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.