Table 3.
Meta-analysis for the safety outcomes (dichotomous data)
| Outcome | Levomilnacipran (n/N) |
Placebo (n/N) |
Effect estimate (95% CI) |
I2 (%) | P-value |
|---|---|---|---|---|---|
| Discontinuation due to all reasonsa | 405/1,583 | 324/1,040 | 1.24 (1.09, 1.42) | 42 | 0.008 |
| Discontinuation due to AE | 139/1,583 | 44/1,040 | 3.15 (2.26, 4.39) | 41 | <0.00001 |
| Erectile dysfunctionb | 29/406 | 9/204 | 3.26 (1.56, 6.81) | 0 | 0.002 |
| Ejaculation delayedb | 16/351 | 0/208 | 10.96 (2.09, 57.56) | 0 | 0.005 |
| Tachycardia | 74/1,408 | 15/858 | 3.12 (1.50, 6.47) | 43 | 0.002 |
| Nausea | 272/1,583 | 60/1,040 | 3.80 (2.47, 5.83) | 62 | <0.00001 |
| Headache | 262/1,583 | 136/1,040 | 1.40 (1.18, 1.66) | 0 | 0.0001 |
| Dry mouth | 160/1,583 | 73/1,040 | 1.40 (1.11, 1.76) | 25 | 0.004 |
| Insomnia | 67/1,207 | 41/854 | 1.22 (0.86, 1.73) | 0 | 0.26 |
| Heart rate increase | 98/1,088 | 13/544 | 0.06 (0.04, 0.09) | 33 | <0.00001 |
| Suicidal ideation | 316/1,573 | 172/1,037 | 1.03 (0.89, 1.19) | 9 | 0.72 |
| Suicidal behavior | 5/573 | 1/390 | 2.17 (0.49, 9.62) | 0 | 0.31 |
Notes:
a
Discontinuation due to AEs, insufficient therapeutic response, protocol violation, loss to follow-up and other reasons.
b
Based on the number of men in the safety population. Bold numbers are considered statistically significant.
Abbreviations: CI, confidence interval; AE, adverse event.