Vardenafil allows successful intercourse initiated rapidly after dosing in japanese patients with diabetes mellitus and erectile dysfunction

Journal of Sexual Medicine

Volumn 6, Issue 10, 2009, Pages 2851-2857

  Nagao, Koichi ^a   Kobayashi, Hideyuki ^a   Fujikawa, Keita ^b   Tachibana, Takashi ^b   Iwamoto, Yasuhiko ^c   Ishii, Nobuhisa ^a   Turek, Paul J ^d   Brant, William O ^e   Kamidono, Sadao ^f  

^a TOHO UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^b BAYER YAKUHIN LTD   (Japan)

^c TOKYO WOMEN'S MEDICAL UNIVERSITY   (Japan)

^d Turek Clinic   (United States)

^e UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

^f Kobe Red Cross Hospital   (Japan)

Author keywords

Diabetes; Erectile dysfunction; Onset of action; Vardenafil

Indexed keywords

PLACEBO; VARDENAFIL; IMIDAZOLE DERIVATIVE; PHOSPHODIESTERASE INHIBITOR; PIPERAZINE DERIVATIVE; SULFONE; TRIAZINE DERIVATIVE; VASODILATOR AGENT;

ADULT; AGE DISTRIBUTION; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIABETES MELLITUS; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; ERECTILE DYSFUNCTION; HOT FLUSH; HUMAN; JAPANESE; MAJOR CLINICAL STUDY; MALE; OPTIC NERVE DISEASE; PRIORITY JOURNAL; RETROSPECTIVE STUDY; RHINOPHARYNGITIS; SEXUAL BEHAVIOR; SEXUAL INTERCOURSE; TREATMENT DURATION; COITUS; COMPLICATION; DIABETES COMPLICATIONS; DOUBLE BLIND PROCEDURE; JAPAN; MIDDLE AGED; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; TIME; YOUNG ADULT;

ADULT; COITUS; DIABETES COMPLICATIONS; DOUBLE-BLIND METHOD; ERECTILE DYSFUNCTION; HUMANS; IMIDAZOLES; JAPAN; MALE; MIDDLE AGED; PHOSPHODIESTERASE INHIBITORS; PIPERAZINES; RETROSPECTIVE STUDIES; SULFONES; TIME FACTORS; TRIAZINES; VASODILATOR AGENTS; YOUNG ADULT;

EID: 70649089532     PISSN: 17436095     EISSN: 17436109     Source Type: Journal    
DOI: 10.1111/j.1743-6109.2009.01439.x     Document Type: Article

References (38)

