Research · PMID 27165609 · Landmark study
Reviewed by Neal Rouzier, MD, Preventive Medicine · Sep 2026
Survival and cardiovascular events in men treated with testosterone replacement therapy: an intention-to-treat observational cohort study.
The lancet. Diabetes & endocrinology · June 2016 · Christopher J D Wallis, Kirk Lo, Yuna Lee, Yonah Krakowsky, Alaina Garbens, et al.
What this study found
Conflicting evidence exists for the association between testosterone replacement therapy and mortality and cardiovascular events. The US Food and Drug Administration recently cautioned that testosterone replacement therapy might increase risk of heart attack and stroke, based on
Why this trial matters
Observational TRT cardiovascular cohort
How RAGMD uses this study
Clinical questions this paper informs
Synthesis lives on the evidence question — this page shows where the study sits in that analysis.
Conflicting evidence
Does testosterone replacement increase cardiovascular risk?
Large randomized data (including TRAVERSE) do not show a significant increase in major adverse cardiovascular events with testosterone therapy in hypogonadal men over median follow-up of roughly three years. Older observational studies conflict, and absolute risk depends on baseline cardiovascular disease, formulation, and monitoring.
Open evidence analysis