Table 2.
Summary of evidence for end-of-study changes in intravaginal ejaculation latency time following treatment of premature ejaculation with dapoxetine
| Level of evidence | Design | Treatment and dose | Intravaginal ejaculatory latency time (minutes) | P value (vs placebo) | Reference | |||
|---|---|---|---|---|---|---|---|---|
|
|
||||||||
| Baseline | Geometric mean (SE) | Arithmetic mean (SD) | ||||||
| 1 | Integrated analysis of five studies | DPX 30 mg or 60 mg, or PBO | DPX 30 | 0.8 (1.02) | 2.0 (1.03) | <0.001 | McMahon et al45 | |
| DPX 60 | 0.8 (1.02) | 2.3 (1.03) | <0.001 | |||||
| PBO | 0.8 (1.02) | 1.3 (1.02) | – | |||||
| DPX 30 | 0.9 (0.49) | 3.1 (3.91) | <0.001 | |||||
| DPX 60 | 0.9 (0.49) | 3.6 (3.85) | <0.001 | |||||
| PBO | 0.9 (0.48) | 1.9 (2.43) | – | |||||
| 1 | Integrated analysis of two studies | DPX 30 mg or 60 mg, or PBO | DPX 30 | 0.92 (0.50) | 2.78 (3.48) | <0.0001 | Pryor et al46 | |
| DPX 60 | 0.91 (0.48) | 3.32 (3.68)† | <0.0001 | |||||
| PBO | 0.90 (0.47) | 1.75 (2.21) | – | |||||
| 1 | Integrated analysis of two studies# | DPX 30 mg or 60 mg, or PBO | Acquired PE | Porst et al47 | ||||
| Geometric | 0.9 (1.03) | <0.001 | ||||||
| Arithmetic | 1.08 (0.48) | 2.5; 2.9; 1.7 | 4.0; 4.1; 2.5 | <0.001 | ||||
| Lifelong PE | ||||||||
| Geometric | 0.8 (1.02) | 2.2; 2.4; 1.2 | 3.3; 3.6; 1.9 | <0.001 | ||||
| Arithmetic | 0.92 (0.48) | <0.001 | ||||||
| 2 | Double-blind RCT, 12 week n = 1067 | DPX 30 mg or 60 mg, or PBO | DPX 30 | 1.0 (1.03) | 2.7 (1.05) | <0.0001 | McMahon et al44 | |
| DPX 60 | 0.9 (1.04) | 3.1 (1.05) | <0.0001 | |||||
| PBO | 0.90 (1.04) | 1.8 (1.05) | 3.9 (3.94) | – | ||||
| DPX 30 | 1.1 (0.45) | 4.2 (3.97) | <0.001 | |||||
| DPX 60 | 1.1 (0.48) | 2.4 (2.05) | <0.001 | |||||
| PBO | 1.0 (0.47) | – | ||||||
| 2 | Double-blind RCT, 24 weeks, n = 1162 | DPX 30 mg or 60 mg, or PBO | DPX 30 | 0.7 (1.04) | 1.8 (1.06) | <0.001 | Buvat et al48 | |
| DPX 60 | 0.7 (1.04) | 2.3 (1.06) | <0.001 | |||||
| PBO | 0.7 (1.04) | 1.1 (1.06) | 3.1 (4.88) | – | ||||
| DPX 30 | 0.9 (0.50) | 3.5 (3.80) | <0.001 | |||||
| DPX 60 | 0.9 (0.50) | 1.9 (2.89) | <0.001 | |||||
| PBO | 0.9 (0.50) | – | ||||||
| 2 | Double-blind RCT, 12 weeks, n = 212 | DPX 60 mg (30 mg twice-daily), or PBO | DPX 60 | 0.47 | 3.22 | 0.001a | Safarinejad43 | |
| PBO | 0.52 | 0.9 | 0.08a | |||||
| 2 | Subanalysis of integrated analysis by Pryor et al46 | DPX 30 mg or 60 mg, or PBO (Authors combined the data for DPX 30 and 60 mg) | DPX | Shabsigh et al49 | ||||
| Patients with at least a 2-category increase in control | 0.9 (0.47) | 4.7 (4.41) | Not reported | |||||
| Patients with less than a 2-category increase in control | 0.9 (0.47) | 1.7 (1.90) | Not reported | |||||
#
Notes: Only data for patients without erectile dysfunction are shown for consistency with other studies;
†
P < 0.0001 vs 30 mg dapoxetine;
a
P value is based on fold-increase from baseline, not difference from placebo as stated for the other studies.
Abbreviations: RCT, randomized controlled trial; SE, standard error; SD, standard deviation; PBO, placebo; DPX, dapoxetine; PE, premature ejaculation.