Hormone pills double heart risk, study says

Women who take hormone replacement pills after menopause nearly double their risk of heart attacks during the first year of treatment, a landmark study concludes.

The findings, part of the federally sponsored Women's Health Initiative, also found the popular therapy appears to compound the risk among those who already have elevated levels of bad cholesterol in their bloodstreams.

Preliminary results, released last year, showed an overall increase in heart attack risk of nearly 30 percent, compared with women taking dummy pills.

The study's final version, published in Thursday's New England Journal of Medicine, found a similar elevated risk of 24 percent, but said the risk was especially high -- 81 percent higher -- during the first year that women took the hormone pill Prempro.

The findings were a surprise because experts had assumed that hormone replacement therapy reduces risk of heart attacks. Sales of Prempro and Premarin have plummeted since last year's results were announced; Wyeth Pharmaceuticals reported April-to-June sales of the drugs were down 36 percent from last year.

The "medical drama" shows the error of believing, without solid proof, that hormone pills would prevent heart disease simply because they lower some of the risk factors, Drs. David M. Herrington and Timothy D. Howard of Wake Forest University School of Medicine wrote in an editorial accompanying the latest findings in Thursday's New England Journal of Medicine.

Nevertheless, the risk for any individual woman on the therapy is small. Over a 5.6-year period, the study found there were 190 heart attacks, 39 of them fatal, among 8,506 women taking Prempro, compared to 148 heart attacks, 34 them fatal, among 8,102 women taking dummy pills.

"Women should not be unduly alarmed. Estrogen and progestin still has a role for treatment of symptoms" of menopause for a couple of years, said one of the lead researchers, Dr. JoAnn E. Manson, chief of preventive medicine at Brigham and Women's Hospital in Boston and a professor at Harvard Medical School. "But it should not be used to prevent heart disease or other chronic diseases."

The latest report also found heart attack risk was about 70 percent higher among women taking the pills who were two decades past menopause or had levels of LDL cholesterol above 155 at the study's start.

Until recently, about 6 million American women were taking hormone replacement pills. Doctors thought doing so long after menopause protected women from age-related conditions -- heart disease, osteoporosis and Alzheimer's disease -- and from breast cancer.

Then last July, Women's Health Initiative researchers reported women taking Prempro had slightly elevated risks of heart attack, stroke, dangerous blood clots and breast cancer. Other studies produced similar findings.

Dr. Victoria Kusiak, North American medical director for Wyeth said the latest results again show hormone pills should be used for the shortest time and at the lowest dose appropriate for each woman. The company last month launched versions of Prempro and its estrogen- only pill Premarin with nearly one-third less estrogen.

On the Net: www.nejm.org

American Heart Association: www.americanheart.org

American College of Obstetricians and Gynecologists: www.acog.org; www.wyeth.com

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