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

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dc.contributor.authorOrtac, M.
dc.contributor.authorCayan, S.
dc.contributor.authorCaliskan, M. K.
dc.contributor.authorYaman, M. O.
dc.contributor.authorOkutucu, T. M.
dc.contributor.authorSemerci, M. B.
dc.contributor.authorAltay, A. B.
dc.contributor.authorBalbay, M. D.
dc.contributor.authorOzcan, M. F.
dc.contributor.authorKadioglu, A.
dc.date.accessioned2019-10-27T21:51:57Z
dc.date.available2019-10-27T21:51:57Z
dc.date.issued2013
dc.departmentEge Üniversitesien_US
dc.description.abstractUdenafil is a potent phosphodiesterase type-5 inhibitor (PDE5) previously shown in studies conducted in populations of Eastern-Asian 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 100mg 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 Questionnaire-Erectile 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 100mg taken as on-demand can effectively improve erectile function and is well tolerated.en_US
dc.description.sponsorshipAbdi Ibrahim Ilac San. Ve Tic. A.S., Turkeyen_US
dc.description.sponsorshipThis work was supported by a grant from Abdi Ibrahim Ilac San. Ve Tic. A.S., Turkey. The authors thank the study participants and study investigators Erdem Ozturk, Ziya Akbulut and Serkan Altinova for their efforts and contributions.en_US
dc.identifier.doi10.1111/j.2047-2927.2013.00085.xen_US
dc.identifier.endpage555en_US
dc.identifier.issn2047-2919
dc.identifier.issn2047-2927
dc.identifier.issue4en_US
dc.identifier.pmid23785019en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage549en_US
dc.identifier.urihttps://doi.org/10.1111/j.2047-2927.2013.00085.x
dc.identifier.urihttps://hdl.handle.net/11454/47405
dc.identifier.volume1en_US
dc.identifier.wosWOS:000320618100004en_US
dc.identifier.wosqualityQ4en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherWileyen_US
dc.relation.ispartofAndrologyen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.subjecterectile dysfunctionen_US
dc.subjectPDE5 inhibitorsen_US
dc.subjectudenafilen_US
dc.titleEfficacy and tolerability of udenafil in Turkish men with erectile dysfunction of psychogenic and organic aetiology: a randomized, double-blind, placebo-controlled studyen_US
dc.typeArticleen_US

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