Cardiovascular Risks of Exogenous Testosterone Use Among Men: A Systematic Review and Meta-Analysis

G. Caleb Alexander, Geetha Iyer, Eleanor Lucas, Dora Lin, Sonal Singh

Research output: Contribution to journalArticlepeer-review

53 Scopus citations


Purpose We sought to evaluate whether exogenous testosterone therapy is associated with increased risk of serious cardiovascular events as compared with other treatments or placebo. Methods Study 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. Results A 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. Conclusions We 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.

Original languageEnglish (US)
Pages (from-to)293-305
Number of pages13
JournalAmerican Journal of Medicine
Issue number3
StatePublished - Mar 1 2017


  • Cardiovascular risks
  • Exogenous testosterone
  • Meta-analysis
  • Systematic review

ASJC Scopus subject areas

  • Medicine(all)


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