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Raloxifene use in clinical practice: efficacy and safety

Goldstein, Steven R. MD1; Duvernoy, Claire S. MD2,3; Calaf, Joaquim MD4; Adachi, Jonathan D. MD, FRCPC5; Mershon, John L. MD6; Dowsett, Sherie A. PhD6; Agnusdei, Donato MD6; Stuenkel, Cynthia A. MD7

doi: 10.1097/gme.0b013e3181883dae
Review Article

Objective and Methods: In this article, we provide an interdisciplinary concise review of the effects of raloxifene on breast, bone, and reproductive organs, as well as the adverse events that may be associated with its use.

Results: Raloxifene has been shown to prevent osteoporosis in postmenopausal women (PMW) with low bone mass and prevent vertebral fractures in those with osteoporosis/low bone mass; it has not been shown to reduce the risk of nonvertebral fractures. Raloxifene reduces the risk of invasive breast cancer in PMW with osteoporosis or at high risk of breast cancer. The risk of venous thromboembolism has been consistently shown to be increased with raloxifene, so it should not be used in women at high risk of venous thromboembolism. Although raloxifene does not increase, nor decrease, the risk of coronary or stroke events overall, in the raloxifene trial of PMW at increased risk of coronary events, the incidence of fatal stroke was higher in women assigned raloxifene versus placebo.

Conclusions: Based on its approved indications, it is appropriate to prescribe raloxifene to prevent or treat osteoporosis, as well as to reduce the risk of invasive breast cancer in PMW with osteoporosis or at high risk of breast cancer. Women at increased risk of both fracture and invasive breast cancer are those most likely to receive a dual benefit with raloxifene. Decision making must involve the incorporation of the woman's personal feelings about the risks and benefits of raloxifene therapy, balanced with her interest in reducing risk of fractures and breast cancer through pharmacological intervention.

Raloxifene is a selective estrogen receptor modulator long used for prevention and treatment of osteoporosis, more recently approved for breast cancer risk reduction in osteoporotic women as well as women at high risk for breast cancer. This article reviews the effects of raloxifene on multiple organ systems.

From the 1New York University School of Medicine, New York, NY; 2Cardiology Section, VA Ann Arbor Healthcare System, Ann Arbor, MI; 3Women's Heart Program, University of Michigan Health System, Ann Arbor, MI; 4Department of Obstetrics and Gynaecology, Hospital de la Santa Creu i Sant Pau, Autonomous University, Barcelona, Spain; 5St Joseph's Healthcare, Michael DeGroote School of Medicine, McMaster University, Hamilton, ON, Canada; 6Eli Lilly and Company, Indianapolis, IN; and 7University of California, San Diego, San Diego, CA.

Received May 29, 2008; revised and accepted July 22, 2008.

Financial disclosure: Dr. Goldstein serves on the GYN Advisory Board for Eli Lilly, Merck, Pfizer, GlaxoSmithKline, Novo Nordisk, Proctor & Gamble and Upsher Smith. He is a consultant for Cook ObGyn, Ackrad Labs (A Cooper Co.), and Philips Ultrasound. Dr. Goldstein is on the Speakers Bureau for Eli Lilly & Co., Pfizer, Proctor & Gamble, and Wyeth. He is a Director of Sonosite, Inc.

Address correspondence to: Steven R. Goldstein MD, New York University School of Medicine, 530 First Avenue, Suite 10N, New York, NY 10016. E-mail:

©2009The North American Menopause Society