Estudio aleatorizado, abierto con comparación cruzada de autoconfianza sexual y otros resultados clínicos terapéuticos tras la administración de tadalafil una vez al día vs. tadalafil o sildenafil a demanda, en hombres mexicanos con disfunción eréctil

Abstract

BackgroundErectile dysfunction is an entity that has a high prevalence worldwide. AimsTo 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. Materials and methodsThe 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. ResultsOf 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. ConclusionsMexican 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.