title: Efficacy and safety of once-daily tadalafil in men with erectile dysfunction who reported no successful intercourse attempts at baseline.
abstract: BACKGROUND
  Tadalafil is efficacious and well tolerated for erectile dysfunction (ED), but effects in men with "complete ED" are unclear.
  
  
  OBJECTIVE
  To investigate effects of once-daily tadalafil in men with no successful intercourse attempts at baseline.
  
  
  METHODS
  Through a post hoc, pooled-data analysis of four randomized, double-blind trials on the effects of tadalafil 2.5 or 5 mg (vs. placebo) in men with ED, we evaluated efficacy and safety in subjects with 0 "yes" responses to Sexual Encounter Profile question 3 (SEP3) during an initial 4-week treatment-free run-in period.
  
  
  METHODS
  Changes from baseline in the SEP diary and the International Index of Erectile Function-erectile function (IIEF-EF) domain were subjected to analysis of covariance models.
  
  
  RESULTS
  Five hundred ninety-five subjects with no successful attempts at baseline were included in the analysis. The mean (± standard deviation) age was 58.2 ± 10.7 years; and most subjects had ED for ≥ 1 year (95.0%). ED was severe in 61.5% and moderate in 26.4%. Approximately 45% had diabetes mellitus or hypertension. After 12 weeks, the mean per-patient SEP3 percentage increased from 0% to 32.4% with tadalafil 2.5 mg and to 46.4% with tadalafil 5 mg (each P < 0.001 vs. placebo). Corresponding data for successful penetration (SEP2) were increases from 21.1% to 48.2% with tadalafil 2.5 mg and from 24.4% to 66.2% with 5 mg (each P < 0.001 vs. placebo). Mean IIEF-EF increased from 9.7 to 15.7 with tadalafil 2.5 mg and from 10.7 to 19.2 with 5 mg (each P < 0.001 vs. placebo). Tadalafil also significantly improved the intercourse-satisfaction and overall-satisfaction domains (vs. placebo). Both doses of tadalafil were generally well tolerated, with adverse event rates similar to placebo.
  
  
  CONCLUSIONS
  The posttreatment intercourse success rate was 32% and 46% for tadalafil 2.5 mg and 5 mg, respectively, in men with no successful intercourse attempts at baseline.
authors.affiliation: Division of Urology, Maimonides Medical Center, New York, NY 11219, USA. rshabsigh@gmail.com
authors.forename: Ridwan
authors.initials: R
authors.lastname: Shabsigh
authors.forename: Allen D
authors.initials: AD
authors.lastname: Seftel
authors.forename: Edward D
authors.initials: ED
authors.lastname: Kim
authors.forename: Xiao
authors.initials: X
authors.lastname: Ni
authors.forename: Patrick R
authors.initials: PR
authors.lastname: Burns
mesh_terms: D000368:Aged; D002243:Carbolines / Q000627:therapeutic use*; D003075:Coitus; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D058986:Phosphodiesterase 5 Inhibitors / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D012720:Severity of Illness Index; D000068581:Tadalafil
chemical_list: D002243:Carbolines; D058986:Phosphodiesterase 5 Inhibitors; D000068581:Tadalafil