Effect of testosterone treatment on cardiovascular events in men: A protocol for a systematic literature review and meta-analysis

Abstract

Background:

Testosterone prescriptions have increased dramatically over recent decades with increasing usage in men. Despite epidemiological association found between higher circulating concentrations of endogenous androgens and lower risk of cardiovascular (CV) events and mortality, effects of exogenous androgens in the form of testosterone therapy seeking to maintain physiological circulating androgen concentrations on the CV system remain uncertain with no published meta-analysis on this topic

Objective:

To investigate the effect of prescribed testosterone, in all forms and durations, from well-developed randomised controlled trials (RCTs), on CV events in men aged 18 years or more.

Methods:

Peer-reviewed journal articles published from 1980 to 2018 will be searched from databases (CINAHL, EMBASE, Medline, Scopus, Cochrane Controlled Register of Trials as well as the Clinical Trial Registry). RCTs or cluster RCTs with at least an intervention arm of testosterone and a control group of usual care or no testosterone treatment will be included in this review and meta-analysis. Studies with men with previous CV events or cardiac vascularisation (coronary bypass surgery or percutaneous coronary intervention) will be excluded. Data related to the primary outcomes, such as clinical events of any type of stroke or transient ischaemic attack, non-fatal myocardial infarction or acute coronary syndrome, emergency coronary artery revascularisation, carotid surgery, cardiac mortality and all-cause mortality, will be extracted for analysis. The criteria for the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) will be followed in the evaluation of evidence.

Results:

Search terms have been piloted and finalised. The study will be completed by end of 2019.

Conclusions:

The protocol will guide a systematic literature review of the evidence around prescribed testosterone and its effect on cardiovascular events in men aged 18 years or more. The findings will inform clinical management of hypogonadal men. Clinical Trial: PROSPERO registration number: CRD42019134278