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Submitted on September 29, 2004
Accepted on November 22, 2004
Departments of Medicine, Emory University School of Medicine (J.L.T.) and Biostatistics (F.D.B.), Rollins School of Public Health, Atlanta, Georgia, and Department of Medicine (S.T.P., J.K.A., B.D.A., A.M.M., W.J.B.), Veterans Affairs Puget Sound Health Care System (B.D.A. and A.M.M.), and Geriatric Research, Education and Clinical Center (A.M.M.), University of Washington School of Medicine, Seattle, WA
Testosterone (T) therapy in older men with low serum testosterone (T) levels increases lean body mass (LBM) and decreases fat mass (FM). These changes might improve physical performance and strength; however, it has not been established whether T therapy improves functional outcome in older men. Moreover, concerns exist about the impact of T therapy on the prostate in older men. The administration of finasteride, which partially blocks the conversion of T to the more potent androgen, dihydrotestosterone (DHT), attenuates the impact of T replacement on prostate size and PSA. We hypothesized that T replacement in older hypogonadal men would improve physical function and that the addition of finasteride to this regimen would continue to provide the T-induced improvements in physical performance, strength, and body composition. Seventy men with low serum T (<350ng/dl), age 65 and older, were randomly assigned to receive one of three regimens for 36 months: T enanthate 200 mg intramuscularly every two weeks with placebo pills daily (T-only), T enanthate 200 mg every two weeks with 5 mg finasteride daily (T+F), or placebo injections and pills (placebo). We obtained serial measurements of timed physical performance, grip strength, lower extremity strength, body composition (by DEXA), fasting cholesterol profiles and hormones. Fifty men completed the 36-month protocol. After 36 months, T therapy significantly improved performance in a timed functional test when compared with baseline and placebo (4.3 ± 1.6% [mean ± SEM, T-only] and 3.8 ± 1.0% [T+F] vs. -5.6 ± 1.9% for placebo, [P < 0.002 for both T and T+F vs. placebo]), and increased handgrip strength compared with baseline and placebo [P < 0.05]. T therapy increased LBM (3.77 ± 0.55 kg [T-only] and 3.64 ± 0.56 kg [T+F] vs. -0.21 ± 0.55 kg for placebo, [P < 0.0001]), decreased FM, and significantly decreased total cholesterol, low-density lipoprotein (LDL-C), and leptin, without affecting high-density lipoprotein (HDL), adiponectin or fasting insulin levels. These results demonstrate that T therapy in older men with low serum T improves physical performance and strength over 36 months both when administered alone or when combined with finasteride and suggest that high serum levels of DHT are not essential for these beneficial effect of T in men.
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