• Luigi Gennari, Daniela Merlotti, Vincenzo De Paola, and Ranuccio Nuti.
• University of Siena, Department of Internal Medicine, Endocrine-Metabolic Sciences and Biochemistry, Viale Bracci 1, 53100 Siena, Italy. gennari@unisi.it
• Expert Opin Drug Saf. 2008 May 1; 7 (3): 259-70.

BackgroundRaloxifene is a benzothiophene, selective estrogen receptor modulator with estrogen-agonist effects in the skeleton and the cardiovascular system but estrogen-antagonist effects in the uterus and the mammary gland. This compound was first approved in different countries for the prevention and treatment of osteoporosis.Objective/MethodsWe performed a literature search to review available preclinical and clinical data that has led to the recent FDA approval of raloxifene as a chemopreventive agent for breast cancer in postmenopausal women.Results/ConclusionsDifferent placebo-controlled trials indicated that raloxifene is effective in reducing invasive breast cancer risk in postmenopausal women. In a recent comparative study, a similar efficacy between raloxifene and tamoxifen for breast cancer prevention was demonstrated, but raloxifene showed a more favorable safety profile.

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