Efficacy and safety of avanafil as compared with sildenafil in the treatment of erectile dysfunction: A randomized, double blind, multicenter clinical trial.

Abstract

ObjectiveTo compare the efficacy and safety of avanafil as compared with sildenafil in the management of patients with erectile dysfunction.MethodsIt was a prospective, randomized, double‐blind, two‐arm, active‐controlled, parallel, multicenter, non‐inferiority clinical study carried out in patients with erectile dysfunction for at least 3 months and International Index of Erectile Function – Erectile Function domain score of <26 at enrolment.ResultsA total of 220 patients were randomized to receive either avanafil tablets 100 mg or sildenafil tablets 50 mg in 1:1 ratio. After 4 weeks of treatment, 40.0% of patients in the avanafil group and 45.6% of patients in the sildenafil group required dose escalation to a high dose (avanafil 200 mg/sildenafil 100 mg). The difference in the mean change of International Index of Erectile Function – Erectile Function score from baseline in the two groups increased from week 4 (1.1, 95% confidence interval −0.2 to 2.5) to week 8 (1.4, 95% confidence interval 0.1–2.7) and week 12 (2.1, 95% confidence interval 0.8–3.5), showing non‐inferiority at week 4, and superiority at week 8 and week 12. Avanafil showed a faster onset of action as shown by a significantly better response to modified Sexual Encounter Profile 1 in the avanafil group (84.8%) as compared with that in the sildenafil group (28.2%; P < 0.001). Both avanafil and sildenafil were well tolerated by all the patients in the study; the most common adverse event reported during the study was headache in both the groups.ConclusionAvanafil is superior to sildenafil in improving the International Index of Erectile Function – Erectile Function domain score at the end of 12 weeks of treatment with the added advantage of faster onset of action.