Avanafil is a potent selective phosphodiesterase type 5 (PDE5) inhibitor newly developed for treating erectile dysfunction (ED).
Preclinical and clinical phase I studies showed that avanafil had enhanced selectivity, faster onset of action and a favourable side-effect profile relative to currently available PDE5 inhibitors. As the result of phase III clinical trial for the efficacy and safety of avanafil treatment (100 and 200 mg), taken as needed over a period of 12 weeks, in Korean patients with ED, avanafil is an effective and well-tolerated therapy for ED of broad-spectrum aetiology and severity.
OBJECTIVE:To evaluate the efficacy and safety of avanafil, a new potent selective phosphodiesterase type 5 (PDE5) inhibitor, in patients with erectile dysfunction (ED).
PATIENTS AND METHODS:The present study was a multicentre, randomized, double-blind, placebo-controlled, fix-dosed phase three clinical trial involving 200 patients with ED. The subjects were treated with placebo or avanafil (100 or 200 mg) for 12 weeks and were asked to complete the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and the Global Assessment Questionnaire (GAQ). The primary outcome variable was the change from baseline for IIEF erectile function domain (EFD) score. The secondary outcome variables were SEP Q2 and Q3, the shift to normal rate (EFD ≥ 26), and response to the GAQ.
RESULTS:Compared with placebo, patients who took 100 or 200 mg of avanafil had significantly improved IIEF-EFD score. There were similar results when comparing Q2 and Q3 in the SEP diary and the GAQ. Flushing was the most common treatment-related adverse event. Most adverse events were transient and mild or moderate in severity.
CONCLUSION: Avanafil is an effective and well-tolerated therapy for ED of broad-spectrum aetiology and severity.
Written by:
Zhao C, Kim SW, Yang DY, Kim JJ, Park NC, Lee SW, Paick JS, Ahn TY, Moon KH, Chung WS, Min KS, Suh JK, Hyun JS, Park K, Park JK. Are you the author?
Department of Urology, Chonbuk National University Medical School, and Institute for Medical Sciences, Chonbuk National University, and Research Institute of Clinical Medicine of Chonbuk National University and Chonbuk National University Hospital and CTC for Medical Device of Chonbuk National University Hospital, Jeonju; Department of Urology, College of Medicine, Catholic University Department of Urology, College of Medicine, Hallym University Department of Urology, College of Medicine, Korea; University Department of Urology, College of Medicine, Sungkyunkwan University Department of Urology, College of Medicine, Seoul; National University Department of Urology, College of Medicine, Ulsan University Department of Urology, College of Medicine, Ihwa University, Seoul; Department of Urology, College of Medicine, Pusan National University Department of Urology, College of Medicine, Inje University, Busan; Department of Urology, College of Medicine, Youngnam University, Daegu; Department of Urology, College of Medicine, Inha University, Incheon; Department of Urology, College of Medicine, Kyungsang National University, Jinju Department of Urology, College of Medicine, Chonnam National University, Gwangju, Korea.
Reference: BJU Int. 2012 Mar 27. Epub ahead of print.
doi: 10.1111/j.1464-410X.2012.11095.x
PubMed Abstract
PMID: 22448738
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