No benefit from raloxifene for CHD; fatal stroke risk up

The selective estrogen-receptor modulator (SERM) raloxifene reduces the risk of invasive breast cancer but does not prevent coronary heart disease (CHD) and increases the risk of venous thromboembolism (VTE) and fatal stroke, according to the Raloxifene Use for The Heart (RUTH) trial results published in the July 13 issue of the New England Journal of Medicine.

Elizabeth Barrett-Connor, MD, of the University of California San Diego in La Jolla, Calif., and RUTH trial members randomized 10,101 postmenopausal women with CHD, or with risk factors for CHD, to either 60 mg of raloxifene daily or a placebo, then measured the incidence of coronary events and invasive breast cancer. Average follow-up was 5.6 years.

While raloxifene reduced the risk of invasive breast cancer by 44% and helped prevent vertebral fractures, it had no effect on CHD incidence in women with or at-risk for CHD. In addition, the risks for VTE and fatal stroke were up by 44% and 49%, respectively.

The study was supported by Eli Lilly.

Barrett-Connor E, Mosca L, Collins P, et al. Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women. N Engl J Med. 2006;355:125-137.