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LILLY’s RALOXIFENE REDUCES BONE RESORPTION WITHOUT STIMULATING UTERUS,

Executive Summary

LILLY's RALOXIFENE REDUCES BONE RESORPTION WITHOUT STIMULATING UTERUS, Phase II trial results of the selective anti-estrogen show. The data were presented March 29 at the International Symposium on Osteoporosis and Consensus Development Conference in Hong Kong. Lilly predicts Phase III trials for the treatment of osteoporosis will begin shortly. The 251-patient Phase II trial compared the short-term effects of raloxifene, conjugated estrogens (Wyeth-Ayerst's Premarin) and placebo on indicators of bone metabolism, serum lipids and the uterus of normal postmenopausal women. Patients received raloxifene 200 mg or 600 mg, estrogen .625 mg or placebo once daily in the morning for eight weeks. All subjects also received 520 mg/day calcium carbonate supplements. Raloxifene-treated subjects, like those receiving estrogen, showed decreases in four of five markers of bone metabolism, including serum alkaline phosphatase, serum osteocalcin, urinary pyridinoline crosslinks and urinary calcium secretion compared to placebo. Neither raloxifene nor estrogen had a significant effect on urinary hydroxyproline. While estrogen stimulates the uterine epithelium, Lilly said raloxifene appears to block the effects of estrogen in the uterus. In the study, the 600 mg dose of raloxifene significantly suppressed the effects of estrogen on the uterine epithelium. The 200 mg dose of raloxifene also suppressed the estrogen effect but not to a statistically significant degree. Estrogen significantly stimulated uterine epithelium of the women in the study. Raloxifene also had a salutory effect on serum lipid levels in the study, significantly decreasing low-density lipoproteins (LDL) at doses of 600 mg. Subjects treated with the 200 mg dose of raloxifene showed a marginal decrease in LDL. Both raloxifene doses significantly decreased total cholesterol, while estrogen did not. However, estrogen decreased LDL and significantly increased high-density lipoprotein (HDL). Raloxifene-treated subjects showed no increase in HDL. Several new osteoporosis therapies, mostly calcium regulators, are more advanced in development than raloxifene. Procter & Gamble Pharmaceuticals' NDA for Didrocal (etidronate) is under review by FDA. The company submitted additional data last year on the drug's long-term effect on bone fractures after FDA's Endocrinologic & Metabolic Drugs Advisory Committee declined to recommend approval at a March 1991 meeting. Merck's Fosomax (alendronate) and Sterling's tiludronate are in Phase III trials.
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