Androgen Society Position Paper on Cardiovascular Risk With Testosterone Therapy

IF 6.9 2区 医学 Q1 MEDICINE, GENERAL & INTERNAL Mayo Clinic proceedings Pub Date : 2024-11-01 DOI:10.1016/j.mayocp.2024.08.008
Abraham Morgentaler MD , Sandeep Dhindsa MD , Adrian S. Dobs MD , Geoff Hackett MD , T. Hugh Jones MD , Robert A. Kloner MD , Martin Miner MD , Michael Zitzmann MD, PhD , Abdulmaged M. Traish PhD
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Abstract

The Androgen Society is an international, multidisciplinary medical organization committed to advancing research and education in the field of testosterone deficiency and testosterone therapy (TTh). This position paper is written in response to results of the TRAVERSE study, published in June 2023, which reported no increased risk of major adverse cardiovascular events (MACE) in men who received TTh compared with placebo.
In 2013-2014, 2 observational studies reported increased cardiovascular (CV) risks with TTh and received wide media attention. Despite strong criticism of those 2 studies, in 2015, the Food and Drug Administration added a CV warning to testosterone product labels and required pharmaceutical companies to perform a CV safety study, which became the TRAVERSE trial.
TRAVERSE enrolled 5246 men at high risk for MACE based on existing heart disease or multiple risk factors. Participants were randomized to daily testosterone gel or placebo gel, with a mean follow-up of 33 months. Results revealed no greater risk of MACE (myocardial infarction, stroke, or CV death) or venothrombotic events in men who received TTh compared with placebo.
Review of the prior literature reveals near uniformity of studies reporting no increased MACE with TTh. This includes 2 additional large randomized controlled trials, multiple smaller randomized controlled trials, several large observational studies, and 19 meta-analyses.
In view of these findings, it is the position of the Androgen Society that it has now been conclusively determined that TTh is not associated with increased risks of heart attack, stroke, or CV death.
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雄激素协会关于睾酮疗法心血管风险的立场文件。
雄激素学会是一个国际性多学科医学组织,致力于推动睾酮缺乏症和睾酮治疗 (TTh) 领域的研究和教育。本立场文件是针对 2023 年 6 月发表的 TRAVERSE 研究结果而撰写的,该研究报告称,与安慰剂相比,接受 TTh 治疗的男性发生重大心血管不良事件 (MACE) 的风险并未增加。2013-2014 年,2 项观察性研究报告 TTh 会增加心血管 (CV) 风险,引起了媒体的广泛关注。尽管对这 2 项研究提出了强烈批评,2015 年,美国食品和药物管理局还是在睾酮产品标签上添加了心血管警告,并要求制药公司开展心血管安全性研究,这就是后来的 TRAVERSE 试验。TRAVERSE 试验招募了 5246 名因患有心脏病或存在多种风险因素而面临 MACE 高风险的男性。参与者被随机分配到每日使用睾酮凝胶或安慰剂凝胶,平均随访 33 个月。结果显示,与安慰剂相比,服用睾酮凝胶的男性发生 MACE(心肌梗死、中风或冠心病死亡)或静脉血栓事件的风险并没有增加。回顾之前的文献,发现几乎所有的研究都报告 TTh 不会增加 MACE。其中包括另外两项大型随机对照试验、多项小型随机对照试验、多项大型观察性研究和 19 项荟萃分析。鉴于这些研究结果,雄激素学会的立场是,目前已最终确定 TTh 不会增加心脏病发作、中风或冠心病死亡的风险。
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来源期刊
Mayo Clinic proceedings
Mayo Clinic proceedings 医学-医学:内科
CiteScore
16.80
自引率
1.10%
发文量
383
审稿时长
37 days
期刊介绍: Mayo Clinic Proceedings is a premier peer-reviewed clinical journal in general medicine. Sponsored by Mayo Clinic, it is one of the most widely read and highly cited scientific publications for physicians. Since 1926, Mayo Clinic Proceedings has continuously published articles that focus on clinical medicine and support the professional and educational needs of its readers. The journal welcomes submissions from authors worldwide and includes Nobel-prize-winning research in its content. With an Impact Factor of 8.9, Mayo Clinic Proceedings is ranked #20 out of 167 journals in the Medicine, General and Internal category, placing it in the top 12% of these journals. It invites manuscripts on clinical and laboratory medicine, health care policy and economics, medical education and ethics, and related topics.
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