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
{"title":"Androgen Society Position Paper on Cardiovascular Risk With Testosterone Therapy","authors":"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","doi":"10.1016/j.mayocp.2024.08.008","DOIUrl":null,"url":null,"abstract":"<div><div>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.</div><div>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.</div><div>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.</div><div>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.</div><div>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.</div></div>","PeriodicalId":18334,"journal":{"name":"Mayo Clinic proceedings","volume":"99 11","pages":"Pages 1785-1801"},"PeriodicalIF":6.9000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Mayo Clinic proceedings","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0025619624004087","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0
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.
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.