’s a big enough blood pressure change to have meaningful reduction in risk of cardiovascular disease,” she said.

This evidence that the leader of the team matters is particularly important because the treatment of hypertension is not in doubt. Something else is not working the way it should.

“We have basically all the scientific evidence we need in terms of what interventions work. But there’s a big gap between that and what’s actually being done in the real world,” she said.

Mills said she was not surprised that pharmacists got the best results “because so much of it has to do with titrating medications and finding the right kind of medications for each patient.”

Additionally, BP management and control falls right into pharmacists’ wheelhouse, Mills noted, including evaluating medication side effects and talking to patients about medication adherence.
 

Why Pharmacists May Be More Successful

In an accompanying editorial, Ross T. Tsuyuki, PharmD, with the EPICORE Centre, Division of Cardiology, University of Alberta in Edmonton, Canada, and coauthors said the Mills study provides further data to support pharmacists leading BP control efforts, but it’s not the data that have been keeping the model from changing. The barriers include turf wars and lack of legislative change.

The editorialists also said having pharmacist-led BP teams is only the first step. “We need pharmacists to independently prescribe,” they wrote.

“Since individual states govern the scope of practice of pharmacists,” the editorialists wrote, “we have the enormous task of changing regulations to allow pharmacists to independently prescribe for hypertension. But it can be done. The Canadian province of Alberta allows pharmacists to prescribe. And more recently, Idaho. While most states allow some sort of collaborative (dependent) prescribing, that is only a first step.”

Allowing pharmacists to independently prescribe will help populations who do not have a physician or can’t get access to a physician, the editorialists wrote. But changing state legislation would be a lengthy and complex effort.
 

Physician-Led BP Control Model ‘Seems to Fail Miserably’

Coauthor of the editorial, Florian Rader, MD, MSc, medical director of the Hypertension Center of Excellence at Cedars-Sinai Medical Center in Los Angeles, California, said in an interview that, currently, physician-led teams are the norm, “and that model seems to fail miserably.”

He offered several key reasons for that. In primary care, patients with hypertension often have other problems — they may have high cholesterol or diabetes. “They may have acute illnesses that bother them as well as hypertension that doesn’t bother them,” he said.

Physicians tend to find excuses not to increase or add BP medications, Rader said. “We tend then to blame ‘white coat effect’ or say ‘you’re just nervous today.’ ”

Pharmacists, comparatively, are more protocol driven, he said. “They essentially look at blood pressure and they have an algorithm in their mind. If the blood pressure hits the guideline-stated bar, start this medication. If it hits another bar, increase or add another medication.”

Rader said turf wars are also keeping physician-led teams from changing, fueled by fears that patients will seek care from pharmacists instead of physicians.

“I don’t think the pharmacists will steal a single patient,” Rader said. “If a physician had a healthcare partner like a pharmacist to optimize blood pressure, then [patients] come back to the physician with normalized BP on the right medications. I think it’s a total win-win. I think we just have to get over that.”

Pharmacist-led warfarin clinics are very well established, Rader said, “but for whatever reason, when it comes to blood pressure, physicians are a little bit more hesitant.”
 

Collaboration Yes, Independent No

Hypertension expert Donald J. DiPette, MD, Health Sciences Distinguished Professor in the Department of Internal Medicine at University of South Carolina, Columbia, said he completely agrees with Mills and colleagues’ conclusion. “Pharmacists and community health workers are most effective at leading BP intervention implementation and should be prioritized in future hypertension control efforts.”

The conclusion “is in line with the thinking of major organizations,” said DiPette, who helped develop the WHO’s most recent pharmacological treatment of hypertension guidelines. “WHO suggests that pharmacological treatment of hypertension can be provided by nonphysician professionals such as pharmacists and nurses as long as the following conditions are met: Proper training, prescribing authority, specific management protocols, and physician oversight.”

DiPette strongly believes BP control efforts should be supervised by a physician, but that could come in different ways. He suggested a collaborative but physician-supervised development of a protocol. Everyone contributes, but the physician signs off on it.

As for the Idaho example of independent practice for pharmacists, DiPette said he doesn’t think that will make a big difference in control rates. “That’s still not team-based care.”
 

Community Health Workers Key

He said he was also glad to see community healthcare workers emerge as the next-most-effective group after pharmacists to lead BP control teams. This is particularly important as BP control efforts globally need to consider the cultural experience of individual communities. “The community worker is on the ground, and can help overcome some of the cultural barriers,” he said.

“The key is to focus on team-based care and moving away from silo practice,” DiPette said.

Physicians, he said, often fall into “clinical or therapeutic inertia,” where BP is concerned. “We fail to titrate or add additional hypertensive medications even when they’re clearly indicated by the blood pressure. This is a problem not with the individual patient or the healthcare system, this is on us as physicians.”

Nonphysicians are more aligned with following protocols and guidelines, irrespective of the dynamics of what’s going on, he said.

And following protocols rigidly is a good thing for hypertension. “We’re not overtreating hypertension,” he emphasized. “We’re undertreating it.”

Reversing the trend on hypertension will take a sea change in medicine — changing institutions, systems, and individuals who have been doing things the same way for decades, he said.

“Our hypertension control rates are dismal,” DiPette said. “What’s more alarming is they’re going down. That’s the urgency. That’s the burning platform. We must strongly consider doing something different.”

Tsuyuki has received investigator-initiated arm’s length research grants from Merck, Pfizer, AstraZeneca, and Sanofi. He has been a speaker/consultant for Merck, Emergent BioSolutions, and Shoppers Drug Mart/Loblaw Companies Limited. Rader has been a consultant for Bristol Meyers Squibb, Cytokinetics, Idorsia, Medtronic, and ReCor Medical. Mills and coauthors reported no relevant financial relationships. DiPette declared no relevant financial relationships. He was part of a leadership team that developed WHO guidelines on hypertension.

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

LOS ANGELES — Use of preexposure prophylaxis (PrEP) to prevent HIV is increasing overall, but both the rate of increase for starting PrEP and the rate of unmet need differ widely by demographic group, according to new data from a large study.

An analysis by Li Tao, MD, MS, PhD, director of real-world evidence at Gilead Sciences, and colleagues looked at statistical trends from 2019 to 2023 and found that Black, Hispanic, and Medicaid-insured populations continue to lack equitable access to PrEP.

Among the findings were that most new PrEP users were men with HIV risk factors who are commercially insured and live in predominantly non-Hispanic White areas (53% in 2019 and 43% in 2023). For comparison, men living in predominantly Black or Hispanic neighborhoods, or who are insured by Medicaid, saw lower proportions of PrEP use (16% in 2019 and 17% in 2023) despite higher annual increases in PrEP use (11% per year) and higher unmet needs.
 

Half a Million Real-World Participants

Tao presented her team’s findings at the Infectious Disease Week (IDWeek) 2024 Annual Meeting. The study included “more than half a million real-world PrEP users over the past 5 years,” she said.

The group with the lowest growth in initiation of PrEP in the study period (an annual percentage increase of 2%) and the lowest unmet need included men with HIV risk factors, who were using commercial insurance and living in White-dominant neighborhoods.

HIV risk factors included diagnosis of any sexually transmitted disease, contact with and exposure to communicable diseases, high-risk sexual behavior, contact with a hypodermic needle, long-term prophylaxis, HIV prevention counseling, and HIV screening.

Other men with HIV risk factors (those who were commercially insured, living in Black/Hispanic neighborhoods, or those on Medicaid across all neighborhoods) had a moderate increase in PrEP initiation (an annual percentage increase of 11%-16%) and higher unmet needs.

Researchers gathered data on PrEP prescriptions and new HIV diagnoses (from 2019 to 2023) through the IQVIA pharmacy claims database. PrEP-to-need ratio (PNR) is the number of individuals using PrEP in a year divided by new HIV diagnoses in the previous year. It was calculated for subgroups defined by five PNR-associated factors: Sex, insurance, recorded HIV risk factors (identified by diagnosis or procedure codes), “Ending the HIV Epidemic” jurisdictions, and neighborhood race/ethnicity mix.
 

Disparities Persist

While PrEP use improved across all the groups studied in the 5 years, “disparities still persist and the need remains very significant,” Tao said. “It’s very crucial for guiding the future HIV prevention options.”

“Long-acting PrEP options may help to address some social determinants structural factors in HIV acquisition,” she added.
 

What Programs Are Helping?

Some guidelines and programs are helping increase uptake, Tao said.

The United States Preventive Services Task Force (USPSTF) guidelines “reinforce more accessible PrEP programs to individuals like zero-cost sharing or same-day dispensing,” Tao said in a press briefing. “Those kinds of policies are really effective. We can see that after the implementation of the USPSTF guidelines, the copay sharing is really decreasing and is coinciding with the HIV rates declining.”

The Medicaid coverage expansion in 40 states “has been really effective” in PrEP uptake, she added.

Colleen Kelley, MD, MPH, with the Division of Infectious Diseases at the Rollins School of Public Health, Emory University, in Atlanta, who was not part of the research, said there has been a slow but improving uptake of PrEP across the board in the United States, “but the issue is that the uptake has been inequitable.”
 

Large Study With Recent Data

“This is an extremely large study with very recent data,” Kelley said. “Additionally, they were able to couple (the uptake) with unmet need. People who are at higher risk of acquiring HIV or who live in high-risk areas for HIV should have greater access to PrEP. They have a greater need for PrEP. What we really need to do from an equity perspective is match the PrEP use with the PrEP need and we have not been successful in doing that.”

Kelley added that the finding that the group that had the highest unmet need for PrEP in the study also had no recorded HIV risk factors. “It’s an interesting time to start thinking about beyond risk factor coverage for PrEP,” she said.

Another issue, Kelley said, is that “people are using (PrEP) but they’re also stopping it. People will need to take PrEP many years for protection, but about half discontinue in the first 6-12 months.

“We need to look at how people will persist on PrEP over the long term. That’s the next frontier,” she said. “We hope the long-acting injectables will help overcome some of the PrEP fatigue. But some may just tire of taking medication repeatedly for an infection they don’t have,” she said.

The study was funded by Gilead Sciences. Tao is employed by and is a shareholder of Gilead Sciences. All relevant financial disclosures have been mitigated, according to the paper. Kelley has research grants to her institution from Gilead, Moderna, Novavax, ViiV, and Humanigen.
 

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

LOS ANGELES — Use of preexposure prophylaxis (PrEP) to prevent HIV is increasing overall, but both the rate of increase for starting PrEP and the rate of unmet need differ widely by demographic group, according to new data from a large study.

An analysis by Li Tao, MD, MS, PhD, director of real-world evidence at Gilead Sciences, and colleagues looked at statistical trends from 2019 to 2023 and found that Black, Hispanic, and Medicaid-insured populations continue to lack equitable access to PrEP.

Among the findings were that most new PrEP users were men with HIV risk factors who are commercially insured and live in predominantly non-Hispanic White areas (53% in 2019 and 43% in 2023). For comparison, men living in predominantly Black or Hispanic neighborhoods, or who are insured by Medicaid, saw lower proportions of PrEP use (16% in 2019 and 17% in 2023) despite higher annual increases in PrEP use (11% per year) and higher unmet needs.
 

Half a Million Real-World Participants

Tao presented her team’s findings at the Infectious Disease Week (IDWeek) 2024 Annual Meeting. The study included “more than half a million real-world PrEP users over the past 5 years,” she said.

The group with the lowest growth in initiation of PrEP in the study period (an annual percentage increase of 2%) and the lowest unmet need included men with HIV risk factors, who were using commercial insurance and living in White-dominant neighborhoods.

HIV risk factors included diagnosis of any sexually transmitted disease, contact with and exposure to communicable diseases, high-risk sexual behavior, contact with a hypodermic needle, long-term prophylaxis, HIV prevention counseling, and HIV screening.

Other men with HIV risk factors (those who were commercially insured, living in Black/Hispanic neighborhoods, or those on Medicaid across all neighborhoods) had a moderate increase in PrEP initiation (an annual percentage increase of 11%-16%) and higher unmet needs.

Researchers gathered data on PrEP prescriptions and new HIV diagnoses (from 2019 to 2023) through the IQVIA pharmacy claims database. PrEP-to-need ratio (PNR) is the number of individuals using PrEP in a year divided by new HIV diagnoses in the previous year. It was calculated for subgroups defined by five PNR-associated factors: Sex, insurance, recorded HIV risk factors (identified by diagnosis or procedure codes), “Ending the HIV Epidemic” jurisdictions, and neighborhood race/ethnicity mix.
 

Disparities Persist

While PrEP use improved across all the groups studied in the 5 years, “disparities still persist and the need remains very significant,” Tao said. “It’s very crucial for guiding the future HIV prevention options.”

“Long-acting PrEP options may help to address some social determinants structural factors in HIV acquisition,” she added.
 

What Programs Are Helping?

Some guidelines and programs are helping increase uptake, Tao said.

The United States Preventive Services Task Force (USPSTF) guidelines “reinforce more accessible PrEP programs to individuals like zero-cost sharing or same-day dispensing,” Tao said in a press briefing. “Those kinds of policies are really effective. We can see that after the implementation of the USPSTF guidelines, the copay sharing is really decreasing and is coinciding with the HIV rates declining.”

The Medicaid coverage expansion in 40 states “has been really effective” in PrEP uptake, she added.

Colleen Kelley, MD, MPH, with the Division of Infectious Diseases at the Rollins School of Public Health, Emory University, in Atlanta, who was not part of the research, said there has been a slow but improving uptake of PrEP across the board in the United States, “but the issue is that the uptake has been inequitable.”
 

Large Study With Recent Data

“This is an extremely large study with very recent data,” Kelley said. “Additionally, they were able to couple (the uptake) with unmet need. People who are at higher risk of acquiring HIV or who live in high-risk areas for HIV should have greater access to PrEP. They have a greater need for PrEP. What we really need to do from an equity perspective is match the PrEP use with the PrEP need and we have not been successful in doing that.”

