Adverse Events Associated with Testosterone Administration

• Published in: The New England journal of medicine Vol. 363; no. 2; pp. 109 - 122
• Main Authors: Basaria, Shehzad, Coviello, Andrea D, Travison, Thomas G, Storer, Thomas W, Farwell, Wildon R, Jette, Alan M, Eder, Richard, Tennstedt, Sharon, Ulloor, Jagadish, Zhang, Anqi, Choong, Karen, Lakshman, Kishore M, Mazer, Norman A, Miciek, Renee, Krasnoff, Joanne, Elmi, Ayan, Knapp, Philip E, Brooks, Brad, Appleman, Erica, Aggarwal, Sheetal, Bhasin, Geeta, Bhasin, Shalender, Hede-Brierley, Leif, Bhatia, Ashmeet, Collins, Lauren, LeBrasseur, Nathan, Fiore, Louis D
• Format: Journal Article
• Language: English
• Published: Waltham, MA Massachusetts Medical Society 08.07.2010
• Subjects: Administration, Cutaneous; Aged; Aged, 80 and over; Aging; Androgens; Biological and medical sciences; Cardiovascular Diseases - chemically induced; Data collection; Design; Double-Blind Method; Exercise Test; Gels; General aspects; Heart attacks; Heart failure; Humans; Hyperlipidemias - complications; Hypertension - complications; Kaplan-Meier Estimate; Logistic Models; Male; Medical sciences; Men; Mens health; Muscle Strength - drug effects; Obesity - complications; Older people; Risk Factors; Testosterone; Testosterone - adverse effects; Testosterone - blood; Testosterone - deficiency; Testosterone - therapeutic use; Walking; Medicine; Drug; Testosterone; Association; Androgen; Toxicity; Secondary effect; Complication; Testicular hormone; Pharmacovigilance; Sex steroid hormone
• ISSN: 0028-4793; 1533-4406; 1533-4406
• DOI: 10.1056/NEJMoa1000485

In a randomized trial, men 65 years of age or older who had low serum testosterone levels and limitations in mobility were assigned to either placebo or testosterone gel to be applied daily for 6 months. The primary end point was improvement in leg-press strength, which was greater with testosterone therapy than with placebo. However, the trial was stopped early because of a greater number of cardiac adverse events in the testosterone group. In men 65 years of age or older with low serum testosterone levels and limitations in mobility, improvement in leg-press strength was greater with testosterone therapy than with placebo. However, there were more cardiac adverse events in the testosterone group. Limited mobility is a common geriatric condition that is a predictor of disability, poor quality of life, and death. 1 – 7 In men, an age-related decline in the serum testosterone concentration is associated with reduced muscle mass and lower-extremity strength, limitations in physical function, and poor mobility. 8 – 13 Testosterone supplementation increases muscle mass and strength and leg power, all of which are important determinants of mobility. 14 – 21 Previous trials of testosterone supplementation have been conducted primarily among healthy older men. The safety and efficacy of testosterone treatment in improving muscle performance and physical function in older men with limitations in mobility . . .