GotoMyDoc - Education - Heart Disease - Hormone Replacement Therapy Studies

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Heart Health

Other studies on women, HRT and heart disease

The HERS study is important since it is the first of several ongoing randomized trials looking at the effects of HRT on heart disease. The NHLBI is supporting several of these trials, including the Women's Health Initiative (WHI), the Women's Angiographic Vitamin and Estrogen (WAVE) Trial, the Women's Estrogen/Progestin and Lipid Lowering Hormone Atherosclerosis Regression Trial (WELL-HART), and the Estrogen Replacement and Atherosclerosis (ERA) Trial.

The Women’s Health Initiative (WHI) differs from HERS in several key ways, including its size, length of study, and objectives. The HRT "arm" or component of WHI involves 27,500 women who do not have a prior history of CHD. The hormones being tested are estrogen alone as well as estrogen combined with progestin, and the trial is scheduled to run for an average of nine years. The WHI will examine the long-term effects of HRT on heart attacks, strokes, blood clots, fractures, and cancers. Recruitment for the study will be completed this month, according to schedule, and results will be available after 2005.

The other trials mentioned above--WAVE, WELL-HART and ERA--involve the use of coronary angiography, a test used to detect the blockages caused by atherosclerosis. They will help to prove whether the theory is correct that HRT produces a long-term positive effect on the progression of atherosclerosis. The WAVE trial is looking at the effect of postmenopausal HRT and/or antioxidant vitamins (C and E) on the progression of coronary artery disease. This is a multi- center trial involving 400 to 450 women. The WELL-HART study is comparing estrogen, estrogen plus progestin (Premarin), and placebo in 226 post-menopausal women with coronary artery disease and moderately elevated LDL cholesterol. Participants also receive the cholesterol-lowering drug lovastatin. ERA, another angiographic study, is a three-armed trial comparing estrogen, estrogen plus progestin, and placebo in 309 post-menopausal women with CHD.

When completed, these studies, together with the results of HERS, should provide the first comprehensive evaluation of the benefits and risks of long-term hormone replacement therapy.

Source: The National Heart, Lung and Blood Institute