title: 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.
abstract: 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.
authors.affiliation: Division of Urology, Urology Residency Training Program, Cooper Medical School of Rowan University, Cooper University Hospital, Camden, NJ 08103, USA. allendseftel@gmail.com
authors.forename: A D
authors.initials: AD
authors.lastname: Seftel
authors.forename: R
authors.initials: R
authors.lastname: Shinghal
authors.forename: E D
authors.initials: ED
authors.lastname: Kim
authors.forename: S M
authors.initials: SM
authors.lastname: Samuels
authors.forename: X
authors.initials: X
authors.lastname: Ni
authors.forename: P R
authors.initials: PR
authors.lastname: Burns
mesh_terms: D000367:Age Factors; D000368:Aged; D002243:Carbolines / Q000008:administration & dosage* / Q000009:adverse effects; D003075:Coitus; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage*; D010919:Placebos; D012189:Retrospective Studies; D000068581:Tadalafil; D016896:Treatment Outcome
chemical_list: D002243:Carbolines; D010726:Phosphodiesterase Inhibitors; D010919:Placebos; D000068581:Tadalafil