To compare the efficacy and safety of avanafil as compared with sildenafil in the management of patients with erectile dysfunction.
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.
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 -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.
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.
International journal of urology : official journal of the Japanese Urological Association. 2022 Jan 26 [Epub ahead of print]
Manish Kumar, Amey D Pathade, S VijayaBhaskara Gupta, Sanjay Goyal, Debadarshi Rath, Manish Thakre, Jayesh Sanmukhani, Ravindra Mittal
Department of Urology, Prakhar Hospital Pvt Ltd, Kanpur, India., Department of Urology, Jeevan Rekha Hospital, Belgavi, India., Department of Psychiatry, Government Medical College & Government General Hospital, Srikakulam, India., Department of Urology, Maharaja Agrasen Superspeciality Hospital, Jaipur, India., Department of Urology, Sparsh Hospitals and Critical Care, Bhubaneshwar, India., Department of Psychiatry, Government Medical College and Hospital, Nagpur, India., Department of Clinical Research and Regulatory Affairs, Zydus Healthcare Limited, India.