Raloxifene: new preparation. Not better than oestrogen.

(1) Raloxifene is marketed in France for the prevention of non traumatic vertebral fracture in postmenopausal women. In animal pharmacology studies it was found to both agonise and antagonise oestrogen. (2) The assessment file is methodologically sound but fails to answer a good number of practical questions. (3) A placebo-controlled trial showed that raloxifene reduced the risk of vertebral collapse after two years of treatment, in both the primary and secondary prevention settings, but no effect was demonstrated on non vertebral fractures. Furthermore, raloxifene reduced the risk of breast cancer in this trial. (4) Two trials versus combined hormone replacement therapy showed a more favourable effect of the latter on surrogate end points reflecting the risk of fracture and the cardiovascular risk (changes in bone mineral density and lipid profile). (5) Compared with combined hormone replacement therapy, raloxifene reduced the incidence of menorrhagia and mastodynia, but did not relieve symptoms linked to the menopause. (6) The results of animal studies call for close clinical monitoring to detect a possible increase in the incidence of ovarian cancer.