Coronary events decrease by 40% with Raloxifene: Results 'as good as in the statin trials'. (Preliminary Evidence of Heart Benefit).

ATLANTA -- Raloxifene shows exciting preliminary evidence of a powerful cardioprotective effect in postmenopausal women at high cardiovascular risk, Dr. Elizabeth Barrett-Conner reported at the annual meeting of the American College of Cardiology.

A secondary analysis of 4-year data from the double-blind Multiple Outcomes of Raloxifene Evaluation (MORE) trial indicates that among the 1,035 MORE participants judged to be at increased cardiovascular risk, those who took 60 mg/day of the selective estrogen receptor modifier had a 40% reduction in risk of coronary events, a 48% reduction in any cerebrovascular event, and a 62% decrease in strokes, compared with those who took placebo.

"Those results are at least as good as in the statin trials and are really quite amazing," said Dr. Barrett-Conner, professor of family and preventive medicine at the University of California, San Diego, and an investigator in the Eli Lilly & Co.-sponsored MORE trial.

Still, she said it was premature to prescribe raloxifene for reduction of cardiovascular risk in women at high risk for heart disease.

In the study, 40 fatal or nonfatal cardiovascular events occurred in the placebo group, compared with 28 among women randomized to 60 mg/day of raloxifene. Among the subset of 202 women with established coronary heart disease at baseline, subsequent coronary or cerebrovascular events occurred in 7.1% on raloxifene and in 22.7% on placebo.

In the overall MORE cohort of 7,705 osteoporotic postmenopausal women, however, raloxifene didn't significantly affect the rate of cardiovascular events, which was quite low. This wasn't surprising. The MORE population was probably at lower than average cardiovascular risk, since there is evidence that osteoporosis is associated with less arterial calcium and a lower rate of coronary disease. If raloxifene does indeed possess a cardioprotective effect, it would be expected to show up in women at high risk of cardiovascular events, Dr. Barrett-Conner explained.

MORE was principally an osteoporosis study Raloxifene resulted in roughly a 50% reduction in risk of vertebral fractures in women ...