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Meta-Analyses of Cardiovascular Adverse Events in Randomized Controlled Trials (RCTs) of T Supplementation in Men
| Study characteristics | Results | ||||
|---|---|---|---|---|---|
| Study author and year | N of RCTs | N active | N placebo | Adverse signal | No adverse signal |
| Haddad RM, 2007 (185) | 30 | 808 | 834 | No significant difference in odds ratio for any cardiovascular adverse event or MI. | |
| Fernandez-Balsells MM, 2010 (147) | 51 | 2,716 | No significant difference for all-cause mortality, coronary bypass surgery or MI. | ||
| Xu L, 2013 (186) | 27 | 2,994 | T associated with increased risk cardiovascular-related event (OR 1.54, 95% CI=1.09-2.18)*. | ||
| Ruige JB, 2013 (187) | 10 (>100 participants) | 1,289 | 848 | No significant difference in cardiovascular adverse events. | |
| Corona G, 2014 (188) | 75 | 3,016 | 2,448 | No association of T supplementation with cardiovascular risk. For MACE OR=1.01 (95% CI 0.57-1.77). | |
| Borst SE, 2015 (189) | 35 | 3,703 | No significant risk for cardiovascular-related adverse events. | ||
| Alexander GC, 2017 (190) | 39, cut-off for T 10.4-16.7 nmol/L | 3,230 | 2,221 | No significant increase in risk of MI OR=0.87 (95% CI 0.39-1.93)*, stroke or mortality. | |
| Elliott J, 2017 (191) | 87, cut-off for T 12 nmol/L or cFT 225 pmol/L | 1,462-2088 | 1,372-1,851 | Improved QoL, libido, depression and erectile function. No increase in risk of adverse events. | |
| Corona G, 2018 (192) | 93 | 4,653 | 3,826 | No clear effect of T on incidence of CVD events. For MACE OR=0.97 (95% CI 0.64-1.46). | |
| Diem SJ, 2020 (193) | 38 | N/A | N/A | Small improvement in sexual function and quality of life. Pooled risk for adverse cardiovascular outcomes did not differ between groups (OR=1.22, 95% CI 0.66-2.23).* | |
| Hudson J, 2022 (194) | 35 RCTs: 17 included in IPD meta-analysis | 1,750 (IPD) | 1,681 (IPD) | No significant difference between groups. For cardiovascular or cerebrovascular events OR=1·07 (95% CI 0·81–1·42). | |
MI=myocardial infarction, MACE=major adverse cardiovascular events, OR=odds ratio, 95% CI=confidence interval. QoL=quality of life, IPD=individual participant data. Unless otherwise specified, meta-analyses were conducted using random effects models. *fixed effects model.
From: Androgens and Cardiovascular Disease in Men
This electronic version has been made freely available under a Creative Commons (CC-BY-NC-ND) license. A copy of the license can be viewed at http://creativecommons.org/licenses/by-nc-nd/2.0/.
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