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Introduction <p>The cardiovascular safety of testosterone-replacement therapy (TRT) for middle-aged and older men with low to low-normal levels of testosterone remains unclear.</p> Methods <p>We systematically searched PubMed, Embase, Cochrane Library, and ClinicalTrials.gov for randomized controlled trials (RCTs) comparing TRT versus placebo for men aged ≥ 40 years old with hypogonadism or low to low-normal testosterone levels (≤&#xa0;14 nmol/L), and at least 12 months of follow-up. We pooled risk ratios (RRs) with 95% confidence intervals (CIs) applying a random-effects model and using R version 4.3.1 for statistical analyses.</p> Results <p>We included 23 RCTs comprising 9280 men with testosterone deficiency, of whom 4800 (51.7%) were randomized to TRT. The mean age was 64.6 years, and the baseline total testosterone was 9.17 nmol/L. Placebo and TRT had similar rates of all-cause mortality (RR 0.85; 95% CI 0.60–1.19; <i>p</i> = 0.33). There was a significant increase in the incidence of cardiac arrhythmias (RR 1.53; 95% CI 1.20–1.97; <i>p</i> &lt; 0.01). There was no significant difference between groups in cardiovascular mortality (RR 0.85; 95% CI 0.65–1.12; <i>p</i> = 0.25), stroke (RR 1.00; 95% CI 0.67–1.50; <i>p</i> = 0.99), and myocardial infarction (RR 0.94; 95% CI 0.69–1.28; <i>p</i> = 0.70).</p> Conclusion <p>In men with low to low-normal testosterone, aged 40 and above, TRT did not increase all-cause mortality, cardiovascular mortality, stroke, or myocardial infarction, but increased the incidence of cardiac arrhythmias.</p> Registration <p>PROSPERO identifier number CRD42024502421.</p>

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Long-Term Cardiovascular Safety of Testosterone-Replacement Therapy in Middle-Aged and Older Men: A Meta-analysis of Randomized Controlled Trials

  • 期刊论文

  • 发表日期：

    2025年7月22日

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  • Marcelo A. P. Braga,
  • André Rivera,
  • Gabriel Marinheiro,
  • Nicole Felix,
  • Pedro E. P. Carvalho,
  • Douglas Mesadri Gewehr,
  • Larissa Teixeira,
  • Mariana R. C. Clemente,
  • Pedro C. Abrahão Reis,
  • Lucas G. C. R. de Amorim,
  • Alice Deberaldini Marinho,
  • Thiago Bosco Mendes,
  • Francesco Costantini Mesquita,
  • Edoardo Pozzi,
  • Ranjith Ramasamy

摘要

Introduction

The cardiovascular safety of testosterone-replacement therapy (TRT) for middle-aged and older men with low to low-normal levels of testosterone remains unclear.

Methods

We systematically searched PubMed, Embase, Cochrane Library, and ClinicalTrials.gov for randomized controlled trials (RCTs) comparing TRT versus placebo for men aged ≥ 40 years old with hypogonadism or low to low-normal testosterone levels (≤ 14 nmol/L), and at least 12 months of follow-up. We pooled risk ratios (RRs) with 95% confidence intervals (CIs) applying a random-effects model and using R version 4.3.1 for statistical analyses.

Results

We included 23 RCTs comprising 9280 men with testosterone deficiency, of whom 4800 (51.7%) were randomized to TRT. The mean age was 64.6 years, and the baseline total testosterone was 9.17 nmol/L. Placebo and TRT had similar rates of all-cause mortality (RR 0.85; 95% CI 0.60–1.19; p = 0.33). There was a significant increase in the incidence of cardiac arrhythmias (RR 1.53; 95% CI 1.20–1.97; p < 0.01). There was no significant difference between groups in cardiovascular mortality (RR 0.85; 95% CI 0.65–1.12; p = 0.25), stroke (RR 1.00; 95% CI 0.67–1.50; p = 0.99), and myocardial infarction (RR 0.94; 95% CI 0.69–1.28; p = 0.70).

Conclusion

In men with low to low-normal testosterone, aged 40 and above, TRT did not increase all-cause mortality, cardiovascular mortality, stroke, or myocardial infarction, but increased the incidence of cardiac arrhythmias.

Registration

PROSPERO identifier number CRD42024502421.