Retrospective analysis of the efficacy and safety of once-daily tadalafil in patient subgroups: men with mild vs moderate ED and aged <50 vs ⩾50 years

• Published in: International journal of impotence research Vol. 25; no. 3; pp. 91 - 98
• Main Authors: Seftel, A D, Shinghal, R, Kim, E D, Samuels, S M, Ni, X, Burns, P R
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 01.05.2013; Nature Publishing Group
• Subjects: 692/308/409; 692/699/2768/1575; 692/700/565/1436; Age Factors; Aged; Analysis; Carbolines - administration & dosage; Carbolines - adverse effects; Coitus; Double-Blind Method; Erectile dysfunction; Erectile Dysfunction - drug therapy; Erectile Dysfunction - physiopathology; Humans; Male; Medicine; Medicine & Public Health; Middle Aged; original-article; Pharmaceutical industry; Phosphodiesterase Inhibitors - administration & dosage; Placebos; Reproductive Medicine; Retrospective Studies; rology; Tadalafil; Treatment Outcome; Urology; United States; severity; tadalafil; treatment outcome; age; efficacy; ED
• ISSN: 0955-9930; 1476-5489
• DOI: 10.1038/ijir.2012.40

The aim of this post-hoc pooled-data analysis was to evaluate the effects of once-daily tadalafil in men with mild or moderate ED and aged <50 or ⩾50 years. Data from three randomized controlled trials were analyzed. Analysis of covariance models included a term for ED severity and age group. The three coprimary outcome measures in the base studies were changes from baseline to end point in the mean International Index of Erectile Function Erectile Function (IIEF-EF) domain score and the mean per-patient percentage successful vaginal penetration and intercourse attempts. Irrespective of baseline severity, once-daily tadalafil 5 mg for 12 weeks compared with placebo significantly increased the mean: (1) IIEF-EF by 6.8; (2) percent successful penetration attempts from 70.1 to 91.3%; and (3) percent successful intercourse attempts from 33.4 to 76.8% (each P <0.001). Treatment-by-age-group interaction P -values for all three coprimary efficacy end points exceeded 0.10, indicating that tadalafil treatment effects did not differ by age <50 vs ⩾50 years. Tadalafil was generally well tolerated.