Effect of Raloxifene on Serum Lipids and Clinical Cardiovascular Events in Osteoporotic Postmenopausal Women Elizabeth Barrett-Connor University of California at San Diego, San Diego, California, USA An early risk of coronary heart disease in postmenopausal women taking hormone replacement therapy has been reported recently in several large-scale clinical trials. The results of the 3-year Multiple Outcomes of Raloxifene Evaluation (MORE) trial show that treatment with raloxifene was not associated with an early increase or overall decrease in the risk of cardiovascular adverse events. To the surprise of many physicians, hormone replacement therapy in postmenopausal women has recently been reported not to reduce cardiovascular risk. In the Heart and Estrogen/Progestin Replacement Study (HERS), women at high risk received no benefit after 5 years of hormone therapy. The Women's Health Initiative reported more cardiac events in women taking estrogen and estrogen/progesterone, and similar results were reported recently in a meta-analysis of 26 smaller studies. Dr. Barrett-Connor said: "Based on these findings, we realized that raloxifene, a selective estrogen receptor modulator used for the prevention and treatment of osteoporosis, could have similar effects. We evaluated safety data from the 3-year Multiple Outcomes of Raloxifene Evaluation (MORE) trial, in which 7,705 osteoporotic postmenopausal women received raloxifene therapy (60 mg or 120 mg) for osteoporosis. For the current analysis, we looked at serious cardiovascular adverse events reported in the trial, and changes in serum lipids." The results showed that raloxifene at both doses significantly reduced total cholesterol and LDL cholesterol. At least 1 cardiovascular event was reported for 205 women, including 116 coronary events, 20 coronary deaths, 29 non-fatal myocardial infarctions, and 89 cerebrovascular events including 61 strokes. Dr. Barrett-Connor concluded: "The 'bottom line' is that there was absolutely no evidence of cardiovascular harm or benefit associated with raloxifene therapy in this study, including no evidence of early harm as has been reported in some large trials of hormone replacement therapy." There is no reason based on cardiovascular risk to avoid raloxifene therapy in postmenopausal women with osteoporosis. Reporter: Andre Weinberger, MD Copyright 2000-2013 by HESCO International, Ltd. All rights reserved.