The results of the first randomized trial comparing hormone replacement therapy (HRT) and a placebo in women with heart disease, published in the August 19 issue of the Journal of the American Medical Association, showed no lowering of the risk of further heart and blood vessel disease for women taking the hormones estrogen and progesterone. Nearly 2800 post-menopausal women known to have heart disease participated in the Heart and Estrogen/progestin Replacement Study (HERS) over 4 years. The overall rates of heart attacks, death, strokes and the need for heart bypass surgery or angioplasty were the same among those treated with hormones as for those who took an inert placebo pill.
These results contrast with many previous "observational" -type studies which had strongly suggested a benefit for HRT. The authors of the new study acknowledge important limitations to the conclusions of their study, however. First, it examined only the effects of HRT on women who already had heart disease (so-called "secondary prevention"). It did not look at the ability of HRT to prevent heart disease in women without known heart disease ("primary prevention"). Second, the study period may have been too short to see a longer-term effect on women’s cardiovascular health by estrogen.
What does this study mean for women who are on hormone replacement therapy, or who are considering taking it? It is most important for women and their physicians to understand that HERS has not uncovered any new risk associated with HRT, only questioned one of the possible benefits. The effectiveness of estrogen for decreasing menopausal symptoms and risk from osteoporosis has been well-established. Women presently taking estrogen for primary or secondary prevention of heart disease have the option of continuing it or withholding it, pending the results of further research which is expected in the next 3-5 years. Meanwhile, for women at risk of heart disease, other proven measures are available to lower the risk, including control of hypertension (high blood pressure), diabetes and high cholesterol, smoking cessation and regular exercise.
Note: Progestin therapy is added to estrogen when a woman still has her uterus as this combination protects against uterine cancer. The effects of estrogen therapy when used alone is not known but is presently being studied in the PEPI trial with results due out within the next 4-5 years. Results of the HERS trial are inclusive regarding the long-term use of estrogen/ progestin and whether this offers protection against heart disease. Women on HRT or considering taking it should have a full discussion of the risks and benefits of treatment with their physicians.
The striking misinformation among physicians prescribing estrogen therapy is disturbing. Based on older observational studies, there seemed to be a suggestion that estrogen replacement decreased cardiovascular events in women. To my knowledge, however, no national professional organization recommended the prescription of estrogen to women specifically for cardiovascular protection. Yet, as portrayed in your article, physicians are enthusiastically encouraging women to take the drug for that specific purpose. Nevertheless, there remain legitimate reasons for women to take estrogen, including the relief of menopausal symptoms and, of more importance long-term, the prevention of osteoporosis in women at risk. Indeed, for many women, the risk of injury and complications related to osteoporosis may outweigh the apparent small increased risk of cardiovascular event. We should not now rush to indict all use of hormone replacement. Women and their physicians need timely, accurate information from impartial sources to make the best health care decisions. - SAS
This article was contributed by Steven A. Samuel, M.D., F.A.C.C., Medical Director, Women's Heart Foundation
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