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Effects of Prasterone on Bone Mineral Density in Women with Systemic Lupus Erythematosus Receiving Chronic Glucocorticoid Therapy
PHILIP J. MEASE, ELLEN M. GINZLER, OSCAR S. GLUCK, MICHAEL SCHIFF, ALLAN GOLDMAN, MARIA GREENWALD, STANLEY COHEN, RITA EGAN, BETTY J. QUARLES, and KENNETH E. SCHWARTZ
ABSTRACT.
Methods. Fifty-five female patients with SLE who had received prednisone (or glucocorticoid equivalent) ≤ 10 mg/day for ≥ 6 months were treated for 1 year with either prasterone 200 mg/day (n = 24) or placebo (n = 31) in this randomized, double blind trial. Prasterone or placebo was added to each patient's one or more concomitant standard SLE medications, including glucocorticoids, nonsteroidal antiinflammatory drugs, antimalarials, methotrexate, azathioprine, and other immunosuppressives, which were to be maintained at fixed doses for the duration of the study. Results. BMD was significantly improved in patients who received prasterone compared to placebo. At the lumbar spine, there was a mean (SEM) gain in BMD of 1.7 ± 0.8% in the prasterone group compared to a mean loss in BMD of –1.1 ± 0.5% in the placebo group (p = 0.003 between groups). For the total hip, mean gain was 2.0 ± 0.9% in the prasterone group vs a mean loss of –0.3 ± 0.4% in the placebo group (p = 0.013 between groups). In the prasterone treatment group, the mean gains from baseline at both lumbar spine and hip were statistically significant. Conclusion. Prasterone treatment prevented BMD loss and significantly increased BMD at both the lumbar spine and total hip in female patients with SLE receiving exogenous glucocorticoids. (J Rheumatol 2005;32:616-21) Key Indexing Terms:
DEHYDROEPIANDROSTERONE From Seattle Rheumatology Associates, Seattle, Washington; State University of New York Medical Center, Brooklyn, New York; Denver Arthritis Clinic, Denver, Colorado; Rheumatic Disease Center, Milwaukee, Wisconsin; Advances in Medicine, Rancho Mirage, California; St. Paul Medical Center, Dallas, Texas; Arthritis Center of Lexington, Lexington, Kentucky; and Genelabs Technologies, Inc., Redwood City, California, USA. Supported by Genelabs Technologies, Inc., Redwood City, California. P.J. Mease, MD, Seattle Rheumatology Associates; E.M. Ginzler, MD, MPH, SUNY Medical Center, Brooklyn; O.S. Gluck, MD, University of Arizona Health Sciences Center (deceased); M. Schiff, MD, Denver Arthritis Clinic; A. Goldman, MD, Rheumatic Disease Center, Milwaukee; M. Greenwald, MD, Advances in Medicine; S. Cohen, MD, St. Paul Medical Center, Dallas; R. Egan, MD, Arthritis Center of Lexington; B.J. Quarles, BS; K.E. Schwartz, MD, Genelabs Technologies, Inc. Address reprint requests to Dr. K.E. Schwartz, Genelabs Technologies, Inc., 505 Penobscot Drive, Redwood City, CA 94063. E-mail: KSchwartz@Genelabs.com Accepted for publication November 19, 2004. |