Cardiovascular Outcomes of Hypogonadal Men Receiving Testosterone Replacement Therapy: A Meta-analysis of Randomized Controlled Trials

Endocr Pract. 2024 Jan;30(1):2-10. doi: 10.1016/j.eprac.2023.09.012. Epub 2023 Oct 4.


Objective: To investigate the impact of testosterone replacement therapy (TRT) on cardiovascular outcomes in hypogonadal men.

Methods: A meta-analysis of 26 randomized controlled trials involving 10 941 participants was conducted. Various clinical outcomes, including all-cause mortality, cardiovascular-related mortality, myocardial infarction, stroke, congestive heart failure, atrial fibrillation, pulmonary embolism, and venous thrombosis, were assessed.

Results: No statistically significant differences were observed between the TRT group and the control group in terms of these clinical outcomes. Sensitivity analysis and publication bias assessment supported the robustness of the findings. Meta-regression analysis found no significant associations between clinical outcomes and potential covariates, including age, diabetes, hypertension, dyslipidemia, and smoking.

Discussion: Previous research on TRT and cardiovascular events, with comparisons to studies like the Testosterone Trials and the studies conducted by Vigen et al, Finkle et al, Layton et al, and Wallis et al, is provided. The significance of the systematic review and meta-analysis approach is emphasized, particularly its exclusive focus on hypogonadal patients.

Conclusion: This study offers reassurance that TRT does not increase mortality risk or worsen cardiovascular outcomes in hypogonadal men. However, further research, especially long-term studies involving diverse populations, is essential to strengthen the evidence base and broaden the applicability of these findings.

Keywords: cardiovascular; hypogonadism; meta-analysis; mortality; testosterone; trials.

Publication types

  • Meta-Analysis
  • Systematic Review

MeSH terms

  • Cardiovascular Diseases / mortality
  • Hormone Replacement Therapy*
  • Humans
  • Hypogonadism* / drug therapy
  • Male
  • Randomized Controlled Trials as Topic
  • Testosterone* / adverse effects
  • Testosterone* / therapeutic use


  • Testosterone