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An open-label, long-term evaluation of the safety, efficacy and tolerability of avanafil in male patients with mild to severe erectile dysfunction
Journal article   Peer reviewed

An open-label, long-term evaluation of the safety, efficacy and tolerability of avanafil in male patients with mild to severe erectile dysfunction

L. H. Belkoff, A. McCullough, I. Goldstein, L. Jones, C. H. Bowden, K. DiDonato, B. Trask and W. W. Day
International journal of clinical practice (Esher), v 67(4), pp 333-341
01 Apr 2013
DOI: https://doi.org/10.1111/ijcp.12065
PMID: 23521325
Featured in Collection :   UN Sustainable Development Goals @ Drexel
url
https://doi.org/10.1111/ijcp.12065View
Published, Version of Record (VoR) Restricted

Abstract

General & Internal Medicine Life Sciences & Biomedicine Medicine, General & Internal Pharmacology & Pharmacy Science & Technology
Aim: Determine the long-term efficacy, safety and tolerability of avanafil, a highly specific, rapidly absorbed phosphodiesterase type 5 inhibitor in male patients with mild to severe erectile dysfunction (ED), with or without diabetes. Methods: This was a 52-week, open-label extension of two 12-week, randomised, placebo-controlled, phase 3 trials. Patients were assigned to avanafil 100mg, but could request 200mg (for increased efficacy; 100/200-mg' group) or 50mg (for improved tolerability). Primary end points included percentage of sexual attempts ending in successful vaginal penetration [Sexual Encounter Profile 2 (SEP2)] and intercourse (SEP3) and erectile function domain score per the International Index of Erectile Function (IIEF-EF). Results: Some 712 patients enrolled; 686 were included in the intent to treat population and contributed to the data. All primary end points showed sustained improvement. SEP2 and SEP3 success rates improved from 44% to 83% and from 13% to 68% (100-mg group) and from 43% to 79% and from 11% to 66% (100/200-mg group), respectively. Mean IIEF-EF domain scores improved from 13.6 to 22.2 (100-mg group) and from 11.9 to 22.7 (100/200-mg group). Avanafil was effective in some patients 15min and >6h postdose. Sixty-five per cent (112/172) of nonresponders' to avanafil 100mg responded to the 200-mg dose. The most common (2%) treatment-emergent adverse events were headache, flushing, nasopharyngitis and nasal congestion; <3% of patients discontinued therapy because of adverse events. Conclusions: The long-term tolerability and improvement in sexual function, coupled with rapid onset, suggest that avanafil is well suited for the on-demand treatment of ED.

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36 citations in Web of Science
40 citations in Scopus

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UN Sustainable Development Goals (SDGs)

This publication has contributed to the advancement of the following goals:

#5 Gender Equality
#3 Good Health and Well-Being

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Collaboration types
Domestic collaboration
Web of Science research areas
Pharmacology & Pharmacy
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