Efficacy and Safety of Once-Daily Dosing of Udenafil in the Treatment of Erectile Dysfunction: Results of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

• Published in: European urology Vol. 60; no. 2; pp. 380 - 387
• Main Authors: Zhao, Chen, Kim, Sae Woong, Yang, Dae Yul, Kim, Je Jong, Park, Nam Cheol, Lee, Sung Won, Paick, Jae Seung, Ahn, Tai Young, Min, Kweon Sik, Park, Kwangsung, Park, Jong Kwan
• Format: Journal Article
• Language: English
• Published: Kidlington Elsevier B.V 01-08-2011; Elsevier
• Subjects: Aged; Biological and medical sciences; Clinical study; Double-Blind Method; Drug Administration Schedule; Erectile dysfunction (ED); Erectile Dysfunction - diagnosis; Erectile Dysfunction - drug therapy; Erectile Dysfunction - physiopathology; Erectile Dysfunction - psychology; Gynecology. Andrology. Obstetrics; Humans; Male; Male genital diseases; Medical sciences; Middle Aged; Nephrology. Urinary tract diseases; Non tumoral diseases; Once-daily dosing; Patient Satisfaction; Penile Erection - drug effects; Phosphodiesterase 5 Inhibitors - administration & dosage; Phosphodiesterase 5 Inhibitors - adverse effects; Phosphodiesterase type 5 inhibitor (PDE5-I); Placebo Effect; Pyrimidines - administration & dosage; Pyrimidines - adverse effects; Republic of Korea; Severity of Illness Index; Sexual Behavior - drug effects; Sulfonamides - administration & dosage; Sulfonamides - adverse effects; Surveys and Questionnaires; Time Factors; Treatment Outcome; Udenafil; Urology; Udenafil; Phosphodiesterase type 5 inhibitor (PDE5-I); Erectile dysfunction (ED); Clinical study; Once-daily dosing; Nephrology; Vasodilator agent; 3',5'-Cyclic-GMP phosphodiesterase; Impotence; Toxicity; Sexual dysfunction; Multicenter study; Esterases; Phosphoric diester hydrolases; Posology; Urology; Male genital diseases; 3',5'-Cyclic-nucleotide phosphodiesterase; Erection disorders; Enzyme; Treatment efficiency; Enzyme inhibitor; Randomized controlled trial; Phosphodiesterase 5 inhibitor; Symptomatology; Treatment; Double blind study; Hydrolases; Daily dose; Phosphodiesterase I
• ISSN: 0302-2838; 1873-7560
• DOI: 10.1016/j.eururo.2011.03.025

Abstract 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.