Review of time of onset and duration of clinical efficacy of phosphodiesterase type 5 inhibitors in treatment of erectile dysfunction

Urology

Volumn 68, Issue 4, 2006, Pages 689-696

  Shabsigh, Ridwan ^a   Seftel, Allen D ^b   Rosen, Raymond C ^c   Porst, Hartmut ^d   Ahuja, Sanjeev ^e   Deeley, Michael C ^e   Garcia, Carmen S ^e   Giuliano, François ^f  

^a NewYork Presbyterian Columbia University Irving Medical Center   (United States)

^b UNIVERSITY HOSPITALS OF CLEVELAND   (United States)

^c RUTGERS ROBERT WOOD JOHNSON MEDICAL SCHOOL   (United States)

^d Urological Practice   (Germany)

^e ELI LILLY AND COMPANY   (United States)

^f RAYMOND POINCARÉ HOSPITAL   (France)

Author keywords

[No Author keywords available]

Indexed keywords

PHOSPHODIESTERASE V INHIBITOR; SILDENAFIL; TADALAFIL; VARDENAFIL;

AREA UNDER THE CURVE; DRUG ABSORPTION; DRUG ACTIVITY; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; ERECTILE DYSFUNCTION; FOOD DRUG INTERACTION; HUMAN; LIPID DIET; MEDICAL ASSESSMENT; MEDICAL DOCUMENTATION; PATIENT SELECTION; PEER REVIEW; PLETHYSMOGRAPHY; PRIORITY JOURNAL; REVIEW; SEXUAL INTERCOURSE; THERAPY EFFECT;

3',5'-CYCLIC-GMP PHOSPHODIESTERASE; CARBOLINES; HUMANS; IMIDAZOLES; IMPOTENCE; MALE; PHOSPHODIESTERASE INHIBITORS; PIPERAZINES; SULFONES; TIME FACTORS; TREATMENT OUTCOME; TRIAZINES;

EID: 33750340662     PISSN: 00904295     EISSN: 15279995     Source Type: Journal    
DOI: 10.1016/j.urology.2006.05.009     Document Type: Review

References (50)

