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Study reveals underrepresentation of women in cardiovascular clinical trials

Published on February 20, 2010 at 3:40 AM · 1 Comment

A special themed issue of Circulation: Cardiovascular Quality and Outcomes highlights studies about women and cardiovascular disease.  In an editorial, researchers wrote that the pool of data on the topic is still limited and has left "more questions than answers."

Researchers in one featured study found women are underrepresented in research areas cited in the American Heart Association's prevention guidelines for women.

Another study found that after a heart attack, low social support is tied to poorer health outcomes, particularly among women.

Women are substantially underrepresented in clinical trials used to formulate women's guidelines and are affected more than men by low social support after a heart attack, according to two studies in the women-themed issue of Circulation: Cardiovascular Quality and Outcomes, a journal of the American Heart Association.

In an editorial, Viola Vaccarino, M.D., Ph.D., notes that sex-specific research has revealed important differences in the causes, symptoms and treatment of heart disease.  But the pool of data is still limited and key questions remain about the development, prevention and treatment of cardiovascular disease in women.

"After at least a decade of renewed interest in women's cardiovascular health, we are left with more questions than answers," wrote Vaccarino, professor of medicine at Emory University School of Medicine in Atlanta.

Cardiovascular disease is the leading killer of U.S. women, causing more than 430,000 deaths per year.

Here are highlights of two studies in the themed issue:

In an analysis of 156 randomized clinical trials cited by the American Heart Association's 2007 guidelines for cardiovascular disease prevention in women, researchers found females were substantially underrepresented compared with how frequently they are affected by various cardiovascular conditions.  

Overall, women made up just 30 percent of the patient population in the clinical trials used to support the 2007 guidelines.  Also, only about one-third of the 156 trials reported sex-specific results.  But women account for at least half the deaths in the affected patient populations studied -- "a proportion that is strikingly higher than their representation in the trials supporting the guidelines -- thereby underscoring the importance of having adequate representation of women in clinical trials to solidify the evidence base supporting practice guidelines," researchers wrote.

Among all the trials, women were most represented in those involving hypertension (44 percent of the research population were women vs. 53 percent of all patients with hypertension) and diabetes (40 percent of the research population vs. 50 percent of all patients with diabetes).

Representation of women was lowest for heart failure (29 percent of the research population vs. 51 percent of all patients); coronary artery disease (25 percent vs. 46 percent); and hyperlipidemia, or high levels of fats such as cholesterol and triglycerides in the bloodstream, (28 percent vs. 49 percent).

Furthermore, the studies' enrollment of women varied among classes of therapies being tested, including aspirin, diabetes medications or statins.

Comments
  1. Barb Gordon Barb Gordon United States says:

    I am a recently retired female RN who has been living with CAD since around 2002... having numerous stents, a 4 vessel CABG in 2004 and would be happy to volunteer for women's health research, how do you go about doing this? Should I ask my cardiologist, call a research facility in the area?? I am now 67 yrs. old. Thanks

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