“Based upon these data, avanafil will provide another reliable treatment option for ED patients,” the authors conclude.
Dr. Jong Kwan Park, at the Medical School of Chonbuk National University in Jeonju, and colleagues note that previous studies have studies have shown that avanafil is a selective, potent inhibitor of PDE5 and is rapidly absorbed, reaching peak blood levels at 0.33-0.52 hours after dosing.
In the current phase III trial, 200 men with ED were randomized to take 100 mg or 200 mg avanafil or placebo as needed over a 12 week period. At the end of the study, mean changes in the erectile function domain (EFD) of the International Index of Erectile Function were 8.5 for the 100 mg group and 8.8 for the 200 mg Group — significantly greater than 3.5 in the placebo group (p<0.001), the investigators report.
“The proportion of patients achieving normal EFD scores has been widely used to evaluate the efficacy of PDE5 inhibitors,” they point out. In this study, after 12 weeks 45.6% and 39.39% of patients achieved normal EFD scores in the 100-mg and 200-mg avanafil groups, respectively, compared with 16.7% in the placebo group.
Most side effects were mild and transient, the team found. The most common adverse event was flushing, occurring in 11.4% and 13.0% of the two avanafil groups compared with 2.9% of the placebo group.
Dr. Park and colleagues conclude, “The unique clinical properties (higher selectivity and faster onset) of avanafil will provide a welcome addition to current ED management.”
BJU Int 2012.