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

IF 3 4区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

American Journal of Cardiovascular Drugs Pub Date : 2025-07-22 DOI:10.1007/s40256-025-00737-w

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

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引用次数: 0

Abstract

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.

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中老年男性睾酮替代疗法的长期心血管安全性：随机对照试验的荟萃分析

导论：睾酮替代疗法（TRT）对睾酮水平低或低于正常水平的中老年男性的心血管安全性尚不清楚。方法：我们系统地检索PubMed、Embase、Cochrane Library和ClinicalTrials.gov，以比较TRT和安慰剂对年龄≥40岁、性腺功能减退或睾酮水平低至低正常水平（≤14 nmol/L）的男性的随机对照试验（rct），并进行至少12个月的随访。我们采用随机效应模型合并95%置信区间（ci）的风险比（rr），并使用R 4.3.1版本进行统计分析。结果：我们纳入了23项随机对照试验，包括9280名睾酮缺乏的男性，其中4800名（51.7%）被随机分配到TRT。平均年龄64.6岁，基线总睾酮9.17 nmol/L。安慰剂组和TRT组的全因死亡率相似(RR 0.85；95% ci 0.60-1.19；p = 0.33)。心律失常的发生率显著增加(RR 1.53；95% ci 1.20-1.97；结论：在睾酮水平低或低于正常水平、年龄在40岁及以上的男性中，TRT不会增加全因死亡率、心血管死亡率、卒中或心肌梗死，但会增加心律失常的发生率。注册：普洛斯彼罗标识号CRD42024502421。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

American Journal of Cardiovascular Drugs 医学-心血管系统

CiteScore

6.70

自引率

3.30%

发文量

审稿时长

>12 weeks

期刊介绍： Promoting rational therapy within the discipline of cardiology, the American Journal of Cardiovascular Drugs covers all aspects of the treatment of cardiovascular disorders, particularly the place in therapy of newer and established agents. Via a program of reviews and original clinical research articles, the journal addresses major issues relating to treatment of these disorders, including the pharmacology, efficacy and adverse effects of the major classes of drugs; information on newly developed drugs and drug classes; the therapeutic implications of latest research into the aetiology of cardiovascular disorders; and the practical management of specific clinical situations. The American Journal of Cardiovascular Drugs offers a range of additional enhanced features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by a Key Points summary, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist patients, caregivers and others in understanding important medical advances. The journal also provides the option to include various other types of enhanced features including slide sets, videos and animations. All enhanced features are peer reviewed to the same high standard as the article itself. Peer review is conducted using Editorial Manager®, supported by a database of international experts. This database is shared with other Adis journals.