Women Underrepresented in Heart Device Studies
More Safety Data Needed on Use of High-Risk Heart Devices in Women
Many Reasons for Gender Gap in Studies
Why the gender gap? The study authors suggest that the number of women with certain heart conditions may be underestimated. Researchers who have had approved applications have also said that their gender breakdown was similar to that of an older study without acknowledging the older study included greater proportions of men. Women may be less likely to be referred to specialists, which could also affect recruitment.
Study authors, who were led by Rita F. Redberg, MD, professor of medicine and the director of Women’s Cardiovascular Services at the University of California in San Francisco, call for meaningful changes to the study review and approval process.
For example, the Heart Disease Education, Analysis and Treatment for Women Act, if passed, would mandate sex-specific data reporting and could help address the disparities seen in the new study.
They also suggest that approval applications be returned to the sender unless gender-specific data are included.
Room for Improvement
“We still have a long way to go to make sure that therapies are tested in women,” says Nieca Goldberg, MD, director of the Women’s Heart Program at New York University’s Langone Medical Center in New York City. “We need to make it easier for women to become aware of clinical trials and make it easier for them to enroll.”
She says that “we pretty much have a lot of data on aspirin and statins and a lot of women should be on statins or aspirin and some shouldn’t be,” she says. “This situation is one where we have a therapy indicated for a special reason and we may be using it in women when we don’t have as much information about the risks and benefits for them.”
“There is increased awareness about heart disease in women, and we have come a long way in that many more studies look at women,” she says.
Although there were no encouraging trends seen in the new study, a recent report did show that cardiac resynchronization therapy with a defibrillator is more effective in women than in men.