Cardiovascular Risks of Exogenous Testosterone Use Among Men: A Systematic Review and Meta-Analysis - 18/04/17
, Geetha Iyer, MBBS a, b, Eleanor Lucas, BA a, b, Dora Lin, MHS a, b, Sonal Singh, MD b, cAbstract |
Purpose |
We sought to evaluate whether exogenous testosterone therapy is associated with increased risk of serious cardiovascular events as compared with other treatments or placebo.
Methods |
Study selection included randomized controlled trials (RCTs) and observational studies that enrolled men aged 18 years or older receiving exogenous testosterone for 3 or more days. The primary outcomes were death due to all causes, myocardial infarction, and stroke. Secondary outcomes were other hard clinical outcomes such as heart failure, arrhythmia, and cardiac procedures. Peto odds ratio was used to pool data from RCTs. Risk of bias was assessed using Cochrane Collaboration tool and Newcastle and Ottawa scale, respectively. The strength of evidence was evaluated using the Grades of Recommendation, Assessment, Development, and Evaluation Working Group approach.
Results |
A total of 39 RCTs and 10 observational studies were included. Meta-analysis was done using data from 30 RCTs. Compared with placebo, exogenous testosterone treatment did not show any significant increase in risk of myocardial infarction (odds ratio [OR] 0.87; 95% CI, 0.39-1.93; 16 RCTs), stroke (OR 2.17; 95% CI, 0.63-7.54; 9 RCTs), or mortality (OR 0.88; 95% CI, 0.55-1.41; 20 RCTs). Observational studies showed marked clinical and methodological heterogeneity. The evidence was rated as very low quality due to the high risk of bias, imprecision, and inconsistency.
Conclusions |
We did not find any significant association between exogenous testosterone treatment and myocardial infarction, stroke, or mortality in randomized controlled trials. The very low quality of the evidence precludes definitive conclusion on the cardiovascular effects of testosterone.
El texto completo de este artículo está disponible en PDF.Keywords : Cardiovascular risks, Exogenous testosterone, Meta-analysis, Systematic review
Esquema
| Funding: This work was supported in part by the Johns Hopkins Center of Excellence in Regulatory Science and Innovation (1 U01 FD004977-02). This funding source had no role in the design and conduct of the study, analysis, or interpretation of the data; and preparation or final approval of the manuscript prior to publication. |
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| Conflict of Interest: GCA is Chair of the Food and Drug Administration's Peripheral and Central Nervous System Advisory Committee, serves as a paid consultant to mobile start-up PainNavigator, serves as a consultant to IMS Health, and serves on an IMS Health scientific advisory board. This arrangement has been reviewed and approved by Johns Hopkins University in accordance with its conflict of interest policies. SS has served as an expert witness for plaintiffs against Pfizer and as a consultant for Eli Lilly, in both cases for products unrelated to those examined herein. The authors have no other conflicts of interest. |
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| Authorship: SS drafted the study protocol; all authors contributed to substantive revisions of the study protocol; EL, DL, and GI conducted study screening and data abstraction; GI developed the preliminary analyses; all authors contributed to substantive interpretation of the study findings; GCA and GI drafted the manuscript; SS performed the meta-analyses; all authors contributed to substantive manuscript revisions and approved of the final manuscript. |
Vol 130 - N° 3
P. 293-305 - mars 2017 Regresar al número
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