The Efficacy and Safety of Udenafil, a New Selective Phosphodiesterase Type 5 Inhibitor, in Patients with Erectile Dysfunction

Abstract

Introduction Udenafil is a potent selective phosphodiesterase type 5 (PDE5) inhibitor newly developed for the treatment of erectile dysfunction (ED). Aim 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. Main Outcome Measures 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.

Effects of repeated dosing with Udenafil (Zydena) on cognition, somatization and erection in patients with erectile dysfunction: a pilot study

“…Subjects with an increase in the IIEF-5 score (47) were considered to be responders. 4 Statistical analysis Statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS Effect of repeated dosing with udenafil on cognition, somatization and erection YS Shim et al version 15.0. for Windows; SPSS Inc., Chicago, IL, USA). Continuous data were reported as the mean±s.d.…”

“…Udenafil (Zydena), which is the most recently developed PDE5 inhibitor, is also used in some countries, such as Korea, Russia, Ukraine and Malaysia, because of the reported safety and efficacy of udenafil in the treatment of erectile dysfunction. [2][3][4] The PDE5 inhibitors are commonly used for erectile dysfunction, but there have been several different attempts to evaluate additional beneficial effect of PDE5 inhibitors in treatments for pulmonary hypertension, 5 benign prostate hyperplasia 6 and stroke. 7 In a recent study, PDE5 has been identified in the rat brain, including the cortex and hippocampus.…”

Prevalence and medical management of erectile dysfunction in Asia

“…These included four RCTs of sildenafil, [31][32][33][34] two RCTs of vardenafil, 35,36 four RCTs of tadalafil, [37][38][39][40] two RCTs of udenafil 41,42 and two RCTs of mirodenafil. 43,44 The efficacy and safety of two novel PDE-5 inhibitors, mirodenafil and udenafil, were evaluated only in Korean men.…”

“…36 Treatment with vardenafil produced significant improvement in the main efficacy measures of IIEF-EF score and SEP2 and SEP3 as well as the GAQ. The efficacy [31][32][33][34][35][36][37][38][39][40][41][42][43][44] Prevalence and management of ED in Asia K Park et al 547…”

“…In a multicentre, doubleblind, placebo-controlled, fixed-dose, parallel-group phase III trial, 167 Korean patients with ED of diverse origin and severity were randomly assigned to take placebo or udenafil at fixed doses of 100 mg or 200 mg as needed for 12 weeks. 41 The efficacy of udenafil was assessed by IIEF-EF domain scores, SEP2, SEP3 and GAQ. The patients treated with udenafil showed a significantly greater change from baseline in the IIEF-EF domain score as compared with those given placebo (placebo, 0.20; 100 mg udenafil, 7.52; and 200 mg udenafil, 9.93) (P,0.0001).…”