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Outcomes with Raloxifene in Women with Above-Average Coronary Risk

Raloxifene use reduces risk for breast cancer but introduces other potentially serious health concerns.

Use of raloxifene, a selective estrogen-receptor modulator that is FDA-approved only for treatment and prevention of osteoporosis, is associated with improvements in serum lipids and other markers of coronary risk. In 1998, industry-supported researchers initiated the RUTH (Raloxifene Use for The Heart) trial to determine whether raloxifene use would lower the incidence of adverse coronary events. More than 10,000 postmenopausal women (age, 55) were randomized to receive daily raloxifene (60 mg) or placebo; enrollment criteria included either a history of coronary heart disease or multiple CHD risk factors.

During a median follow-up of 5.6 years, no significant difference was found between the raloxifene and placebo groups in the incidence of a composite coronary endpoint (coronary death, nonfatal myocardial infarction, or hospitalization for acute coronary syndrome). However, the following significant differences between raloxifene and placebo were noted (expressed as events per 1000 woman-years):

• • lower incidence of invasive breast cancer with raloxifene (1.5 vs. 2.7)
  
• • lower incidence of clinical vertebral fractures with raloxifene (2.4 vs. 3.7), but no difference for non-vertebral fractures
  
• • higher incidence of fatal stroke with raloxifene (2.2 vs. 1.5)
  
• • higher incidence of venous thromboembolism with raloxifene (3.9 vs. 2.7)
  

Comment: Among postmenopausal women with CHD or above-average coronary risk, raloxifene conferred no coronary benefit, lowered risk for breast cancer, and increased risk for fatal stroke and venous thromboembolism. This study complements the recently published STAR trial, a raloxifene-tamoxifen comparison without a placebo group (Journal Watch Jul 7 2006). An editorialist discusses the difficult task of weighing the benefits and harms of raloxifene and concludes that "there is no magic bullet" that reduces risk for estrogen-related health problems without introducing other potentially serious health concerns.

— Allan S. Brett, MD

Published in Journal Watch General Medicine July 13, 2006

Citation(s):

Barrett-Connor E et al. Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women. N Engl J Med 2006 Jul 13; 355:125-37.

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Stefanick ML. Risk-benefit profiles of raloxifene for women. N Engl J Med 2006 Jul 13; 355:190-2.

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• Medline abstract (Free)