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    Researchers Explore the Role of Hormone Replacement Therapy in Preventing Heart Disease

    Menopausal women with heart disease do not necessarily benefit from taking estrogen or an estrogen/progesterone combination, according to a study presented Monday at the 49th annual American College of Cardiology meeting in Anaheim, Calif.

    "This study provides additional evidence that hormone replacement therapy may not be as effective as we thought previously," said David Herrington, M.D., of Wake Forest University Baptist Medical Center in Winston-Salem, N.C. "The message for women and their doctors is that they should make full use of medications for lowering lipids."

    The randomized, double blind, placebo-controlled study, known as the Estrogen Replacement and Atherosclerosis (ERA) Trial, involved 309 postmenopausal women with heart disease. Each underwent an angiogram before the trial began to establish that they had narrowing of the arteries, caused by a buildup of fatty deposits.

    Then the women were randomly assigned to take either estrogen, an estrogen/progesterone combination or a placebo. Throughout the three-year study, a computerized technique was used to measure the slightest of changes in the women's arteries.

    Overall, there was "no difference between the groups in how quickly the disease progressed," Herrington said. "The hormone replacement therapy did lower cholesterol, but this change didn't translate into a measurable benefit in the coronary arteries."

    The ERA trial is the second large study to question the belief that hormone replacement is an effective treatment for heart disease. The first -- the Heart and Estrogen/progesterone Replacement Study (HERS) -- involved about 2,700 women and concluded in 1998. It found that women who took estrogen and progesterone for four years had as many heart attacks as women who didn't take hormones.

    "The big difference between the HERS study and this one is that the HERS looked at clinical events (like heart attack), and this one looked at the arteries in the heart," Herrington said.

    In another study presented at the conference, researchers at Mount Sinai School of Medicine in New York City looked at the effect of estrogen on the formation of blood clots in the arteries.

    Researchers enrolled 25 women, whose mean age was 80 and who had evidence of heart disease. Their symptoms included chest pain upon stress testing; prior heart attack; and evidence of atherosclerosis -- the build up of fatty deposits on the walls of the arteries.

    The women were randomly assigned to take either estrogen, estrogen and progesterone or a placebo. Participants in all three groups also took a low dose of aspirin (162 milligrams).

    Researchers found that there was a 20 percent reduction in clot formation in the women who took estrogen. This could translate into a lower risk of heart problems and death, said Mary Ann McLaughlin, M.D.

    Two other studies at the conference highlighted the relationship between hormones and the cardiovascular system.

    Researchers at the University of Cagliari in Italy found that giving estrogen to two dozen men and women helped alleviate cardiac ischemia -- the reduction of oxygen going to the heart -- when they exercised. However, giving testosterone helped only the men.
    Researchers at the Chicago Center for Clinical Research and the Heart Disease Prevention Clinic in Minneapolis found that giving either hormone replacement therapy or simvastatin (a cholesterol-lowering drug) to 139 post-menopausal women decreased the lipid levels in their blood. But giving them in combination was even more effective.

    Researchers expect that results of the Women's Health Initiative (funded by the National Institute of Health) will further explain the vascular effects of estrogen. The trial will be completed in 2002.


    Editorial Comment: The effects of estrogen on heart disease are not fully understood. This is an area of intense study, with a great deal of misinformation and unsupported conclusions. This is particularly problematic in light of the apparent risks of cancer with estrogens. The studies are complex and we must not make simplistic statements based on the results.

    The HERS study was designed to see if estrogen or estrogen/progesterone therapy could prevent second heart attacks. The data showed that there was a trend towards less myocardial infarction in the patients receiving hormones, but the change was not significant statistically. Reviewing the data closely showed that there was an increasing benefit with longer use. The study only lasted 4 years and thus more benefit may have been shown with additional time. The study design has been questioned and was likely too short.

    The lack of plaque regression shown in the ACC meeting here is meaningless. None of the cholesterol-lowering drugs cause significant regression either. This is not how these drugs or estrogens prevent myocardial infarction. Estrogens appear to be beneficial due to favorable effects on HDL and LDL cholesterol and by restoring the ability of blood vessels to autoregulate (control there own blood flow).

    We need to be careful in analyzing these studies. We anxiously await results of the Women's Health Initiative. Until the Women's Health Initiative is completed, women should consult their doctors about the risks and benefits before considering estrogen replacement in menopause.


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