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July 3, 2002


New Research: Hormone Replacement Therapy Doesn't Protect Hearts, Does Increase Risk for Blood Clots and Gallbladder Disease

Women with heart disease going through menopause who are taking hormone replacement therapy (HRT) in hopes of preventing future coronary problems will not take heart in new research reported in the July 3rd issue of JAMA (the Journal of the American Medical Association).

"We concluded that estrogen and progesterone therapy provides no coronary benefit and may cause harm," says Nanette Wenger, M.D., chief of cardiology at Grady Hospital and Professor of Medicine at Emory University School of Medicine. Dr. Wenger is co-author of the paper which reports on HERS II (Heart and Estrogen/Progesterone Replacement Study).

Results of HERS II show that HRT offers no protection from heart disease. While researchers found no increased risk of cancer linked to HRT, they did note a significant increase in the risk of venous thromboembolism (blood clots) and gall bladder disease. "We found a two fold increase in venous thromboembolism with the greatest risk in the first two years of therapy. We also found an almost 50% risk in gallbladder disease requiring surgery," says Dr. Wenger co-author of the JAMA paper and principal investigator for the HERS II study at Emory.

HERS II grew out of the landmark clinical trial, HERS, reported in l998, which examined the effect of conjugated equine estrogen plus progesterone (medroxyprogesterone acetate) on coronary risk. HERS investigators studied 2,763 menopausal women with documented coronary disease. After four years, they found no difference between hormone treated and placebo treated women in the occurrence of non- fatal or fatal heart events. "In fact, further analysis of the original paper suggested an increased risk of coronary events during the first year of treatment , but a decreased risk in years three to five," notes Dr. Wenger, who was also a co-investigator of the original HERS.

HERS II was designed to find out if the risk reduction noted after several years of HRT usage persisted. Investigators followed 93% of the surviving research subjects from the initial HERS, 2321 women, who agreed to an unblinded follow-up . At the end of almost 7 years, HERS II researchers found no reduction in coronary events - including heart attacks - compared with the placebo group.

"Certainly, hormone therapy is the best therapy for menopausal symptoms and it is good for the prevention of osteoporosis - the only two conditions for which it is licensed by the FDA," says Dr. Wenger. "However, the new HERS II findings indicate that, as recommended by the American Heart Association, menopausal hormone therapy should not be used to reduce the risk of cardiovascular events in women with coronary disease."

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