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.
Mayo Clinic proceedings. 2024 Oct 22 [Epub]
Abraham Morgentaler, Sandeep Dhindsa, Adrian S Dobs, Geoff Hackett, T Hugh Jones, Robert A Kloner, Martin Miner, Michael Zitzmann, Abdulmaged M Traish
Division of Urology, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA. Electronic address: ., Division of Endocrinology and Metabolism, St Louis University, St Louis, MO., Division of Endocrinology, Diabetes and Metabolism, The Johns Hopkins University School of Medicine, Baltimore, MD., Aston University Medical School, Birmingham, United Kingdom., Department of Endocrinology, Barnsley Hospital, Barnsley, UK; Department of Biochemistry, University of Sheffield Medical School, Sheffield, United Kingdom., Cardiovascular Division, Department of Medicine, Keck School of Medicine of University of Southern California, Los Angeles, CA., Departments of Family Medicine and Urology, Warren Alpert School of Medicine, Brown University, Providence, RI., Department of Clinical and Surgical Andrology, Centre of Reproductive Medicine and Andrology, Münster University Hospital, Münster, Germany., Departments of Biochemistry and Urology, Boston University School of Medicine, Boston, MA.