Table 3.
The results of safety outcomes of flibanserin vs placebo in the meta-analysis.
| Safety variables | Flibanserin 100 mg vs Placebo | Flibanserin 50 mg vs Placebo | ||||||
|---|---|---|---|---|---|---|---|---|
| No. of RCTs (participants) | Pooled effect size, RR [95% CI] | I2 (%) | P | No. of RCTs (Participants) | Pooled effect size, RR [95% CI] | I 2 (%) | P | |
| AEs – All | 8 (5809) | 1.37 [1.14, 1.65] | 93 | .009 | 4 (2725) | 1.18 [1.03, 1.36] | 72 | .02 |
| Drug-related AEs | 2 (2034) | 2.33 [1.96, 2.76] | 0 | <.00001 | – | – | – | – |
| Serious AEs | 7 (5476) | 1.23 [0.77, 1.95] | 0 | .38 | 4 (2725) | 1.46 [0.89, 2.41] | 0 | .14 |
| Severe AEs | 4 (3112) | 1.36 [0.87, 2.12] | 34 | .18 | – | – | – | – |
| AEs leading to study discontinuation | 5 (3697) | 2.08 [1.39, 3.10] | 50 | .0003 | – | – | – | – |
| Dizziness | 8 (5809) | 3.95 [2.40, 6.51] | 70 | <.00001 | 4 (2725) | 2.39 [1.61, 3.55] | 0 | <.0001 |
| Headache | 7 (4722) | 1.12 [0.92, 1.36] | 0 | .25 | 4 (2725) | 0.97 [0.76, 1.23] | 0 | .79 |
| Fatigue | 6 (4117) | 1.91 [1.30, 2.81] | 53 | .01 | 4 (2725) | 1.08 [0.80, 1.46] | 0 | .61 |
| Nausea | 8 (5809) | 2.37 [1.69, 3.33] | 54 | <.00001 | 4 (2725) | 1.50 [1.05, 2.16] | 18 | .03 |
| Somnolence | 7 (5476) | 4.04 [3.15, 5.18] | 0 | <.00001 | 4 (2725) | 2.08 [1.30, 3.35] | 34 | .002 |
| Insomnia | 3 (1663) | 1.69 [1.09, 2.62] | 0 | .02 | – | – | – | – |
AE = adverse event, CI = confidence interval, RCT = randomized controlled trials, RR = risk ratio.