Kelley added that the finding that the group that had the highest unmet need for PrEP in the study also had no recorded HIV risk factors. “It’s an interesting time to start thinking about beyond risk factor coverage for PrEP,” she said.

Another issue, Kelley said, is that “people are using (PrEP) but they’re also stopping it. People will need to take PrEP many years for protection, but about half discontinue in the first 6-12 months.

“We need to look at how people will persist on PrEP over the long term. That’s the next frontier,” she said. “We hope the long-acting injectables will help overcome some of the PrEP fatigue. But some may just tire of taking medication repeatedly for an infection they don’t have,” she said.

The study was funded by Gilead Sciences. Tao is employed by and is a shareholder of Gilead Sciences. All relevant financial disclosures have been mitigated, according to the paper. Kelley has research grants to her institution from Gilead, Moderna, Novavax, ViiV, and Humanigen.
 

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

LOS ANGELES — Use of preexposure prophylaxis (PrEP) to prevent HIV is increasing overall, but both the rate of increase for starting PrEP and the rate of unmet need differ widely by demographic group, according to new data from a large study.

An analysis by Li Tao, MD, MS, PhD, director of real-world evidence at Gilead Sciences, and colleagues looked at statistical trends from 2019 to 2023 and found that Black, Hispanic, and Medicaid-insured populations continue to lack equitable access to PrEP.

Among the findings were that most new PrEP users were men with HIV risk factors who are commercially insured and live in predominantly non-Hispanic White areas (53% in 2019 and 43% in 2023). For comparison, men living in predominantly Black or Hispanic neighborhoods, or who are insured by Medicaid, saw lower proportions of PrEP use (16% in 2019 and 17% in 2023) despite higher annual increases in PrEP use (11% per year) and higher unmet needs.
 

Half a Million Real-World Participants

Tao presented her team’s findings at the Infectious Disease Week (IDWeek) 2024 Annual Meeting. The study included “more than half a million real-world PrEP users over the past 5 years,” she said.

The group with the lowest growth in initiation of PrEP in the study period (an annual percentage increase of 2%) and the lowest unmet need included men with HIV risk factors, who were using commercial insurance and living in White-dominant neighborhoods.

HIV risk factors included diagnosis of any sexually transmitted disease, contact with and exposure to communicable diseases, high-risk sexual behavior, contact with a hypodermic needle, long-term prophylaxis, HIV prevention counseling, and HIV screening.

Other men with HIV risk factors (those who were commercially insured, living in Black/Hispanic neighborhoods, or those on Medicaid across all neighborhoods) had a moderate increase in PrEP initiation (an annual percentage increase of 11%-16%) and higher unmet needs.

Researchers gathered data on PrEP prescriptions and new HIV diagnoses (from 2019 to 2023) through the IQVIA pharmacy claims database. PrEP-to-need ratio (PNR) is the number of individuals using PrEP in a year divided by new HIV diagnoses in the previous year. It was calculated for subgroups defined by five PNR-associated factors: Sex, insurance, recorded HIV risk factors (identified by diagnosis or procedure codes), “Ending the HIV Epidemic” jurisdictions, and neighborhood race/ethnicity mix.
 

Disparities Persist

While PrEP use improved across all the groups studied in the 5 years, “disparities still persist and the need remains very significant,” Tao said. “It’s very crucial for guiding the future HIV prevention options.”

“Long-acting PrEP options may help to address some social determinants structural factors in HIV acquisition,” she added.
 

What Programs Are Helping?

Some guidelines and programs are helping increase uptake, Tao said.

The United States Preventive Services Task Force (USPSTF) guidelines “reinforce more accessible PrEP programs to individuals like zero-cost sharing or same-day dispensing,” Tao said in a press briefing. “Those kinds of policies are really effective. We can see that after the implementation of the USPSTF guidelines, the copay sharing is really decreasing and is coinciding with the HIV rates declining.”

The Medicaid coverage expansion in 40 states “has been really effective” in PrEP uptake, she added.

Colleen Kelley, MD, MPH, with the Division of Infectious Diseases at the Rollins School of Public Health, Emory University, in Atlanta, who was not part of the research, said there has been a slow but improving uptake of PrEP across the board in the United States, “but the issue is that the uptake has been inequitable.”
 

Large Study With Recent Data

“This is an extremely large study with very recent data,” Kelley said. “Additionally, they were able to couple (the uptake) with unmet need. People who are at higher risk of acquiring HIV or who live in high-risk areas for HIV should have greater access to PrEP. They have a greater need for PrEP. What we really need to do from an equity perspective is match the PrEP use with the PrEP need and we have not been successful in doing that.”

Kelley added that the finding that the group that had the highest unmet need for PrEP in the study also had no recorded HIV risk factors. “It’s an interesting time to start thinking about beyond risk factor coverage for PrEP,” she said.

Another issue, Kelley said, is that “people are using (PrEP) but they’re also stopping it. People will need to take PrEP many years for protection, but about half discontinue in the first 6-12 months.

“We need to look at how people will persist on PrEP over the long term. That’s the next frontier,” she said. “We hope the long-acting injectables will help overcome some of the PrEP fatigue. But some may just tire of taking medication repeatedly for an infection they don’t have,” she said.

The study was funded by Gilead Sciences. Tao is employed by and is a shareholder of Gilead Sciences. All relevant financial disclosures have been mitigated, according to the paper. Kelley has research grants to her institution from Gilead, Moderna, Novavax, ViiV, and Humanigen.
 

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

LOS ANGELES — Embedding a new discharge order set into electronic health records (EHRs) with a preselected 5-day antibiotic course for children aged 2 years or older diagnosed with acute otitis media (AOM) cut antibiotic duration sharply, according to new data presented at the Infectious Disease Week (IDWeek) 2024 Annual Meeting.

“We were effectively able to cut antibiotic use in half by shortening the duration of treatment,” said lead author Joana Dimo, DO, a Pediatric Infectious Diseases fellow at the University of Colorado Denver/Children’s Hospital Colorado.

In the United States, 80% of children will experience otitis media during their lifetime. Untreated ear infections can lead to symptoms ranging from mild ear discharge to life-threatening conditions such as mastoiditis and intracranial abscesses.
 

Most Cases Resolve Without Antibiotics

Ear infections “are the leading reason for antibiotic prescriptions in kids,” Dimo noted, adding that 24% of all pediatric antibiotic prescriptions are for AOM. Amoxicillin is the preferred first-line treatment. “Research supports that 75% of children get better on their own without antibiotics, and when needed, short courses of just 5 days are safe and effective.”

Antibiotics can cause side effects such as diarrhea and rashes. “Each additional day of antibiotics that are not needed leads to more side effects,” Dimo said, as well as contributing to antibiotic resistance.

Dimo’s team implemented new EHR order sets across the University of Colorado/Children’s Hospital Colorado health network’s four emergency departments and four urgent care centers and included 31,929 patients in the study.

Then they conducted a retrospective review of patients 61 days to 18 years old who entered those settings and had confirmed AOM between January 2019 through December 2023, before and after the April 2021 intervention. The researchers also developed a guideline on managing ear infections to support clinicians as part of the intervention in December 2022.
 

Compliance Grew From 3% to 83%

Dimo said they found very few clinicians in their study had been prescribing according to current guidelines. Their results showed a jump from 3% to 83% in providers prescribing 5-day durations of antibiotics for children aged 2 years or older after their intervention.

The intervention did not lead to increased treatment failures or complications, she added. The team looked for diagnostic codes for mastoiditis, subperiosteal abscess, petrositis, labyrinthitis, meningitis, and intracranial abscess, and “none of our patients” developed any of those complications, Dimo said.

Dimo said the overall rate of prescribing, however, increased. Finding out why prescribing rates remained high throughout the study, before and after their intervention, is a question they are investigating in future work, she said.
 

Cost-Effective and Scalable

“The benefit of this strategy to other institutions is that it’s not labor-intensive. It’s cost-effective, and it can result in dramatic changes in antibiotic use,” Dimo said.

“In the outpatient setting, there’s still a lot of antibiotics being given unnecessarily to children with acute otitis media,” said William Schaffner, MD, infectious disease specialist at Vanderbilt University School of Medicine in Nashville, Tennessee, who was not part of the research. “The American Academy of Pediatrics has been working on that for about a decade — to get pediatricians attuned to when you use them. Most of these episodes of acute otitis media — it’s now well-established — are due to viral infections.”

He said that some physicians may still be defaulting to the longer doses — up to 10 days — that they may have learned in medical school or residency.

“The data would indicate that 5 days of treatment — when treatment is appropriate — is, in the vast majority of instances, sufficient,” Schaffner said.

The researchers “were remarkably successful,” he said, adding that another question is ripe for research. “They still have to get to this issue of whether all of these antibiotic starts were necessary.”

Not knowing whether antibiotic prescriptions in this study were warranted is a limitation of the study, Dimo said, as was not being able to track whether patients presented to institutions outside their own for a return visit or for complications.

She said she thinks one of the reasons for such a sharp increase in compliance was that clinicians in their system routinely use order sets, so using the new order sets easily became part of their workflow.

Dimo and Schaffner reported no relevant financial relationships.

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

LOS ANGELES — Embedding a new discharge order set into electronic health records (EHRs) with a preselected 5-day antibiotic course for children aged 2 years or older diagnosed with acute otitis media (AOM) cut antibiotic duration sharply, according to new data presented at the Infectious Disease Week (IDWeek) 2024 Annual Meeting.

“We were effectively able to cut antibiotic use in half by shortening the duration of treatment,” said lead author Joana Dimo, DO, a Pediatric Infectious Diseases fellow at the University of Colorado Denver/Children’s Hospital Colorado.

In the United States, 80% of children will experience otitis media during their lifetime. Untreated ear infections can lead to symptoms ranging from mild ear discharge to life-threatening conditions such as mastoiditis and intracranial abscesses.
 

Most Cases Resolve Without Antibiotics

Ear infections “are the leading reason for antibiotic prescriptions in kids,” Dimo noted, adding that 24% of all pediatric antibiotic prescriptions are for AOM. Amoxicillin is the preferred first-line treatment. “Research supports that 75% of children get better on their own without antibiotics, and when needed, short courses of just 5 days are safe and effective.”

Antibiotics can cause side effects such as diarrhea and rashes. “Each additional day of antibiotics that are not needed leads to more side effects,” Dimo said, as well as contributing to antibiotic resistance.

Dimo’s team implemented new EHR order sets across the University of Colorado/Children’s Hospital Colorado health network’s four emergency departments and four urgent care centers and included 31,929 patients in the study.

Then they conducted a retrospective review of patients 61 days to 18 years old who entered those settings and had confirmed AOM between January 2019 through December 2023, before and after the April 2021 intervention. The researchers also developed a guideline on managing ear infections to support clinicians as part of the intervention in December 2022.
 

Compliance Grew From 3% to 83%

Dimo said they found very few clinicians in their study had been prescribing according to current guidelines. Their results showed a jump from 3% to 83% in providers prescribing 5-day durations of antibiotics for children aged 2 years or older after their intervention.

The intervention did not lead to increased treatment failures or complications, she added. The team looked for diagnostic codes for mastoiditis, subperiosteal abscess, petrositis, labyrinthitis, meningitis, and intracranial abscess, and “none of our patients” developed any of those complications, Dimo said.

Dimo said the overall rate of prescribing, however, increased. Finding out why prescribing rates remained high throughout the study, before and after their intervention, is a question they are investigating in future work, she said.
 

Cost-Effective and Scalable

“The benefit of this strategy to other institutions is that it’s not labor-intensive. It’s cost-effective, and it can result in dramatic changes in antibiotic use,” Dimo said.

“In the outpatient setting, there’s still a lot of antibiotics being given unnecessarily to children with acute otitis media,” said William Schaffner, MD, infectious disease specialist at Vanderbilt University School of Medicine in Nashville, Tennessee, who was not part of the research. “The American Academy of Pediatrics has been working on that for about a decade — to get pediatricians attuned to when you use them. Most of these episodes of acute otitis media — it’s now well-established — are due to viral infections.”

He said that some physicians may still be defaulting to the longer doses — up to 10 days — that they may have learned in medical school or residency.

“The data would indicate that 5 days of treatment — when treatment is appropriate — is, in the vast majority of instances, sufficient,” Schaffner said.

The researchers “were remarkably successful,” he said, adding that another question is ripe for research. “They still have to get to this issue of whether all of these antibiotic starts were necessary.”

Not knowing whether antibiotic prescriptions in this study were warranted is a limitation of the study, Dimo said, as was not being able to track whether patients presented to institutions outside their own for a return visit or for complications.

She said she thinks one of the reasons for such a sharp increase in compliance was that clinicians in their system routinely use order sets, so using the new order sets easily became part of their workflow.

Dimo and Schaffner reported no relevant financial relationships.

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

LOS ANGELES — Embedding a new discharge order set into electronic health records (EHRs) with a preselected 5-day antibiotic course for children aged 2 years or older diagnosed with acute otitis media (AOM) cut antibiotic duration sharply, according to new data presented at the Infectious Disease Week (IDWeek) 2024 Annual Meeting.

“We were effectively able to cut antibiotic use in half by shortening the duration of treatment,” said lead author Joana Dimo, DO, a Pediatric Infectious Diseases fellow at the University of Colorado Denver/Children’s Hospital Colorado.

In the United States, 80% of children will experience otitis media during their lifetime. Untreated ear infections can lead to symptoms ranging from mild ear discharge to life-threatening conditions such as mastoiditis and intracranial abscesses.
 

Most Cases Resolve Without Antibiotics

Ear infections “are the leading reason for antibiotic prescriptions in kids,” Dimo noted, adding that 24% of all pediatric antibiotic prescriptions are for AOM. Amoxicillin is the preferred first-line treatment. “Research supports that 75% of children get better on their own without antibiotics, and when needed, short courses of just 5 days are safe and effective.”

Antibiotics can cause side effects such as diarrhea and rashes. “Each additional day of antibiotics that are not needed leads to more side effects,” Dimo said, as well as contributing to antibiotic resistance.

