Combination Hormone Replacement Therapy Increases Women’s Risk of Heart Attack, Study Finds
Hormone replacement therapy increases a woman's risk of having a heart attack, according to an analysis of data from the Women's Health Initiative published today in the New England Journal of Medicine, the New York Times reports (Duenwald, New York Times, 8/7). Researchers analyzed existing data from a portion of the initiative that examined combination HRT, which was halted three years early last year because researchers determined that the potential harm of taking combination estrogen-progestin, sold as Prempro by Wyeth, outweighed the benefits (Hechinger, Wall Street Journal, 8/7). The new analysis found that over the course of the 5.6-year study, the overall risk of heart attack was 24% higher among women taking HRT compared with those taking a placebo, and the risk was "especially high" -- 81% -- during the women's first year of taking HRT, the AP/Atlanta Journal-Constitution reports (Johnson, AP/Atlanta Journal-Constitution, 8/7). The increased risk was similar across most subgroups of women, including those with factors such as diabetes and high blood pressure that predispose them to heart disease. Women with high cholesterol levels were found to have "an especially high increase in risk," according to the Journal (Wall Street Journal, 8/7). Overall, researchers found that among 8,506 women who were taking Prempro, 190 had heart attacks, 39 of which were fatal, and that among the 8,102 women taking placebos, there were 148 heart attacks, 34 of which were fatal (Feder Ostrov, San Jose Mercury News, 8/7). However, for healthy women who are less than 10 years past menopause, the increased risk is only two heart attacks per 1,000 women annually -- low enough for the benefits of the treatment, such as alleviating menopausal symptoms like hot flashes and night sweats, to be considered "an acceptable trade-off" for the increased risk, according to Dr. JoAnn Manson, chief of preventive medicine at Harvard's Brigham and Women's Hospital in Boston and the study's lead author (Wall Street Journal, 8/7). An abstract of the study is available online.
The new study contributes to mounting evidence of the risks associated with HRT, which puts physicians in the difficult position of "having to decide whether to allow women to take drugs that increase their risk for serious diseases to alleviate menopause symptoms that are annoying, perhaps even incapacitating, but not life-threatening," the Washington Post reports (Stein, Washington Post, 8/7). "The risk (of HRT) is very small. The benefit -- if any -- is also small. I don't think we have enough information right now to say which is smaller," John Bailar, a clinical trials expert at the University of Chicago and author of an editorial accompanying the study, said (Sternberg, USA Today, 8/7). Norman Lasser, a professor of medicine at the University of Medicine and Dentistry of New Jersey and an author of the study, said, "Any way you look at it, the only really good reason to take it is if you have really bad menopausal symptoms that outweigh the increased risk of heart disease and stroke" (MacPherson, Newark Star-Ledger, 8/7). A Wyeth spokesperson said that "for women who are suffering, hormone therapy is still a valuable treatment" (Wall Street Journal, 8/7). In another NEJM editorial today, David Herrington and Timothy Howard of Wake Forest University School of Medicine write that the drugs became "wildly popular because of wishful thinking" that replacing hormones lost through normal aging would be beneficial, the Milwaukee Journal Sentinel reports (Marchione, Milwaukee Journal Sentinel, 8/7).
Another study published in today's NEJM looked at whether HRT that contains only estrogen protects the cardiovascular system. Researchers divided 226 postmenopausal women with atherosclerosis into three groups that were given estrogen with progestin, estrogen or no HRT. They found that the arteries of those who took estrogen alone were just as likely to narrow during the study's three-year period than the others. Another Women's Health Initiative clinical trial, which will run until 2005, is also examining the effects of estrogen therapy alone (New York Times, 8/7). An abstract of the estrogen study is available online. CBS' "The Early Show" today examined the two new HRT studies (Senay, "The Early Show," CBS, 8/7). The segment is available online in RealPlayer. Also, CBS' "Evening News" reported yesterday on some women's continued use of HRT (Kaledin, "CBS Evening News," CBS, 8/6). The segment is available online in RealPlayer.This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.