Table 1.
Pooled odds ratios for adverse events in randomized, clinical trials of testosterone in older men.
| Event | Adverse event rate for testosterone |
Adverse event rate for placebo |
Pooled odds ratio (95% CI) |
|---|---|---|---|
| Prostate biopsies | 38.7 | 2.8 | 1.87 (0.84–4.15) |
| Prostate cancers | 9.2 | 8.3 | 1.09 (0.48–2.49) |
| PSA >4 ng/ml or 1.5 ng/ml increase during study |
57.1 | 41.6 | 1.19 (0.67–2.09) |
| Increase in IPSS score | 5.5 | 2.8 | 1.08 (0.46–2.52) |
| Acute urinary retention | 2.2 | 0 | 0.99 (0.40–2.44) |
| All prostate events | 112.4 | 55.7 | 1.78 (1.07–2.95)a |
| Hematocrit >50% | 64.5 | 2.8 | 3.69 (1.82–7.51)a |
| Atrial fibrillation or arrhythmia | 9.2 | 2.8 | 1.22 (0.53–2.81) |
| Myocardial infarction | 7.4 | 8.3 | 0.99 (0.44–2.26) |
| Chest pain or ischemia | 7.4 | 8.3 | 0.93 (0.39–2.26) |
| Coronary procedure or CABG | 3.7 | 13.9 | 0.79 (0.35–1.79) |
| Vascular events or cerebrovascular accidents |
5.5 | 11.1 | 0.86 (0.38–1.95) |
| All cardiovascular events | 33.2 | 44.3 | 1.14 (0.59–2.20) |
| Death | 0 | 5.5 | 0.78 (0.32–1.93) |
The adverse event rate (shown per 1,000 patient-years) was calculated on the basis of an average study duration of ten months, standardized to one year and multiplied by 1,000 for testosterone-treated or placebo-treated men. Adapted from Calof et al.69 Copyright © The Gerontological Society of America. Reproduced by permission of the publisher.
a
Here, the incidence of adverse events was significantly higher in the testosterone group.
CABG, coronary artery bypass graft; IPSS, international prostate symptom score; PSA, prostate-specific antigen.