NEW YORK, New York, July 17, 2001 – Researchers at Columbia University today announced the findings of a large-scale clinical study that show low-dose hormone replacement therapy (HRT) is effective at managing cholesterol levels, offering protection from cardiovascular disease (CVD). CVD is the leading cause of death among postmenopausal women. The data, from the Women’s Health, Osteoporosis, Progestin, and Estrogen (HOPE) Study, is published in the July 2001 edition of the medical journal Fertility and Sterility.
The study findings reveal that lower doses of HRT showed a significant (10%) increase in HDL, or good cholesterol, and an approximate 7% decrease in LDL, or bad cholesterol—similar to results seen with standard therapy. “For the first time, we have found that lower doses of HRT have similar metabolic effects as the standard, most commonly prescribed dose,” said Rogerio Lobo, M.D., Willard C. Rappeleye Professor of Obstetrics & Gynecology at Columbia University College of Physicians & Surgeons and chairman of the Department of Obstetrics & Gynecology at Columbia Presbyterian Medical Center of NewYork-Presbyterian Hospital.. “This is good news for women entering menopause who want the benefits of hormone replacement therapy at a lower dose.”
Previous observational studies have suggested that there are long-term benefits from HRT in reducing women’s risk for cardiovascular disease. The Women’s HOPE Study is the first large, randomized clinical trial to study low-dose HRT and its effect on metabolic parameters. One goal of this study is to determine whether lower doses of HRT [0.45mg/d conjugated equine estrogen (CEE)/1.5mg/d medroxyprogesterone acetate (MPA)] are as beneficial as higher doses [0.625 mg CEE/2.5mg MPA] in protecting cardiovascular health.
Cholesterol and Menopause
Several population studies have shown that the loss of natural estrogen as women age may contribute to a higher risk of vascular events in women after menopause. Elevated LDL cholesterol levels, for example, are four times higher among women 55-64 years of age compared to women aged 35-44. Because high LDL cholesterol and low HDL cholesterol are primary risk factors for CVD, finding appropriate treatments to help women manage cholesterol is critical. CVD accounts for approximately $60.4 billion in total medical care costs for women over the age of 45 and is the leading cause of death in postmenopausal women in the U.S.
Women’s HOPE Study Overview
The Women’s HOPE Study is the longest controlled trial ever undertaken to assess the efficacy and benefits of low-dose hormone replacement therapy. Previously published data from the Women’s HOPE Study found that lower doses of HRT were as effective as standard doses in treating the disruptive symptoms of menopause, including hot flashes and night sweats, with fewer side effects. Those data also showed that lower doses reduced vaginal changes and caused less breakthrough bleeding than the standard dose.
The Women’s HOPE Study is supported by Wyeth-Ayerst Laboratories. The low-dose HRT evaluated in the study is currently under review by the U.S. Food and Drug Administration. According to Wyeth-Ayerst, an approval decision is expected by the end of the summer.
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