1. NIH Consensus Conference. NIH Consensus Development Panel on Impotence. JAMA 270 (1993) 83-90
2. McKinlay J.B. The worldwide prevalence and epidemiology of erectile dysfunction. Int J Impot Res 12 (2000) S6-S11
3. Reporters and Participants of the First Latin American Erectile Dysfunction Consensus. Anatomy and physiology of erection: pathophysiology of erectile dysfunction. Int J Impot Res 15 (2003) S5-S8
4. Reporters and Participants of the First Latin American Erectile Dysfunction Consensus. Psychogenic erectile dysfunction and ejaculation disorders. Int J Impot Res 15 (2003) S16-S21
5. Brotons F.B., Campos J.C., Gonzalez-Correales R., et al. Core document on erectile dysfunction: key aspects in the care of a patient with erectile dysfunction. Int J Impot Res 16 (2004) S26-S39
6. Viagra® [package insert] (2002), Pfizer, New York
7. Levitra®, vardenafil hydrochloride. Summary of product specifications (2003), Bayer Healthcare
8. Cialis® [package insert] (2003), Lilly ICOS LLC, Indianapolis
9. Cialis® (tadalafil). Summary of product specifications (2003), Lilly ICOS LLC, Indianapolis
10. Viagra® (sildenafil citrate). Summary of product specifications (2003), Pfizer Ltd, New York
11. Levitra® [package insert] (2003), Bayer Pharmaceuticals Corporation, West Haven, CT
12. Hanson-Divers C., Jackson S.E., Lue T.F., et al. Health outcomes important to patients in the treatment of erectile dysfunction. J Urol 159 (1998) 1541-1547
13. Swindle R.W., Cameron A.E., Lockhart D.C., et al. The psychological and interpersonal relationship scales: assessing psychological and relationship outcomes associated with erectile dysfunction and its treatment. Arch Sex Behav 33 (2004) 19-30
14. Cappelleri J.C., Althof S.E., Siegel R.L., et al. Development and validation of the Self-Esteem And Relationship (SEAR) questionnaire in erectile dysfunction. Int J Impot Res 16 (2004) 30-38
15. Althof S.E., Cappelleri J.C., Shpilsky A., et al. Treatment responsiveness of the Self-Esteem And Relationship questionnaire in erectile dysfunction. Urology 61 (2003) 888-892
16. Althof S.E., Corty E.W., Levine S.B., et al. EDITS: development of questionnaires for evaluating satisfaction with treatments for erectile dysfunction. Urology 53 (1999) 793-799
17. Wagner T.H., Patrick D.L., McKenna S.P., et al. Cross-cultural development of a quality of life measure for men with erection difficulties. Qual Life Res 5 (1996) 443-449
18. MacDonagh R., Ewings P., and Porter T. The effect of erectile dysfunction on quality of life: psychometric testing of a new quality of life measure for patients with erectile dysfunction. J Urol 167 (2002) 212-217
19. Hardman J.G., and Limbird L.E. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. (2001), McGraw-Hill Medical Publishing Division, New York 3-31
20. Mulhall J.P. Deciphering erectile dysfunction drug trials. J Urol 170 (2003) 353-358
21. Rosen R.C., Riley A., Wagner G., et al. The International Index of Erectile Function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology 49 (1997) 822-830
22. Padma-Nathan H., Rosen R.C., Shabsigh R., et al. Tadalafil (IC351) provides prompt response and extended period of response for the treatment of men with erectile dysfunction (ED). Int J Impot Res 13 (2001) S64
23. Nichols D.J., Muirhead G.J., and Harness J.A. Pharmacokinetics of sildenafil after single oral doses in healthy male subjects: absolute bioavailability, food effects and dose proportionality. Br J Clin Pharmacol 53 (2002) 5S-12S
24. Walker D.K., Ackland M.J., James G.C., et al. Pharmacokinetics and metabolism of sildenafil in mouse, rat, rabbit, dog and man. Xenobiotica 29 (1999) 297-310
25. 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 19 (2001) 32-39
26. Rajagopalan P., Mazzu A., Xia C., et al. Effect of high-fat breakfast and moderate-fat evening meal on the pharmacokinetics of vardenafil, an oral phosphodiesterase-5 inhibitor for the treatment of erectile dysfunction. J Clin Pharmacol 43 (2003) 260-267
27. Milligan P.A., Marshall S.F., and Karlsson M.O. A population pharmacokinetic analysis of sildenafil citrate in patients with erectile dysfunction. Br J Clin Pharmacol 53 (2002) 45S-52S
28. Lilly-ICOS LLC, data on file.
29. Forgue S.T., Patterson B., Bedding A.W., et al. Tadalafil pharmacokinetics in healthy subjects. Br J Clin Pharm 61 (2006) 280-288
30. Patterson B., Bedding A., Jewell H., et al. Dose normalized pharmacokinetics of tadalafil (IC351) in healthy volunteers. Int J Impot Res 13 (2001) S62
