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Review confirms knowledge gap in women's heart research

The underrepresentation of women means that evidence on the effectiveness of some cardiovascular treatments for female patients is less than sufficient.

By Susan J. Landers, AMNews staff. Aug. 4, 2003.

Washington -- Although coronary heart disease is a leading cause of death among women, most research done over the past 20 years has either excluded women or failed to tease out the findings specific to women, according to researchers for two federal agencies.

"To date, most of the information on chronic diseases like heart disease has been collected from studies on men, and the findings have been extrapolated to women, said Rosaly Correa-de-Araujo, MD, PhD, senior adviser for Women's Health at the Agency for Healthcare Research and Quality.

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This was done despite the fact that signs, symptoms, outcomes, or responses to therapy may be different in women than men, said Dr. Correa-de-Araujo.

AHRQ and the Office of Research on Women's Health at the National Institutes of Health sponsored the research review, which was carried out by the Stanford University-University of California, San Francisco, Evidence-based Practice Center. The results were published by AHRQ.

The fact that the new findings come more than a decade after the realization that women were unwisely excluded from clinical studies isn't surprising to Dr. Correa-de-Araujo. It takes time to design and complete the large studies that are needed to fill the knowledge gaps, she said.

Meanwhile physicians and their female patients may be on slightly uncertain ground when it comes to weighing adequate treatments and prevention strategies. While AHRQ recommends that a follow-up research agenda be established, "for now the only thing one can do is to try to use the best evidence available," said Dr. Correa-de-Araujo.

Despite the discouraging findings, AHRQ's examination of the issue is regarded as a major step toward obtaining better information for women. "After all, it's a government agency that is recognizing that much more needs to be done. This is the first time a step like that has been taken," said Nieca Goldberg, MD, a cardiologist at Lenox Hill Hospital in New York and a spokesperson for the American Heart Assn.

The AHRQ's finding is "incredibly important," agreed Sarah Keitt, program manager for the Society for Women's Health Research. While greater numbers of women are being included in studies, AHRQ's research points up the lack of appropriate analyses of the findings, said Keitt.

Although the General Accounting Office and the National Institutes of Health began drawing attention to the need for the inclusion of women in studies several years ago, now women themselves are speaking out.

Dr. Goldberg, who is the author of the book Women Are Not Small Men, said results from the ongoing Women's Health Initiative represent the first time that researchers have actually heard from the women who are at risk for chronic diseases.

"We are talking about a very vocal group of women, the baby boomers, who are used to being healthy and are very savvy health care consumers," she said.

Women had traditionally been excluded from studies due to still valid concerns about risk exposure during childbearing years. But researchers were also operating under the misperceptions that women were not generally affected by heart disease and that for other health conditions, women and men could be treated similarly.

Many studies, including some conducted at Women's Health Research at Yale, have found some real differences between women and men in the area of heart disease, said Carolyn M. Mazure, PhD, who directs this center. Women can experience very different symptoms of heart disease than men, and women may also sustain greater rates of infection and rehospitalization after heart bypass operations, said Dr. Mazure.

Analyzing the evidence

In their quest for valid research on women and heart disease, the AHRQ investigators examined studies that could provide answers for women to several specific questions. Among the questions are: the accuracy of noninvasive tests for diagnosing women's cardiovascular disease; the effectiveness of lipid-lowering drugs for reducing cardiovascular risk for women with and without heart disease; and the prognostic value of troponin for women.

They found that many studies could not be included in their reviews because the data were not stratified by sex. In an attempt to obtain that information, they also contacted the researchers for the original studies and received additional data on 23% of the studies.

In reviewing acceptable studies, the AHRQ researchers found:

• Fair or good evidence to suggest that the use of diagnostic tests and treatments may differ by gender. Men are more likely than women to undergo diagnostic testing and treatment for coronary heart disease, but women are more likely to be treated for hypertension than are men.
• Fair or good evidence to suggest that beta-blockers, aspirin and angiotensin-converting enzyme inhibitors reduce risk for heart attacks in women.
• Good evidence to suggest that treatment of hypertension lowers the risk for heart disease in women and that these benefits may be greater for African-American women.
• Fair evidence to suggest that smoking cessation after a heart attack lowers the risk for coronary heart disease in women.
• Fair evidence to suggest that women who receive glycoprotein IIb/IIIa inhibitor drugs during coronary procedures seem to benefit from this treatment, but good evidence to suggest that the use of the blood thinning drugs in women with acute coronary syndromes may be associated with an increased risk of death.

The researchers also failed to find sufficient evidence to determine whether lipid-lowering drugs reduce the risk for heart disease in women who have no evidence of disease.

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