Head-to-head Comparison of the Safety and Efficacy Profiles of Three Phosphodiesterase Type 5 Inhibitors through Patient-reported Outcomes of 130 000 Patients from a Direct-to-consumer Platform Database
Abstract
BACKGROUND AND OBJECTIVE
Direct-to-consumer (DTC) telemedical platforms facilitate the discreet management of sensitive medical conditions, including erectile dysfunction. We aimed to use a large dataset to generate a head-to-head comparison on the efficacy, onset of action, and adverse events (AEs) of phosphodiesterase type 5 inhibitors (PDE5is).
METHODS
Data for this retrospective cohort study were obtained from a data pool of 132 100 patients treated with sildenafil, tadalafil, or vardenafil. Efficacy, onset of action, and AEs collected by digital questionnaires were used as the primary endpoints. Group comparisons between intermediate/high and low doses of the respective PDE5is were performed for AEs (sildenafil, tadalafil, and vardenafil) and efficacy as well as onset of action (sildenafil vs tadalafil).
KEY FINDINGS AND LIMITATIONS
Medium (50 mg) and high (100 mg) doses of sildenafil improved patient satisfaction (mean change in score ± standard deviation [SD] 2.534 ± 1.3 vs 2.235 ± 1.4, p < 0.0001) and sexual performance (mean change in score ± SD for hardness: 2.245 ± 1.2 vs 2.105 ± 1.3, p < 0.0001, and for maintenance: 2.264 ± 1.2 vs 2.120 ± 1.3, p < 0.0001), compared with similar doses of tadalafil (10 and 20 mg). Sildenafil (35.0%, 3572/10 201) and tadalafil (33.9%, 2225/6564) revealed similar AE rates (d = 0.011, 95% confidence interval [CI]: -0.0037 to 0.0257, p = 0.1424), but vardenafil revealed higher rates (47.4%, 268/565) than sildenafil (d = -0.124, 95% CI:…
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: 132 participants or records.
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