News Brief: Hormone replacement trial stopped due to risk
News Brief: Hormone replacement trial stopped due to risk
The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) has stopped 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 multicenter 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. The study did not address the short-term risks and benefits of hormones for the treatment of menopausal symptoms.
"The bottom-line answer from WHI is that this combined form of hormone therapy is unlikely to benefit the heart," says NHLBI director Claude Lenfant, MD. "The cardiovascular and cancer risks of estrogen plus progestin outweigh any benefits — and a 26% increase in breast cancer risk is too high a price to pay, even if there were a heart benefit. Similarly, the risks outweigh the benefits of fewer hip fractures."
The report from the WHI investigators on the findings of the estrogen plus progestin study were published in the July 17 issue of the Journal of the American Medical Association.
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.