Dimo’s team implemented new EHR order sets across the University of Colorado/Children’s Hospital Colorado health network’s four emergency departments and four urgent care centers and included 31,929 patients in the study.

Then they conducted a retrospective review of patients 61 days to 18 years old who entered those settings and had confirmed AOM between January 2019 through December 2023, before and after the April 2021 intervention. The researchers also developed a guideline on managing ear infections to support clinicians as part of the intervention in December 2022.
 

Compliance Grew From 3% to 83%

Dimo said they found very few clinicians in their study had been prescribing according to current guidelines. Their results showed a jump from 3% to 83% in providers prescribing 5-day durations of antibiotics for children aged 2 years or older after their intervention.

The intervention did not lead to increased treatment failures or complications, she added. The team looked for diagnostic codes for mastoiditis, subperiosteal abscess, petrositis, labyrinthitis, meningitis, and intracranial abscess, and “none of our patients” developed any of those complications, Dimo said.

Dimo said the overall rate of prescribing, however, increased. Finding out why prescribing rates remained high throughout the study, before and after their intervention, is a question they are investigating in future work, she said.
 

Cost-Effective and Scalable

“The benefit of this strategy to other institutions is that it’s not labor-intensive. It’s cost-effective, and it can result in dramatic changes in antibiotic use,” Dimo said.

“In the outpatient setting, there’s still a lot of antibiotics being given unnecessarily to children with acute otitis media,” said William Schaffner, MD, infectious disease specialist at Vanderbilt University School of Medicine in Nashville, Tennessee, who was not part of the research. “The American Academy of Pediatrics has been working on that for about a decade — to get pediatricians attuned to when you use them. Most of these episodes of acute otitis media — it’s now well-established — are due to viral infections.”

He said that some physicians may still be defaulting to the longer doses — up to 10 days — that they may have learned in medical school or residency.

“The data would indicate that 5 days of treatment — when treatment is appropriate — is, in the vast majority of instances, sufficient,” Schaffner said.

The researchers “were remarkably successful,” he said, adding that another question is ripe for research. “They still have to get to this issue of whether all of these antibiotic starts were necessary.”

Not knowing whether antibiotic prescriptions in this study were warranted is a limitation of the study, Dimo said, as was not being able to track whether patients presented to institutions outside their own for a return visit or for complications.

She said she thinks one of the reasons for such a sharp increase in compliance was that clinicians in their system routinely use order sets, so using the new order sets easily became part of their workflow.

Dimo and Schaffner reported no relevant financial relationships.

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

Common arm positions for blood pressure (BP) measurements that stray from guidelines — arm in lap or hanging at side — led to substantial overestimation of hypertension in a study published in JAMA Internal Medicine.

Guidelines for BP measurement recommend arm support on a desk with the midcuff at heart level. Overestimating BP can lead to unnecessary patient follow-up and overtreatment. Hypertension affects approximately 86 million  adults in the United States and more than 1 billion people globally.

This study has widespread implications given the number of settings where BP checks are performed and the growth in patients taking their own BP readings at home, said Donald DiPette, MD, who was not part of the research and was asked to comment on the findings. Dr. DiPette is the Distinguished Health Sciences Professor at the School of Medicine, University of South Carolina, Columbia.
 

Substantial Overestimation

In the crossover, randomized trial of 133 adults, Hairong Liu, MHS, with the Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, and colleagues found that supporting the arm on the lap overestimated systolic BP (SBP) by 3.9 mmHg and diastolic BP (DBP) by 4.0 mm Hg. When the arm hung at the side, readings overestimated SBP by 6.5 mm Hg and DBP by 4.4 mm Hg, with consistent results across subgroups.

Participants were randomly assigned to get a series of BP measurements with the arm positioned in three ways: Supported on a desk; hand supported on lap; and arm unsupported at the side. Because BP readings are intrinsically variable, all had a fourth set of BP measurements with the arm supported on a desk. 

Participants’ mean age was 57 years; 48 participants (36%) had SBP of ≥ 130 mm Hg; and 55 participants (41%) had a body mass index of ≥ 30.

Two researcher team staff members conducted all the measurements. They received standardized training and completed a certification test in BP measurement, administered by a study author. Measurements were taken from 9 am to 6 pm using a validated oscillometric BP device (ProBP 2000 Digital Blood Pressure Device, Welch Allyn). Only the right arms were used unless a specific condition was present, such as an open sore.
 

Study’s Design Sets It Apart

The authors wrote that the design of the study set this work apart. “Earlier studies have shown that unsupported or arm positioning below heart level can overestimate SBP by 4-23 mm Hg and DBP by 3-12 mm Hg.” But the strength of this study is the randomized, crossover design, “which is in contrast to the majority of published studies where the order of arm positions before seated BP measurement was not randomized or not clearly described.”

Dr. DiPette, who says, “I’ve given my career to understanding hypertension,” praised the design as well.

Randomization of which position patients were assigned to first was important because the first reading is often higher than subsequent readings, Dr. DiPette said.

“That makes sense as the person acclimatizes to the environment,” he explained. BP can even vary within the same reading, he noted.
 

Incorrect Readings for Many Reasons

Incorrect measures are common given the number of settings and number of providers and patients taking blood pressure even with training, certification in the method, and educational materials.

“We recommend taking a blood pressure in any possible setting you can. Because it’s that critical,” he said. “Most of the time it’s taken in busy primary care settings. The pressures are there. Most times it’s only one reading. It’s the medical environment of today.”

He noted that although this study finds overestimation, different arm positions not recommended by guidelines could potentially result in underestimation of hypertension. 

“I liken the BP measurement to a laboratory test that has clear treatment implications. We would want the BP measurement to have the same rigorous accuracy as a blood test or radiologic machine,” he said. 

Dr. DiPette said more education is needed for patients as well as providers as patients may be monitoring their own BP at home. Patients should also know they can ask for a measurement to be repeated, know the correct arm position recommended by guidelines, and the implications of incorrect readings, he said.

This study was supported by Resolve to Save Lives, which is funded by Bloomberg Philanthropies, the Bill and Melinda Gates Foundation, and Gates Philanthropy Partners, which is funded with support from the Chan Zuckerberg Foundation. 

Ms. Liu reported grants from Resolve to Save Lives outside the submitted work. One coauthor reported grants from the National Institutes of Health and personal fees from Kowa, RhythmX AI, and Fukuda Denshi outside the submitted work. Dr. DiPette declared no relevant financial relationships. He was part of a leadership team that developed World Health Organization guidelines on hypertension.

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

Common arm positions for blood pressure (BP) measurements that stray from guidelines — arm in lap or hanging at side — led to substantial overestimation of hypertension in a study published in JAMA Internal Medicine.

Guidelines for BP measurement recommend arm support on a desk with the midcuff at heart level. Overestimating BP can lead to unnecessary patient follow-up and overtreatment. Hypertension affects approximately 86 million  adults in the United States and more than 1 billion people globally.

This study has widespread implications given the number of settings where BP checks are performed and the growth in patients taking their own BP readings at home, said Donald DiPette, MD, who was not part of the research and was asked to comment on the findings. Dr. DiPette is the Distinguished Health Sciences Professor at the School of Medicine, University of South Carolina, Columbia.
 

Substantial Overestimation

In the crossover, randomized trial of 133 adults, Hairong Liu, MHS, with the Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, and colleagues found that supporting the arm on the lap overestimated systolic BP (SBP) by 3.9 mmHg and diastolic BP (DBP) by 4.0 mm Hg. When the arm hung at the side, readings overestimated SBP by 6.5 mm Hg and DBP by 4.4 mm Hg, with consistent results across subgroups.

Participants were randomly assigned to get a series of BP measurements with the arm positioned in three ways: Supported on a desk; hand supported on lap; and arm unsupported at the side. Because BP readings are intrinsically variable, all had a fourth set of BP measurements with the arm supported on a desk. 

Participants’ mean age was 57 years; 48 participants (36%) had SBP of ≥ 130 mm Hg; and 55 participants (41%) had a body mass index of ≥ 30.

Two researcher team staff members conducted all the measurements. They received standardized training and completed a certification test in BP measurement, administered by a study author. Measurements were taken from 9 am to 6 pm using a validated oscillometric BP device (ProBP 2000 Digital Blood Pressure Device, Welch Allyn). Only the right arms were used unless a specific condition was present, such as an open sore.
 

Study’s Design Sets It Apart

The authors wrote that the design of the study set this work apart. “Earlier studies have shown that unsupported or arm positioning below heart level can overestimate SBP by 4-23 mm Hg and DBP by 3-12 mm Hg.” But the strength of this study is the randomized, crossover design, “which is in contrast to the majority of published studies where the order of arm positions before seated BP measurement was not randomized or not clearly described.”

Dr. DiPette, who says, “I’ve given my career to understanding hypertension,” praised the design as well.

Randomization of which position patients were assigned to first was important because the first reading is often higher than subsequent readings, Dr. DiPette said.

“That makes sense as the person acclimatizes to the environment,” he explained. BP can even vary within the same reading, he noted.
 

Incorrect Readings for Many Reasons

Incorrect measures are common given the number of settings and number of providers and patients taking blood pressure even with training, certification in the method, and educational materials.

“We recommend taking a blood pressure in any possible setting you can. Because it’s that critical,” he said. “Most of the time it’s taken in busy primary care settings. The pressures are there. Most times it’s only one reading. It’s the medical environment of today.”

He noted that although this study finds overestimation, different arm positions not recommended by guidelines could potentially result in underestimation of hypertension. 

“I liken the BP measurement to a laboratory test that has clear treatment implications. We would want the BP measurement to have the same rigorous accuracy as a blood test or radiologic machine,” he said. 

Dr. DiPette said more education is needed for patients as well as providers as patients may be monitoring their own BP at home. Patients should also know they can ask for a measurement to be repeated, know the correct arm position recommended by guidelines, and the implications of incorrect readings, he said.

This study was supported by Resolve to Save Lives, which is funded by Bloomberg Philanthropies, the Bill and Melinda Gates Foundation, and Gates Philanthropy Partners, which is funded with support from the Chan Zuckerberg Foundation. 

Ms. Liu reported grants from Resolve to Save Lives outside the submitted work. One coauthor reported grants from the National Institutes of Health and personal fees from Kowa, RhythmX AI, and Fukuda Denshi outside the submitted work. Dr. DiPette declared no relevant financial relationships. He was part of a leadership team that developed World Health Organization guidelines on hypertension.

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

Common arm positions for blood pressure (BP) measurements that stray from guidelines — arm in lap or hanging at side — led to substantial overestimation of hypertension in a study published in JAMA Internal Medicine.

Guidelines for BP measurement recommend arm support on a desk with the midcuff at heart level. Overestimating BP can lead to unnecessary patient follow-up and overtreatment. Hypertension affects approximately 86 million  adults in the United States and more than 1 billion people globally.

This study has widespread implications given the number of settings where BP checks are performed and the growth in patients taking their own BP readings at home, said Donald DiPette, MD, who was not part of the research and was asked to comment on the findings. Dr. DiPette is the Distinguished Health Sciences Professor at the School of Medicine, University of South Carolina, Columbia.
 

Substantial Overestimation

In the crossover, randomized trial of 133 adults, Hairong Liu, MHS, with the Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, and colleagues found that supporting the arm on the lap overestimated systolic BP (SBP) by 3.9 mmHg and diastolic BP (DBP) by 4.0 mm Hg. When the arm hung at the side, readings overestimated SBP by 6.5 mm Hg and DBP by 4.4 mm Hg, with consistent results across subgroups.

Participants were randomly assigned to get a series of BP measurements with the arm positioned in three ways: Supported on a desk; hand supported on lap; and arm unsupported at the side. Because BP readings are intrinsically variable, all had a fourth set of BP measurements with the arm supported on a desk. 

Participants’ mean age was 57 years; 48 participants (36%) had SBP of ≥ 130 mm Hg; and 55 participants (41%) had a body mass index of ≥ 30.

Two researcher team staff members conducted all the measurements. They received standardized training and completed a certification test in BP measurement, administered by a study author. Measurements were taken from 9 am to 6 pm using a validated oscillometric BP device (ProBP 2000 Digital Blood Pressure Device, Welch Allyn). Only the right arms were used unless a specific condition was present, such as an open sore.
 

Study’s Design Sets It Apart

The authors wrote that the design of the study set this work apart. “Earlier studies have shown that unsupported or arm positioning below heart level can overestimate SBP by 4-23 mm Hg and DBP by 3-12 mm Hg.” But the strength of this study is the randomized, crossover design, “which is in contrast to the majority of published studies where the order of arm positions before seated BP measurement was not randomized or not clearly described.”

Dr. DiPette, who says, “I’ve given my career to understanding hypertension,” praised the design as well.

Randomization of which position patients were assigned to first was important because the first reading is often higher than subsequent readings, Dr. DiPette said.

“That makes sense as the person acclimatizes to the environment,” he explained. BP can even vary within the same reading, he noted.
 

Incorrect Readings for Many Reasons

Incorrect measures are common given the number of settings and number of providers and patients taking blood pressure even with training, certification in the method, and educational materials.

“We recommend taking a blood pressure in any possible setting you can. Because it’s that critical,” he said. “Most of the time it’s taken in busy primary care settings. The pressures are there. Most times it’s only one reading. It’s the medical environment of today.”

He noted that although this study finds overestimation, different arm positions not recommended by guidelines could potentially result in underestimation of hypertension. 

“I liken the BP measurement to a laboratory test that has clear treatment implications. We would want the BP measurement to have the same rigorous accuracy as a blood test or radiologic machine,” he said. 

Dr. DiPette said more education is needed for patients as well as providers as patients may be monitoring their own BP at home. Patients should also know they can ask for a measurement to be repeated, know the correct arm position recommended by guidelines, and the implications of incorrect readings, he said.

This study was supported by Resolve to Save Lives, which is funded by Bloomberg Philanthropies, the Bill and Melinda Gates Foundation, and Gates Philanthropy Partners, which is funded with support from the Chan Zuckerberg Foundation. 

