Here's what Reuter's had to say about Raloxifene: INDIANAPOLIS, June 5 (Reuter) - Eli Lilly and Co. said Thursday results from trials of its new anti-osteoporosis drug raloxifene showed that it increased bone mass while producing fewer side effects than estrogen replacement therapy currently in use.
The results, presented to a Washington symposium on osteoporosis, showed the compound, currently seeking U.S. Food and Drug Administration approval under the brand name Evista, prevented bone loss in the subjects' spines and hips and increased bone mineral density by up to 3 percent.
Assessing side effects from the drug in Phase III trials, the company said raloxifene did not stimulate tissue in the uterus, nor did it induce spotting or bleeding. It also spared women breast swelling, tenderness and pain, which are common complaints of women undergoing estrogen replacement therapy.
The most commonly observed side effect from the drug was that 24 percent of the women reported a higher rate of hot flashes, compared to 18 percent taking a placebo.
Raloxifene produced similar beneficial results to estrogen therapy in terms of protecting post-menopausal women from conditions leading to cardiovascular disease.
The drug is among a new group of compounds designed for menopausal women at risk of losing up to 20 percent of their bone mass. Osteoporosis affects about 25 million Americans, mostly older women during or after menopause.
Merck & Co. Inc <MRK.N> received FDA approval in 1995 for its Fosamax treatment for osteoporosis, and other drug makers have similar bisphosophonate therapy drugs in development.
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