The efficacy and safety of udenafil, a new selective phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction.
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.
Paick
Jae-Seung
JS
Department of Urology, Seoul National University Hospital, Seoul, Korea;. Electronic address: jspaick@snu.ac.kr.
Kim
Sae Woong
SW
Department of Urology, St Mary's Hospital, Seoul, Korea.
Yang
Dae Yeol
DY
Department of Urology, Hallym Medical Center, Seoul, Korea.
Kim
Ja Jong
JJ
Department of Urology, Korea University Hospital, Seoul, Korea.
Lee
Sung Won
SW
Department of Urology, Samsung Medical Center, Seoul, Korea.
Ahn
Tai Young
TY
Department of Urology, Asan Medical Center, Seoul, Korea.
Choi
Hyung Ki
HK
Department of Urology, Youngdong Severance Hospital, Seoul, Korea.
Suh
Jun-Kyu
JK
Department of Urology, Inha University Hospital, Incheon, Korea.
Kim
Sae Chul
SC
Department of Urology, Chung-Ang University Medical Center, Seoul, Korea.
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
D010726:Phosphodiesterase Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; C419664:udenafil; D000096926:Benzenesulfonamides