Review of raloxifene and its clinical applications in osteoporosis

Raloxifene, a selective oestrogen receptor modulator, is currently utilised for both the prevention and treatment of postmenopausal osteoporosis. Prevention studies with raloxifene have demonstrated preservation of bone density, suppression of markers of bone turnover and maintenance of normal bone histology for up to 4 years in young postmenopausal women. The Multiple Outcomes of Raloxifene Evaluation (MORE) trial, the pivotal treatment trial of raloxifene, demonstrated significant reductions in the risk of vertebral fractures after 1 and 3 years, which is comparable to other currently available agents. Significant reductions in non-vertebral fractures with raloxifene have not been demonstrated yet. In addition to the effects of raloxifene on bone, a number of beneficial non-skeletal effects have been reported on the breast, uterus and cardiovascular system. These latter findings are mainly derived from secondary end points and analyses of the large osteoporosis studies with raloxifene. Two large, prospective, randomised, double-blind studies examining the effects of raloxifene on breast cancer prevention and cardiovascular protection are now underway. Recent information on the effects of raloxifene in postmenopausal osteoporosis, breast cancer prevention and cardiovascular disease in high-risk women and those with uterine disorders is reviewed in this article.