An open-label, long-term evaluation of the safety, efficacy and tolerability of avanafil in male patients with mild to severe erectile dysfunction

Belkoff, L. H.
McCullough, A.
Goldstein, I.
Jones, L.
Bowden, C. H.
DiDonato, K.
Trask, B.
Day, W. W.

¹Urologic Consultants of Southeastern Pennsylvania, Bala Cynwyd, PA, USA
²Division of Urology, Albany College of Medicine, Albany, NY, USA
³Alvarado Hospital, San Diego, CA, USA
⁴Urology San Antonio, San Antonio, TX, USA
⁵VIVUS, Inc, Mountain View, CA, USA

Correspondence to Laurence H. Belkoff, Chairman, Department of Specialty Surgeries and Division of Urology, Philadelphia College of Osteopathic Medicine, Bala Cynwyd, PA, USA Tel.: +1 6106673020 Fax: +1 6106671817 Email: [email protected]

Paper received June 2012, accepted September 2012

Clinical Trial Registration Number: ClinicalTrials.gov, NCT00853606; http://clinicaltrials.gov/ct2/show/NCT00853606

Disclosures Dr. Belkoff has served as a speaker for Dendreon, Ferring, GlaxoSmithKline, Sanofi-Aventis, VIVUS Inc., and Warner-Chilcott.Andrew McCullough has received grants and research support from Auxilium and VIVUS, and has served as a consultant for Slate.Irwin Goldstein has received grants and research support from various pharmaceutical companies, including but not limited to Astellas, Auxilium, BioSante, Boehringer Ingelheim, Endoceutics, G & H Brands, GSK, Medtronic, Pfizer, Slate and VIVUS. He has served as a consultant for Alagin, Auxilium, Boehringer Ingelheim, Fabre Kramer, Medtronic, Neocutis, Pfizer, Shionogi, Slate, Trimel and VIVUS, and has been a speaker for Abbott, Ascend, Auxilium, Boehringer Ingelheim, Coloplast, Medtronic, Slate, VIVUS and Warner-Chilcott. LeRoy A. Jones has received grants and research funding from various pharmaceutical companies, including but not limited to Auxillium, Lilly Icos, GSK, Pfizer, Endo Pharmaceuticals, Coloplast, BioSante and VIVUS. He is a consultant for American Medical Systems, Astellas and Coloplast. He has been a speaker for Endo Pharmaceuticals, Asetellas, Coloplast, American Medical Systems, Pfizer and Lilly Icos.Charles H. Bowden, Karen DiDonato, Brenda Trask and Wesley W. Day are employees of VIVUS, Inc.

International Journal of Clinical Practice 67(4):p 333-341, April 2013. | DOI: 10.1111/ijcp.12065

SUMMARY

Aim:

Determine the long-term efficacy, safety and tolerability of avanafil, a highly specific, rapidly absorbed phosphodiesterase type 5 inhibitor in male patients with mild to severe erectile dysfunction (ED), with or without diabetes.

Methods:

This was a 52-week, open-label extension of two 12-week, randomised, placebo-controlled, phase 3 trials. Patients were assigned to avanafil 100 mg, but could request 200 mg (for increased efficacy; ‘100/200-mg’ group) or 50 mg (for improved tolerability). Primary end points included percentage of sexual attempts ending in successful vaginal penetration [Sexual Encounter Profile 2 (SEP2)] and intercourse (SEP3) and erectile function domain score per the International Index of Erectile Function (IIEF-EF).

Results:

Some 712 patients enrolled; 686 were included in the intent to treat population and contributed to the data. All primary end points showed sustained improvement. SEP2 and SEP3 success rates improved from 44% to 83% and from 13% to 68% (100-mg group) and from 43% to 79% and from 11% to 66% (100/200-mg group), respectively. Mean IIEF-EF domain scores improved from 13.6 to 22.2 (100-mg group) and from 11.9 to 22.7 (100/200-mg group). Avanafil was effective in some patients ≤ 15 min and > 6 h postdose. Sixty-five per cent (112/172) of ‘nonresponders’ to avanafil 100 mg responded to the 200-mg dose. The most common (≥ 2%) treatment-emergent adverse events were headache, flushing, nasopharyngitis and nasal congestion; < 3% of patients discontinued therapy because of adverse events.

Conclusions:

The long-term tolerability and improvement in sexual function, coupled with rapid onset, suggest that avanafil is well suited for the on-demand treatment of ED.