Ms. Liu reported grants from Resolve to Save Lives outside the submitted work. One coauthor reported grants from the National Institutes of Health and personal fees from Kowa, RhythmX AI, and Fukuda Denshi outside the submitted work. Dr. DiPette declared no relevant financial relationships. He was part of a leadership team that developed World Health Organization guidelines on hypertension.

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

Higher daily buprenorphine doses may help patients better manage opioid use disorder (OUD), data from a National Institutes of Health (NIH) study suggested.

The new data highlight that the dose size currently recommended by the US Food and Drug Administration (FDA) and insurance caps on doses are outdated and harmful in the age of fentanyl overdoses, according to the American Medical Association (AMA) and physicians who have studied the issue.

Findings of the study, led by Sarah Axeen, PhD, with the Schaeffer Center for Health Policy & Economics, University of Southern California, Los Angeles, were published in JAMA Network Open.

The researchers reviewed insurance claims data from more than 35,000 people diagnosed with OUD who started on buprenorphine treatment between 2016 and 2021. They found that 12.5% had an emergency department (ED) or inpatient visit related to behavioral health within the study period.

They analyzed whether a patient’s buprenorphine dose was linked with the length of time between treatment start and an ED or inpatient visit.
 

Higher Doses, Better Outcomes

The FDA’s recommended target dose for buprenorphine is 16 mg/d. Dr. Axeen’s team found that those taking higher daily doses (> 16 to 24 mg) took 20% longer to have an ED or inpatient visit related to behavioral health within the first year after receiving treatment than those who took > 8 to 16 mg/d.

“Those taking daily doses of more than 24 mg of buprenorphine went 50% longer before having a subsequent emergency or inpatient healthcare visit related to behavioral health within the first year after receiving treatment, compared to those receiving > 8 to 16 mg a day,” the researchers said in a press release.
 

AMA Says the Findings Should Change Policies

Bobby Mukkamala, MD, president-elect of the AMA and Chair of the AMA Substance Use and Pain Care Task Force, said the association welcomed the study findings and urged policymakers and insurance providers to act on them with updated policies.

“The findings support AMA policy calling for flexibility in buprenorphine dosing, allowing patients to receive doses exceeding FDA-approved limits when clinically recommended by their prescriber,” he said in a statement. “Policymakers must take note of these findings and the growing body of evidence that further affirm buprenorphine as a safe, effective, and lifesaving tool in the fight against the illicit fentanyl overdose epidemic. It is also critically important for health insurance companies, Medicaid, and Medicare to remove dosage caps for buprenorphine.”
 

‘Tangible Economic Impact’

Lucinda Grande, MD, a family physician and addiction specialist with Pioneer Family Practice in Lacey, Washington, said in an interview that she was happy to see this study because “it is the first buprenorphine dose study that addresses an outcome with a tangible economic impact that would affect the bottom line of payers and healthcare systems” and may capture the attention of policymakers in changing what she says are outdated recommendations.

“This study is also unusual because it looked specifically at the dose range above 24 mg. Even though that top tier included only a tiny proportion (1.8%) of patients, it was the group that had the greatest long-term benefit from buprenorphine,” Dr. Grande said, adding that other studies have not included that high a dose.

Dr. Grande, who published on a related topic in 2023, noted that Medicaid patients were excluded from the current study, and they make up a substantial portion of those using buprenorphine for OUD. Had they been included, she said, she suspects the evidence would have been even stronger in favor of higher doses.

Physicians can prescribe higher doses off-label, but buprenorphine is expensive, and some insurers have caps based on the FDA recommendations. Dr. Grande says she rarely prescribes > 32 mg/d, and the patients who need the higher doses often have chronic pain. “In Washington State,” she said, “we have had the luxury of prescribing up to 32 mg daily to Medicaid patients for years. I have had a lot of opportunity to work in that dose rage for people who really need it, and I can really see a difference.”

As fentanyl has grown into the primary illicit opioid, she says, the FDA recommendations for buprenorphine have become progressively weaker.

“Fentanyl is 50 times more potent than heroin, the opioid prevalent when the FDA guidelines were written,” she said. “It’s like a popgun that you’re using against a cannon.”

This manuscript was prepared with support from the National Institute on Drug Abuse. Dr. Axeen reported no relevant financial disclosures. Coauthor Jessica S. Merlin, MD, reported grants from Cambia Health Foundation outside the submitted work. Adam J. Gordon, MD, reported grants from NIH and the Veterans Affairs (institution) during the conduct of the study; he reported service as editor-in-chief with the Association for Multidisciplinary Education and Research in Substance use and Addiction. Bradley D. Stein, MD, reported grants from the NIH during the conduct of the study. Dr. Mukkamala and Dr. Grande reported no relevant financial relationships.
 

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

Higher daily buprenorphine doses may help patients better manage opioid use disorder (OUD), data from a National Institutes of Health (NIH) study suggested.

The new data highlight that the dose size currently recommended by the US Food and Drug Administration (FDA) and insurance caps on doses are outdated and harmful in the age of fentanyl overdoses, according to the American Medical Association (AMA) and physicians who have studied the issue.

Findings of the study, led by Sarah Axeen, PhD, with the Schaeffer Center for Health Policy & Economics, University of Southern California, Los Angeles, were published in JAMA Network Open.

The researchers reviewed insurance claims data from more than 35,000 people diagnosed with OUD who started on buprenorphine treatment between 2016 and 2021. They found that 12.5% had an emergency department (ED) or inpatient visit related to behavioral health within the study period.

They analyzed whether a patient’s buprenorphine dose was linked with the length of time between treatment start and an ED or inpatient visit.
 

Higher Doses, Better Outcomes

The FDA’s recommended target dose for buprenorphine is 16 mg/d. Dr. Axeen’s team found that those taking higher daily doses (> 16 to 24 mg) took 20% longer to have an ED or inpatient visit related to behavioral health within the first year after receiving treatment than those who took > 8 to 16 mg/d.

“Those taking daily doses of more than 24 mg of buprenorphine went 50% longer before having a subsequent emergency or inpatient healthcare visit related to behavioral health within the first year after receiving treatment, compared to those receiving > 8 to 16 mg a day,” the researchers said in a press release.
 

AMA Says the Findings Should Change Policies

Bobby Mukkamala, MD, president-elect of the AMA and Chair of the AMA Substance Use and Pain Care Task Force, said the association welcomed the study findings and urged policymakers and insurance providers to act on them with updated policies.

“The findings support AMA policy calling for flexibility in buprenorphine dosing, allowing patients to receive doses exceeding FDA-approved limits when clinically recommended by their prescriber,” he said in a statement. “Policymakers must take note of these findings and the growing body of evidence that further affirm buprenorphine as a safe, effective, and lifesaving tool in the fight against the illicit fentanyl overdose epidemic. It is also critically important for health insurance companies, Medicaid, and Medicare to remove dosage caps for buprenorphine.”
 

‘Tangible Economic Impact’

Lucinda Grande, MD, a family physician and addiction specialist with Pioneer Family Practice in Lacey, Washington, said in an interview that she was happy to see this study because “it is the first buprenorphine dose study that addresses an outcome with a tangible economic impact that would affect the bottom line of payers and healthcare systems” and may capture the attention of policymakers in changing what she says are outdated recommendations.

“This study is also unusual because it looked specifically at the dose range above 24 mg. Even though that top tier included only a tiny proportion (1.8%) of patients, it was the group that had the greatest long-term benefit from buprenorphine,” Dr. Grande said, adding that other studies have not included that high a dose.

Dr. Grande, who published on a related topic in 2023, noted that Medicaid patients were excluded from the current study, and they make up a substantial portion of those using buprenorphine for OUD. Had they been included, she said, she suspects the evidence would have been even stronger in favor of higher doses.

Physicians can prescribe higher doses off-label, but buprenorphine is expensive, and some insurers have caps based on the FDA recommendations. Dr. Grande says she rarely prescribes > 32 mg/d, and the patients who need the higher doses often have chronic pain. “In Washington State,” she said, “we have had the luxury of prescribing up to 32 mg daily to Medicaid patients for years. I have had a lot of opportunity to work in that dose rage for people who really need it, and I can really see a difference.”

As fentanyl has grown into the primary illicit opioid, she says, the FDA recommendations for buprenorphine have become progressively weaker.

“Fentanyl is 50 times more potent than heroin, the opioid prevalent when the FDA guidelines were written,” she said. “It’s like a popgun that you’re using against a cannon.”

This manuscript was prepared with support from the National Institute on Drug Abuse. Dr. Axeen reported no relevant financial disclosures. Coauthor Jessica S. Merlin, MD, reported grants from Cambia Health Foundation outside the submitted work. Adam J. Gordon, MD, reported grants from NIH and the Veterans Affairs (institution) during the conduct of the study; he reported service as editor-in-chief with the Association for Multidisciplinary Education and Research in Substance use and Addiction. Bradley D. Stein, MD, reported grants from the NIH during the conduct of the study. Dr. Mukkamala and Dr. Grande reported no relevant financial relationships.
 

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

Higher daily buprenorphine doses may help patients better manage opioid use disorder (OUD), data from a National Institutes of Health (NIH) study suggested.

The new data highlight that the dose size currently recommended by the US Food and Drug Administration (FDA) and insurance caps on doses are outdated and harmful in the age of fentanyl overdoses, according to the American Medical Association (AMA) and physicians who have studied the issue.

Findings of the study, led by Sarah Axeen, PhD, with the Schaeffer Center for Health Policy & Economics, University of Southern California, Los Angeles, were published in JAMA Network Open.

The researchers reviewed insurance claims data from more than 35,000 people diagnosed with OUD who started on buprenorphine treatment between 2016 and 2021. They found that 12.5% had an emergency department (ED) or inpatient visit related to behavioral health within the study period.

They analyzed whether a patient’s buprenorphine dose was linked with the length of time between treatment start and an ED or inpatient visit.
 

Higher Doses, Better Outcomes

The FDA’s recommended target dose for buprenorphine is 16 mg/d. Dr. Axeen’s team found that those taking higher daily doses (> 16 to 24 mg) took 20% longer to have an ED or inpatient visit related to behavioral health within the first year after receiving treatment than those who took > 8 to 16 mg/d.

“Those taking daily doses of more than 24 mg of buprenorphine went 50% longer before having a subsequent emergency or inpatient healthcare visit related to behavioral health within the first year after receiving treatment, compared to those receiving > 8 to 16 mg a day,” the researchers said in a press release.
 

AMA Says the Findings Should Change Policies

Bobby Mukkamala, MD, president-elect of the AMA and Chair of the AMA Substance Use and Pain Care Task Force, said the association welcomed the study findings and urged policymakers and insurance providers to act on them with updated policies.

“The findings support AMA policy calling for flexibility in buprenorphine dosing, allowing patients to receive doses exceeding FDA-approved limits when clinically recommended by their prescriber,” he said in a statement. “Policymakers must take note of these findings and the growing body of evidence that further affirm buprenorphine as a safe, effective, and lifesaving tool in the fight against the illicit fentanyl overdose epidemic. It is also critically important for health insurance companies, Medicaid, and Medicare to remove dosage caps for buprenorphine.”
 

‘Tangible Economic Impact’

Lucinda Grande, MD, a family physician and addiction specialist with Pioneer Family Practice in Lacey, Washington, said in an interview that she was happy to see this study because “it is the first buprenorphine dose study that addresses an outcome with a tangible economic impact that would affect the bottom line of payers and healthcare systems” and may capture the attention of policymakers in changing what she says are outdated recommendations.

“This study is also unusual because it looked specifically at the dose range above 24 mg. Even though that top tier included only a tiny proportion (1.8%) of patients, it was the group that had the greatest long-term benefit from buprenorphine,” Dr. Grande said, adding that other studies have not included that high a dose.

Dr. Grande, who published on a related topic in 2023, noted that Medicaid patients were excluded from the current study, and they make up a substantial portion of those using buprenorphine for OUD. Had they been included, she said, she suspects the evidence would have been even stronger in favor of higher doses.

Physicians can prescribe higher doses off-label, but buprenorphine is expensive, and some insurers have caps based on the FDA recommendations. Dr. Grande says she rarely prescribes > 32 mg/d, and the patients who need the higher doses often have chronic pain. “In Washington State,” she said, “we have had the luxury of prescribing up to 32 mg daily to Medicaid patients for years. I have had a lot of opportunity to work in that dose rage for people who really need it, and I can really see a difference.”

As fentanyl has grown into the primary illicit opioid, she says, the FDA recommendations for buprenorphine have become progressively weaker.

“Fentanyl is 50 times more potent than heroin, the opioid prevalent when the FDA guidelines were written,” she said. “It’s like a popgun that you’re using against a cannon.”

This manuscript was prepared with support from the National Institute on Drug Abuse. Dr. Axeen reported no relevant financial disclosures. Coauthor Jessica S. Merlin, MD, reported grants from Cambia Health Foundation outside the submitted work. Adam J. Gordon, MD, reported grants from NIH and the Veterans Affairs (institution) during the conduct of the study; he reported service as editor-in-chief with the Association for Multidisciplinary Education and Research in Substance use and Addiction. Bradley D. Stein, MD, reported grants from the NIH during the conduct of the study. Dr. Mukkamala and Dr. Grande reported no relevant financial relationships.
 

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

Hormone therapy (HT) can help women manage menopause symptoms into their 80s and the reasons are varied, according to a retrospective analysis being presented at the annual meeting of The Menopause Society.

“It’s important to know that this is a preselected group of women who had no contraindications to continuing their hormone therapy,” senior author Wendy Wolfman, MD, director of the Menopause Clinic and The Premature Ovarian Insufficiency Clinic at Mount Sinai Hospital in Toronto, Ontario, Canada, said in an interview. “They had the initiation of hormone therapy closer to menopause and carried on their hormones. We followed them for a long time and basically saw no real concerns about taking the hormones and the patients did very well. It’s important to emphasize this was not the new initiation of hormone therapy in elderly women.”

