Table 3.
Summary of evidence for end-of-study changes in patient-reported outcomes following treatment of premature ejaculation with dapoxetine
| Level of evidence | Design | Treatment and dose | Patient-reported outcome | Reference | ||||
|---|---|---|---|---|---|---|---|---|
|
| ||||||||
| Control over ejaculation | Satisfaction with intercourse | Personal distress related to ejaculation | Interpersonal difficulty related to ejaculation | CGI of change in PE | ||||
| 1 | Integrated analysis of five studies | DPX 30 mg or 60 mg, or PBO | Improvement over placebo for both doses of DPX (both P < 0.001) | Improvement over placebo for both doses of DPX (both P < 0.001) | Improvement over placebo for both doses of DPX (both P < 0.001) | Improvement over placebo for both doses of DPX (both P < 0.001) | Improvement over placebo for both doses of DPX (both P < 0.001) | McMahon et al45 |
| 1 | Integrated analysis of two studies | DPX 30 mg or 60 mg, or PBO | Improvement over placebo for both doses of DPX (both P < 0.0001) | Improvement over placebo for both doses of DPX (both P < 0.0001) | NR | NR | Improvement over placebo for both doses of DPX (both P < 0.0001) | Pryor et al46 |
| 1 | Integrated analysis of two studies# | DPX 30 mg or 60 mg, or PBO | Improvement over placebo for both doses of DPX (both P < 0.01). Similar results for acquired/lifelong PE |
Improvement over placebo for both doses of DPX (both P < 0.05). Similar results for acquired/lifelong PE |
Improvement over placebo for both doses of DPX (both P < 0.001). Similar results for acquired/lifelong PE |
Improvement over placebo for both doses of DPX (both P < 0.05). Similar results for acquired/lifelong PE |
NR | Porst et al47 |
| 2 | Double-blind RCT, 12 weeks, n = 1067 | DPX 30 mg or 60 mg, or PBO | % patients rating control “good” or “very good”: DPX 30: 33.5% DPX 60: 33.5% PBO: 18.7% (both P < 0.001 vs PBO) |
% patients with ≥ one category increase: DPX 30: 69.3% DPX 60: 75.9% PBO: 57.8% (both P < 0.01 vs PBO) |
% patients with ≥ one category increase: DPX 30: 66.6% DPX 60: 72.7% PBO: 56.0% (both P < 0.01 vs PBO) |
% patients rating difficulty level as “quite a bit” or “extremely”: DPX 30: 17.9% DPX 60: 13.4% PBO: 27.3% (both P ≤ 0.005 vs PBO) |
% patients rating CGI “better” or “much better”: DPX 30: 37.4% DPX 60: 41.5% PBO: 22.0% (both P < 0.001 vs PBO) |
McMahon et al44 |
| 2 | Double-blind RCT, 24 weeks, n = 1162 | DPX 30 mg or 60 mg, or PBO | Improvement over placebo for both doses of DPX (both P < 0.001) | % patients with ≥ one category increase: DPX 30: 48.5% DPX 60: 55.8% PBO: 35.7% (both P < 0.001 vs PBO) |
% patients with ≥ one category increase: DPX 30: 60.0% DPX 60: 68.6% PBO: 47.8% (both P < 0.001 vs PBO) |
Improvement over placebo for both doses of DPX (both P < 0.001) | % patients rating CGI “better” or “much better”: DPX 30: 30.6% DPX 60: 39.2% PBO: 15.6% (both P < 0.001 vs PBO) |
Buvat et al48 |
| 2 | Double-blind RCT, 9 weeks n = 1238 | DPX 60 mg or PBO | Baseline to end of study scores: DPX: 0.6–2.1 PBO: 0.6–1.6 (P < 0.001 vs PBO) |
Baseline to end of study scores: DPX: 1.4–2.5 PBO: 1.5–2.0 (P < 0.001 vs PBO) |
Baseline to end of study scores: DPX: 2.8–1.5 PBO: 2.8–2.0 (P < 0.001 vs PBO) |
Baseline to end of study scores: DPX: 1.7–0.8 PBO: 1.8–1.1 (P < 0.001 vs PBO) |
% patients rating CGI “better” or “much better”: DPX: 41.3% PBO: 20.8% (P < 0.001 vs PBO) |
Kaufman et al52 |
| 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) | Across all treatment groups 32% achieved ≥ two category increase in control | 74% of patients with ≥ two-category increase in control rated satisfaction “good” or “ very good” | NR | NR | 67.1% of patients with ≥ two-category increase in control rated CGI “better” or “much better” | Shabsigh et al49 |
| 3 | Open-label extension study (9 months, n = 1774) of integrated analysis by Pryor et al46 | DPX 60 mg | Approximately 70% rated control “fair”, “good”; or “very good”, regardless of prior treatment group | Over 80% rated satisfaction as “fair”, “good”, or “very good”, regardless of prior treatment group | NR | NR | NR | Steidle et al54 |
#
Note: Only data for patients without erectile dysfunction are shown for consistency with other studies.
Abbreviations: CGI, Clinical Global Impression; NR, not reported; RCT, randomized, placebo-controlled trial; PBO, placebo; DPX, dapoxetine.