EVISTA TO PREVENT OSTEOPOROSIS
FDA has approved Evista for the prevention of osteoporosis in postmenopausal women. Osteoporosis is a condition of progressive thinning of bone mass and reduced bone strength that most commonly affects postmenopausal women and often leads to hip, wrist or spine fractures.
The approval of Evista today gives an estimated 19 million Americans -- 80 percent of them women -- at risk for osteoporosis another possible avenue for preventing this disease and its outcomes. Evista is one of a new class of drugs called selective estrogen receptor modulators (SERMs) that are being studied for their ability to mimic the effects of estrogen in some tissues but not others. Clinical data on Evista indicate that it acts like estrogen, though to a lesser degree than estrogen, in increasing bone density and in lowering blood lipids but, does not increase HDL "good cholesterol" levels. It also did not adversely affect breast and uterine tissue in clinical trials.
Under FDA guidelines, drugs to treat or prevent osteoporosis must be shown to preserve or increase bone density and maintain bone quality. The effect of Evista on actual bone fracture risk is not yet known but is being evaluated in ongoing trials.
The effects of Evista on bone mineral density were studied in three large trials of approximately 1,800 postmenopausal women for 24 months. Women taking 400 mg to 600 mg of calcium and 60 mg of Evista daily had a greater increase in bone density compared with women taking only calcium supplementation. There was no evidence of an increased risk of breast or endometrial cancer in women who received Evista up to two and one-half years in the clinical trials.
The most serious side effect associated with Evista was increased risk of venous thromboembolic events (VTEs) -- blood clots that form in the veins and may break off and travel to the lungs. The 2.5 fold increase in the risk for VTE in women treated with Evista was similar to that reported for women on hormone replacement therapy. Other commonly reported side effects were hot flashes and leg cramps.
Women with a history of blood clots in their veins should not use Evista, nor should women who are pregnant or may become pregnant, because of potential danger to the fetus. Abnormalities were observed in fetuses of rats given the drug.
Evista is manufactured by Eli Lilly and Company of Indianapolis, Ind., and will be marketed under the trade name Evista.