She said that, in her large tertiary referral center, “I still see patients who are referred who are told that they have to stop their hormones after 5 years based on a false assumption. Everybody ages at different rates and everybody has different risk factors.”

About 70%-80% of women experience menopause symptoms that restrict quality of life and productivity, the authors noted. HT has consistently been the most effective means for managing many of the side effects, especially hot flashes.

Hot flashes last on average 7-11 years. But they continue in up to 40% of women in their 60s and 10%-15% in their 70s, the authors wrote. 

The analysis included more than 100 women in Canada older than 65 who continue to use HT and explored the motivations of the women to use them.

The average age of the women was 71 and nearly 8% were age 80 or older. The mean age for starting HT was 52 years and the women continued HT for an average 18 years, though 42% used it regularly for more than 20 years. Most of the women (nearly 88%) used a transdermal form of estrogen; only 12% used oral estrogen pills. Fewer than 5% of participants used synthetic progestins.

Controlling hot flashes was the No. 1 reason the women continued HT beyond age 65 (55%), followed by a desire for a better quality of life (29%), and to reduce chronic pain and arthritis symptoms (7%).

Some adverse effects were reported – postmenopausal bleeding was the most common – but no strokes, myocardial infarctions, or uterine cancers were documented.

More than one fourth (26.4%) of the women tried stopping HT once, but 87% reported that the return of hot flashes was the main reason to restart HT.

In addition, “many women choose to continue hormone therapy long term for relief of nonvasomotor symptoms, preservation of bone density, and a desire to benefit from potential long-term cardiovascular protection,” said Lauren F. Streicher, MD, Professor of Obstetrics and Gynecology at Feinberg School of Medicine at Northwestern University in Chicago, who was not part of the research.

In 2022, The Menopause Society position statement on hormone therapy acknowledged that, on an individual basis, it is appropriate for women to continue hormone therapy long term with counseling on benefits and risks.

“However, few studies have evaluated the outcomes of using hormone therapy for more than 10 years, and individual motivation for doing so,” Dr. Streicher said. She pointed to a study that analyzed the insurance records of more than 10 million women who continued their HT past the age of 65 and reassuringly found that there were significant risk reductions in all-cause mortality, breast cancer, lung cancer, colorectal cancer, heart failure, venous thromboembolism, atrial fibrillation, acute myocardial infarction, and dementia. In that study, however, the reasons women chose to continue hormone therapy were not specified. 

“In this retrospective Canadian study,” she noted, “the outcomes were again reassuring, with no increase in strokes, myocardial infarctions, or uterine cancers. The reasons cited for continuing hormone therapy were not just to treat ongoing vasomotor symptoms, but also other menopause symptoms such as musculoskeletal aches and pains, and overall quality of life.

Dr. Streicher said that, while long-term longitudinal studies are needed to make definitive recommendations, “It is reassuring that women who choose to extend hormone therapy can safely do so. It is irresponsible, cruel, and nonsensical to continue to make blanket statements that hormone therapy should be discontinued based on age or years of use and commit women to enduring symptoms and depriving them of possible long-term benefits.”

Dr. Streicher gives lectures for Midi Health and owns Sermonix stock. Dr. Wolfman has been on the advisory boards for many pharmaceutical companies. She is the past president of the Canadian Menopause Society and is on the board of the International Menopause Society.

Hormone therapy (HT) can help women manage menopause symptoms into their 80s and the reasons are varied, according to a retrospective analysis being presented at the annual meeting of The Menopause Society.

“It’s important to know that this is a preselected group of women who had no contraindications to continuing their hormone therapy,” senior author Wendy Wolfman, MD, director of the Menopause Clinic and The Premature Ovarian Insufficiency Clinic at Mount Sinai Hospital in Toronto, Ontario, Canada, said in an interview. “They had the initiation of hormone therapy closer to menopause and carried on their hormones. We followed them for a long time and basically saw no real concerns about taking the hormones and the patients did very well. It’s important to emphasize this was not the new initiation of hormone therapy in elderly women.”

She said that, in her large tertiary referral center, “I still see patients who are referred who are told that they have to stop their hormones after 5 years based on a false assumption. Everybody ages at different rates and everybody has different risk factors.”

About 70%-80% of women experience menopause symptoms that restrict quality of life and productivity, the authors noted. HT has consistently been the most effective means for managing many of the side effects, especially hot flashes.

Hot flashes last on average 7-11 years. But they continue in up to 40% of women in their 60s and 10%-15% in their 70s, the authors wrote. 

The analysis included more than 100 women in Canada older than 65 who continue to use HT and explored the motivations of the women to use them.

The average age of the women was 71 and nearly 8% were age 80 or older. The mean age for starting HT was 52 years and the women continued HT for an average 18 years, though 42% used it regularly for more than 20 years. Most of the women (nearly 88%) used a transdermal form of estrogen; only 12% used oral estrogen pills. Fewer than 5% of participants used synthetic progestins.

Controlling hot flashes was the No. 1 reason the women continued HT beyond age 65 (55%), followed by a desire for a better quality of life (29%), and to reduce chronic pain and arthritis symptoms (7%).

Some adverse effects were reported – postmenopausal bleeding was the most common – but no strokes, myocardial infarctions, or uterine cancers were documented.

More than one fourth (26.4%) of the women tried stopping HT once, but 87% reported that the return of hot flashes was the main reason to restart HT.

In addition, “many women choose to continue hormone therapy long term for relief of nonvasomotor symptoms, preservation of bone density, and a desire to benefit from potential long-term cardiovascular protection,” said Lauren F. Streicher, MD, Professor of Obstetrics and Gynecology at Feinberg School of Medicine at Northwestern University in Chicago, who was not part of the research.

In 2022, The Menopause Society position statement on hormone therapy acknowledged that, on an individual basis, it is appropriate for women to continue hormone therapy long term with counseling on benefits and risks.

“However, few studies have evaluated the outcomes of using hormone therapy for more than 10 years, and individual motivation for doing so,” Dr. Streicher said. She pointed to a study that analyzed the insurance records of more than 10 million women who continued their HT past the age of 65 and reassuringly found that there were significant risk reductions in all-cause mortality, breast cancer, lung cancer, colorectal cancer, heart failure, venous thromboembolism, atrial fibrillation, acute myocardial infarction, and dementia. In that study, however, the reasons women chose to continue hormone therapy were not specified. 

“In this retrospective Canadian study,” she noted, “the outcomes were again reassuring, with no increase in strokes, myocardial infarctions, or uterine cancers. The reasons cited for continuing hormone therapy were not just to treat ongoing vasomotor symptoms, but also other menopause symptoms such as musculoskeletal aches and pains, and overall quality of life.

Dr. Streicher said that, while long-term longitudinal studies are needed to make definitive recommendations, “It is reassuring that women who choose to extend hormone therapy can safely do so. It is irresponsible, cruel, and nonsensical to continue to make blanket statements that hormone therapy should be discontinued based on age or years of use and commit women to enduring symptoms and depriving them of possible long-term benefits.”

Dr. Streicher gives lectures for Midi Health and owns Sermonix stock. Dr. Wolfman has been on the advisory boards for many pharmaceutical companies. She is the past president of the Canadian Menopause Society and is on the board of the International Menopause Society.

Hormone therapy (HT) can help women manage menopause symptoms into their 80s and the reasons are varied, according to a retrospective analysis being presented at the annual meeting of The Menopause Society.

“It’s important to know that this is a preselected group of women who had no contraindications to continuing their hormone therapy,” senior author Wendy Wolfman, MD, director of the Menopause Clinic and The Premature Ovarian Insufficiency Clinic at Mount Sinai Hospital in Toronto, Ontario, Canada, said in an interview. “They had the initiation of hormone therapy closer to menopause and carried on their hormones. We followed them for a long time and basically saw no real concerns about taking the hormones and the patients did very well. It’s important to emphasize this was not the new initiation of hormone therapy in elderly women.”

She said that, in her large tertiary referral center, “I still see patients who are referred who are told that they have to stop their hormones after 5 years based on a false assumption. Everybody ages at different rates and everybody has different risk factors.”

About 70%-80% of women experience menopause symptoms that restrict quality of life and productivity, the authors noted. HT has consistently been the most effective means for managing many of the side effects, especially hot flashes.

Hot flashes last on average 7-11 years. But they continue in up to 40% of women in their 60s and 10%-15% in their 70s, the authors wrote. 

The analysis included more than 100 women in Canada older than 65 who continue to use HT and explored the motivations of the women to use them.

The average age of the women was 71 and nearly 8% were age 80 or older. The mean age for starting HT was 52 years and the women continued HT for an average 18 years, though 42% used it regularly for more than 20 years. Most of the women (nearly 88%) used a transdermal form of estrogen; only 12% used oral estrogen pills. Fewer than 5% of participants used synthetic progestins.

Controlling hot flashes was the No. 1 reason the women continued HT beyond age 65 (55%), followed by a desire for a better quality of life (29%), and to reduce chronic pain and arthritis symptoms (7%).

Some adverse effects were reported – postmenopausal bleeding was the most common – but no strokes, myocardial infarctions, or uterine cancers were documented.

More than one fourth (26.4%) of the women tried stopping HT once, but 87% reported that the return of hot flashes was the main reason to restart HT.

In addition, “many women choose to continue hormone therapy long term for relief of nonvasomotor symptoms, preservation of bone density, and a desire to benefit from potential long-term cardiovascular protection,” said Lauren F. Streicher, MD, Professor of Obstetrics and Gynecology at Feinberg School of Medicine at Northwestern University in Chicago, who was not part of the research.

In 2022, The Menopause Society position statement on hormone therapy acknowledged that, on an individual basis, it is appropriate for women to continue hormone therapy long term with counseling on benefits and risks.

“However, few studies have evaluated the outcomes of using hormone therapy for more than 10 years, and individual motivation for doing so,” Dr. Streicher said. She pointed to a study that analyzed the insurance records of more than 10 million women who continued their HT past the age of 65 and reassuringly found that there were significant risk reductions in all-cause mortality, breast cancer, lung cancer, colorectal cancer, heart failure, venous thromboembolism, atrial fibrillation, acute myocardial infarction, and dementia. In that study, however, the reasons women chose to continue hormone therapy were not specified. 

“In this retrospective Canadian study,” she noted, “the outcomes were again reassuring, with no increase in strokes, myocardial infarctions, or uterine cancers. The reasons cited for continuing hormone therapy were not just to treat ongoing vasomotor symptoms, but also other menopause symptoms such as musculoskeletal aches and pains, and overall quality of life.

Dr. Streicher said that, while long-term longitudinal studies are needed to make definitive recommendations, “It is reassuring that women who choose to extend hormone therapy can safely do so. It is irresponsible, cruel, and nonsensical to continue to make blanket statements that hormone therapy should be discontinued based on age or years of use and commit women to enduring symptoms and depriving them of possible long-term benefits.”

Dr. Streicher gives lectures for Midi Health and owns Sermonix stock. Dr. Wolfman has been on the advisory boards for many pharmaceutical companies. She is the past president of the Canadian Menopause Society and is on the board of the International Menopause Society.

Information readily available on a newborn screening, combined with clinical risk factors, may eventually be able to help identify infants at increased risk for sudden infant death syndrome (SIDS), new data suggest.

Findings of the study by Scott P. Oltman, MS, of the Department of Epidemiology & Biostatistics, University of California, San Francisco, and colleagues were published in JAMA Pediatrics.

The case-controlled study showed a link between aberrant metabolic analytes at birth and SIDS. Researchers used data from the California Office of Statewide Health Planning and Development and the California Department of Public Health and included 2.3 million infants born between 2005 and 2011 in the dataset.

Of the 2.3 million infants, 354 had SIDS. The researchers found that 14 newborn screening metabolites were significantly associated with SIDS. After the screens, the babies who had elevated metabolite markers, compared with the control babies had 14.4 times higher odds of having SIDS, the researchers reported.

“It’s really promising research,” Joanna J. Parga-Belinkie, MD, an attending neonatologist who was not involved in the study, said in an interview. She practices in the Division of Neonatology at Children’s Hospital of Philadelphia in Pennsylvania. “It doesn’t really give us the answer to what causes SIDS, but I think in the long term it’s going to inform a lot of research that will help us understand whether there are biomarkers that can predict SIDS.”

Other studies have looked at different metabolic markers to see if they can help predict SIDS, she said, but the innovation in this study is that it uses newborn screens, which are collected on all babies born in a hospital. Dr. Parga-Belinkie added that another strength of the study is its large sample size and matched controls to compare the SIDS cases with healthy babies.

“That said, newborn screens are a screening test, they are not diagnostic,” Dr. Parga-Belinkie said. “We definitely need further testing to see if (the metabolic biomarkers) really make that link to SIDS.”

It will be important to test this in a prospective study over time and in real time, she said, which is something the authors acknowledge. They list the retrospective design of the study as a major limitation.

These study results won’t change the counseling for families on decreasing risk, Dr. Parga-Belinkie said, “because there’s not a clear biomarker that has emerged and we don’t have a clear link yet.” Safe sleep hygiene will continue to be the primary focus of counseling parents, such as placing the baby on its back on a firm, flat surface with no loose bedding or stuffed animals.

The study authors said several things will need to be clarified with future research, noting that a majority of the infants in the California database were of Hispanic ethnicity. Testing other populations will help determine generalizability.

Also, there has been ambiguity in the definition of SIDS, which has led to inconsistencies in classifying a death as SIDS or death from an unknown cause of suffocation or asphyxiation.

They added: “It may also be the case that these markers are predictive and reliable but not causal in nature and distinguishing between the two is a crucial topic for future investigation.”

This work was supported in part by the California Preterm Birth Initiative within the University of California, San Francisco, and by the National Institutes of Health. Mr. Oltman reported having a patent pending for a newborn metabolic vulnerability model for identifying preterm infants at risk of adverse outcomes and uses thereof. One coauthor reported having a patent pending and a patent issued; another reported having a patent pending for a newborn metabolic vulnerability model for identifying preterm infants at risk of adverse outcomes and uses thereof. Dr. Parga-Belinkie declared no relevant financial disclosures.

