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Hormone therapy study stopped due to increased breast cancer risk, lack of overall benefit

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) has stopped early a major clinical trial of the risks and benefits of combined estrogen and progestin in healthy menopausal women due to an increased risk of invasive breast cancer. The large multi-center trial, a component of the Women's Health Initiative (WHI), also found increases in coronary heart disease, stroke, and pulmonary embolism in study participants on estrogen plus progestin compared to women taking placebo pills. There were noteworthy benefits of estrogen plus progestin, including fewer cases of hip fractures and colon cancer, but on balance the harm was greater than the benefit. The study, which was scheduled to run until 2005, was stopped after an average follow-up of 5.2 years.

Participants in this component of WHI, like most women with a uterus who take hormone therapy, were given progestin in combination with estrogen. This practice is known to prevent endometrial cancer. A separate WHI study of estrogen alone in women who had a hysterectomy before joining the WHI hormone program continues unchanged because, at this point, the balance of risks and benefits of estrogen alone is still uncertain.

The report from the WHI investigators on the estrogen plus progestin study findings will be published in the July 17 issue of The Journal of the American Medical Association (JAMA); because of the importance of the information, the study is being released early on Tuesday, July 9, as an expedited article on the JAMA Web site. (Full text version available to all at www.jama.com.)

"We have long sought the answer to the question: Does postmenopausal hormone therapy prevent heart disease and, if it does, what are the risks? The bottom-line answer from WHI is that this combined form of hormone therapy is unlikely to benefit the heart. The cardiovascular and cancer risks of estrogen plus progestin outwei
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Contact: NHLBI Communications Office
301-496-4236
NIH/National Heart, Lung, and Blood Institute
9-Jul-2002


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