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Use of Statins and Fracture
Results of 4 Prospective Studies and Cumulative Meta-analysis of Observational Studies and Controlled Trials
Douglas C. Bauer, MD;
Greg R. Mundy, MD;
Sophie A. Jamal, MD;
Dennis M. Black, PhD;
Jane A. Cauley, DrPH;
Kristine E. Ensrud, MD, MPH;
Marjolein van der Klift, MSc;
Huibert A. P. Pols, MD, PhD
Arch Intern Med. 2004;164:146-152.
Background The 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) are widely used for the treatment of hyperlipidemia, and recent in vitro and animal data suggest that statins promote bone formation and increase bone strength.
Methods To determine whether statin use is associated with a reduced risk for fracture, we analyzed statin use and fracture rates in 4 large prospective studies (the Study of Osteoporotic Fractures, the Fracture Intervention Trial, the Heart and Estrogen/Progestin Replacement Study, and the Rotterdam Study). We searched MEDLINE through January 2002 and abstracts from major scientific meetings and performed a cumulative meta-analysis of published and unpublished observational studies and clinical trials. The meta-analysis included 8 observational studies and 2 clinical trials that reported statin use and documented fracture outcomes.
Results After adjustment for multiple factors, including age, body mass index, and estrogen use, we found a trend toward fewer hip fractures (relative hazards [RHs], 0.19-0.62) and, to a lesser extent, nonspine fractures (RHs, 0.49-0.95) among statin users in each of the 4 prospective studies. The meta-analysis of observational studies was consistent with these findings. The summary odds ratio (OR) for statin use and hip fracture was 0.43 (95% confidence interval [CI], 0.25-0.75), whereas that for nonspine fracture was 0.69 (95% CI, 0.55-0.88). The meta-analysis of clinical trial results did not support a protective effect with statin use for hip fracture (summary OR, 0.87; 95% CI, 0.48-1.58) or nonspine fracture (OR, 1.02; 95% CI, 0.83-1.26).
Conclusions Observational studies suggest that the risk for hip and nonspine fractures is lower among older women taking statin medications for hyperlipidemia, but post hoc analyses of cardiovascular trials do not. Controlled trials specifically designed to test the effect of statins on skeletal metabolism and fracture are needed.
From the Departments of Medicine (Dr Bauer) and Epidemiology and Biostatistics (Drs Bauer and Black), University of California, San Francisco; the Division of Endocrinology, University of Texas Health Sciences Center, San Antonio (Dr Mundy); the Osteoporosis Research Program, Women's College Ambulatory Care Center, Toronto, Ontario (Dr Jamal); the Department of Epidemiology, University of Pittsburgh, Pittsburgh, Pa (Dr Cauley); the Division of Epidemiology, School of Public Health, University of Minnesota (Dr Ensrud), and the Section of General Internal Medicine, Minneapolis Veterans Affairs Medical Center (Dr Ensrud), Minneapolis, Minn; and the Departments of Medicine and Epidemiology and Biostatistics, Erasmus Medical Centre, Rotterdam, the Netherlands (Ms van der Klift and Dr Pols). Dr Bauer has consulted for Pfizer and Astra Zeneca and has received research support from Merck. Dr Mundy has consulted for Astra Zeneca and Novartis, has a research contract with Biogen, and has stock in Osteoscreen, Inc. Dr Black has received research support from Merck and Novartis. Dr Cauley has received research funding from Merck, Pfizer, Eli Lilly, Roche, and Wyeth Ayerst and is on the speaker bureau for Eli Lilly and Proctor and Gamble. Dr Ensrud has received research grant support from Merck, Eli Lilly, Berlex, and Pfizer. Dr Pols has consulted for Merck, Eli Lilly, and Aventis/Procter and Gamble.
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