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Investigators Stop Part of Drug-Taking In Women's Health Initiative

WINSTON-SALEM, N.C. – Women in one major study group of the massive Women''s Health Initiative -- those who are taking a combination of estrogen plus progestin as hormone replacement therapy -- are being told to stop taking their study drugs. About 570 women in Winston-Salem and Greensboro are enrolled in that portion of the Women''s Health Initiative, according to one of the study''s local investigators, Denise E. Bonds, M.D., M.P.H., assistant professor of internal medicine (general) at Wake Forest University Baptist Medical Center.

The study''s Data and Safety Monitoring Board found that the risks of taking the combination -- 0.625 milligrams a day of conjugated equine estrogens plus 2.5 milligrams per day of medroxyprogesterone -- now exceed the benefits. "Compared to those taking placebo, more women taking active estrogen plus progestin developed breast cancer or experienced cardiovascular events such as heart attacks, strokes, pulmonary emboli and deep vein thromboses."

The study was testing this estrogen-progestin combination because 7 million women in the United States take this same combination daily. One trade name for it is Prempro.

Both Bonds and the National Heart, Lung and Blood Institute stressed that nothing has changed for other groups in the study, and women taking estrogen alone and women in the dietary, calcium and vitamin D groups and the observational study are asked to participate as before.

Though they are being told to stop taking their study medication of estrogen plus progestin, women in that group will continue to have their regular contacts with the Women''s Health Initiative and continue to get regular examinations and mammograms. The study investigators found some positive benefits from estrogen plus progestin: the women had a lower risk of colorectal cancer and of fractures, especially hip fractures. "But the balance of risks significantly outweighed the benefits," they said.

However, the investigators stressed that only a tiny fraction of the women taking estrogen plus progestin -- about 2.5 percent -- had any problems. "These results tell us that during one year, for every 10,000 women taking estrogen plus progestin, we would expect seven more women would have heart attacks (than in the placebo group), eight more women with strokes, eight more women with breast cancer, and 18 more women with blood clots," but six fewer cases of colorectal cancer, five fewer hip factures.

Bonds said the decision to stop the estrogen-progestin arm of the study also is being rapidly disseminated to physicians through the Journal of the American Medical Association, which will publish the results in the July 17 issue.

Gregory L. Burke, M.D., professor and chairman of the Department of Public Health Sciences, now heads the Wake Forest portion of the study, which began in 1993 and ultimately enrolled about 3,500 women in the Piedmont Triad, especially Winton-Salem and Greensboro.

In addition, 2,200 women in the Triad who were not eligible for the clinical trial were enrolled in an observational study, which essentially monitored their health over the years.

Wake Forest was a Vanguard Center, one of 16 university sites chosen to launch the massive study. Ultimately, the initiative enrolled 157,000 women between 50 and 79 years old at 45 clinical centers across the United States, making it the largest clinical trial ever undertaken in the United States.

The estrogen-only group, which is continuing, was open to women who had had a hysterectomy. Other groups test the effect of a low fat diet -- less than 20 percent of calories from fat -- on breast and colon cancer and heart disease, and the effect of calcium and vitamin D supplements on fractures, osteoporosis and colorectal cancer, and those are also unchanged.

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