Efficacy of once-daily administration of udenafil for 24 weeks on erectile dysfunction: results from a randomized multicenter placebo-controlled clinical trial.
BACKGROUND
The method of administration of oral phosphodiesterase-5 inhibitors has been expanded to once-daily repeated administration with lower initial dosage than on-demand administration.


OBJECTIVE
The aim of this study was to evaluate the efficacy and safety of once-daily udenafil as a treatment for erectile dysfunction (ED) for intermediate-term period.


METHODS
This multicenter, randomized, double-blind clinical trial included 346 ED patients (placebo, udenafil 50 mg, udenafil 75 mg). Subjects were treated with each medication once daily for 24 weeks.


METHODS
Subjects were asked to complete the International Index of Erectile Function (IIEF)-erectile function (EF) domain at baseline, 12 weeks, and 24 weeks and the development of adverse drug reactions (ADRs) was inspected.


RESULTS
Both dosages of udenafil induced a significant increase in IIEF-EF compared with placebo at both 12 and 24 weeks. When patients were divided according to the severity of baseline EF score, significant improvement was observed only with udenafil 75 mg regardless of the degree of ED. At 24 weeks, the proportions of patients who reported a return to normal EF (IIEF-EF over 26) were 39.1% for udenafil 50 mg and 47.0% for udenafil 75 mg. In terms of safety, ADRs were observed in 6.1%, 12.9%, and 17.9% for placebo, udenafil 50 mg, and 75 mg, respectively. Although a statistically higher rate of ADRs was observed in the udenafil 75 mg group (P = 0.024), the majority were mild and recovered without treatment.


CONCLUSIONS
Once-daily administration of udenafil 50 mg and 75 mg for 24 weeks resulted in improvement of EF. In particular, udenafil 75 mg improves EF regardless of the baseline degree of ED.
Department of Urology, College of Medicine, Yeungnam University, Daegu, Korea.
Ki Hak
KH
Moon
Department of Urology, College of Medicine, Yeungnam University, Daegu, Korea.
Young Hwii
YH
Ko
Department of Urology, The Catholic University of Korea College of Medicine, Seoul, Korea.
Sae Woong
SW
Kim
Department of Urology, College of Medicine, Korea University, Seoul, Korea.
Du Geon
du G
Moon
Department of Urology, College of Medicine, Korea University, Seoul, Korea.
Je Jong
JJ
Kim
Department of Urology, Pusan National University School of Medicine, Busan, Korea.
Nam Cheol
NC
Park
Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Sung Won
SW
Lee
Department of Urology, Seoul National University Medical School, Seoul, Korea.
Jae-Seung
JS
Paick
Department of Urology, Asan Medical Center, Ulsan University School of Medicine, Seoul, Korea.
Tae Young
TY
Ahn
Department of the Urology, Ewha Womans University School of Medicine, Seoul, Korea.
Woo Sik
WS
Chung
Department of Urology, College of Medicine, Inje University, Pusan, Korea.
Kwon Sik
KS
Min
Department of Urology, Chonbuk National University Medical School, Jeonju, Korea.
Jong Kwan
JK
Park
Department of Urology, College of Medicine, Hallym University, Seoul, Korea.
Dae Yul
DY
Yang
Department of Urology, Chonnam National University Medical School, Gwangju, Korea.
Kwangsung
K
Park
D004311:Double-Blind Method; D004334:Drug Administration Schedule; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010410:Penile Erection / Q000187:drug effects*; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage*; D011743:Pyrimidines / Q000008:administration & dosage*; D056910:Republic of Korea / Q000453:epidemiology; D012725:Sexual Behavior; D013449:Sulfonamides / Q000008:administration & dosage*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D000096926:Benzenesulfonamides
D058986:Phosphodiesterase 5 Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; C419664:udenafil; D000096926:Benzenesulfonamides
Clinical Trial; Erectile Dysfunction; Phosphodiesterase 5 Inhibitors; Udenafil