Purpose: To critically appraise recent randomized controlled trials (RCT) of raloxifene and its effects on the long-term consequences of menopause.
Data sources: All RCTs of greater than six months duration in post-menopausal women found in MEDLINE through July 2000.
Conclusions: Raloxifene lowered lipids, but estrogen had a more beneficial effect on HDL and fibrinolytic markers. Raloxifene had a more beneficial effect on triglycerides, inflammatory and thrombogenic markers. Compared to placebo, raloxifene reduced vertebral fractures but had a similar although lesser effect on bone mineral density and markers of bone turnover than estrogen. Estrogen receptor positive breast cancer was reduced by 90% with no increase in the incidence of endometrial cancer with raloxifene. The most serious side effect of raloxifene was an increased incidence of deep vein thromboses and pulmonary emboli.
Implications: Raloxifene has been shown to be beneficial using cardiovascular and osteoporosis end-points in studies of short duration. More RCTs of longer duration with comparisons to other traditional treatments are needed before raloxifene becomes the treatment of choice.