The Pharmaceutical Journal
Vol 269 No 7205 p6
6 July 2002

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JAMA (jama.ama-assn.org)

Hormone replacement therapy offers no protection against heart attacks ...

Long-term use of hormone replacement therapy (HRT) in postmenopausal women does not reduce the risk of heart attack or death, say researchers. Furthermore, such therapy increases the risk of venous thromboembolism and biliary tract surgery and does not seem to offer any benefit for other major disease outcomes.

Trial details HERS II was a 2.7-year follow-up of the 4.1-year HERS study. Participants in HERS were randomly assigned to receive either 0.625mg conjugated estrogen plus 2.5mg medroxyprogesterone acetate, or placebo daily. During the HERS II follow-up the women chose whether or not to take hormones based on advice from their doctor (many in the hormone group continued taking hormones and few in the placebo group began). A total of 2,763 postmenopausal women with coronary heart disease were enrolled in HERS.

These conclusions come from HERS II, a follow-up to HERS (heart and estrogen/progestin replacement study), a randomised, placebo-controlled trial to determine the effects of estrogen plus progestin in older postmenopausal women with heart disease (see Panel).

The researchers previously reported that risk of heart attack increased among women during the first year of HRT (PJ 29 August 1998, p300) and that coronary events among hormone-treated women then seemed to decrease over the next several years. The researchers speculated that the results were a consequence of early thrombotic effects masking HRT's cardioprotective effects. This led to the recommendation that women with coronary heart disease should not start taking HRT because of the immediate increased risk but that women who had used HRT for several years could continue therapy.

However, data from the current study suggest that the trend toward a reduced risk of heart attacks does not persist. Over the seven years of the combined studies, there was no overall reduction in risk for coronary events among women taking hormones. "These results raise the possibility that the early increase in risk of coronary heart disease events observed in HERS, as well as the decrease in risk during years three to five, may have occurred by chance," the researchers say. They also suggest that chance may explain their finding that risk of hip fracture was higher among women treated with HRT than among women treated with placebo (JAMA 2002;288:49 and 58).