Lessons from RUTH.

The Raloxifene Use for The Heart (RUTH) trial was designed to investigate possible cardioprotective effects of raloxifene in elderly women with coronary artery disease (CAD) or at risk for CAD. While RUTH results demonstrated a neutral effect on CAD risk during 5.6 years of follow-up, they also open a debate whether primary prevention of fractures or breast cancer by raloxifene is justified in view of the serious adverse events which were recorded in this trial. Furthermore, the absolute numbers of saved events (breast cancer and clinical vertebral fractures) or added events (stroke and venous thromboembolism) were in the order of only 1 case per 1,000 treated women/year, a figure which should be evaluated on a pharmacoeconomic scale as well.