Prempro - Overview
Prempro, also known as conjugated estrogen/medroxyprogesterone acetate, was approved by the U.S. Food and Drug Administration (FDA) in November 1995, to relieve menopause symptoms and osteoporosis. It is a combination of two hormones, an estrogen and a progestin, and is used only by menopausal women who have not undergone hysterectomy. Prempro was the first estrogen/progestin combination available for hormone replacement therapy (HRT), and is still one of the most common HRT's prescribed by physicians today. In 2003, it was estimated that more than 10 million postmenopausal women in the U.S. take estrogen or estrogen-progestin products to treat the symptoms of menopause. Prempro is manufactured by Wyeth-Ayerst Laboratories.
Health Concerns Regarding Prempro
In 1991, the National Heart, Lung, and Blood Institute (NHLBI) began a long-term study of ways to prevent heart disease, breast and colorectal cancer, and osteoporosis in women, called the Women's Health Initiative ("WHI"). The WHI consists of a set of clinical studies and an observational study, and involves more than 161,000 healthy, postmenopausal women.
One of the clinical studies involved 16,608 women who took either Prempro or a placebo. The main goal of this study was to see if Prempro would help prevent heart disease and hip fractures. The Prempro portion of that study was cut short three years early, however, because the researchers determined that the risks associated with Prempro, which include breast cancer, stroke, heart disease and blood clots, outweighed its benefits, which include a lower rate of fractures and a reduction in the risk of colorectal cancer. Women had been studied in the trial for over 5 years before it was halted.
Most of the women in the Prempro portion of the WHI study did not have prior evidence of heart disease, so the increased risk in healthy women of incidents like heart attack or stroke was a new finding, according to researchers. Unfortunately, because of differences in the formulas of other combination estrogen/progestin products, it was unclear whether the concerns of this study should also be considered for other, similar products.
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