title: Avanafil for male erectile dysfunction: a systematic review and meta-analysis.
abstract: 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.
authors.forename: Yuan-Shan
authors.initials: YS
authors.lastname: Cui
authors.forename: Nan
authors.initials: N
authors.lastname: Li
authors.forename: Huan-Tao
authors.initials: HT
authors.lastname: Zong
authors.forename: Hui-Lei
authors.initials: HL
authors.lastname: Yan
authors.affiliation: Department of Urology, Beijing Tian-Tan Hospital, Capital Medical University, Beijing, China.
authors.forename: Yong
authors.initials: Y
authors.lastname: Zhang
mesh_terms: D003075:Coitus; D004305:Dose-Response Relationship, Drug; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000503:physiopathology; D005260:Female; D005483:Flushing / Q000139:chemically induced; D006261:Headache / Q000139:chemically induced; D006801:Humans; D008297:Male; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011743:Pyrimidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic
chemical_list: D058986:Phosphodiesterase 5 Inhibitors; D011743:Pyrimidines; C553414:avanafil