Design and methods of the Raloxifene Use for The Heart (RUTH) study.
Raloxifene is a selective estrogen receptor modulator that lowers total and low-density lipoprotein (LDL) cholesterol, reduces the risk of vertebral fracture, and is associated with a reduced incidence of invasive breast cancer in postmenopausal women with osteoporosis. The Raloxifene Use for The Heart (RUTH) trial is designed to determine whether raloxifene 60 mg/day compared with placebo: (1) lowers the risk of the coronary events (coronary death, nonfatal myocardial infarction [MI], or hospitalized acute coronary syndromes other than MI); and (2) reduces the risk of invasive breast cancer in women at risk for a major coronary event. RUTH is a double-blind, placebo-controlled, randomized clinical trial of 10,101 postmenopausal women aged > or =55 years from 26 countries. Women are eligible for randomization if they are postmenopausal and have documented coronary heart disease (CHD), peripheral arterial disease, or multiple risk factors for CHD. Use of estrogen within the previous 6 months is an exclusion factor. The study will be terminated after a minimum of 1,670 participants experience a primary coronary end point. Secondary end points include cardiovascular death, myocardial revascularization, noncoronary arterial revascularization, stroke, all-cause hospitalization, all-cause mortality, all breast cancers, clinical fractures, and venous thromboembolic events, in addition to the individual components of the composite primary coronary end point. RUTH will provide important information about the risk-benefit ratio of raloxifene in preventing acute coronary events and invasive breast cancer, as well as information about the natural history of CHD in women at risk of major coronary events.
Mosca
L
L
Preventive Cardiology, New York Presbyterian Hospital, Columbia University, New York, New York 10032, USA. ljm10@columbia.edu
Barrett-Connor
E
E
Wenger
N K
NK
Collins
P
P
Grady
D
D
Kornitzer
M
M
Moscarelli
E
E
Paul
S
S
Wright
T J
TJ
Helterbrand
J D
JD
Anderson
P W
PW
D000789:Angina, Unstable / Q000517:prevention & control; D001943:Breast Neoplasms / Q000517:prevention & control*; D003327:Coronary Disease / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009203:Myocardial Infarction / Q000517:prevention & control; D015663:Osteoporosis, Postmenopausal / Q000517:prevention & control; D020849:Raloxifene Hydrochloride / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D020845:Selective Estrogen Receptor Modulators / Q000627:therapeutic use*
D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride