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Women still excluded from cardiovascular clinical trials

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Journal of the American College of Cardiology
Reuters Health - 20/08/2021 -  Three decades after the U.S. government demanded that women be included in clinical trials, they continue to be underrepresented in cardiovascular studies, according to a perspective piece in the Journal of the American College of Cardiology.

"To break through and achieve the goal of parity, it takes regulators, like the FDA, patient groups and physician awareness to really bring these trials to the patient and really do everything we can to have patients enroll," said lead author Dr. Leslie Cho, a Cleveland Clinic cardiologist. "The patient groups and physicians and payers and regulators have to demand that we raise the bar."

The article, written by Cho and the rest of the college's Cardiovascular Disease in Women Committee Leadership Council, questions the efficacy of heart-failure medications and other cardiovascular treatments for women given the dearth of women in the trials.

"Research has shown that women respond differently than men and may even be harmed or experience side effects from some drugs when taken at the same dosage as men," Cho said. "Sex-specific data is essential to optimal care."

"If we approve drugs for everybody, we should have good information for everybody," she told Reuters Health in a phone interview.

Though previous studies have established that men and women metabolize drugs differently, researchers have historically relied on male data and applied it to females, the authors say.

They cite numerous examples of evidence demonstrating inadequate female representation, particularly minority women, in cardiovascular trials as well as studies showing that women's care could suffer as a result.

A 2019 Lancet study, for example, showed that women in heart failure benefitted maximally from only half of the goal dose of angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers and beta blockers. (https://bit.ly/3fS1EkY)

Women accounted for only 36% of participants in pivotal cardio-metabolic drug trials from 2008 through 2017, according to an analysis last year in the Journal of the American Heart Association. (https://bit.ly/3CMTsMW) In addition, overall enrollment of women in the trials, upon which the U.S. Food and Drug Administration relied to approve new molecular entities, failed to increase significantly during the 10 years.

The National Institutes of Health Revitalization Act of 1993 established guidelines to increase diversity by gender, race and ethnicity in clinical trials supporting novel drug approvals. But the authors of the new report found woefully little, if any, progress.

Dr. Joan Briller, director of the women's heart disease program at the University of Illinois, Chicago, said in an email that she has seen progress. "But," she added, "we are far from equity in knowing how to provide cardiovascular health care to women."

She attributed part of the gender imbalance in cardiovascular trials to men dominating the field. Only 14% of practicing cardiologists and 21% of academic cardiologists are women, she said.

Briller, who was not involved in the new report, also credited any progress to women assuming leadership roles.

"When I look at some of the major advances of our understanding of cardiovascular disease in women, many have been championed by women researchers," she said. "So I think the number of women in academic medicine is an important component."

Trials led by women tend to recruit more women participants, the report found.

Cho and the leadership council outlined potential barriers to enrolling women and underrepresented minorities and recommended ways to knock down the barriers.

One barrier is that cardiologists treat fewer women, and therefore recruit fewer women into clinical trials. Another barrier is that women tend to present with symptoms at older ages, and older patients often are excluded from trials.

Other barriers include minority women's distrust of the medical community as well as women lacking time to travel to medical centers for trials because of family commitments.

But, Cho said, the pandemic has proven that care frequently can be offered on video while patients are at home. The report also promoted recruiting trial participants where they tend to congregate, like the Faith-Based Approaches in the Treatment of Hypertension study did when it found Black women with uncontrolled hypertension in churches. (https://bit.ly/3iDczRq)

"We have to acknowledge our understanding of the reluctance to participate and mistrust of the medical care system, and we need to educate populations with regard to the importance of trials and to provide solutions to some barriers, like childcare and transportation," Briller said.

"Thirty years after the NIH call for inclusion of women in clinical trials," Cho said, "we still can do more than we're doing."

SOURCE: https://bit.ly/3xCHRMq Journal of the American College of Cardiology, August 9, 2021.

By Ronnie Cohen

 



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