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 While heart disease is the leading killer of both women and men in
the U.S., female patients have long been underrepresented in
clinical trials testing new medications, devices and treatment
approaches, researchers note in the Journal of the American College
of Cardiology. This is problematic because there are sex and gender
differences in how heart disease impacts the body, symptoms and
treatment outcomes.
For the current study, researchers focused on the numbers of women
and men who participated in cardiovascular trials submitted to the
U.S. Food and Drug Administration (FDA) to win marketing approvals
for 35 medications between 2005 and 2015.
On average, less than half of the participants across all of the
studies were women, although the proportion of female patients
ranged from 22 percent to 81 percent.
"The participation of both women and men in clinical trials is
essential in determining potential sex differences in safety or
efficacy of medical products. Sex-based differences may be because
of physiological, anatomical (such as body weight), or hormonal
differences," study co-author Dr. Marjorie Jenkins of the Office of
Women's Health at the FDA in Silver Spring, Maryland, said by email.
"Women also may have more adverse events than men because of their
smaller size when men and women are given the same doses of a drug,"
Jenkins added.
To assess how well studies did at including women, researchers
divided the percentage of women among trial participants by the
percentage of women with the disease in the general population.
They found women were well represented in trials for drugs to treat
atrial fibrillation, a heart rhythm disorder, and high blood
pressure. Women were underrepresented in trials for medications to
treat heart failure, coronary artery disease and heart attack,
however.
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Researchers also looked for but didn't find evidence of gender
differences in the safety and effectiveness of drugs tested in the
trials, apart from three hypertension drugs whose labels did
identify clinically meaningful differences.
While some previous research investigating the lack of women in
clinical trials has found screening criteria might exclude too many
women, the current study examined this issue and found fewer women
may be enrolling in studies because they're not being invited to
participate as often as men.
One limitation of the study is that it only looks at the late-stage
trials used to win FDA approval, and it's possible that proportions
of women might be different in more preliminary studies. Researchers
also lacked some data needed to determine the full impact of
screening criteria on how many women enrolled in studies.
Part of the problem could be that the classic heart disease symptoms
common in men, but not always in women, may be the criteria used to
include patients in clinical trials, said Dr. Louise Pilote, author
of an accompanying editorial and a researcher at McGill University
Health Center in Montreal. This means even the women who are
included may not give an accurate picture of how drugs will work in
many other women.
"In contemporary medicine, neither a pharmacological treatment nor a
medical device should be prescribed without a clear evidence of
benefit and safety for the patients," Pilote said by email.
"Therefore, testing drugs or devices in a group of patients that
includes an adequate representation of women is a must that we can't
deny to guarantee the best treatment for men and women."
SOURCE: https://bit.ly/2wrRu6g and https://bit.ly/2wts6NN Journal of
the American College of Cardiology, online April 20, 2018.
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