title: Efficacy and safety of on-demand oral tadalafil in the treatment of men with erectile dysfunction in Taiwan: a randomized, double-blind, parallel, placebo-controlled clinical study.
abstract: BACKGROUND
  Tadalafil is a phosphodiesterase type 5 inhibitor for the treatment of erectile dysfunction (ED). Past clinical trials have assessed its efficacy and safety in western populations. Tadalafil has not been investigated in a large clinical trial with a South-east Asian population.
  
  
  OBJECTIVE
  To assess the efficacy and safety of on-demand tadalafil for the treatment of ED in a 12-week, double-blind, placebo-controlled study in Taiwan.
  
  
  METHODS
  Men with mild to severe ED of various etiologies were randomized to receive placebo, tadalafil 10 mg, or tadalafil 20 mg, taken as needed (maximum once daily). Efficacy assessments included the International Index of Erectile Function, the Sexual Encounter Profile (SEP) diary, and a Global Assessment Question (GAQ).
  
  
  RESULTS
  Tadalafil significantly improved erectile function compared with placebo (P < 0.005, all measures). At endpoint, the patients receiving tadalafil reported a greater mean per-patient percentage of successful intercourse attempts (SEP question 3: 70.0%, 10 mg; 78.0%, 20 mg) than placebo-treated patients (42.8%) and a greater proportion of improved erections (GAQ: 92.3% and 84.6% vs. 54.5%). Most treatment-emergent adverse events were mild or moderate. The most common adverse events were back pain, dyspepsia, and myalgia.
  
  
  CONCLUSIONS
  Tadalafil was an effective, well-tolerated therapy for men in Taiwan with ED of broad-spectrum severity and etiology.
authors.affiliation: Department of Surgery, Taipei Veterans General Hospital, Taiwan. kkchen@vghtpe.gov.tw
authors.forename: Kuang-Kuo
authors.initials: KK
authors.lastname: Chen
authors.forename: Bang-Ping
authors.initials: BP
authors.lastname: Jiann
authors.forename: Johnny Shinn-Nan
authors.initials: JS
authors.lastname: Lin
authors.forename: Shang-Sen
authors.initials: SS
authors.lastname: Lee
authors.forename: Shih-Tsung
authors.initials: ST
authors.lastname: Huang
authors.forename: Chii-Jye
authors.initials: CJ
authors.lastname: Wang
authors.forename: Hsieh
authors.initials: H
authors.lastname: Ju-Ton
authors.forename: Chung-Kuang
authors.initials: CK
authors.lastname: Su
authors.forename: Timothy M
authors.initials: TM
authors.lastname: Costigan
authors.forename: Jeffrey T
authors.initials: JT
authors.lastname: Emmick
mesh_terms: D000284:Administration, Oral; D000368:Aged; D001416:Back Pain / Q000139:chemically induced; D002243:Carbolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004415:Dyspepsia / Q000139:chemically induced; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D000068581:Tadalafil; D013624:Taiwan; D016896:Treatment Outcome
chemical_list: D002243:Carbolines; D010726:Phosphodiesterase Inhibitors; D010919:Placebos; D000068581:Tadalafil