The Inaugural Pre-Treatment Nomogram to Assess the Eight-Week Efficacy of Dapoxetine: A Prospective Multi-Center Study
Abstract
Background: Although a nomogram for predicting the efficacy of dapoxetine (DapE-Nomo) has already been developed, its reliability is limited due to only 4 weeks of follow-up and a lack of external validation. Several patients with premature ejaculation (PE) achieve satisfactory therapeutic effects after longer periods of treatment clinically, we therefore aimed to develop and validate an 8-week DapE-Nomo.
Methods: The training cohort included 243 patients with lifelong PE from Xijing Hospital and Northwest Women's and Children's Hospital (Jan 2019-Jul 2020), while the validation cohort comprised 397 patients from Xijing Hospital and Xi'an Daxing Hospital (Aug 2020-Jan 2022). Efficacy was measured using the Clinical Global Impression of Change (CGIC) scale, with a CGIC score ≥ 1 indicating an improvement (iCGI). LASSO regression was utilized to identify the most valuable predictors (MVPs) of iCGI. The DapE-Nomo was developed utilizing logistic regression coefficients of MVPs and validated across both cohorts.
Results: After 8 weeks of medication, 47.7% of patients in the training cohort and 47.6% in the validation cohort achieved iCGI. MVPs of iCGI included intravaginal ejaculation latency time, difficulty delaying ejaculation, and education level. The DapE-Nomo showed discriminatory abilities of 0.722 and 0.709 in internal and external validations, respectively, with satisfactory calibration and clinical utility in both. The optimal cutoff value of the DapE-Nomo was…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 397 participants or records.
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