Rationale and overview of the Raloxifene Use for the Heart (RUTH) trial.

Raloxifene is a selective estrogen receptor modulator (SERM) that has beneficial effects on several cardiovascular risk factors and has also been associated with a reduced risk of breast cancer in osteoporosis prevention trials. The Raloxifene Use for the Heart (RUTH) study was designed to test the hypothesis that, compared to placebo, raloxifene at 60 mg/day (1) lowers the risk of the combined end point of coronary death, nonfatal myocardial infarction (MI), and hospitalized acute coronary syndromes other than MI and (2) reduces the risk of invasive breast cancer (coprimary end point) in women at high risk for major coronary events based on established cardiovascular disease (CVD) or multiple risk factors. RUTH is a double-blind, placebo-controlled, randomized, clinical trial of 10,101 women aged 55 years or older from 26 countries and is expected to be completed in approximately 5 years.