• G Caleb Alexander, Geetha Iyer, Eleanor Lucas, Dora Lin, and Sonal Singh.
• Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Md; Center for Drug Safety and Effectiveness, Johns Hopkins University, Baltimore, Md; Division of General Internal Medicine, Department of Medicine, Johns Hopkins Medicine, Baltimore, Md. Electronic address: galexan9@jhmi.edu.
• Am. J. Med. 2017 Mar 1; 130 (3): 293-305.

PurposeWe sought to evaluate whether exogenous testosterone therapy is associated with increased risk of serious cardiovascular events as compared with other treatments or placebo.MethodsStudy selection included randomized controlled trials (RCTs) and observational studies that enrolled men aged 18 years or older receiving exogenous testosterone for 3 or more days. The primary outcomes were death due to all causes, myocardial infarction, and stroke. Secondary outcomes were other hard clinical outcomes such as heart failure, arrhythmia, and cardiac procedures. Peto odds ratio was used to pool data from RCTs. Risk of bias was assessed using Cochrane Collaboration tool and Newcastle and Ottawa scale, respectively. The strength of evidence was evaluated using the Grades of Recommendation, Assessment, Development, and Evaluation Working Group approach.ResultsA total of 39 RCTs and 10 observational studies were included. Meta-analysis was done using data from 30 RCTs. Compared with placebo, exogenous testosterone treatment did not show any significant increase in risk of myocardial infarction (odds ratio [OR] 0.87; 95% CI, 0.39-1.93; 16 RCTs), stroke (OR 2.17; 95% CI, 0.63-7.54; 9 RCTs), or mortality (OR 0.88; 95% CI, 0.55-1.41; 20 RCTs). Observational studies showed marked clinical and methodological heterogeneity. The evidence was rated as very low quality due to the high risk of bias, imprecision, and inconsistency.ConclusionsWe did not find any significant association between exogenous testosterone treatment and myocardial infarction, stroke, or mortality in randomized controlled trials. The very low quality of the evidence precludes definitive conclusion on the cardiovascular effects of testosterone.Copyright © 2016 Elsevier Inc. All rights reserved.

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