Avanafil for male erectile dysfunction: a systematic review and meta-analysis

• Main Authors: Yuan-Shan Cui, Nan Li, Huan-Tao Zong, Hui-Lei Yan, Yong Zhang
• Format: Article
• Language: English
• Published: Wolters Kluwer Medknow Publications 2014-06-01
• Series: Asian Journal of Andrology
• Subjects: avanafil; erectile dysfunction; meta-analysis; randomized controlled trial
• Online Access: http://www.ajandrology.com/article.asp?issn=1008-682X;year=2014;volume=16;issue=3;spage=472;epage=477;aulast=Cui
• ISSN: 1008-682X; 1745-7262

Avanafil, a potent new selective phosphodiesterase type 5 (PDE5) inhibitor, has been developed for the treatment of erectile dysfunction (ED). We carried out a systematic review and meta-analysis to assess the efficacy and safety of this drug for the treatment of ED. A literature review was performed to identify all published randomized, double-blind, placebo-controlled trials of avanafil for the treatment of ED. The search included the following databases: MEDLINE, EMBASE and the Cochrane Controlled Trials Register. The reference lists of the retrieved studies were also investigated. Four publications, involving a total of 1381 patients, were used in the analysis, including four randomized controlled trials (RCTs) that compared avanafil with a placebo. Among the co-primary efficacy end points indicating that avanafil 100 mg was more effective than a placebo were successful vaginal penetration (SEP2) (the odds ratio (OR) =5.06, 95% confidence interval (CI) =3.29-7.78, P< 0.00001) and successful intercourse (SEP3) (OR = 3.99, 95% CI = 2.80-5.67, P< 0.00001). Men randomized to receive avanafil were less likely than those receiving the placebo to drop out due to an adverse event (AE) (OR = 1.48, 95% CI = 0.54-4.08, P= 0.44). Specific AEs with avanafil included headache and flushing, which were significantly less likely to occur with placebo. This meta-analysis indicates that avanafil 100 or 200 mg is an effective and well-tolerated treatment for ED. Compared with avanafil 100 mg, patients who take avanafil 200 mg are more likely to experience headaches.