Information readily available on a newborn screening, combined with clinical risk factors, may eventually be able to help identify infants at increased risk for sudden infant death syndrome (SIDS), new data suggest.

Findings of the study by Scott P. Oltman, MS, of the Department of Epidemiology & Biostatistics, University of California, San Francisco, and colleagues were published in JAMA Pediatrics.

The case-controlled study showed a link between aberrant metabolic analytes at birth and SIDS. Researchers used data from the California Office of Statewide Health Planning and Development and the California Department of Public Health and included 2.3 million infants born between 2005 and 2011 in the dataset.

Of the 2.3 million infants, 354 had SIDS. The researchers found that 14 newborn screening metabolites were significantly associated with SIDS. After the screens, the babies who had elevated metabolite markers, compared with the control babies had 14.4 times higher odds of having SIDS, the researchers reported.

“It’s really promising research,” Joanna J. Parga-Belinkie, MD, an attending neonatologist who was not involved in the study, said in an interview. She practices in the Division of Neonatology at Children’s Hospital of Philadelphia in Pennsylvania. “It doesn’t really give us the answer to what causes SIDS, but I think in the long term it’s going to inform a lot of research that will help us understand whether there are biomarkers that can predict SIDS.”

Other studies have looked at different metabolic markers to see if they can help predict SIDS, she said, but the innovation in this study is that it uses newborn screens, which are collected on all babies born in a hospital. Dr. Parga-Belinkie added that another strength of the study is its large sample size and matched controls to compare the SIDS cases with healthy babies.

“That said, newborn screens are a screening test, they are not diagnostic,” Dr. Parga-Belinkie said. “We definitely need further testing to see if (the metabolic biomarkers) really make that link to SIDS.”

It will be important to test this in a prospective study over time and in real time, she said, which is something the authors acknowledge. They list the retrospective design of the study as a major limitation.

These study results won’t change the counseling for families on decreasing risk, Dr. Parga-Belinkie said, “because there’s not a clear biomarker that has emerged and we don’t have a clear link yet.” Safe sleep hygiene will continue to be the primary focus of counseling parents, such as placing the baby on its back on a firm, flat surface with no loose bedding or stuffed animals.

The study authors said several things will need to be clarified with future research, noting that a majority of the infants in the California database were of Hispanic ethnicity. Testing other populations will help determine generalizability.

Also, there has been ambiguity in the definition of SIDS, which has led to inconsistencies in classifying a death as SIDS or death from an unknown cause of suffocation or asphyxiation.

They added: “It may also be the case that these markers are predictive and reliable but not causal in nature and distinguishing between the two is a crucial topic for future investigation.”

This work was supported in part by the California Preterm Birth Initiative within the University of California, San Francisco, and by the National Institutes of Health. Mr. Oltman reported having a patent pending for a newborn metabolic vulnerability model for identifying preterm infants at risk of adverse outcomes and uses thereof. One coauthor reported having a patent pending and a patent issued; another reported having a patent pending for a newborn metabolic vulnerability model for identifying preterm infants at risk of adverse outcomes and uses thereof. Dr. Parga-Belinkie declared no relevant financial disclosures.

Information readily available on a newborn screening, combined with clinical risk factors, may eventually be able to help identify infants at increased risk for sudden infant death syndrome (SIDS), new data suggest.

Findings of the study by Scott P. Oltman, MS, of the Department of Epidemiology & Biostatistics, University of California, San Francisco, and colleagues were published in JAMA Pediatrics.

The case-controlled study showed a link between aberrant metabolic analytes at birth and SIDS. Researchers used data from the California Office of Statewide Health Planning and Development and the California Department of Public Health and included 2.3 million infants born between 2005 and 2011 in the dataset.

Of the 2.3 million infants, 354 had SIDS. The researchers found that 14 newborn screening metabolites were significantly associated with SIDS. After the screens, the babies who had elevated metabolite markers, compared with the control babies had 14.4 times higher odds of having SIDS, the researchers reported.

“It’s really promising research,” Joanna J. Parga-Belinkie, MD, an attending neonatologist who was not involved in the study, said in an interview. She practices in the Division of Neonatology at Children’s Hospital of Philadelphia in Pennsylvania. “It doesn’t really give us the answer to what causes SIDS, but I think in the long term it’s going to inform a lot of research that will help us understand whether there are biomarkers that can predict SIDS.”

Other studies have looked at different metabolic markers to see if they can help predict SIDS, she said, but the innovation in this study is that it uses newborn screens, which are collected on all babies born in a hospital. Dr. Parga-Belinkie added that another strength of the study is its large sample size and matched controls to compare the SIDS cases with healthy babies.

“That said, newborn screens are a screening test, they are not diagnostic,” Dr. Parga-Belinkie said. “We definitely need further testing to see if (the metabolic biomarkers) really make that link to SIDS.”

It will be important to test this in a prospective study over time and in real time, she said, which is something the authors acknowledge. They list the retrospective design of the study as a major limitation.

These study results won’t change the counseling for families on decreasing risk, Dr. Parga-Belinkie said, “because there’s not a clear biomarker that has emerged and we don’t have a clear link yet.” Safe sleep hygiene will continue to be the primary focus of counseling parents, such as placing the baby on its back on a firm, flat surface with no loose bedding or stuffed animals.

The study authors said several things will need to be clarified with future research, noting that a majority of the infants in the California database were of Hispanic ethnicity. Testing other populations will help determine generalizability.

Also, there has been ambiguity in the definition of SIDS, which has led to inconsistencies in classifying a death as SIDS or death from an unknown cause of suffocation or asphyxiation.

They added: “It may also be the case that these markers are predictive and reliable but not causal in nature and distinguishing between the two is a crucial topic for future investigation.”

This work was supported in part by the California Preterm Birth Initiative within the University of California, San Francisco, and by the National Institutes of Health. Mr. Oltman reported having a patent pending for a newborn metabolic vulnerability model for identifying preterm infants at risk of adverse outcomes and uses thereof. One coauthor reported having a patent pending and a patent issued; another reported having a patent pending for a newborn metabolic vulnerability model for identifying preterm infants at risk of adverse outcomes and uses thereof. Dr. Parga-Belinkie declared no relevant financial disclosures.

Pregnant women in a large North American sample reported nearly double the rate of cannabidiol (CBD) use compared with nonpregnant women, new data published in a research letter in Obstetrics & Gynecology indicates.

Healthcare providers should be aware of the high rate of CBD use in pregnancy, especially as legal use of cannabis is increasing faster than evidence on outcomes for exposed offspring, note the researchers, led by Devika Bhatia, MD, from the Department of Psychiatry, Colorado School of Medicine, University of Colorado Anschutz Medical Campus in Aurora.

In an accompanying editorial, Torri D. Metz, MD, MS, deputy editor for obstetrics for Obstetrics & Gynecology, writes that the study “is critically important.” She points out that pregnant individuals may perceive that CBD is a safe drug to use in pregnancy, despite there being essentially no data examining whether or not this is the case.

Large Dataset From United States and Canada

Researchers used data from the International Cannabis Policy Study (2019-2021), a repeated cross-sectional survey of people aged 16-65 years in the United States and Canada. There were 66,457 women in the sample, including 1096 pregnant women.

Particularly concerning, the authors write, is the prenatal use of CBD-only products. Those products are advertised to contain only CBD, rather than tetrahydrocannabinol (THC). They point out CBD-only products are often legal in North America and often marketed as supplements.

The prevalence of CBD-only use in pregnant women in the study was 20.4% compared with 11.3% among nonpregnant women, P < .001. The top reason for use by pregnant women was anxiety (58.4%). Other top reasons included depression (40.3%), posttraumatic stress disorder (32.1%), pain (52.3%), headache (35.6%), and nausea or vomiting (31.9%).

“Nonpregnant women were significantly more likely to report using CBD for pain, sleep, general well-being, and ‘other’ physical or mental health reasons, or to not use CBD for mental health,” the authors write, adding that the reasons for CBD use highlight drivers that may be important to address in treating pregnant patients.
 

Provider Endorsement in Some Cases

Dr. Metz, associate professor of obstetrics and gynecology with the University of Utah Health in Salt Lake City, says in some cases women may be getting endorsement of CBD use from their provider or at least implied support when CBD is prescribed. In the study, pregnant women had 2.33 times greater adjusted odds of having a CBD prescription than nonpregnant women (95% confidence interval, 1.27-2.88).

She points to another cross-sectional study of more than 10,000 participants using PRAMS (Pregnancy Risk Assessment Monitoring System) data that found that “from 2017 to 2019, 63% of pregnant women reported that they were not told to avoid cannabis use in pregnancy, and 8% noted that they were advised to use cannabis by their prenatal care practitioner.”

The American College of Obstetricians and Gynecologists recommends against prescribing cannabis products for pregnant or lactating women.

Studies that have explored THC and its metabolites have shown “a consistent association between cannabis use and decreased fetal growth,” Dr. Metz noted. “There also remain persistent concerns about the long-term neurodevelopmental effects of maternal cannabis use on the fetus and, subsequently, the newborn.”

Limitations of the study include the self-reported responses and participants’ ability to accurately distinguish between CBD-only and THC-containing products.

Because self-reports of CBD use in pregnancy may be drastically underestimated and nonreliable, Dr. Metz writes, development of blood and urine screens to help detect CBD product use “will be helpful in moving the field forward.”

Study senior author David Hammond, PhD, has been a paid expert witness on behalf of public health authorities in response to legal challenges from the cannabis, tobacco, vaping, and food industries. Other authors did not report any potential conflicts. Dr. Metz reports personal fees from Pfizer, and grants from Pfizer for her role as a site principal investigator for SARS-CoV-2 vaccination and for her role as a site PI for RSV vaccination in pregnancy study.

Pregnant women in a large North American sample reported nearly double the rate of cannabidiol (CBD) use compared with nonpregnant women, new data published in a research letter in Obstetrics & Gynecology indicates.

Healthcare providers should be aware of the high rate of CBD use in pregnancy, especially as legal use of cannabis is increasing faster than evidence on outcomes for exposed offspring, note the researchers, led by Devika Bhatia, MD, from the Department of Psychiatry, Colorado School of Medicine, University of Colorado Anschutz Medical Campus in Aurora.

In an accompanying editorial, Torri D. Metz, MD, MS, deputy editor for obstetrics for Obstetrics & Gynecology, writes that the study “is critically important.” She points out that pregnant individuals may perceive that CBD is a safe drug to use in pregnancy, despite there being essentially no data examining whether or not this is the case.

Large Dataset From United States and Canada

Researchers used data from the International Cannabis Policy Study (2019-2021), a repeated cross-sectional survey of people aged 16-65 years in the United States and Canada. There were 66,457 women in the sample, including 1096 pregnant women.

Particularly concerning, the authors write, is the prenatal use of CBD-only products. Those products are advertised to contain only CBD, rather than tetrahydrocannabinol (THC). They point out CBD-only products are often legal in North America and often marketed as supplements.

The prevalence of CBD-only use in pregnant women in the study was 20.4% compared with 11.3% among nonpregnant women, P < .001. The top reason for use by pregnant women was anxiety (58.4%). Other top reasons included depression (40.3%), posttraumatic stress disorder (32.1%), pain (52.3%), headache (35.6%), and nausea or vomiting (31.9%).

“Nonpregnant women were significantly more likely to report using CBD for pain, sleep, general well-being, and ‘other’ physical or mental health reasons, or to not use CBD for mental health,” the authors write, adding that the reasons for CBD use highlight drivers that may be important to address in treating pregnant patients.
 

Provider Endorsement in Some Cases

Dr. Metz, associate professor of obstetrics and gynecology with the University of Utah Health in Salt Lake City, says in some cases women may be getting endorsement of CBD use from their provider or at least implied support when CBD is prescribed. In the study, pregnant women had 2.33 times greater adjusted odds of having a CBD prescription than nonpregnant women (95% confidence interval, 1.27-2.88).

She points to another cross-sectional study of more than 10,000 participants using PRAMS (Pregnancy Risk Assessment Monitoring System) data that found that “from 2017 to 2019, 63% of pregnant women reported that they were not told to avoid cannabis use in pregnancy, and 8% noted that they were advised to use cannabis by their prenatal care practitioner.”

The American College of Obstetricians and Gynecologists recommends against prescribing cannabis products for pregnant or lactating women.

Studies that have explored THC and its metabolites have shown “a consistent association between cannabis use and decreased fetal growth,” Dr. Metz noted. “There also remain persistent concerns about the long-term neurodevelopmental effects of maternal cannabis use on the fetus and, subsequently, the newborn.”

Limitations of the study include the self-reported responses and participants’ ability to accurately distinguish between CBD-only and THC-containing products.

Because self-reports of CBD use in pregnancy may be drastically underestimated and nonreliable, Dr. Metz writes, development of blood and urine screens to help detect CBD product use “will be helpful in moving the field forward.”

Study senior author David Hammond, PhD, has been a paid expert witness on behalf of public health authorities in response to legal challenges from the cannabis, tobacco, vaping, and food industries. Other authors did not report any potential conflicts. Dr. Metz reports personal fees from Pfizer, and grants from Pfizer for her role as a site principal investigator for SARS-CoV-2 vaccination and for her role as a site PI for RSV vaccination in pregnancy study.

Pregnant women in a large North American sample reported nearly double the rate of cannabidiol (CBD) use compared with nonpregnant women, new data published in a research letter in Obstetrics & Gynecology indicates.

Healthcare providers should be aware of the high rate of CBD use in pregnancy, especially as legal use of cannabis is increasing faster than evidence on outcomes for exposed offspring, note the researchers, led by Devika Bhatia, MD, from the Department of Psychiatry, Colorado School of Medicine, University of Colorado Anschutz Medical Campus in Aurora.

In an accompanying editorial, Torri D. Metz, MD, MS, deputy editor for obstetrics for Obstetrics & Gynecology, writes that the study “is critically important.” She points out that pregnant individuals may perceive that CBD is a safe drug to use in pregnancy, despite there being essentially no data examining whether or not this is the case.

