Investigators stop part of drug-taking in Women's Health Initiative

WINSTON-SALEM, N.C. Women on 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 inve

Contact: Robert Conn
Wake Forest University Baptist Medical Center

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