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Raloxifene and Risk for Cardiovascular Events and Breast Cancer

For older postmenopausal women, the benefits of raloxifene may not outweigh the risks.

In this manufacturer-supported, international, double-blind trial, more than 10,000 postmenopausal women who had known coronary heart disease or were at increased risk for it were assigned to raloxifene (60 mg daily) or placebo. The participants’ mean age was 67.5 years, and median duration of follow-up was 5.6 years.

Raloxifene did not affect the risk for primary coronary events, but did significantly increase the risk for venous thromboembolism (hazard ratio, 1.44) and fatal stroke (HR, 1.49). In terms of benefits, raloxifene significantly reduced the risks for invasive breast cancer (HR, 0.56) and clinical vertebral fractures (HR, 0.65).

Comment: As an editorialist points out, we have no "magic bullet" that can reduce breast cancer risk without increasing other health risks. Although women at elevated risk for breast cancer may wish to consider using raloxifene as chemoprophylaxis, the cardiovascular risks, as well as the side effects associated with use of this selective estrogen receptor modulator (see Journal Watch Women’s Health Jul 13 2006), make widespread adoption of such a strategy unlikely.

— Andrew M. Kaunitz, MD

Published in Journal Watch Women's Health July 27, 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.

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

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