A randomized, open-label, crossover trial evaluating sexual self- confidence and other therapeutic clinical results following the once-a-day administration of tadalafil vs. on-demand tadalafil or sildenafil in Mexican men with erectile dysfunction

Background: Erectile dysfunction is an entity that has a high prevalence worldwide. Aims: To compare the psychosocial clinical results of the analysis of a subgroup of Mexican men with erectile dysfunction that received tadalafil once a day (OaD), tadalafil on demand (PRN), or sildenafil PRN. Methods: The present study was a post hoc analysis of a subgroup of Mexican men taken from an open, randomized, cross-sectional study of men presenting with erectile dysfunction that were previously treated with phosphodiesterase type 5 (PDE5) inhibitors PRN. Results: Of the 378 patients included in the study, 84 were Mexican subjects. The change from the baseline to the endpoint was significantly greater in the Psychological and Interpersonal Relationship Scales (PAIRS) score of the Sexual Self-Confidence domain with tadalafil OaD vs. sildenafil PRN and also with tadalafil PRN vs. sildenafil PRN (differences of 0.25 ± 0.08 [0.10, 0.40]; p=0.001 and 0.28 ± 0.08; [0.13, 0.43]; p<0.001, respectively). No significant difference was observed with tadalafil OaD vs. tadalafil PRN (-0.03 ± 0.08 [-0.19, 0.12]; p=0.652). The changes in the PAIRS scores for the domains of Spontaneity and Time Concerns were significantly higher with tadalafil OaD vs. sildenafil PRN and with tadalafil PRN vs. sildenafil PRN. Three serious adverse events (SAEs) were reported. Conclusions: Mexican men with ED showed a superior improvement in sexual self-confidence, spontaneity, and reduced time concerns related to sexual activity when treated with tadalafil OaD and tadalafil PRN, as opposed to sildenafil PRN.