Cardiovascular adverse events associated with testosterone administration

January 01, 0001

Cardiovascular adverse events associated with testosterone administration

These US investigators enrolled community-dwelling men, 65 years of age or older, with limitations in mobility and a total serum testosterone level of 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). They were randomly assigned to receive placebo gel or testosterone gel, to be applied daily for 6 months. Adverse events were categorized with the use of the Medical Dictionary for Regulatory Activities classification. The data and safety monitoring board recommended that the trial be discontinued early because there was a significantly higher rate of adverse cardiovascular events in the testosterone group than in the placebo group.

They found: "A total of 209 men (mean age, 74 years) were enrolled at the time the trial was terminated. At baseline, there was a high prevalence of hypertension, diabetes, hyperlipidemia, and obesity among the participants. During the course of the study, the testosterone group had higher rates of cardiac, respiratory, and dermatologic events than did the placebo group. A total of 23 subjects in the testosterone group, as compared with 5 in the placebo group, had cardiovascular-related adverse events. The relative risk of a cardiovascular-related adverse event remained constant throughout the 6- month treatment period. As compared with the placebo group, the testosterone group had significantly greater improvements in leg-press and chest-press strength and in stair climbing while carrying a load."

The authors concluded: "In this population of older men with limitations in mobility and a high prevalence of chronic disease, the application of a testosterone gel was associated with an increased risk of cardiovascular adverse events. The small size of the trial and the unique population prevent broader inferences from being made about the safety of testosterone therapy."

Best to avoid testosterone supplementation in elderly men - first do no harm.

For the full abstract, click here.

N Engl J Med Published at www.nejm.org, 30 June 2010 © 2010 to the Massachusetts Medical Society
Adverse Events Associated with Testosterone Administration. Shehzad Basaria, Andrea D. Coviello, Thomas G. Travison, et al. Correspondence to Dr. Bhasin: [email protected]

Category: K. Circulatory, T. Endocrine/Metabolic/Nutritional. Keywords: testosterone, elderly, men, mobility, cardiovascular, adverse events, randomized controlled trial, journal watch.
Synopsis edited by Dr Linda French, Toledo, Ohio. Posted on Global Family Doctor 20 July 2010

Pearls are an independent product of the Cochrane primary care group and are meant for educational use and not to guide clinical care.