Elsevier

Mayo Clinic Proceedings

Volume 87, Issue 9, September 2012, Pages 843-852
Mayo Clinic Proceedings

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

Previous Presentation: The data in this manuscript have been presented at the International Society of Sexual Medicine Meeting, September 26-30, 2010, Seoul, South Korea, and as a poster at the European Association for the Study of Diabetes 47th Annual Meeting, September 12-16, 2011, Lisbon, Portugal.
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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.

Abbreviations and Acronyms

AE
adverse event
BP
blood pressure
ED
erectile dysfunction
IIEF-EF
International Index of Erectile Function erectile function
LS
least square
PDE
phosphodiesterase
SEP
Sexual Encounter Profile

Cited by (0)

The participating investigators are listed at the end of the article.

Potential Competing Interests: Dr Goldstein has received grants and research support from various pharmaceutical companies, including but not limited to Absorption Pharmaceuticals, Astellas, Auxilium, BioSante, Boehringer Ingelheim, Emotional Brain, EndoCeutics, G&H Brands, GlaxoSmithKline, Medtronic, Palatin, Pfizer, Slate, Target Health, and VIVUS Inc; acted as a consultant for Absorption Pharmaceuticals, Auxilium, Emotional Brain, Fabre-Kramer, GlaxoSmithKline, Medtronic, Neocutis, Slate, Trimel, and VIVUS Inc; and has served as a speaker for Abbott, Ascend, Auxilium, Boehringer Ingelheim, Coloplast, Eli Lilly, Medtronic, and Slate. Dr Jones has served as a consultant for American Medical Systems and Coloplast Corporation, has served as a speaker for Astellas and GlaxoSmithKline, and has received research support from Auxilium, Lilly ICOS, VIVUS Inc, and Warner Chilcott. Dr Belkoff has served as a speaker for Dendreon, Ferring, GlaxoSmithKline, Sanofi-Aventis, VIVUS Inc, and Warner Chilcott. Dr Karlin has received research support from various pharmaceutical companies, including but not limited to Active Biotech, Allergan, Amgen, Astellas, Auxilium, Bayer, BioSante, Boehringer Ingelheim, Eli Lilly, Endo Pharmaceuticals, GTx, GlaxoSmithKline, Johnson and Johnson, Medtronic, Pfizer, Slate, VIVUS Inc, and Warner Chilcott and has served as a consultant for Amgen, Auxilium, Ferring, GP Pharma, Medtronic, Pfizer, and VIVUS Inc. Dr Karlin has participated in speaking presentations for multiple pharmaceutical companies. Dr Bowden, Dr Day, Mr Peterson, and Ms Trask are employees of VIVUS Inc.

Participating Investigators: Investigators who participated in this study are as follows: Miguel Trevino, MD, Clearwater, FL; James Clower, MD, Jacksonville, FL; Gerard Henry, MD, Shreveport, LA; George Adams, MD, Homewood, AL; Selwyn Spangenthal, MD, Charlotte, NC; James Barada, MD, Albany, NY; Laurence Belkoff, DO, Bala Cynwyd, PA; Gary Karlin, MD, Lawrenceville, NJ; Martin van Cleeff, MD, Cary, NC; Wilbur Wells, Jr, MD, Birmingham, AL; Richard Egelhof, MD, Wichita, KS; Bret Wittmer, MD, Madisonville, KY; Michael Cromer, MD, Tampa, FL; John Ervin, MD, Kansas City, MO; Larry Gilderman, DO, Pembroke Pines, FL; Steven Bowman, MD, Clearwater, FL; Richard Townsend, MD, Jacksonville, FL; Irwin Goldstein, MD, San Diego, CA; Brian Goldman, MD, Raleigh, NC; Dario Altamirano, DO, Hialeah, FL; Ronald Surowitz, DO, Jupiter, FL; Jeffrey Rosen, MD, Coral Gables, FL; Garth Denyer, MD, Spring, TX; Mira Baron, MD, Cleveland, OH; George Raad, MD, Charlotte, NC; Wayne Cline, MD, Salisbury, NC; Gladstone Sellers, MD, Sandy Springs, GA; Joseph Soufer, MD, Waterbury, CT; David Miller, MD, Harrisburg, NC; Sergio Rovner, MD, El Paso, TX; Douglas Young, MD, Sacramento, CA; Michael Bennett, MD, San Diego, CA; David Cook, MD, Winston-Salem, NC; LeRoy Jones, MD, San Antonio, TX; Maxwell Axler, MD, Houston, TX; Sidney Clevinger, MD, Ocala, FL; John McGettigan, MD, Tucson, AZ; Jonathan Staub, MD, Wilmington, NC; and Michael Warren, MD, Lancaster, PA.