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Am J Med. 2019 Apr 3. pii: S0002-9343(19)30281-5. doi: 10.1016/j.amjmed.2019.03.022. [Epub ahead of print]

Cardiovascular and Cerebrovascular Safety of Testosterone Replacement Therapy Among Aging Men with Low Testosterone Levels: A Cohort Study.

Author information

1
Centre for Clinical Epidemiology, Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada.
2
Centre for Clinical Epidemiology, Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Québec, Canada; Gerald Bronfman Department of Oncology, McGill University, Montreal, Québec, Canada.
3
Centre for Clinical Epidemiology, Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada; Division of Endocrinology, Jewish General Hospital, Montreal, Québec, Canada.
4
Centre for Clinical Epidemiology, Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Québec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Québec, Canada; Department of Neurology and Neurosurgery, McGill University, Montreal, Québec, Canada. Electronic address: christel.renoux@mcgill.ca.

Abstract

PURPOSE:

We assessed the risk of ischemic stroke, transient ischemic attack, and myocardial infarction associated with testosterone replacement therapy (TRT) among aging men with low testosterone levels.

METHODS:

Using the UK Clinical Practice Research Datalink, we formed a cohort of men aged 45 years or older with low testosterone levels and no evidence of hypogonadotropic or testicular disease, between 1995 and 2017. Hazard ratios (HRs) and 95% confidence intervals (CIs) of a composite of ischemic stroke/transient ischemic attack and myocardial infarction were estimated using time-dependent Cox proportional hazards models, comparing current use of TRT with nonuse.

RESULTS:

The cohort included 15,401 men. During 71,541 person-years of follow-up, 850 patients experienced an ischemic stroke/transient ischemic attack/myocardial infarction (crude incidence rate 1.19 [95% confidence interval (CI), 1.11-1.27] per 100 persons per year). Compared with nonuse, current use of TRT was associated with an increased risk of the composite outcome (HR 1.21; 95% CI, 1.00-1.46). This risk was highest in the first 6 months to 2 years of continuous TRT use (HR 1.35; 95% CI, 1.01-1.79), as well as among men aged 45-59 years (HR 1.44; 95% CI, 1.07-1.92).

CONCLUSIONS:

TRT may increase the risk of cardiovascular events in aging men with low testosterone levels, particularly in the first 2 years of use. In the absence of identifiable causes of hypogonadism, TRT should be initiated with caution among aging men with low testosterone levels.

KEYWORDS:

Hypogonadism; Myocardial infarction; Stroke; Testosterone replacement therapy

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