Abstract
Testosterone replacement therapy (TRT) has become increasingly popular over the years and there has been an increasing debate on whether testosterone replacement should be offered to older men due to its association with cardiovascular events. In this study, we evaluated the risk of myocardial infarction (MI) associated with TRT in hypogonadal men through a meta-analysis. We carried out the analysis by following the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines and conducted a literature search utilizing the following databases: Google Scholar, PubMed, Science Direct, Cochrane Library trials, and ClinicalTrials.gov. The search strategy resulted in a total of 782 articles, after applying our inclusion and exclusion criteria. Six observational studies and two randomized controlled trials (RCTs) were included for the analysis. A total of 55,806 hypogonadal men with baseline testosterone levels <300ng/mL were included in the analysis. The intervention group received testosterone in various routes including transdermal patches, gels, mouth patches, testosterone injections, and deposits. The incidence of MI was taken to be the primary measure outcomes. The pooled data from eight studies showed MI incidence in 249 out of 11,720 (2.1%) in the TRT group and 1420 out of 33,086 (4.3%) in the control group. The pooled OD showed no statistically significant association of TRT and MI compared to the control group (OR = 0.76, 95% CI 0.36-1.31; p=0.48). The model revealed high heterogeneity with I2 =79%. With sensitivity analysis and, excluding two studies out of the eight, the pooled data was able to achieve low heterogeneity with I2 = 0%. The newly pooled data from six studies showed MI incidence in 226 out of 10,137 (2.2%) in the TRT group and 969 out of 36,304 (2.7%) in the control group. The pooled OD shows no statistical significance in the association between TRT treatment and MI compared to the control group. (OR =0.87, 95% CI 0.75-1.01; P =0.08). It appears that TRT does not increase the risk of MI as compared to the non-intervention group. Further RCTs with greater population size are needed that could produce more solid results, allowing more definitive conclusions to be made on this topic.
Highlights
IntroductionHypogonadism in men is a growing burden for the population around the world
BackgroundHypogonadism in men is a growing burden for the population around the world
The pooled OD shows no statistical significance in the association between Testosterone replacement therapy (TRT) treatment and myocardial infarction (MI) compared to the control group. (OR =0.87, 95% CI 0.75-1.01; P =0.08)
Summary
Hypogonadism in men is a growing burden for the population around the world. It is estimated that the overall prevalence rate of hypogonadism in men for the general population in the United States (US) is between 3.8-20.4%, Chile 28.1%, Germany 3.4-5%, Finland 19.8%, Malaysia 6-16.1%, Taiwan 12.0%, and Hong Kong 9.5% [1]. Testosterone is the primary sex hormone in males and it is produced mainly by the Leydig cells of the testes in men under the stimulation by luteinizing hormone. Primary hypogonadism is caused by disruption at the level of the testis whilst secondary form is due to disruption at the level of the hypothalamus and pituitary. A decline in testosterone level in older men is associated with impaired mobility, lower muscle strength, and a decrease in muscle mass [3,4]. In the US, approximately 31% of men experience sexual dysfunction [8]
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