Lower-Dose Version of HRT Drug Approved
Prempro treats menopausal symptoms
FRIDAY, March 14, 2003 (HealthDayNews) -- In the wake of last fall's study that found a link between hormone replacement therapy (HRT) and a higher risk of cancer and heart disease, the U.S. Food and Drug Administration has approved a lower-dose version of the popular drug Prempro.
The combination of hormones is commonly used to treat menopausal symptoms, including hot flashes, night sweats and vaginal dryness. When compared to the traditional composition of Prempro, the new formulation includes 28 percent less estrogen (0.45 mg.) and 40 percent less progestin (1.5 mg), the drug's two active ingredients.
Both formulations are produced by Wyeth Pharmaceuticals, which says it began work on the lower-dose formula years before the results of last fall's study were announced. The new formula was tested in a multi-center trial of 2,805 healthy postmenopausal women between the ages of 40 and 65.
The company says it expects the new product will be available in the United States in early summer.