Cardiovascular safety of testosterone therapy-Insights from the TRAVERSE trial and beyond: A position statement of the European Expert Panel for Testosterone Research

Michael Zitzmann; Giulia Rastrelli; Robert D Murray; David Edwards; Yacov Reisman; Preethi Mohan Rao; Alexander Sahi; Thomas Hugh Jones; Alberto Ferlin; Eleni Armeni; Emiliano Corpas; Jann-Frederik Cremers; Janine David; Stefan Arver; Leen Antonio; Giovanni Corona

doi:10.1111/andr.70062

Cardiovascular safety of testosterone therapy-Insights from the TRAVERSE trial and beyond: A position statement of the European Expert Panel for Testosterone Research

Zitzmann M, Rastrelli G, Murray RD, Edwards D, Reisman Y, Rao PM, Sahi A, Jones TH, Ferlin A, Armeni E, Corpas E, Cremers JF, David J, Arver S, Antonio L, Corona G

Published January 2026 Andrology

DOI 10.1111/andr.70062 PMID 40372318 PMC PMC12670475

RRM Academy Synopsis

Expert panel judges testosterone heart-safe in monitored hypogonadism

A European expert panel's position statement finds that testosterone therapy is safe for the heart in men with hypogonadism when managed properly. The statement builds on TRAVERSE, a placebo-controlled trial of 5246 men aged 45 to 80. TRAVERSE found no significant rise in heart attacks, strokes or heart-related deaths.

Key Findings

TRAVERSE enrolled 5246 men aged 45 to 80 (mean age 63.3 years) with functional hypogonadism. They received testosterone gel or placebo for a mean of 22 months.
The testosterone group had no statistically significant increase versus placebo in the main outcome (cardiovascular death, nonfatal heart attack or nonfatal stroke) or in a secondary outcome adding coronary revascularization.
Among secondary outcomes, the paper reports no significant differences in cardiovascular death or heart failure, and a minor but significant increase in atrial fibrillation and nonfatal arrhythmias with testosterone.
TRAVERSE found that testosterone modestly raised hematocrit, the share of blood made up of red cells, without a significant rise in thromboembolic events.
A cited meta-analysis of 106 placebo-controlled trials found no significant difference in major cardiovascular events. The pooled arrhythmia odds ratio was 1.61 (CI 0.84 to 3.08) and did not reach significance.

Interpretation

A European expert panel issued this position statement after meeting in London in September 2024. The panel's conclusion rests chiefly on TRAVERSE, a randomized, placebo-controlled trial. TRAVERSE followed older men, most with existing heart disease or high heart risk, for a mean of 22 months. The authors note that the findings apply less well to younger, healthier men. The findings support further study of testosterone therapy across a wider range of patients.

RRM Context

The panel puts lifestyle change first for functional hypogonadism, naming weight management and physical activity, since the condition is most often tied to obesity. Guidelines cited in the paper advise against starting testosterone when a man wants to father a child. RRM looks for the cause first and treats the couple together.

Our editorial summary of this paper, not the article's abstract.

Abstract

Introduction

Testosterone therapy has become a cornerstone treatment for men with hypogonadism, offering significant benefits such as improved sexual function, mood, muscle mass, and bone density. However, concerns about its cardiovascular safety have historically tempered its use. This position statement synthesizes the current evidence on the cardiovascular safety of testosterone therapy, drawing from key studies including the TRAVERSE trial, other trials, and recent meta-analyses.

Background and Importance

Testosterone therapy aims to restore testosterone levels in men with hypogonadism, a condition associated with increased cardiovascular and metabolic risks. Early research produced mixed results, with some studies suggesting a potential increase in cardiovascular events such as myocardial infarction and stroke, while others indicated possible cardiovascular benefits, particularly in men with coexisting conditions like metabolic syndrome and type 2 diabetes.

Findings from Recent Studies

The TRAVERSE trial, a large-scale, randomized, placebo-controlled study, provided robust evidence that testosterone therapy does not significantly increase the risk of major adverse cardiovascular events. Testosterone therapy was found to effectively mitigate anemia in hypogonadal men, highlighting a dual benefit of increasing red blood cell production while managing cardiovascular risks. The findings from the TRAVERSE trial align with those from previous meta-analyses that concluded that testosterone therapy is safe and does not increase cardiovascular risk.

Consensus and Clinical Implications

There is consensus that testosterone therapy, when prescribed to appropriately selected patients and monitored regularly, is safe from a cardiovascular standpoint, with the potential benefits outweighing the risks when the therapy is used responsibly. Current guidelines recommend individualized treatment plans with careful monitoring, especially of hematocrit levels. This position statement amalgamates previous knowledge with current data and is in agreement with recent United States Food and Drug Administration label changes for testosterone products.

Topics

Therapeutics

Hormonal Agents Androgens and DHEA

Therapeutics › Hormonal Agents › Androgens and DHEA

Michael Zitzmann, Giulia Rastrelli, Robert D Murray, David Edwards, Yacov Reisman, Preethi Mohan Rao, Alexander Sahi, Thomas Hugh Jones, Alberto Ferlin, Eleni Armeni, Emiliano Corpas, Jann-Frederik Cremers, Janine David, Stefan Arver, Leen Antonio, Giovanni Corona

Mike Zitzmann, M Zitzmann, G Rastrelli, Bob Murray, Rob Murray, Bobby Murray, R Murray, Dave Edwards, D Edwards, Y Reisman, P Rao, Alex Sahi, A Sahi, Tom Jones, T Jones, A Ferlin, E Armeni, E Corpas, J Cremers, J David, S Arver, L Antonio, G Corona

PMID 40372318 40372318 DOI 10.1111/andr.70062 10.1111/andr.70062 Zitzmann et al. 2026, Zitzmann 2026

Cardiovascular safety of testosterone therapy-Insights from the TRAVERSE trial and beyond: A position statement of the European Expert Panel for Testosterone Research

Expert panel judges testosterone heart-safe in monitored hypogonadism

Key Findings

Interpretation

RRM Context

Abstract

Topics

By this author

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