TY - JOUR
T1 - Efficacy and safety of once-daily dosing of udenafil in the treatment of erectile dysfunction
T2 - Results of a multicenter, randomized, double-blind, placebo-controlled trial
AU - Zhao, Chen
AU - Kim, Sae Woong
AU - Yang, Dae Yul
AU - Kim, Je-Jong
AU - Park, Nam Cheol
AU - Lee, Sung Won
AU - Paick, Jae Seung
AU - Ahn, Tai Young
AU - Min, Kweon Sik
AU - Park, Kwangsung
AU - Park, Jong Kwan
PY - 2011/8/1
Y1 - 2011/8/1
N2 - Background: A once-daily dosing regimen with a phosphodiesterase type 5 inhibitor is needed for the treatment of erectile dysfunction (ED), in part because of the behavioral complexities associated with sexual intimacy. Many patients prefer spontaneous rather than scheduled sexual activities or they anticipate frequent sexual encounters. The pharmacokinetic profiles of udenafil with a time of maximal concentration of 1.0-1.5 h and a terminal half-life of 11-13 h make udenafil a good candidate for once-daily dosing. Objective: To evaluate the efficacy and safety of once-daily dosing of udenafil in the treatment of ED. Design, setting, and participants: This multicenter randomized double-blind, placebo-controlled, fix-dosed clinical trial involved 237 patients with ED. The subjects, who were treated with placebo or udenafil (25 mg, 50 mg, or 75 mg) once daily for 12 wk, were asked to complete the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and the Global Assessment Questionnaire (GAQ) during the study. Measurements: The primary outcome parameter was the change from baseline for the IIEF erectile function domain (EFD) score. The secondary outcome parameters were SEP questions 2 and 3, the shift to normal rate (EFD ≥26), and the response to the GAQ. Results and limitations: Compared with placebo, patients who took 50 mg or 75 mg of udenafil had a significantly improved IIEF-EFD score. Similar results were observed in comparing questions 2 and 3 in the SEP diary and the GAQ. Flushing was the most common treatment-related adverse event, which was transient and mild to moderate in severity. Conclusions: Udenafil significantly improved erectile function among ED patients when administered in doses of 50 mg or 75 mg once daily for 12 wk. Daily administration of udenafil (50 mg) may be another treatment option for ED.
AB - Background: A once-daily dosing regimen with a phosphodiesterase type 5 inhibitor is needed for the treatment of erectile dysfunction (ED), in part because of the behavioral complexities associated with sexual intimacy. Many patients prefer spontaneous rather than scheduled sexual activities or they anticipate frequent sexual encounters. The pharmacokinetic profiles of udenafil with a time of maximal concentration of 1.0-1.5 h and a terminal half-life of 11-13 h make udenafil a good candidate for once-daily dosing. Objective: To evaluate the efficacy and safety of once-daily dosing of udenafil in the treatment of ED. Design, setting, and participants: This multicenter randomized double-blind, placebo-controlled, fix-dosed clinical trial involved 237 patients with ED. The subjects, who were treated with placebo or udenafil (25 mg, 50 mg, or 75 mg) once daily for 12 wk, were asked to complete the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and the Global Assessment Questionnaire (GAQ) during the study. Measurements: The primary outcome parameter was the change from baseline for the IIEF erectile function domain (EFD) score. The secondary outcome parameters were SEP questions 2 and 3, the shift to normal rate (EFD ≥26), and the response to the GAQ. Results and limitations: Compared with placebo, patients who took 50 mg or 75 mg of udenafil had a significantly improved IIEF-EFD score. Similar results were observed in comparing questions 2 and 3 in the SEP diary and the GAQ. Flushing was the most common treatment-related adverse event, which was transient and mild to moderate in severity. Conclusions: Udenafil significantly improved erectile function among ED patients when administered in doses of 50 mg or 75 mg once daily for 12 wk. Daily administration of udenafil (50 mg) may be another treatment option for ED.
KW - Clinical study
KW - Erectile dysfunction (ED)
KW - Once-daily dosing
KW - Phosphodiesterase type 5 inhibitor (PDE5-I)
KW - Udenafil
UR - http://www.scopus.com/inward/record.url?scp=79959568696&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=79959568696&partnerID=8YFLogxK
U2 - 10.1016/j.eururo.2011.03.025
DO - 10.1016/j.eururo.2011.03.025
M3 - Article
C2 - 21458153
AN - SCOPUS:79959568696
SN - 0302-2838
VL - 60
SP - 380
EP - 387
JO - European Urology
JF - European Urology
IS - 2
ER -