Private institute to assess estrogen therapy

$12 million study will look at effects on women 40-55

April 21, 2004|By Roni Rabin | Roni Rabin,NEWSDAY

Just weeks after the National Institutes of Health halted a large study, finding that estrogen's risks outweighed benefits for post-menopausal women, a privately funded trial will look at whether hormone therapy prevents hardening of the arteries in younger women, ages 40-55.

The private Kronos Longevity Research Institute, based in Phoenix, Ariz., selected eight research centers at some of the most prestigious medical schools - including Columbia, Harvard and Yale - to participate in the $12 million study.

The centers plan to enroll 720 women in the five-year study, with more than half randomly assigned to take placebos.

"The pendulum has swung from `Estrogen is good for all women' to `Estrogen is bad for all women,'" said Dr. JoAnn Manson, an expert on cardiovascular disease in women and a principal investigator for the Kronos Early Estrogen Prevention Study, or KEEPS, at Harvard University Medical School/Brigham and Women's Hospital.

That, she said, is "a gross oversimplification."

"It is not a good idea for women in their 60s, 70s or older, or women with advanced atherosclerotic disease, to take hormone therapy," Manson said. But, she said, there was still a question of whether younger women might benefit from estrogen during a "window of opportunity" going through menopause and shortly afterward.

The new trial hints at the heated debate still raging over estrogen supplementation. For decades, the assumption was that women develop heart disease later than men because estrogen protects them until they go through menopause, when estrogen levels drop.

But the NIH halted two large-scale, long-term Women's Health Initiative trials early after researchers found the hormones did not protect women from cardiovascular disease and increased the risk of stroke.

Women who received estrogen with progestin had an increased risk of heart attacks as well as stroke, blood clots and breast cancer. Women on both estrogen and estrogen plus progestin benefited from better bone health but had a slight increase in Alzheimer's.

The number of hormone therapy prescriptions plummeted after the first trial was halted in July 2002. This year, the American Heart Association released new guidelines that specifically discourage hormone replacement therapy, and the Food and Drug Administration required warnings that hormones should be taken only to relieve hot flashes for a short time and at the lowest dose possible.

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