Raloxifene Use for The Heart (RUTH) trial update by Emory researcher at ACC meeting

Dr. Nanette Wenger, cardiologist and professor of medicine, Emory University School of Medicine, and chief of cardiology at Grady Memorial Hospital in Atlanta, presented an update from the Raloxifene Use for The Heart (RUTH) trial in Orlando at the 2001 American College of Cardiology meeting.

The trial is designed to test whether 60 mg daily of oral Raloxifene compared to placebo will reduce the risk of coronary syndromes other than myocardial infarction. It also is designed to test whether this therapy will reduce the risk of invasive breast cancer in a population of postmenopausal women, 55 years of age or older, with coronary heart disease or at risk for major coronary events. RUTH is an international, multi-center, randomized, double-blind placebo-controlled trial whose goal was to enroll 10,000 such women in 26 countries. The co-principal investigators for the international study are Dr. Elizabeth Barrett-Connor of the University of California San Diego and Dr. Nanette Wenger of Emory University School of Medicine.

As of August 2000, 10,101 women were enrolled. They will be sent at six monthly visits for clinical evaluation and periodic laboratory tests, electrocardiograms, and mammograms. The study is projected to last a minimum of five years, until at least 1,670 primary endpoints have occurred.

The clinical characteristics of the enrolled women will be presented, comparing the populations with and without documented coronary heart disease.

Raloxifene is a selective estrogen receptor modulator (SERM) drug that has estrogen agonist effects on bone and on cardiovascular risk factors and estrogen antagonist effects on the breast and uterus.

Postmenopausal women were eligible for inclusion in the trial if they had myocardial infarction, coronary revascularization, or angina pectoris with angiographically documented significant coronary disease. As well, based on a point score system, reflecting the presence of factors shown in epidemiologic studies to increase of myocardial infraction and coronary death, they were eligible for ramomization.