A phase II, single-blind, randomized, crossover evaluation of the safety and efficacy of avanafil using visual sexual stimulation in patients with mild to moderate erectile dysfunction

BJU International

Volumn 111, Issue 1, 2013, Pages 137-147

  Hellstrom, Wayne J G ^a   Freier, Matthew T ^a   Serefoglu, Ege Can ^a   Lewis, Ronald W ^b   Didonato, Karen ^c   Peterson, Craig A ^c  

^a TULANE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b MEDICAL COLLEGE OF GEORGIA   (United States)

^c Menlo Park and VIVUS   (United States)

Author keywords

avanafil; erectile dysfunction; oral phosphodiesterase type 5 inhibitor; phase II study; RigiScan

Indexed keywords

ANALGESIC AGENT; ANTIHYPERTENSIVE AGENT; ANTIINFLAMMATORY AGENT; AVANAFIL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; PLACEBO; PROTON PUMP INHIBITOR; SILDENAFIL; VITAMIN;

ADULT; AGED; ARTICLE; CLINICAL EVALUATION; CONTROLLED STUDY; CROSSOVER PROCEDURE; DISEASE SEVERITY; DRUG EFFICACY; DRUG FATALITY; DRUG POTENTIATION; DRUG SAFETY; ERECTILE DYSFUNCTION; FLUSHING; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEXUAL BEHAVIOR; SIDE EFFECT; SINGLE BLIND PROCEDURE; STIMULUS RESPONSE; TREATMENT DURATION; TREATMENT RESPONSE; VISUAL IMPAIRMENT; VISUAL STIMULATION;

EID: 84871617455     PISSN: 14644096     EISSN: 1464410X     Source Type: Journal    
DOI: 10.1111/j.1464-410X.2012.11267.x     Document Type: Article

References (45)

