title: The efficacy and safety of udenafil, a new selective phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction.
abstract: BACKGROUND
  Udenafil is a potent selective phosphodiesterase type 5 (PDE5) inhibitor newly developed for the treatment of erectile dysfunction (ED).
  
  
  OBJECTIVE
  This study was performed to evaluate the efficacy and safety of udenafil therapy in patients with ED.
  
  
  METHODS
  In this multicenter, double-blind, placebo-controlled, fixed-dose, parallel-group phase III trial, 167 patients with ED of diverse origin and severity were randomized to take placebo or udenafil at fixed doses of 100 or 200 mg as needed for 12 weeks.
  
  
  METHODS
  Primary efficacy variable was change from baseline in erectile function (EF) domain scores of the International Index of Erectile Dysfunction (IIEF) questionnaire. Secondary efficacy variables include change from baseline in scores on the IIEF Questions 3 and 4 (IIEF Q3 and Q4), change from baseline in all domain scores of the IIEF, patients' responses to questions 2 and 3 of the Sexual Encounter Profile (SEP2 and SEP3), and patients' responses to the Global Assessment Question (GAQ). Any adverse events were also recorded during the trial.
  
  
  RESULTS
  After 12 weeks of treatment, the patients treated with udenafil showed significantly greater change from baseline in the IIEF-EF domain score compared with placebo (placebo, 0.20; 100-mg udenafil, 7.52; and 200-mg udenafil, 9.93, respectively) (P < 0.0001). Compared with placebo, udenafil significantly enhanced the rates of successful penetration (SEP Q2) and maintenance of erection (SEP Q3) (P < 0.0001). Furthermore, significantly greater proportions of udenafil treatment groups responded positively to the GAQ compared with the placebo group (GAQ: placebo, 25.9%; 100-mg udenafil, 81.5%; and 200-mg udenafil, 88.5%, respectively) (P < 0.0001). Treatment-related adverse events were generally mild to moderate with facial flushing and headache being the most common.
  
  
  CONCLUSIONS
  Udenafil is an effective and well-tolerated therapy for ED of broad-spectrum etiology and severity.
authors.affiliation: Department of Urology, Seoul National University Hospital, Seoul, Korea;. Electronic address: jspaick@snu.ac.kr.
authors.forename: Jae-Seung
authors.initials: JS
authors.lastname: Paick
authors.affiliation: Department of Urology, St Mary's Hospital, Seoul, Korea.
authors.forename: Sae Woong
authors.initials: SW
authors.lastname: Kim
authors.affiliation: Department of Urology, Hallym Medical Center, Seoul, Korea.
authors.forename: Dae Yeol
authors.initials: DY
authors.lastname: Yang
authors.affiliation: Department of Urology, Korea University Hospital, Seoul, Korea.
authors.forename: Ja Jong
authors.initials: JJ
authors.lastname: Kim
authors.affiliation: Department of Urology, Samsung Medical Center, Seoul, Korea.
authors.forename: Sung Won
authors.initials: SW
authors.lastname: Lee
authors.affiliation: Department of Urology, Asan Medical Center, Seoul, Korea.
authors.forename: Tai Young
authors.initials: TY
authors.lastname: Ahn
authors.affiliation: Department of Urology, Youngdong Severance Hospital, Seoul, Korea.
authors.forename: Hyung Ki
authors.initials: HK
authors.lastname: Choi
authors.affiliation: Department of Urology, Inha University Hospital, Incheon, Korea.
authors.forename: Jun-Kyu
authors.initials: JK
authors.lastname: Suh
authors.affiliation: Department of Urology, Chung-Ang University Medical Center, Seoul, Korea.
authors.forename: Sae Chul
authors.initials: SC
authors.lastname: Kim
mesh_terms: D000328:Adult; D000368:Aged; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010410:Penile Erection / Q000187:drug effects*; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage*; D011743:Pyrimidines / Q000008:administration & dosage*; D011788:Quality of Life; D012107:Research Design; D012720:Severity of Illness Index; D012725:Sexual Behavior / Q000187:drug effects; D013449:Sulfonamides; D016896:Treatment Outcome; D000096926:Benzenesulfonamides
chemical_list: D010726:Phosphodiesterase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; C419664:udenafil; D000096926:Benzenesulfonamides