Large Dataset From United States and Canada

Researchers used data from the International Cannabis Policy Study (2019-2021), a repeated cross-sectional survey of people aged 16-65 years in the United States and Canada. There were 66,457 women in the sample, including 1096 pregnant women.

Particularly concerning, the authors write, is the prenatal use of CBD-only products. Those products are advertised to contain only CBD, rather than tetrahydrocannabinol (THC). They point out CBD-only products are often legal in North America and often marketed as supplements.

The prevalence of CBD-only use in pregnant women in the study was 20.4% compared with 11.3% among nonpregnant women, P < .001. The top reason for use by pregnant women was anxiety (58.4%). Other top reasons included depression (40.3%), posttraumatic stress disorder (32.1%), pain (52.3%), headache (35.6%), and nausea or vomiting (31.9%).

“Nonpregnant women were significantly more likely to report using CBD for pain, sleep, general well-being, and ‘other’ physical or mental health reasons, or to not use CBD for mental health,” the authors write, adding that the reasons for CBD use highlight drivers that may be important to address in treating pregnant patients.
 

Provider Endorsement in Some Cases

Dr. Metz, associate professor of obstetrics and gynecology with the University of Utah Health in Salt Lake City, says in some cases women may be getting endorsement of CBD use from their provider or at least implied support when CBD is prescribed. In the study, pregnant women had 2.33 times greater adjusted odds of having a CBD prescription than nonpregnant women (95% confidence interval, 1.27-2.88).

She points to another cross-sectional study of more than 10,000 participants using PRAMS (Pregnancy Risk Assessment Monitoring System) data that found that “from 2017 to 2019, 63% of pregnant women reported that they were not told to avoid cannabis use in pregnancy, and 8% noted that they were advised to use cannabis by their prenatal care practitioner.”

The American College of Obstetricians and Gynecologists recommends against prescribing cannabis products for pregnant or lactating women.

Studies that have explored THC and its metabolites have shown “a consistent association between cannabis use and decreased fetal growth,” Dr. Metz noted. “There also remain persistent concerns about the long-term neurodevelopmental effects of maternal cannabis use on the fetus and, subsequently, the newborn.”

Limitations of the study include the self-reported responses and participants’ ability to accurately distinguish between CBD-only and THC-containing products.

Because self-reports of CBD use in pregnancy may be drastically underestimated and nonreliable, Dr. Metz writes, development of blood and urine screens to help detect CBD product use “will be helpful in moving the field forward.”

Study senior author David Hammond, PhD, has been a paid expert witness on behalf of public health authorities in response to legal challenges from the cannabis, tobacco, vaping, and food industries. Other authors did not report any potential conflicts. Dr. Metz reports personal fees from Pfizer, and grants from Pfizer for her role as a site principal investigator for SARS-CoV-2 vaccination and for her role as a site PI for RSV vaccination in pregnancy study.

Topical sildenafil (citrate) cream 3.6% used by healthy premenopausal women with a primary symptom of female sexual arousal disorder did not show statistically significant improvement over placebo in the coprimary or secondary endpoints over a 3-month period in new preliminary study data published in Obstetrics & Gynecology.

Topical sildenafil cream is currently used for erectile dysfunction in men. There are no US Food and Drug Administration–approved treatments for female sexual arousal disorder, which affects up to 26% of women in the United States by some estimates.

Isabella Johnson, senior manager of product development at Daré Bioscience, San Diego, California, led a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream’s potential to help women improve their sexual experiences.

The study included 200 women with female sexual arousal disorder randomized to sildenafil cream (n = 101) or placebo cream (n = 99); 177 completed the trial and made up the intention-to-treat group. Healthy premenopausal women at least 18 years old and their sexual partners were screened for the study.

The authors report that the primary endpoints were scores on Sexual Function Questionnaire (SFQ28) arousal sensation domain and question 14 on the Female Sexual Distress Scale — Desire/Arousal/Orgasm (FSD-DAO), which asks “How often in the past 30 days did you feel concerned by difficulties with sexual arousal?”  The secondary endpoint was the average number and average proportion of satisfactory sexual events. Topical sildenafil was not more effective than placebo with these primary or secondary endpoints.
 

Some Subgroups Benefited

However, a post hoc analysis told a different story. “[A]mong a subset of women with female sexual arousal disorder only or female sexual arousal disorder with concomitant decreased desire, we found either trends or significant improvements in sexual functioning with sildenafil cream compared with placebo cream across multiple aspects of sexual function,” the authors write.

The researchers also noted that several FSDS-DAO questions, other than question 14, asked about generalized feelings related to sexual distress and interpersonal difficulties and scores on those questions showed significant improvement with sildenafil cream compared with placebo in the exploratory subset.

“The total FSDS-DAO score decreased by about 7 points for sildenafil cream users in the subset population (a clinically meaningful decrease in sexual distress) compared with a two-point decrease for placebo cream users (P = .10),” they write.

Post Hoc Analysis Is Exploratory

JoAnn V. Pinkerton, MD, with the Department of Obstetrics and Gynecology, University of Virginia Health in Charlottesville, writes in an editorial that because the authors did not adjust for multiple hypothesis testing, the post hoc subset analyses should be considered only exploratory.

She notes that the trial was underpowered partly because it was halted after recruitment challenges during the COVID-19 pandemic. The small sample size and the varied reasons for arousal disorder among the women “may have limited the ability to find a positive outcome.”

The underlying mechanisms of female sexual arousal disorder are not well understood. But the study findings point to some groups that may benefit or likely will not benefit, Dr. Pinkerton writes.

“Because improvement in genital arousal is thought to be due to the increased genital blood flow from sildenafil citrate, the subset of participants found least likely to benefit from sildenafil citrate cream were those with concomitant orgasmic dysfunction with or without genital pain,” she writes.
 

Data May Inform Phase 3 Trial

This phase 2b trial sets the stage for a phase 3 trial, she writes, to evaluate sildenafil topical cream in women with female sexual arousal disorder in the subsets where there were positive findings (those with or without a secondary diagnosis of decreased desire) but not among women having difficulty reaching orgasm.

“If positive, it could lead to a new therapeutic area for the unmet treatment needs of premenopausal and postmenopausal women with female sexual arousal disorder,” Dr. Pinkerton writes.

A study coauthor, Clint Dart, reports money was paid to his institution from Daré Bioscience, he provided independent data verification, and he is an employee of Premier Research. Isabella Johnson, Andrea Ries Thurman, MD, Jessica Hatheway, MBA, David R. Friend, PhD, and Andrew Goldstein, MD, are employees of Daré Bioscience. Katherine A. Cornell is an employee of Strategic Science & Technologies, LLC. C. Paige Brainard, MD, was financially compensated by Del Sol Research Management and her practice received funding from Daré Bioscience for study-specific activities. Dr. Goldstein also reported receiving payments from Nuvig, Ipsen, and AbbVie. Dr. Pinkerton’s institution received funds from Bayer Pharmaceuticals as she served as PI for a multinational clinical trial.

Topical sildenafil (citrate) cream 3.6% used by healthy premenopausal women with a primary symptom of female sexual arousal disorder did not show statistically significant improvement over placebo in the coprimary or secondary endpoints over a 3-month period in new preliminary study data published in Obstetrics & Gynecology.

Topical sildenafil cream is currently used for erectile dysfunction in men. There are no US Food and Drug Administration–approved treatments for female sexual arousal disorder, which affects up to 26% of women in the United States by some estimates.

Isabella Johnson, senior manager of product development at Daré Bioscience, San Diego, California, led a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream’s potential to help women improve their sexual experiences.

The study included 200 women with female sexual arousal disorder randomized to sildenafil cream (n = 101) or placebo cream (n = 99); 177 completed the trial and made up the intention-to-treat group. Healthy premenopausal women at least 18 years old and their sexual partners were screened for the study.

The authors report that the primary endpoints were scores on Sexual Function Questionnaire (SFQ28) arousal sensation domain and question 14 on the Female Sexual Distress Scale — Desire/Arousal/Orgasm (FSD-DAO), which asks “How often in the past 30 days did you feel concerned by difficulties with sexual arousal?”  The secondary endpoint was the average number and average proportion of satisfactory sexual events. Topical sildenafil was not more effective than placebo with these primary or secondary endpoints.
 

Some Subgroups Benefited

However, a post hoc analysis told a different story. “[A]mong a subset of women with female sexual arousal disorder only or female sexual arousal disorder with concomitant decreased desire, we found either trends or significant improvements in sexual functioning with sildenafil cream compared with placebo cream across multiple aspects of sexual function,” the authors write.

The researchers also noted that several FSDS-DAO questions, other than question 14, asked about generalized feelings related to sexual distress and interpersonal difficulties and scores on those questions showed significant improvement with sildenafil cream compared with placebo in the exploratory subset.

“The total FSDS-DAO score decreased by about 7 points for sildenafil cream users in the subset population (a clinically meaningful decrease in sexual distress) compared with a two-point decrease for placebo cream users (P = .10),” they write.

Post Hoc Analysis Is Exploratory

JoAnn V. Pinkerton, MD, with the Department of Obstetrics and Gynecology, University of Virginia Health in Charlottesville, writes in an editorial that because the authors did not adjust for multiple hypothesis testing, the post hoc subset analyses should be considered only exploratory.

She notes that the trial was underpowered partly because it was halted after recruitment challenges during the COVID-19 pandemic. The small sample size and the varied reasons for arousal disorder among the women “may have limited the ability to find a positive outcome.”

The underlying mechanisms of female sexual arousal disorder are not well understood. But the study findings point to some groups that may benefit or likely will not benefit, Dr. Pinkerton writes.

“Because improvement in genital arousal is thought to be due to the increased genital blood flow from sildenafil citrate, the subset of participants found least likely to benefit from sildenafil citrate cream were those with concomitant orgasmic dysfunction with or without genital pain,” she writes.
 

Data May Inform Phase 3 Trial

This phase 2b trial sets the stage for a phase 3 trial, she writes, to evaluate sildenafil topical cream in women with female sexual arousal disorder in the subsets where there were positive findings (those with or without a secondary diagnosis of decreased desire) but not among women having difficulty reaching orgasm.

“If positive, it could lead to a new therapeutic area for the unmet treatment needs of premenopausal and postmenopausal women with female sexual arousal disorder,” Dr. Pinkerton writes.

A study coauthor, Clint Dart, reports money was paid to his institution from Daré Bioscience, he provided independent data verification, and he is an employee of Premier Research. Isabella Johnson, Andrea Ries Thurman, MD, Jessica Hatheway, MBA, David R. Friend, PhD, and Andrew Goldstein, MD, are employees of Daré Bioscience. Katherine A. Cornell is an employee of Strategic Science & Technologies, LLC. C. Paige Brainard, MD, was financially compensated by Del Sol Research Management and her practice received funding from Daré Bioscience for study-specific activities. Dr. Goldstein also reported receiving payments from Nuvig, Ipsen, and AbbVie. Dr. Pinkerton’s institution received funds from Bayer Pharmaceuticals as she served as PI for a multinational clinical trial.

Topical sildenafil (citrate) cream 3.6% used by healthy premenopausal women with a primary symptom of female sexual arousal disorder did not show statistically significant improvement over placebo in the coprimary or secondary endpoints over a 3-month period in new preliminary study data published in Obstetrics & Gynecology.

Topical sildenafil cream is currently used for erectile dysfunction in men. There are no US Food and Drug Administration–approved treatments for female sexual arousal disorder, which affects up to 26% of women in the United States by some estimates.

Isabella Johnson, senior manager of product development at Daré Bioscience, San Diego, California, led a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream’s potential to help women improve their sexual experiences.

The study included 200 women with female sexual arousal disorder randomized to sildenafil cream (n = 101) or placebo cream (n = 99); 177 completed the trial and made up the intention-to-treat group. Healthy premenopausal women at least 18 years old and their sexual partners were screened for the study.

The authors report that the primary endpoints were scores on Sexual Function Questionnaire (SFQ28) arousal sensation domain and question 14 on the Female Sexual Distress Scale — Desire/Arousal/Orgasm (FSD-DAO), which asks “How often in the past 30 days did you feel concerned by difficulties with sexual arousal?”  The secondary endpoint was the average number and average proportion of satisfactory sexual events. Topical sildenafil was not more effective than placebo with these primary or secondary endpoints.
 

Some Subgroups Benefited

However, a post hoc analysis told a different story. “[A]mong a subset of women with female sexual arousal disorder only or female sexual arousal disorder with concomitant decreased desire, we found either trends or significant improvements in sexual functioning with sildenafil cream compared with placebo cream across multiple aspects of sexual function,” the authors write.

The researchers also noted that several FSDS-DAO questions, other than question 14, asked about generalized feelings related to sexual distress and interpersonal difficulties and scores on those questions showed significant improvement with sildenafil cream compared with placebo in the exploratory subset.

“The total FSDS-DAO score decreased by about 7 points for sildenafil cream users in the subset population (a clinically meaningful decrease in sexual distress) compared with a two-point decrease for placebo cream users (P = .10),” they write.

Post Hoc Analysis Is Exploratory

JoAnn V. Pinkerton, MD, with the Department of Obstetrics and Gynecology, University of Virginia Health in Charlottesville, writes in an editorial that because the authors did not adjust for multiple hypothesis testing, the post hoc subset analyses should be considered only exploratory.

She notes that the trial was underpowered partly because it was halted after recruitment challenges during the COVID-19 pandemic. The small sample size and the varied reasons for arousal disorder among the women “may have limited the ability to find a positive outcome.”

The underlying mechanisms of female sexual arousal disorder are not well understood. But the study findings point to some groups that may benefit or likely will not benefit, Dr. Pinkerton writes.

“Because improvement in genital arousal is thought to be due to the increased genital blood flow from sildenafil citrate, the subset of participants found least likely to benefit from sildenafil citrate cream were those with concomitant orgasmic dysfunction with or without genital pain,” she writes.
 