1. Selvin E, Burnett AL, Platz EA,. Prevalence and risk factors for erectile dysfunction in the US. Am J Med 2007; 120: 151-157
2. Aytac IA, McKinlay JB, Krane RJ,. The likely worldwide increase in erectile dysfunction between 1995 and 2025 and some possible policy consequences. BJU Int 1999; 84: 50-56
3. Montague DK, Jarow JP, Broderick GA, et al. The management of erectile dysfunction: an update. Am Urol Assoc 2007; Chapter 1-5. Available at: http://www.auanet.org/content/guidelines-and-quality-care/clinical-guidelines. cfm?sub=ed. Accessed May 2012
4. Kimura M, Bañez LL, Schroeck FR, et al. Factors predicting early and late phase decline of sexual health-related quality of life following radical prostatectomy. J Sex Med 2011; 8: 2935-2943
5. Laumann EO, Nicolosi A, Glasser DB, et al. Sexual problems among women and men aged 40-80 y: prevalence and correlates identified in the Global Study of Sexual Attitudes and Behaviors. Int J Impot Res 2005; 17: 39-57
6. Kirby MG, Schnetzler G, Zou KH, Symonds T,. Prevalence and detection rate of underlying disease in men with erectile dysfunction receiving phosphodiesterase type 5 inhibitors in the United Kingdom: a retrospective database study. Int J Clin Pract 2011; 65: 797-806
7. Batty GD, Li Q, Czernichow S, et al. Erectile dysfunction and later cardiovascular disease in men with type 2 diabetes: prospective cohort study based on the ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified-Release Controlled Evaluation) trial. J Am Coll Cardiol 2010; 56: 1908-1913
8. Navaneethan SD, Vecchio M, Johnson DW, et al. Prevalence and correlates of self-reported sexual dysfunction in CKD: a meta-analysis of observational studies. Am J Kidney Dis 2010; 56: 670-685
9. Seftel AD, Sun P, Swindle R,. The prevalence of hypertension, hyperlipidemia, diabetes mellitus and depression in men with erectile dysfunction. J Urol 2004; 171: 2341-2345
10. Burchardt M, Burchardt T, Baer L, et al. Hypertension is associated with severe erectile dysfunction. J Urol 2000; 164: 1188-1191
11. Thompson IM, Tangen CM, Goodman PJ, Probstfield JL, Moinpour CM, Coltman CA,. Erectile dysfunction and subsequent cardiovascular disease. JAMA 2005; 294: 2996-3002
12. Chew KK, Finn J, Stuckey B, et al. Erectile dysfunction as a predictor for subsequent atherosclerotic cardiovascular events: findings from a linked-data study. J Sex Med 2010; 7: 192-202
13. Eaton CB, Liu YL, Mittleman MA, Miner M, Glasser DB, Rimm EB,. A retrospective study of the relationship between biomarkers of atherosclerosis and erectile dysfunction in 988 men. Int J Impot Res 2007; 19: 218-225
14. Fung MM, Bettencourt R, Barrett-Connor E,. Heart disease risk factors predict erectile dysfunction 25 years later: the Rancho Bernardo study. J Am Coll Cardiol 2004; 43: 1405-1411
15. Mulhall J, Teloken P, Brock G, Kim E,. Obesity, dyslipidemias and erectile dysfunction: a report of a subcommittee of the Sexual Medicine Society of North America. J Sex Med 2006; 3: 778-786
16. Riedner CE, Rhoden EL, Ribeiro EP, Fuchs SC,. Central obesity is an independent predictor of erectile dysfunction in older men. J Urol 2006; 176: 1519-1523
17. Derby CA, Mohr BA, Goldstein I, Feldman HA, Johannes CB, McKinlay JB,. Modifiable risk factors and erectile dysfunction: can lifestyle changes modify risk? Urology 2000; 56: 302-306
18. Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB,. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol 1994; 151: 54-61
19. Johannes CB, Araujo AB, Feldman HA, Derby CA, Kleinman KP, McKinlay JB,. Incidence of erectile dysfunction in men 40 to 69 years old: longitudinal results from the Massachusetts Male Aging Study. J Urol 2000; 163: 460-463
20. Lewis RW, Fugl-Meyer KS, Corona G, et al. Definitions/epidemiology/risk factors for sexual dysfunction. J Sex Med 2010; 7: 1598-1607
21. Hatzimouratidis K, Amar E, Eardley I, et al. Guidelines on male sexual dysfunction: erectile dysfunction and premature ejaculation. Eur Urol 2010; 57: 804-814
22. Eli Lilly and Company. Cialis (Package Insert). Indianapolis, IN: Eli Lilly and Company, 2011
23. Bayer HealthCare Pharmaceuticals. Levitra (Package Insert). Wayne, NJ: Bayer HealthCare Pharmaceuticals, 2011
24. Pfizer Labs. Viagra (Package Insert). New York, NY: Pfizer Labs, 2010
25. VIVUS Inc. STENDRA (Package Insert). Mountain View, CA, USA: VIVUS Inc, 2012
26. Allison M, Grant T, Obaidi M, Marenco T, Yee S, Day WW,. Pharmacokinetics of avanafil, a novel, rapidly absorbed, selective PDE5 inhibitor for the treatment of mild to severe erectile dysfunction (ED). J Sex Med 2011; 8: S466-467
27. Kotera J, Mochida H, Inoue H, et al. Avanafil, a potent and highly selective phosphodiesterase-5 inhibitor for the treatment of erectile dysfunction. J Urol 2012; June 14 [Epub ahead of print]
28. International Conference on Harmonisation. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Available at: http://www.ich.org/products/guidelines.html. Accessed May 2012
29. World Medical Association General Assembly. WMA Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects. Available at: http://www.wma.net/en/30publications/10policies/b3/. Accessed May 2012
30. Gingell C, Sultana SR, Wulff MB, Gepi-Attee S,. Duration of action of sildenafil citrate in men with erectile dysfunction. J Sex Med 2004; 1: 179-184
31. Klotz T, Sachse R, Heidrich A, et al. Vardenafil increases penile rigidity and tumescence in erectile dysfunction patients: a RigiScan and pharmacokinetic study. World J Urol 2001; 19: 32-39
32. Eardley I, Ellis P, Boolell M, Wulff M,. Onset and duration of action of sildenafil for the treatment of erectile dysfunction. Br J Clin Pharmacol 2002; 53 (Suppl. 1): 61S-65
33. Montorsi F, Maga T, Strambi LF, et al. Sildenafil taken at bedtime significantly increases nocturnal erections: results of a placebo-controlled study. Urology 2000; 56: 906-911
34. Boolell M, Gepi-Attee S, Gingell JC, Allen MJ,. Sildenafil, a novel effective oral therapy for male erectile dysfunction. Br J Urol 1996; 78: 257-261
35. Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PA,. Oral sildenafil in the treatment of erectile dysfunction. Sildenafil Study Group. N Engl J Med 1998; 338: 1397-1404
36. Waldhauser M, Schramek P,. Efficiency and side effects of prostaglandin E1 in the treatment of erectile dysfunction. J Urol 1988; 140: 525-527
37. Belkoff L, McCullough A, Goldstein I, DiDonato K, Trask B, Bowden CH,. An open-label, long-term evaluation of the safety and tolerability of avanafil in males with erectile dysfunction. J Sex Med 2011; 8: S396
38. Goldstein I, McCullough AR, Jones LA, et al. A randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of avanafil in subjects with generalized erectile dysfunction. J Sex Med 2012; 9: 1122-1133
39. Goldstein I, Jones LA, Belkoff LH, et al. Avanafil for the treatment of erectile dysfunction: a multicenter, randomized, double-blind study in men with diabetes. Mayo Clin Proc; in press
40. Mulhall JP, Moul JW, Wang R, et al. A phase III, placebo-controlled study of the safety and efficacy of avanafil in the treatment of erectile dysfunction following bilateral, nerve-sparing radical prostatectomy. J Sex Med 2012; 9: S42-43
41. Hellstrom JG, Freier MT, Serefoglu EC, et al. Onset of action and time to efficacy of avanafil, a novel, rapid-onset PDE5 inhibitor in men with mild to severe erectile dysfunction: data from phase 2 and phase 3 clinical trails presented at the American Urological Association (AUA) Annual Meeting; May 19-23, 2012; Atlanta, GA. Poster #MP-53
42. Hellstrom WJ, Gittelman M, Karlin G, et al. Vardenafil for treatment of men with erectile dysfunction: efficacy and safety in a randomized, double-blind, placebo-controlled trial. J Androl 2002; 23: 763-771
43. Brock GB, McMahon CG, Chen KK, et al. Efficacy and safety of tadalafil in the treatment of erectile dysfunction: results of integrated analyses. J Urol 2002; 168: 1332-1336
44. Carson CC, Rajfer J, Eardley I, et al. The efficacy and safety of tadalafil: an update. Br J Urol Int 2004; 93: 1276-1281
45. Mulhall JP, Burnett AL, McVary KT, et al. Efficacy and safety of avanafil, a next-generation, phosphodiesterase type 5 inhibitor for the treatment of men with erectile dysfunction: data from phase 2 and 3 studies in difficult-to-treat populations. Presented at the American Urological Association (AUA) Annual Meeting; May 19-23, 2012; Atlanta, GA. Oral presentation