1. Panel on Impotence NIH Consensus Conference: Impotence. JAMA 1993, 270:83-90. NIH Consensus Development
2. Vinik A, Richardson D. Erectile dysfunction in diabetes. Diabetes Rev 1998, 6:16-33.
3. Fedele D, Coscelli C, Santeusanio F, Bortolotti A, Chatenoud L, Colli E, Landoni M, Parazzini F. Erectile dysfunction in diabetic subjects in Italy. Diabetes Care 1998, 21:1973-7.
4. Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: Prevalence and predictors. JAMA 1999, 281:537-44.
5. De Berardis G, Franciosi M, Belfiglio M, Di Nardo B, Greenfield S, Kaplan SH, Pellegrini F, Sacco M, Tognoni G, Valentini M, Nicolucci A. Erectile dysfunction and quality of life in type 2 diabetic patients: A serious problem too often overlooked. Diabetes Care 2002, 25:284-91.
6. Shabsigh R, Klein LT, Seidman S, Kaplan SA, Lehrhoff BJ, Ritter JS. Increased incidence of depressive symptoms in men with erectile dysfunction. Urology 1998, 52:848-52.
7. Saenz de Tejada I, Angulo J, Cuevas P, Fernandez A, Moncada I, Allona A, Lledo E, Korschen HG, Niewohner U, Haning H, Pages E, Bischoff E. The phosphodiesterase inhibitory selectivity and the in vitro and in vivo potency of the new PDE5 inhibitor vardenafil. Int J Impot Res 2001, 13:282-90.
8. Bischoff E, Schneider K. A conscious-rabbit model to study vardenafil hydrochloride and other agents that influence penile erection. Int J Impot Res 2001, 13:230-5.
9. Kim NN, Huang YH, Goldstein I, Bischoff E, Traish AM. Inhibition of cyclic GMP hydrolysis in human corpus cavernosum smooth muscle cells by vardenafil, a novel, selective phosphodiesterase type 5 inhibitor. Life Sci 2001, 69:2249-56.
10. Traish A, Kim N. Is Vardenafil " noninferior" or superior to sildenafil in the management of erectile dysfunction? Revisiting the biochemical, physiological, and clinical evidence. J Sex Med 2008, 5:1762-8.
11. Hellstrom W, Gittelman M, Karlin G, Thibonnier M, Padma-Nathan H. Vardenafil for treatment of men with erectile dysfunction: Efficacy and safety in a randomized, double-blind, placebo-controlled trial. J Androl 2002, 23:763-71.
12. Nagao K, Ishii N, Kamidono S, Osada T. Safety and efficacy of vardenafil (BAY38-9456) in patients with erectile dysfunction: A phase IIb study in Japan. Int J Urol 2004, 11:515-24.
13. Chen KK, Paick JS, Ishii N. The efficacy and safety of Vardenafil in East Asian men with erectile dysfunction. J Sex Med 2007, 4:753-61.
14. Brock G, Nehra A, Lipshultz LI, Karlin GS, Gleave M, Seger M, Padma-Nathan H. Safety and efficacy of vardenafil for the treatment of men with erectile dysfunction after radical retropubic prostatectomy. J Urol 2003, 170:1278-83.
15. Carson C, Hatzichristou D, Carrier S, Lording D, Young J. Murdoch M, for the Vardenafil Study Group. Vardenafil exhibits efficacy in men with erectile dysfunction unresponsive to prior sildenafil therapy: Results of a Phase III Clinical trial-Patient Response with Vardenafil in Sildenafil Nonresponders (PROVEN). Int J Impot Res 2003, 15:S175.
16. Miner M, Gilderman L, Bailen J, Cook D, Dawson K, Stanislaus M, Beresford E, Barnes A. Vardenafil in men with stable statin therapy and dyslipidemia. J Sex Med 2008, 5:1455-67. Epub March 26, 2008
17. Azadzoi KM, Saenz de Tejada I. Diabetes mellitus impairs neurogenic and endothelium-dependent relaxation of rabbit corpus cavernosum smooth muscle. J Urol 1992, 148:1587-91.
18. Ayan S, Yildirim S, Ucar C, Sarioglu Y, Gultekin Y, Butuner C. Corporal reactivity to adenosine and prostaglandin E1 in alloxan-induced diabetic rabbit corpus cavernosum, and the effect of insulin therapy. BJU Int 1999, 83:108-12.
19. Ishii N, Nagao K, Fujikawa K, Tachibana T, Iwamoto Y, Kamidono S. Vardenafil 20 mg demonstrated superior efficacy to 10 mg in Japanese men with diabetes mellitus suffering from erectile dysfunction. Int J Urol 2006, 13:1066-72.
20. Montorsi F, Padma-Nathan H, Buvat J, Schwaibold H, Beneke M, Ulbrich E, Bandel TJ, Porst H. Earliest time to onset of action leading to successful intercourse with vardenafil determined in an at-home setting: A randomized, double-blind, placebo-controlled trial. J Sex Med 2004, 1:168-78.
21. Eardley I, Dean J, Barnes T, Kirby M, Glasser D, Solanki J. The sexual habits of British men and women over 40 years old. BJU Int 2004, 93:563-7.
22. Manecke RG, Mulhall JP. Medical treatment of erectile dysfunction. Ann Med 1999, 31:388-98.
23. Lue TF. Erectile dysfunction. N Engl J Med 2000, 342:1802-13.
24. Montorsi F, Althof SE, Sweeney M, Menchini-Fabris F, Sasso F, Giuliano F. Treatment satisfaction in patients with erectile dysfunction switching from prostaglandin E(1) intracavernosal injection therapy to oral sildenafil citrate. Int J Impot Res 2003, 15:444-9.
25. Montorsi F, Salonia A, Zanoni M, Pompa P, Cestari A, Guazzoni G, Barbieri L, Rigatti P. Current status of local penile therapy. Int J Impot Res 2002, 14:S70-81.
26. Kimoto Y, Fujikawa K, Tachibana T, Yamamoto N, Otani T. Uptitration of Vardenafil dose from 10 mg to 20 mg improved erectile function in men with spinal cord injury. Int J Urol 2006, 13:1428-33.
27. Padma-Nathan H, Montorsi F, Giuliano F, Meuleman E, Auerbach S, Eardley I, McCullough A, Homering M, Segerson T. Vardenafil restores erectile function to normal range in men with erectile dysfunction. J Sex Med 2007, 4:152-61.
28. Goldstein I, Young JM, Fischer J, Bangerter K, Segerson T, Taylor T. Vardenafil, a new phosphodiesterase type 5 inhibitor, in the treatment of erectile dysfunction in men with diabetes: A multicenter double-blind placebo-controlled fixed-dose study. Diabetes Care 2003, 26:777-83.
29. Hatzicristou D, Gambla M, Rubio-Auriolest E, Buvat J, Brocks GB, Speral G, Rose L, Loading D, Liang S. Efficacy of tadalafil once daily in men with diabetes mellitus and erectile dysfunction. Diabet Med 2008, 25:138-46.
30. Ziegler D, Merfort F, van Ahlen H, Yassin A, Reblin T, Neureither M. Efficacy and safety to flexible-dose vardenafil in men with type 1 diabetes and erectile dysfunction. J Sex Med 2006, 3:883-91.
31. Vardi M, Nini A. Phosphodiesterase inhibitors for erectile dysfunction in patients with diabetes mellitus. Cochrane Database Syst Rev 2007, 1.
32. Padma-Nathan H, Stecher VJ, Sweeney M, Orazem J, Tseng LJ, Deriesthal H. Minimal time to successful intercourse after sildenafil citrate: Results of a randomized, double-blind, placebo-controlled trial. Urology 2003, 62:400-3.
33. Rosen RC, Padma-Nathan H, Shabsigh R, Saikali K, Watkins V, Pullman W. 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 2004, 1:193-200.
34. Cheng E. Real-life safety and efficacy of vardenafil in the treatment of erectile dysfunction-Results from 30,010 U.S. patients. J Sex Med 2007, 4:432-9.
35. Valiquette L, Montorsi F, Auerbach S. Vardenafil demonstrates first-dose success and reliability of penetration and maintenance of erection in men with erectile dysfunction-RELY-II. Can Urol Assoc J 2008, 2:187-95.
36. Althof SE. Quality of life and erectile dysfunction. Urology 2002, 59:803-10.
37. Rosen R, Goldstein I, Huang XY, Bangerter K, Taylor T. The Treatment Satisfaction Scale (TSS) is a sensitive measure of treatment effectiveness for both patients and partners: Results of a randomized controlled trial with vardenafil. J Sex Med 2007, 4:1009-21. 4 Pt 1
38. Martin-Morales A, Meijide F, Garcia N, Artes M, Munoz A. Efficacy of vardenafil and influence on self-esteem and self-confidence in patients with severe erectile dysfunction. J Sex Med 2007, 4:440-7.