Table 4.

Meta-Analyses of Cardiovascular Adverse Events in Randomized Controlled Trials (RCTs) of T Supplementation in Men

Study characteristicsResults
Study author and yearN of RCTsN
active
N placeboAdverse signalNo adverse signal
Haddad RM, 2007 (185)30808834No significant difference in odds ratio for any cardiovascular adverse event or MI.
Fernandez-Balsells MM, 2010 (147)512,716No significant difference for all-cause mortality, coronary bypass surgery or MI.
Xu L, 2013 (186)272,994T associated with increased risk cardiovascular-related event (OR 1.54, 95% CI=1.09-2.18)*.
Ruige JB, 2013 (187)10 (>100 participants)1,289848No significant difference in cardiovascular adverse events.
Corona G, 2014 (188)753,0162,448No association of T supplementation with cardiovascular risk. For MACE OR=1.01 (95% CI 0.57-1.77).
Borst SE, 2015 (189)353,703No significant risk for cardiovascular-related adverse events.
Alexander GC, 2017 (190)39, cut-off for T 10.4-16.7 nmol/L3,2302,221No 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/L1,462-20881,372-1,851Improved QoL, libido, depression and erectile function. No increase in risk of adverse events.
Corona G, 2018 (192)934,6533,826No clear effect of T on incidence of CVD events. For MACE OR=0.97 (95% CI 0.64-1.46).
Diem SJ, 2020 (193)38N/AN/ASmall 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-analysis1,750 (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

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