The Efficacy and Safety of Avanafil During a Treatment of Male Erectile Dysfunction: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Purpose: Erectile dysfunction (ED) contributes to a large burden and impairs the quality of life among males. Avanafil appears to be a promising treatment for ED; however, its efficacy and safety profile remain unclear. This study aimed to evaluate the efficacy and safety of avanafil for the treatment of ED.

Patients and methods: An extensive search of PubMed, ScienceDirect, Web of Science, and Embase databases with 11 publications was performed, with outcomes evaluated are International Index of Erectile Function - Erectile Function (IIEF-EF), Sexual Encounter Profile (SEP), and Treatment-Emergent Adverse Events (TEAE). Statistical parameter Mean Difference (MD) and Risk Ratio (RR) with 95% Confidence Interval (CI) were used to measure effect size.

Results: The pooled estimates demonstrated that changes in IIEF-EF function (MD=4.39, 95% CI [3.41, 5.37], p<0.001), SEP-2 (RR=3.43, 95% CI [2.79, 4.22], p<0.001), SEP-3 (RR=2.30, 95% CI [2.01, 2.62], p<0.001), and TEAE (RR=1.49, 95% CI [1.12, 1.96], p=0.005) were significantly higher in the avanafil group than in the placebo group. Moreover, 200 mg avanafil was superior to that mg 100 mg-avanafil, indicated by the IIEF-EF score (MD=-1.15, 95% CI [-1.40, -0.89], p<0.001). In contrary, there were no significant differences in SEP-2 (RR=0.90, 95% CI [0.75, 1.08], p=0.26), SEP-3 (RR=0.92, 95% CI [0.81, 1.05], p=0.21) and TEAE (RR=1.00, 95% CI [0.87, 1.15], p=0.99) for both 100 mg and 200 mg doses.

Conclusion: This review highlights the potential use of this drug in ED treatment. Further large-scale Randomized Controlled Trials investigations involving various racial groups are required to confirm these findings.