Avanafil for the Treatment of Erectile Dysfunction: A Multicenter, Randomized, Double-Blind Study in Men With Diabetes Mellitus

• Published in: Mayo Clinic proceedings Vol. 87; no. 9; pp. 843 - 852
• Main Authors: Goldstein, Irwin, MD, Jones, LeRoy A., MD, Belkoff, Laurence H., DO, Karlin, Gary S., MD, Bowden, Charles H., MD, Peterson, Craig A., MS, Trask, Brenda A., BS, Day, Wesley W., PhD
• Format: Journal Article
• Language: English
• Published: Rochester, MN Elsevier Inc 01.09.2012; Mayo Foundation; Elsevier, Inc; Elsevier Limited
• Subjects: Avanafil; Biological and medical sciences; Complications and side effects; Diabetes; Diabetes Mellitus; Diabetes. Impaired glucose tolerance; Dosage and administration; Double-Blind Method; Drug therapy; Endocrine pancreas. Apud cells (diseases); Endocrinopathies; Erectile Dysfunction - drug therapy; Etiopathogenesis. Screening. Investigations. Target tissue resistance; General aspects; Humans; Impotence; Internal Medicine; Least-Squares Analysis; Male; Medical sciences; Middle Aged; Original; Penile Erection - drug effects; Placebos; Prospective Studies; Pyrimidines - therapeutic use; Risk factors; Treatment Outcome; United States; blood pressure; AE; LS; IIEF-EF; adverse event; BP; least square; erectile dysfunction; PDE; Sexual Encounter Profile; phosphodiesterase; International Index of Erectile Function erectile function; ED; SEP; Endocrinopathy; Human; Vasodilator agent; Erection disorders; 3',5'-Cyclic-GMP phosphodiesterase; Enzyme; Diabetes mellitus; Multicenter study; Avanafil; Enzyme inhibitor; Male; Esterases; Phosphoric diester hydrolases; Phosphodiesterase 5 inhibitor; Medicine; Randomization; Treatment; Double blind study; Hydrolases; Adult; Male genital diseases
• ISSN: 0025-6196; 1942-5546
• DOI: 10.1016/j.mayocp.2012.06.016

Abstract Objective To prospectively assess the safety and effectiveness of the investigational phosphodiesterase 5 inhibitor avanafil to treat erectile dysfunction in men with diabetes mellitus. Patients and Methods This 12-week, multicenter, double-blind, placebo-controlled study conducted between December 15, 2008, and February 11, 2010, randomized 390 men with diabetes and erectile dysfunction 1:1:1 to receive avanafil, 100 mg (n=129), avanafil, 200 mg (n=131), or placebo (n=130). Coprimary end points assessed changes in the percentage of sexual attempts in which men were able to maintain an erection of sufficient duration to have successful intercourse (Sexual Encounter Profile [SEP] 3), percentage of sexual attempts in which men were able to insert the penis into the partner's vagina (SEP 2), and International Index of Erectile Function erectile function domain score. Results Compared with placebo, least-squares mean change from baseline to study end in SEP 3, SEP 2, and International Index of Erectile Function erectile function domain score were significantly improved with both avanafil, 100 mg ( P ≤.002), and avanafil, 200 mg ( P <.001). Additional analyses indicated that successful intercourse could be initiated in 15 minutes or less through more than 6 hours after avanafil dosing. Adverse events most commonly reported with avanafil treatment were headache, nasopharyngitis, flushing, and sinus congestion. Conclusion Avanafil was safe and effective for treating erectile dysfunction in men with diabetes and was effective as early as 15 minutes and more than 6 hours after dosing. The adverse events seen with avanafil were similar to those seen with other phosphodiesterase 5 inhibitors. Trial Registration clinicaltrials.gov Identifier NCT00809471.