March 02, 2004

CHAPEL HILL – The National Institutes of Health today (March 2) announced that it was halting the active phase of a Women’s Health Initiative study of the effects of taking estrogen among postmenopausal women who had hysterectomies.Participating women received letters saying they should stop taking pills containing either the hormone estrogen or an inactive compound and begin the study’s follow-up phase. Investigators took the action after data analysis, which is continuing, showed none of the hoped-for heart disease-related benefits after an average of almost seven years of treatment per patient.

“On the other hand, the data did show a slight increase in the risk of stroke among these women and a clear but small decrease in the risk of hip fractures,” said Dr. Gerardo Heiss, professor of epidemiology at the University of North Carolina at Chapel Hill School of Public Health. “We saw no change in the rate of breast cancer.

“But increasing the risk of stroke among a group of generally healthy people even a small amount is unacceptable,” said Heiss, principal investigator for UNC’s WHI clinical center and a member of the overall WHI steering committee. “The increase is similar to the excess risk of eight strokes per year among 10,000 women that we observed the trial of the possible benefits of estrogen plus progestin therapy, which we stopped in July 2002.”

Eleven thousand women have participated in the “estrogen alone” investigation, he said. The overall Women’s Health Initiative study, chiefly sponsored by the National Heart, Lung and Blood Institute, involves more than 161,000 women who enrolled in either a larger observational study or a set of hormone preventive health trials.

Those trials focus on ways to prevent heart disease, osteoporosis and the resulting fractures, and breast and colorectal cancer. WHI researchers nationwide also are continuing to evaluate the potential benefits of low-fat diets and calcium and vitamin D supplementation.

Overall, 1,515 women are participating in one or more WHI clinical trials at UNC, Heiss said. UNC physicians and staff are following another 2,067 through the observational study, which does not involve a special hormone or treatment regimen. More than 630 are involved in the hormone therapy studies in Chapel Hill.

“Over the next few weeks, we will continue to evaluate data from the estrogen-alone study, but NIH felt that the results we’ve seen so far showed both the main risks and benefits and would be unlikely to change in any meaningful way if the study continued,” he said. “Analysis of data collected through the end of February will be completed over the next few weeks, and we’ll publish the final results by around the middle of April.”

The follow-up arm of the study, which chiefly relates to safety, involves participants continuing to have annual physicals and mammograms. That work was not intended to test the efficacy of estrogen therapy for minimizing menopausal symptoms.

Results of a separate but related investigation of the effects of estrogen alone on brain function also will be published, Heiss said. Preliminary results of that trial, known as the WHI-Memory Study or “WHIMS,” revealed a slight trend toward dementia or mild cognitive impairment among women taking estrogen alone compared with those taking a placebo.

In 2002, the multi-center WHI made headlines by concluding that taking a combination of the hormones estrogen and progestin did not improve the quality of life for women free of menopause-related symptoms but did expose them to a slightly higher risk of heart attacks and breast cancer as well as stroke.

For that reason, many doctors began recommending against the combined therapy in the absence of such symptoms, saying the risks of estrogen plus progestin outweighed the benefits.

More recent findings provided new evidence that the combined hormone therapy boosted the risks of dementia and strokes in postmenopausal women while not improving what scientists call “global cognitive function” — how the brain works.

Details about menopausal hormone therapy are available at www.nhlbi.nih.gov. The National Cancer Institute, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute on Aging and the Office of Research on Women’s Health also support the Women’s Health Initiative investigations. Wyeth Ayerst Research supplied the hormone for the estrogen-alone study and funded the WHIMS study.

This news release was researched and written by David Williamson of University News Services.

Note: Heiss can be reached at (919) 962-3253.

School of Public Health Contact: Lisa Katz, (919) 966-7467

News Services Contact: David Williamson, (919) 962-8596

 

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