Adverse events reported by postmenopausal women in controlled trials with raloxifene

Objective: To assess the incidence of adverse events in postmenopausal wome n treated with raloxifene compared with placebo, hormone replacement therap y (HRT), or unopposed estrogen. Methods: Common treatment groups were pooled across eight randomized, paral lel clinical trials (6-30 months' duration) of raloxifene to create the fol lowing three databases: placebo-controlled, HRT-controlled, and estrogen-co ntrolled databases. Incidence and severity of all treatment-emergent advers e events, defined as events that first occurred or worsened during treatmen t, were compared among groups in each of the databases. Results: Discontinuation rates overall, and those related to adverse events , were not significantly different between treatment groups in any database . There was no significant difference in incidence of vaginal bleeding or b reast discomfort between women treated with raloxifene (60 mg/d) or placebo . Both of these events were reported more frequently in women receiving HRT or estrogen. Vaginal bleeding was responsible for significantly more disco ntinuations from the HRT groups compared with the raloxifene group. Hot fla shes was the only event common to all three databases that was significantl y increased in the raloxifene group, but this event did not increase the di scontinuation rates. The incidence of leg cramps was greater in raloxifene- treated women compared with placebo-treated women in the placebo-controlled database, but did not cause any discontinuations of therapy. Raloxifene ha d no effect on the incidence of vaginal symptoms or central nervous system events. Conclusion: Raloxifene had an adverse event profile distinct from HRT and u nopposed estrogen and was well tolerated by postmenopausal women. (Obstet G ynecol 1999; 93:558-65. (C) 1999 by The American College of Obstetricians a nd Gynecologists.).