Data May Inform Phase 3 Trial

This phase 2b trial sets the stage for a phase 3 trial, she writes, to evaluate sildenafil topical cream in women with female sexual arousal disorder in the subsets where there were positive findings (those with or without a secondary diagnosis of decreased desire) but not among women having difficulty reaching orgasm.

“If positive, it could lead to a new therapeutic area for the unmet treatment needs of premenopausal and postmenopausal women with female sexual arousal disorder,” Dr. Pinkerton writes.

A study coauthor, Clint Dart, reports money was paid to his institution from Daré Bioscience, he provided independent data verification, and he is an employee of Premier Research. Isabella Johnson, Andrea Ries Thurman, MD, Jessica Hatheway, MBA, David R. Friend, PhD, and Andrew Goldstein, MD, are employees of Daré Bioscience. Katherine A. Cornell is an employee of Strategic Science & Technologies, LLC. C. Paige Brainard, MD, was financially compensated by Del Sol Research Management and her practice received funding from Daré Bioscience for study-specific activities. Dr. Goldstein also reported receiving payments from Nuvig, Ipsen, and AbbVie. Dr. Pinkerton’s institution received funds from Bayer Pharmaceuticals as she served as PI for a multinational clinical trial.

Most young people, ages 10-24 years old, who die by suicide have no previously documented mental health diagnosis, according to a large analysis of Centers for Disease Control and Prevention data.

Sofia Chaudhary, MD, with the Department of Pediatrics and Emergency Medicine at Emory University School of Medicine in Atlanta, Georgia, and colleagues, analyzed data from the National Violent Death Reporting System and found in the cross-sectional study of 40, 618 youths that 24,192 (59.6%) had no such diagnosis previously. Findings were published online in JAMA Network Open.
 

Gaps by Race, Sex and Age

The odds of having a mental health diagnosis before death by suicide differed by race and sex. Compared with White youths, the odds were lower among youths who were American Indian or Alaska Native (adjusted odds ratio [aOR], 0.45; Asian, Native Hawaiian, or Other Pacific Islander (aOR, 0.58); and Black youths (aOR, 0.62). And more than half of female youths who died by suicide had a mental health diagnosis (4429 youths [52.4%]), compared with 11,994 male youths (37.3%).

The researchers also found wide gaps by age, specifically lower odds of having a mental health diagnosis before suicide in children ages 10-14 compared with those 20-24.

“This finding is particularly notable because suicide rates have risen to become the second leading cause of death in youths aged 10 to 14 years,” the authors wrote. “Suicide prevention strategies for young children in primary care and community settings should focus on fostering resilience, promoting peer and family connectedness, and empowering children with strategies to cope with stress and adversity.”

Youths who died by firearm suicide, the most common mechanism, had the lowest rate of diagnosis. “Similar to a prior study, we found that decedents without a documented mental health diagnosis were far more likely to utilize a firearm than those with a documented mental health diagnosis,” the authors wrote. 

In an invited commentary, Lisa M. Horowitz, PhD, MPH, with the Office of the Clinical Director, Intramural Research Program, National Institute of Mental Health, in Bethesda, Maryland, and colleagues wrote that the data show that identifying youth early who have mental disorders or are at-risk for suicide “is more the exception than the rule” in the United States.

The editorialists highlight that the study showed that about one-quarter of youths who have attempted suicide and nearly one-half of youths with depressed mood had no documented mental health diagnosis. Decedents were categorized with depressed mood if they were perceived by themselves or others as depressed at the time of death.
 

Intervention Recommendations

The study authors point to the high number of youth firearm suicide (the method used by nearly half of those who died — 19,027 (46.8%) and recommended interventions. “Suicide prevention strategies are needed for the estimated 22.6 million US children living in households with firearms, of whom 4.5 million are exposed to firearms stored loaded and unlocked,” they wrote.

A mental health diagnosis was documented for only 6308 of 19,027 youths who died by firearms (33.2%).

They noted that research has shown that more than 75% of guns used in youth suicide are owned by a family member, most commonly parents, and the presence of a firearm in the home is linked with a higher risk of youth suicide.

They wrote that the risk can be mitigated by storing all guns locked and unloaded, with ammunition stored and locked in a separate location.

The editorialists said the study highlights the need for action in several primary areas. “Suicide prevention strategies should not solely rely on a history of mental illness to identify at-risk youths, and universal suicide risk screening in healthcare settings deserves greater consideration,” they wrote.

Equitable access to care is essential to youth suicide risk detection. Interventions such as lethal means safety counseling, safety planning, and a helpline number, such as 988, should be accessible to every family and healthcare clinician.

Community-level interventions are critical, including school-based suicide prevention programs, as well as population-based training for families on the safe storage of lethal means at home.

“Every trusted adult working with children and adolescents can and should be trained to recognize the warning signs of suicide risk and help young people develop the coping strategies needed to manage difficult life experiences so that suicide is never an option,” Dr. Horowitz and colleagues wrote.

A coauthor of the study, Jennifer A. Hoffmann, MD, reports receiving grants from Children’s Research Fund Junior Board outside the submitted work. Another coauthor, Joel Fein, MD, reports fees for a patent owned by Children’s Hospital of Philadelphia licensed to Potential for the Behavioral Health Screen-Emergency Department. Among the editorialists, Jeffrey A. Bridge, PhD, reported grants from the National Institute of Mental Health, Patient Centered Outcomes Research Institute, and Centers for Disease Control and Prevention; and being a member of the Scientific Advisory Board of Clarigent Health and the Scientific Council of the American Foundation for Suicide Prevention outside the submitted work.

Most young people, ages 10-24 years old, who die by suicide have no previously documented mental health diagnosis, according to a large analysis of Centers for Disease Control and Prevention data.

Sofia Chaudhary, MD, with the Department of Pediatrics and Emergency Medicine at Emory University School of Medicine in Atlanta, Georgia, and colleagues, analyzed data from the National Violent Death Reporting System and found in the cross-sectional study of 40, 618 youths that 24,192 (59.6%) had no such diagnosis previously. Findings were published online in JAMA Network Open.
 

Gaps by Race, Sex and Age

The odds of having a mental health diagnosis before death by suicide differed by race and sex. Compared with White youths, the odds were lower among youths who were American Indian or Alaska Native (adjusted odds ratio [aOR], 0.45; Asian, Native Hawaiian, or Other Pacific Islander (aOR, 0.58); and Black youths (aOR, 0.62). And more than half of female youths who died by suicide had a mental health diagnosis (4429 youths [52.4%]), compared with 11,994 male youths (37.3%).

The researchers also found wide gaps by age, specifically lower odds of having a mental health diagnosis before suicide in children ages 10-14 compared with those 20-24.

“This finding is particularly notable because suicide rates have risen to become the second leading cause of death in youths aged 10 to 14 years,” the authors wrote. “Suicide prevention strategies for young children in primary care and community settings should focus on fostering resilience, promoting peer and family connectedness, and empowering children with strategies to cope with stress and adversity.”

Youths who died by firearm suicide, the most common mechanism, had the lowest rate of diagnosis. “Similar to a prior study, we found that decedents without a documented mental health diagnosis were far more likely to utilize a firearm than those with a documented mental health diagnosis,” the authors wrote. 

In an invited commentary, Lisa M. Horowitz, PhD, MPH, with the Office of the Clinical Director, Intramural Research Program, National Institute of Mental Health, in Bethesda, Maryland, and colleagues wrote that the data show that identifying youth early who have mental disorders or are at-risk for suicide “is more the exception than the rule” in the United States.

The editorialists highlight that the study showed that about one-quarter of youths who have attempted suicide and nearly one-half of youths with depressed mood had no documented mental health diagnosis. Decedents were categorized with depressed mood if they were perceived by themselves or others as depressed at the time of death.
 

Intervention Recommendations

The study authors point to the high number of youth firearm suicide (the method used by nearly half of those who died — 19,027 (46.8%) and recommended interventions. “Suicide prevention strategies are needed for the estimated 22.6 million US children living in households with firearms, of whom 4.5 million are exposed to firearms stored loaded and unlocked,” they wrote.

A mental health diagnosis was documented for only 6308 of 19,027 youths who died by firearms (33.2%).

They noted that research has shown that more than 75% of guns used in youth suicide are owned by a family member, most commonly parents, and the presence of a firearm in the home is linked with a higher risk of youth suicide.

They wrote that the risk can be mitigated by storing all guns locked and unloaded, with ammunition stored and locked in a separate location.

The editorialists said the study highlights the need for action in several primary areas. “Suicide prevention strategies should not solely rely on a history of mental illness to identify at-risk youths, and universal suicide risk screening in healthcare settings deserves greater consideration,” they wrote.

Equitable access to care is essential to youth suicide risk detection. Interventions such as lethal means safety counseling, safety planning, and a helpline number, such as 988, should be accessible to every family and healthcare clinician.

Community-level interventions are critical, including school-based suicide prevention programs, as well as population-based training for families on the safe storage of lethal means at home.

“Every trusted adult working with children and adolescents can and should be trained to recognize the warning signs of suicide risk and help young people develop the coping strategies needed to manage difficult life experiences so that suicide is never an option,” Dr. Horowitz and colleagues wrote.

A coauthor of the study, Jennifer A. Hoffmann, MD, reports receiving grants from Children’s Research Fund Junior Board outside the submitted work. Another coauthor, Joel Fein, MD, reports fees for a patent owned by Children’s Hospital of Philadelphia licensed to Potential for the Behavioral Health Screen-Emergency Department. Among the editorialists, Jeffrey A. Bridge, PhD, reported grants from the National Institute of Mental Health, Patient Centered Outcomes Research Institute, and Centers for Disease Control and Prevention; and being a member of the Scientific Advisory Board of Clarigent Health and the Scientific Council of the American Foundation for Suicide Prevention outside the submitted work.

Most young people, ages 10-24 years old, who die by suicide have no previously documented mental health diagnosis, according to a large analysis of Centers for Disease Control and Prevention data.

Sofia Chaudhary, MD, with the Department of Pediatrics and Emergency Medicine at Emory University School of Medicine in Atlanta, Georgia, and colleagues, analyzed data from the National Violent Death Reporting System and found in the cross-sectional study of 40, 618 youths that 24,192 (59.6%) had no such diagnosis previously. Findings were published online in JAMA Network Open.
 

Gaps by Race, Sex and Age

The odds of having a mental health diagnosis before death by suicide differed by race and sex. Compared with White youths, the odds were lower among youths who were American Indian or Alaska Native (adjusted odds ratio [aOR], 0.45; Asian, Native Hawaiian, or Other Pacific Islander (aOR, 0.58); and Black youths (aOR, 0.62). And more than half of female youths who died by suicide had a mental health diagnosis (4429 youths [52.4%]), compared with 11,994 male youths (37.3%).

The researchers also found wide gaps by age, specifically lower odds of having a mental health diagnosis before suicide in children ages 10-14 compared with those 20-24.

“This finding is particularly notable because suicide rates have risen to become the second leading cause of death in youths aged 10 to 14 years,” the authors wrote. “Suicide prevention strategies for young children in primary care and community settings should focus on fostering resilience, promoting peer and family connectedness, and empowering children with strategies to cope with stress and adversity.”

Youths who died by firearm suicide, the most common mechanism, had the lowest rate of diagnosis. “Similar to a prior study, we found that decedents without a documented mental health diagnosis were far more likely to utilize a firearm than those with a documented mental health diagnosis,” the authors wrote. 

In an invited commentary, Lisa M. Horowitz, PhD, MPH, with the Office of the Clinical Director, Intramural Research Program, National Institute of Mental Health, in Bethesda, Maryland, and colleagues wrote that the data show that identifying youth early who have mental disorders or are at-risk for suicide “is more the exception than the rule” in the United States.

The editorialists highlight that the study showed that about one-quarter of youths who have attempted suicide and nearly one-half of youths with depressed mood had no documented mental health diagnosis. Decedents were categorized with depressed mood if they were perceived by themselves or others as depressed at the time of death.
 

Intervention Recommendations

The study authors point to the high number of youth firearm suicide (the method used by nearly half of those who died — 19,027 (46.8%) and recommended interventions. “Suicide prevention strategies are needed for the estimated 22.6 million US children living in households with firearms, of whom 4.5 million are exposed to firearms stored loaded and unlocked,” they wrote.

A mental health diagnosis was documented for only 6308 of 19,027 youths who died by firearms (33.2%).

They noted that research has shown that more than 75% of guns used in youth suicide are owned by a family member, most commonly parents, and the presence of a firearm in the home is linked with a higher risk of youth suicide.

They wrote that the risk can be mitigated by storing all guns locked and unloaded, with ammunition stored and locked in a separate location.

The editorialists said the study highlights the need for action in several primary areas. “Suicide prevention strategies should not solely rely on a history of mental illness to identify at-risk youths, and universal suicide risk screening in healthcare settings deserves greater consideration,” they wrote.

Equitable access to care is essential to youth suicide risk detection. Interventions such as lethal means safety counseling, safety planning, and a helpline number, such as 988, should be accessible to every family and healthcare clinician.

Community-level interventions are critical, including school-based suicide prevention programs, as well as population-based training for families on the safe storage of lethal means at home.

“Every trusted adult working with children and adolescents can and should be trained to recognize the warning signs of suicide risk and help young people develop the coping strategies needed to manage difficult life experiences so that suicide is never an option,” Dr. Horowitz and colleagues wrote.

A coauthor of the study, Jennifer A. Hoffmann, MD, reports receiving grants from Children’s Research Fund Junior Board outside the submitted work. Another coauthor, Joel Fein, MD, reports fees for a patent owned by Children’s Hospital of Philadelphia licensed to Potential for the Behavioral Health Screen-Emergency Department. Among the editorialists, Jeffrey A. Bridge, PhD, reported grants from the National Institute of Mental Health, Patient Centered Outcomes Research Institute, and Centers for Disease Control and Prevention; and being a member of the Scientific Advisory Board of Clarigent Health and the Scientific Council of the American Foundation for Suicide Prevention outside the submitted work.