PMID- 33118952 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20201120 IS - 1929-0748 (Print) IS - 1929-0748 (Electronic) IS - 1929-0748 (Linking) VI - 9 IP - 10 DP - 2020 Oct 29 TI - Effect of Testosterone Treatment on Cardiovascular Events in Men: Protocol for a Systematic Literature Review and Meta-Analysis. PG - e15163 LID - 10.2196/15163 [doi] LID - e15163 AB - BACKGROUND: Testosterone prescriptions have increased dramatically in recent decades, with increasing usage in men. Despite epidemiological associations reported high circulating concentrations of endogenous androgens and low risk of cardiovascular events and mortality, the effects of exogenous androgens in the form of testosterone therapy for maintaining physiological circulating androgen concentrations on the cardiovascular system remain uncertain with no published meta-analysis on this topic. OBJECTIVE: The aim of this study was to investigate the effects of prescribed testosterone treatment, in all forms and durations, from well-developed randomized controlled trials, on cardiovascular events in men aged 18 years or older. METHODS: Peer-reviewed journal articles published from 1980 to 2019 will be searched from databases (ie CINAHL [Cumulated Index to Nursing and Allied Health Literature], Embase, Medline, Scopus, Cochrane Controlled Register of Trials as well as the Clinical Trial Registry). Randomized controlled trials or cluster randomized controlled trials with at least one 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 on men with previous cardiovascular events or cardiac vascularization (coronary bypass surgery or percutaneous coronary intervention) will be excluded. Data related to primary outcomes such as clinical events of any type of stroke or transient ischemic attack, nonfatal myocardial infarction or acute coronary syndrome, emergency coronary artery revascularization, carotid surgery, cardiac mortality, and all-cause mortality will be extracted for analysis. The criteria for PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) will be followed in the evaluation of evidence. RESULTS: Search terms have been piloted and finalized. This study will be completed by the end of 2020. CONCLUSIONS: This 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 older. The findings will inform clinical management of hypogonadal men. TRIAL REGISTRATION: PROSPERO International Prospective Register of Systematic Reviews CRD42019134278; https://tinyurl.com/y6t7ggge. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/15163. CI - (c)HuiJun Chih, Christopher M Reid, Bu B Yeap, Girish Dwivedi. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 29.10.2020. FAU - Chih, HuiJun AU - Chih H AUID- ORCID: 0000-0001-9294-0996 AD - School of Public Health, Curtin University, Perth, Australia. FAU - Reid, Christopher M AU - Reid CM AUID- ORCID: 0000-0001-9173-3944 AD - School of Public Health, Curtin University, Perth, Australia. AD - School of Public Health & Preventative Medicine, Monash University, Melbourne, Australia. FAU - Yeap, Bu B AU - Yeap BB AUID- ORCID: 0000-0002-7612-5892 AD - Medical School, University of Western Australia, Perth, Australia. AD - Department of Endocrinology and Diabetes, Fiona Stanley Hospital, Perth, Australia. FAU - Dwivedi, Girish AU - Dwivedi G AUID- ORCID: 0000-0003-0717-740X AD - Medical School, University of Western Australia, Perth, Australia. AD - Harry Perkins Institute of Medical Research, University of Western Australia, Perth, Australia. AD - Department of Cardiology, Fiona Stanley Hospital, Perth, Australia. LA - eng PT - Journal Article DEP - 20201029 PL - Canada TA - JMIR Res Protoc JT - JMIR research protocols JID - 101599504 PMC - PMC7661242 OTO - NOTNLM OT - cardiac mortality OT - carotid surgery OT - emergency revascularization OT - exogenous testosterone OT - nonfatal myocardial infarction OT - stroke COIS- Conflicts of Interest: None declared. EDAT- 2020/10/30 06:00 MHDA- 2020/10/30 06:01 PMCR- 2020/10/29 CRDT- 2020/10/29 12:11 PHST- 2019/06/24 00:00 [received] PHST- 2020/02/28 00:00 [accepted] PHST- 2020/02/27 00:00 [revised] PHST- 2020/10/29 12:11 [entrez] PHST- 2020/10/30 06:00 [pubmed] PHST- 2020/10/30 06:01 [medline] PHST- 2020/10/29 00:00 [pmc-release] AID - v9i10e15163 [pii] AID - 10.2196/15163 [doi] PST - epublish SO - JMIR Res Protoc. 2020 Oct 29;9(10):e15163. doi: 10.2196/15163.