Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels.

By R. Vigen, Colin I. O’Donnell, A. Baron, Gary K. Grunwald, Thomas M. Maddox, S. Bradley, A. Barqawi, Glenn Woning, M. Wierman, M. Plomondon and 2 more. Journal of the American Medical Association (JAMA), 2013

959 citations recorded by the source corpus.

IMPORTANCE Rates of testosterone therapy are increasing and the effects of testosterone therapy on cardiovascular outcomes and mortality are unknown. A recent randomized clinical trial of testosterone therapy in men with a high prevalence of cardiovascular diseases was stopped prematurely due to adverse cardiovascular events raising concerns about testosterone therapy safety. OBJECTIVES To assess the association between testosterone therapy and all-cause mortality, myocardial infarction (MI), or stroke among male veterans and to determine whether this association is modified by underlying coronary artery disease. DESIGN, SETTING, AND PATIENTS A retrospective national cohort study of men with low testosterone levels (<300 ng/dL) who underwent coronary angiography in the Veterans Affairs (VA) system between 2005 and 2011. MAIN OUTCOMES AND MEASURES Primary outcome was a composite of all-cause mortality, MI, and ischemic stroke. RESULTS Of the 8709 men with a total testosterone level lower than 300 ng/dL, 1223 patients started testosterone therapy after a median of 531 days following coronary angiography. Of the 1710 outcome events, 748 men died, 443 had MIs, and 519 had strokes. Of 7486 patients not receiving testosterone therapy, 681 died, 420 had MIs, and 486 had strokes. Among 1223 patients receiving testosterone therapy, 67 died, 23 had MIs, and 33 had strokes. At 3 years after coronary angiography, the Kaplan-Meier estimated cumulative percentages with events were 19.9%in the no testosterone therapy group vs 25.7%in the testosterone therapy group,with an absolute risk difference of 5.8%(95%CI, -1.4%to 13.1%) [corrected].The Kaplan-Meier estimated cumulative percentages with events among the no testosterone therapy group vs testosterone therapy group at 1 year after coronary angiography were 10.1% vs 11.3%; at 2 years, 15.4% vs 18.5%; and at 3 years, 19.9% vs 25.7 [corrected].There was no significant difference in the effect size of testosterone therapy among those with and without coronary artery disease (test for interaction, P = .41). CONCLUSIONS AND RELEVANCE Among a cohort of men in the VA health care system who underwent coronary angiography and had a low serum testosterone level, the use of testosterone therapy was associated with increased risk of adverse outcomes. These findings may inform the discussion about the potential risks of testosterone therapy.

Subfields: Endocrinology, Diabetes and Metabolism, Experimental and Cognitive Psychology, Psychiatry and Mental health

View Paper: https://www.semanticscholar.org/paper/a777bcc94932e088bdb9223d80158d411adbd74e

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Citations in the corpus

Cardiovascular Risks Associated with Gender and Aging (2019, background): “One clinical trial reported an increased risk for MI, stroke, and mortality with testosterone therapy [144], while another trial suggested that testosterone protected men against all of these same risks [145].”
Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men (2014, background): “[6] In the two studies assessing timing of the increase, it was noted to appear very soon following initiation of therapy.”
Using Electronic Health Records for Population Health Research: A Review of Methods and Applications (2015, background): “…EHR delivery and birth data from 19 hospitals; the Clinical Assessment, Reporting, and Tracking system in Veterans Administration (VA) hospitals (128); and the Chronic Hepatitis Cohort Study, which combined data from four health care systems on more than 1.6 million adults to identify a cohort…”