Efficacy and tolerability of udenafil in Turkish men with erectile dysfunction of psychogenic and organic aetiology: a randomized, double‐blind, placebo‐controlled study

Abstract

SUMMARYUdenafil is a potent phosphodiesterase type-5 inhibitor (PDE5) previously shown in studies conducted in populations of EasternAsian ethnicity, to significantly improve sexual function, in addition to a favourable safety profile. The purpose of this study was to evaluate the efficacy and safety of udenafil for the treatment of erectile dysfunction (ED), for the first time in a non-Eastern-Asian population. In this multicentre, randomized, double-blind, parallel, placebo-controlled study conducted in five centres in Turkey, 118 eligible subjects were randomized to receive udenafil 100 mg taken as on-demand or matching placebo for an 8-week treatment period. The primary efficacy variable was the change from baseline of the International Index of Erectile Function QuestionnaireErectile Function Domain (IIEF-EFD) score, secondary efficacy variables were changes from baseline in IIEF Questionnaire Domains' 2-5 scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, Overall Sexual Satisfaction) and IIEF Questionnaire Grand Total score, changes from baseline in penetration success rates (SEP2) and intercourse completion rates (SEP3) and evaluation of responses to the global assessment question (GAQ). Patients treated with udenafil demonstrated significantly higher increase in the IIEF-EFD scores compared with placebo-treated subjects [4.0 (95% CI: 1.3-6.6; p = 0.003)]. Similarly, greater improvements were observed in the scores for SEP2 [0.65 (95% CI: 0.02-1.3, p = 0.043)], SEP3 [0.9 (95% CI: 0.3-1.5, p = 0.003)] and two other IIEF Questionnaire Domains (Domain 4: Sexual Desire, Domain 5: Overall Sexual Satisfaction). The proportion of positive responses to the GAQ was greater in the udenafil compared to the placebo group (72.2% vs. 49.1%, p = 0.014). The most frequent treatment-emergent adverse events were headache, flushing and rhinorrhea, all of mild or moderate severity. This is the first study to demonstrate in a non-Eastern-Asian population that udenafil 100 mg taken as on-demand can effectively improve erectile function and is well tolerated.

Pharmacotherapy for Erectile Dysfunction: Recommendations From the Fourth International Consultation for Sexual Medicine (ICSM 2015)

“…Three of these studies 233,234,238 reported significant improvement of psychosocial outcomes (limited to IIEF satisfaction domains) vs placebo.…”

Udenafil for the treatment of erectile dysfunction

“…A Phase II, double-blind, placebo-controlled, multi-center, parallel-group clinical trial showed that udenafil produced a highly significant improvement in erectile function, with an up to 91% vaginal penetration success rate 53. The clinical efficacy of udenafil in patients with ED of a variety of underlying etiologies, severities, and ages of the patients has been suggested in several randomized, placebo-controlled trials 27–29,31–33. Patient characteristics, outcome measures, and results of these trials are summarized in Tables 1 and 2.…”

“…A recent multicenter, randomized, double-blind, placebo-controlled, parallel-group study assessed the efficacy and safety of 8-week 100 mg udenafil treatment in 118 Turkish men aged 19 to 70 years with ED of organic or psychogenic etiology 33. The primary efficacy variable was change from baseline in IIEF-EF scores.…”

“…All clinical trials evaluating the efficacy and safety of udenafil in men with ED reported that most adverse effects were mild-to-moderate in severity, without any serious adverse event during the study period 27–33. The most common udenafil-related adverse effects include flushing and headache 19.…”

“…Its molecular structure is similar to that of sildenafil citrate (Viagra; Pfizer Inc, New York, NY, USA), and the isoenzyme selectivity profile of udenafil is comparable to that of sildenafil 26. Clinical efficacy and safety of udenafil have been evaluated in men with ED of a broad spectrum of etiologies or severity in several randomized, controlled trials;27–33 thus, the availability of a variety of PDE5Is, including udenafil, can assist clinicians in tailoring treatment regimens to the specific needs of each patient with ED and in prescribing the PDE5I that has the highest efficacy for erection or satisfaction and the least overall adverse effects in a given patient. In this review, we highlight the preclinical and clinical evidence for the efficacy and safety of udenafil in the treatment of ED.…”