Risk-benefit profile for raloxifene: 4-year data From the Multiple Outcomes of Raloxifene Evaluation (MORE) randomized trial

Journal of Bone and Mineral Research : the Official Journal of the American Society for Bone and Mineral Research
Elizabeth Barrett-ConnorMary Jane Geiger

Abstract

Posthoc analysis of the MORE osteoporosis treatment trial assessed risk-benefit profile of raloxifene in 7705 postmenopausal women. A major disease outcomes global index resulted in annual rates of 1.39% and 1.83% in the raloxifene and placebo groups, respectively (HR, 0.75; 95% CI, 0.62-0.92), compatible with a favorable risk-benefit profile for raloxifene for treating postmenopausal osteoporosis. The Women's Health Initiative (WHI) trial reported overall risks that exceeded benefits from use of estrogen-progestin in healthy postmenopausal women. The objective of this posthoc analysis of the Multiple Outcomes of Raloxifene Evaluation (MORE) trial was to assess the safety profile of raloxifene, a selective estrogen receptor modulator indicated for the prevention and treatment of osteoporosis, using the global index method from the WHI trial. A total of 7705 postmenopausal women (mean age, 67 years) were enrolled in the MORE osteoporosis treatment trial and randomly assigned to receive placebo or one of two doses of raloxifene (60 or 120 mg/day) for 4 years. A global index of clinical outcomes, defined as described for the WHI trial (the earliest occurrence of coronary heart disease, stroke, pulmonary embolism, invasive breast c...Continue Reading

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