Raloxifene. Not better than estrogen

Raloxifene is marketed in France for prevention of nontraumatic vertebral fracture in postmenopausal women. In animal pharmacology studies, it was found to both agonize and antagonize estrogen. The assessment file is methodologically sound but fails to answer many practical questions. A placebo-controlled trial showed that raloxifene reduced the risk of vertebral collapse after 2 years of treatment, in both primary and secondary prevention, but demonstrated no effect on nonvertebral fractures. In this trial, raloxifene also reduced the risk of breast cancer. Two trials versus combined hormone replacement therapy (HRT) showed HRT had a more favourable effect on surrogate end points reflecting the risk of fracture and cardiovascular risk (changes in bone mineral density and lipid profile). Compared with combined HRT, raloxifene reduced the incidence of menorrhagia and mastodynia, but did not relieve symptoms linked to menopause. Results of animal studies call for close clinical monitoring to detect a possible increase in the incidence of ovarian cancer.