Table 5.
Summary of frequently reported treatment-emergent adverse events in trials of dapoxetine for the treatment of premature ejaculation
| Reference | Design | Treatment and dose | Treatment-emergent adverse events (% patients) | ||||||
|---|---|---|---|---|---|---|---|---|---|
|
| |||||||||
| Nausea | Diarrhea | Headache | Dizziness | Somnolence | Vomiting | ||||
| Pryor et al46,^ | Integrated analysis of two studies | DPX 30 mg or 60 mg, or PBO | DPX 30 | 8.7 | 3.9 | 5.9 | 3.0 | 3.2 | – |
| DPX 60 | 20.1 | 6.8 | 6.8 | 6.2 | 3.7 | ||||
| PBO | 1.9 | 1.4 | 4.0 | 0.8 | 0.2 | ||||
| McMahon et al44,* | Double-blind RCT, 12 weeks, n = 1067 | DPX 30 mg or 60 mg, or PBO | DPX 30 | 10.5 | 2.0 | 3.4 | 10.5 | 3.4 | 0.3 |
| DPX 60 | 26.4 | 1.7 | 4.8 | 18.8 | 6.2 | 2.5 | |||
| PBO | 2.0 | 0.8 | 2.0 | 3.9 | 0.6 | 0 | |||
| Buvat et al48 | Double-blind RCT, 24 weeks n = 1162 | DPX 30 mg or 60 mg, or PBO | DPX 30 | 16.5 | 3.9 | 6.4 | 7.7 | 3.9 | 1.3 |
| DPX 60 | 30.6 | 11.3 | 13.6 | 13.4 | 7.2 | 3.1 | |||
| PBO | 2.9 | 1.6 | 8.3 | 2.6 | 1.0 | 0.5 | |||
| Kaufman et al52,~ | Double-blind RCT, 9 weeks, n = 1238 | DPX 60 mg or PBO | DPX 60 | 15.3 | 6.1 | 8.1 | 10.2 | 3.7 | – |
| PBO | 1.6 | 2.0 | 6.1 | 2.9 | 0.8 | ||||
| Safarinejad43 | Double-blind RCT, 12 weeks, n = 212 | DPX 60 mg (30 mg twice daily), or PBO | DPX 60 | 5.4 | 5.4 | 4.3 | 3.2 | – | – |
| PBO | 1.0 | 0 | 1.0 | 0 | |||||
^
Notes: Treatment-emergent adverse events more frequent with dapoxetine than with placebo;
*
occurring in ≥1% of subjects;
~
occurring in ≥2% of subjects.
Abbreviations: RCT, randomized, placebo-controlled trial; PBO, placebo; DPX, dapoxetine.