Home »   Print

Adverse Events Associated with Testosterone Administration


Testosterone supplementation has been shown to increasemuscle mass and strength in healthy older men. The safety andefficacy of testosterone treatment in older men who have limitationsin mobility have not been studied. In the recent issue of the New England Journal of Medicine, this article studied a community-dwelling men, 65 years of age or older, withlimitations in mobility and a total serum testosterone levelof 100 to 350 ng per deciliter (3.5 to 12.1 nmol per liter)or a free serum testosterone level of less than 50 pg per milliliter(173 pmol per liter) were randomly assigned to receive placebogel or testosterone gel, to be applied daily for 6 months. Adverseevents were categorized with the use of the Medical Dictionaryfor Regulatory Activities classification. The data and safetymonitoring board recommended that the trial be discontinuedearly because there was a significantly higher rate of adversecardiovascular events in the testosterone group than in theplacebo group. The results showed a total of 209 men (mean age, 74 years) were enrolledat the time the trial was terminated. At baseline, there wasa high prevalence of hypertension, diabetes, hyperlipidemia,and obesity among the participants. During the course of thestudy, the testosterone group had higher rates of cardiac, respiratory,and dermatologic events than did the placebo group. A totalof 23 subjects in the testosterone group, as compared with 5in the placebo group, had cardiovascular-related adverse events.The relative risk of a cardiovascular-related adverse eventremained constant throughout the 6-month treatment period. Ascompared with the placebo group, the testosterone group hadsignificantly greater improvements in leg-press and chest-pressstrength and in stair climbing while carrying a load. The authors concluded that in this population of older men with limitationsin mobility and a high prevalence of chronic disease, the applicationof a testosterone gel was associated with an increased riskof cardiovascular adverse events. The small size of the trialand the unique population prevent broader inferences from beingmade about the safety of testosterone therapy.

REFERENCE:

Shehzad Basaria, M.D., Andrea D. Coviello, M.D., Thomas G. Travison, Ph.D., Thomas W. Storer, Ph.D., Wildon R. Farwell, M.D., M.P.H., Alan M. Jette, Ph.D., Richard Eder, B.A., Sharon Tennstedt, Ph.D., Jagadish Ulloor, Ph.D., Anqi Zhang, Ph.D., Karen Choong, M.D., Kishore M. Lakshman, M.D., Norman A. Mazer, M.D., Ph.D., Renee Miciek, M.S., Joanne Krasnoff, Ph.D., Ayan Elmi, B.A., Philip E. Knapp, M.D., Brad Brooks, B.S., Erica Appleman, M.A., Sheetal Aggarwal, B.S., C.C.R.P., Geeta Bhasin, B.A., Leif Hede-Brierley, Ashmeet Bhatia, M.B., B.S., Lauren Collins, R.N.P., Nathan LeBrasseur, Ph.D., Louis D. Fiore, M.D., and Shalender Bhasin, M.D. Adverse Events Associated with Testosterone Administration. NEJM 2010; 363:109-122.