Table 1. Summary of clinical trials reporting increased CV risk after TTh.
| Author | Year | Study population | Follow-up | Study design | Primary outcome | Treatment/duration | Level of evidence | Significant finding |
|---|---|---|---|---|---|---|---|---|
| Basaria et al [25] | 2010 | 106 TTh 103 Controls |
9 mo | Double-blind PC, RCT |
LE strength Physical function |
TTh vs. placebo Duration: 6 mo (plus 3 mo observation period) |
1b | - Trial terminated early secondary to increased CV events in TTh group |
| - HR, 2.4 (p=0.05) | ||||||||
| - TTh group: 23 reported CV events, only 4 MACE | ||||||||
| Vigen et al [12] | 2013 | 1,223 TTh 7,486 Control |
27.5 mo | Retrospective observational cohort | All-cause mortality, MI, stroke | TTh vs. no treatment Duration not defined |
3b | - TTh associated with increased risk of adverse outcomes (HR, 1.29; 95% CI, 1.04–1.58; p=0.02) |
| Finkle et al [13] | 2014 | 55,593 TTh 167,279 Control |
180 d | Retrospective observational cohort | Acute MI | TTh vs. PDE5is Duration not defined |
3b | - Increased RR, 1.36 (95% CI, 1.03–1.81) of MI post-testosterone prescription |
| - Men with age>65 y RR, 2.19 (95% CI, 1.27–3.77) vs. <65 y RR, 1.17 (95% CI, 0.84–1.63) |
CV: cardiovascular, TTh: testosterone therapy, PC: placebo-controlled, RCT: randomized control trial, LE: lower extremity, MI: myocardial infarction, PDE5is: phosphodiesterase type 5 inhibitors, HR: hazard ratio, MACE: major adverse cardiac event, CI: confidence interval, RR: relative risk.