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

Abstract

To compare the efficacy and safety of avanafil as compared with sildenafil in the management of patients with erectile dysfunction. Methods: It 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. Results: A 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 À0.2 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. Conclusion: Avanafil 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.

Safety, tolerability, and pharmacokinetics of aildenafil citrate tablets, a novel oral PDE5 inhibitor, in healthy Chinese volunteers after multiple-dose administration

“…Prominent AEs included myalgia, fatigue, nasal congestion, and flushing, aligning with the profiles of other PDE5 inhibitors. 1 , 2 , 9 These events are often attributed to the nonselective inhibition of additional PDE isoenzymes within the body. 2 , 4 Instances of myalgia and fatigue exhibited a dose-dependent increase exclusively within the 60-mg group.…”

“… 1 , 2 , 9 These events are often attributed to the nonselective inhibition of additional PDE isoenzymes within the body. 2 , 4 Instances of myalgia and fatigue exhibited a dose-dependent increase exclusively within the 60-mg group. Efforts to elucidate the potential causative factors for myalgia and fatigue included creatine kinase assessments on day 4, which failed to reveal any noteworthy deviations when compared with baseline, indicating no association with muscular injury.…”

“…Due to their ease of use, impressive efficacy, and favorable tolerability, PDE5 inhibitors are recommended as the primary line of treatment for ED. 2 …”

A real-world pilot study assessing treatment satisfaction with avanafil in patients with erectile dysfunction

“…Similarly, a significant increase in the mean SHIM total score from 12.4 to 19.9 was observed in Taiwanese patients receiving PDE5 inhibitor therapy, and erectile function returned to normal in 33.3% of patients in our previous observational study. 19 The proportions of patients with normal erectile function (International Index of Erectile Function erectile function domain score ≥26) after 12-week treatment with avanafil, sildenafil, tadalafil, and vardenafil were 39% to 65%, 20 - 22 37% to 60%, 22 , 23 36% to 64%, 24 , 25 and 32% to 56%, 26 , 27 respectively. Higher dose (100/200 mg), longer treatment duration, and less severe ED at baseline were associated with better improvement in erectile function in patients treated with avanafil.…”

“…Higher dose (100/200 mg), longer treatment duration, and less severe ED at baseline were associated with better improvement in erectile function in patients treated with avanafil. 11 , 22 …”