31. Padma-Nathan H., Stecher V.J., Sweeney M., et al. Minimal time to successful intercourse after sildenafil citrate: results of a randomized, double-blind, placebo-controlled trial. Urology 62 (2003) 400-403
32. Montorsi F., Padma-Nathan H., Buvat J., et al. Earliest time of onset to action leading to successful intercourse with vardenafil determined in an at-home setting: a randomized double-blind, placebo-controlled trial. J Sex Med 1 (2004) 168-178
33. Rosen R.C., Padma-Nathan H., Shabsigh R., et al. Determining the earliest time within 30 minutes to erectogenic effect after tadalafil 10 and 20 mg: a multicenter, randomized, double-blind, placebo-controlled, at-home study. J Sex Med 1 (2004) 193-200
34. Eardley I., Ellis P., Boolell M., et al. Onset and duration of action of sildenafil for the treatment of erectile dysfunction. Br J Clin Pharmacol 53 (2002) 61S-65S
35. Stark S., Sachse R., and Liedl T. Vardenafil increases penile rigidity and tumescence in men with erectile dysfunction after a single oral dose. Eur Urol 40 (2001) 181-190
36. Food and Drug Administration, Center for Drug Evaluation and Research: Viagra (sildenafil citrate) "Joint Clinical Review" for NDA-20-895, March 27, 1998, Appendix A55, p. 222: A54. Study 148-369: a double blind, randomized, placebo-controlled, sequential design, two way crossover study to investigate the duration of action of a single oral dose of sildenafil (100 mg) on penile erectile activity during visual sexual stimulation in patients with male erectile dysfunction without an established organic cause. Available at: http://www.fda.gov/cder/consumerinfo/viagra/default.htm. Accessed February 21, 2006.
37. Gingell C., Sultans S.R., Wulff M.B., et al. Duration of action of sildenafil citrate among men with erectile dysfunction. J Sex Med 1 (2004) 179-184
38. Moncada I., Jara J., Subirá D., et al. Efficacy of sildenafil citrate at 12 hours after dosing: re-exploring the therapeutic window. Eur Urol 46 (2004) 357-361
39. Aliotta P., Carson C.C., Murdock M., et al. Vardenafil provides erections sufficient for successful vaginal penetration, regardless of time from dosing in patients nonresponsive to sildenafil by history: PROVEN trial results. J Androl 25 suppl 1 (2004) 61 Poster 69
40. Hatzichristou D., Carson C., Lording D., et al. Vardenafil allows rapid and reliable erection achievement: results of the patient response with vardenafil in sildenafil nonresponders (PROVEN) trial. (abstract). Eur Urol Suppl 3 (2004) 104
41. Hellstrom W.J.G., Kendirci M., Gittleman M., et al. Vardenafil improves penetration success rates from within 15 minutes to up to 8 hours from time of dosing to start of sexual activity. J Androl 25 suppl 1 (2004) 93 Poster 163
42. Aliotta P., Carson C., Murdoch M., et al. Vardenafil allows rapid initiation of sustainable erections in sildenafil nonresponders by history: PROVEN trial results. J Androl 25 suppl 1 (2004) 96 Poster 171
43. Porst H., Padma-Nathan H., Giuliano F., et al. Efficacy of tadalafil for the treatment of erectile dysfunction at 24 and 36 hours after dosing: a randomized controlled trial. Urology 62 (2003) 121-126
44. Young J.M., Feldman R.A., Auerbach S.M., et al. Tadalafil improved erectile function at 24 and 36 hours after dosing in men with erectile dysfunction: US trial. J Androl 26 (2005) 310-318
45. Carson C.C., Rajfer J., Eardley I., et al. The efficacy and safety of tadalafil: an update. BJU Int 93 (2004) 1276-1281
46. Hatzichristou D., Vardi Y., Papp G., et al. Effect of tadalafil on sexual timing behavior patterns in men with erectile dysfunction: integrated analysis of randomized, placebo-controlled trials. J Urol 174 (2005) 1356-1359
47. Rosen R.C., Broderick G.A., Shabsigh R., et al. Sensitivity of the Psychological and Interpersonal Relationship Scales to treatment for erectile dysfunction. (abstract). J Sex Med 1 suppl 1 (2004) 125
48. Buvat J., Lemaire A., Colson M.H., et al. Efficacy and tolerance of tadalafil in erectile dysfunction (ED): real world experience. (abstract). J Urol 171 suppl (2004) 240
49. Porst H., Arnds S., and Kleingarn M. The 3 PDE 5 inhibitors sildenafil, tadalafil and vardenafil: results of an independent intraindividual comparative study. (abstract). Eur Urol Suppl 3 (2004) 104
50. Porst H., Kleingarn M., and Arnds S. The two PDE 5 inhibitors sildenafil and tadalafil-results of an independent intraindividual comparative study. (abstract). Eur Urol Suppl 3 (2004) 27