Feb. 15, 1999
Volume 51, No. 20
Emory included in worldwide study of raloxifene for heart disease
Recruitment is beginning in Atlanta and some 200 other sites worldwide for the raloxifene use for the heart (RUTH) study, a clinical research trial evaluating use of the osteoporosis drug raloxifene for possibly preventing coronary death and heart attack in postmenopausal women with coronary disease or at high risk for its occurrence.
Emory cardiologist Nanette Kass Wenger is co-principal investigator of the trial, along with Elizabeth Barrett-Conner, professor of Family and Preventive Medicine at the University of California at San Diego. The research team is hoping to recruit 10,000 postmenopausal women in 26 countries (200 sites). Eli Lilly and Co. is sponsoring the research.
Raloxifene is in a class of new drugs called selective estrogen receptor modulators approved by the Food and Drug Administration for preventing postmenopausal osteoporosis. During studies of its use for osteoporosis, researchers noted the ability of raloxifene to preserve bone, decrease low-density lipoprotein cholesterol (LDL, the "bad" cholesterol) and blood clotting factors without stimulating reproductive tissues such as the breast and uterus.
"Indeed the drug is currently being studied by the National Institutes of Health as a possible breast cancer preventive therapy," Wenger said. "We are particularly excited about this research study because of the possibility that one compound could help prevent osteoporosis and heart disease in postmenopausal women and not put them at risk for breast or uterine cancer."
Heart disease is the leading killer of women in America and other developed nations. According to recent statistics, cardiovascular disease kills about half a million women a year in the United States--translating to about one in every two deaths, compared to one in 27 who die of breast cancer.
Wenger and Emory co-investigator Sally McNagny, associate professor of medicine, hope to enroll 100 women in the Atlanta study site. Qualified participants should be age 55 or older, have coronary disease or be at high risk for its occurrence, and should not have been on hormone replacement therapy for at least six months.
Volunteers will be asked to visit Emory Clinic every six months for about five to seven years. Once a year they will be examined by an Emory physician, receive an electrocardiogram (EKG), lab work and blood pressure check and other evaluations including a mammogram.
All exams, tests and medications associated with the study will be provided at no cost. For more information call the RUTH research coordinator, Janice Parrott, at 404-778-RUTH.