Researchers from Mexico, the US, and Europe collaborated to compare Sexual Self-Confidence and other treatment outcomes following 8 weeks of treatment with tadalafil 5 mg daily versus tadalafil 20mg or sildenafil 100mg as needed in men with erectile dysfunction (ED). This study was a randomized, open-label, crossover study in men >= 18 years of age with history of ED and satisfactory response to phosphodiesterase type 5 inhibitors (PDE5Is). The primary objective was to test the hypothesis that tadalafil daily would provide superior psychosocial outcomes to sildenafil as needed in men with ED who had reported a previous satisfactory response to on demand PDE5I therapy. Secondary objectives included comparison of daily tadalafil, on demand tadalafil, and on demand sildenafil comparing other outcomes to Sexual Self-Confidence, Time Concerns, and Spontaneity scales (PAIRS domains).
A total of 378 men naïve to daily tadalafil treatment were randomized to the various treatment arms. A significant improvement was noticed in all PAIRS domains from baseline when comparing daily tadalafil and on demand tadalafil and sildenafil. There was no observable difference in Sexual Self-Confidence between daily versus on demand tadalafil. Changes in SEAR (Self-Esteem and Relationship), the erectile function domain of the International Index of Erectile Function, and Erectile Dysfunction Inventory of Treatment Satisfaction scores from baseline to post-treatment endpoint were statistically similar. One advantage of the crossover design methodology was that each individual patient could serve as their own pre- and post-treatment control with respect to treatment effect. Open-label design may have introduced some degree of bias in treatment outcomes, given the highly subjective treatment outcome measures. Nonetheless, this study is the first comparative trial between daily tadalafil therapy and on demand PDE5Is, and most notably, there was no statistically significant difference in Sexual Self-Confidence improvement between daily and on demand tadalafil.
Reference: Rubio-Aurioles E, Porst H, Kim ED, et al. A randomized open-label trial with a crossover comparison of sexual self-confidence and other treatment outcomes following tadalafil once a day vs. tadalafil or sildenafil on-demand in men with erectile dysfunction. J Sex Med 2012;9:1418-1429.