European Urology
Volume 50, Issue 5 , Pages 1086-1095 , November 2006

Extended Duration of Efficacy of Vardenafil When Taken 8 Hours Before Intercourse: A Randomized, Double-Blind, Placebo-Controlled Study

  • Hartmut Porst

      Affiliations

    • Urological Practice, Hamburg, Germany
    • Corresponding Author InformationCorresponding author. Urological Practice, Neuer Jungfernstieg 6a, 20354 Hamburg, Germany. Tel. +49 40 34 61 84; Fax: +49 40 35 11 17.
    • ,
  • Ira D. Sharlip

      Affiliations

    • University of California, San Francisco, California, USA
    • ,
  • Dimitris Hatzichristou

      Affiliations

    • Aristotle University of Thessaloniki, Thessaloniki, Greece
    • ,
  • Eusebio Rubio-Aurioles

      Affiliations

    • Asociación Mexicana Para la Salud Sexual, Tlalpan, Mexico
    • ,
  • Marc Gittelman

      Affiliations

    • South Florida Medical Research, Aventura, Florida, USA
    • ,
  • Britt-Nicole Stancil

      Affiliations

    • GlaxoSmithKline, Research Triangle Park, North Carolina, USA
    • ,
  • Peter M. Smith

      Affiliations

    • GlaxoSmithKline, Research Triangle Park, North Carolina, USA
    • ,
  • H. Jeffrey Wilkins

      Affiliations

    • GlaxoSmithKline, King of Prussia, Pennsylvania, USA
    • ,
  • Peter Pommerville

      Affiliations

    • Can-Med Clinical Research Inc., Victoria, British Columbia, Canada
    • ,
  • for the Vardenafil Study Group

,Accepted 18 May 2006.

References 

  1. McKinlay JB. The worldwide prevalence and epidemiology of erectile dysfunction. Int J Impot Res. 2000;12:S6–S11
  2. Aytaç 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. Althof SE. Quality of life and erectile dysfunction. Urology. 2002;59:803–810
  4. Meyer J-P, Gillatt DA, Lockyer R, Macdonagh R. The effect of erectile dysfunction on the quality of life of men after radical prostatectomy. BJU Int. 2003;92:929–931
  5. De Berardis G, Franciosi M, Belfiglio M, et al. for the Quality of Care and Outcomes in Type 2 Diabetes (QuED) Study Group Erectile dysfunction and quality of life in type 2 diabetic patients. A serious problem too often overlooked. Diabetes Care. 2002;25:284–291
  6. Guest JF, Das Gupta R. Health-related quality of life in a UK-based population of men with erectile dysfunction. Pharmacoeconomics. 2002;20:109–117
  7. Montague DK, Jarow JP, Broderick GA, et al. The Erectile Dysfunction Guideline Update Panel. The management of erectile dysfunction: an AUA update. J Urol. 2005;174:230–239
  8. Montorsi F, Briganti A, Salonia A, Montorsi P, Rigatti P. The use of phosphodiesterase type 5 inhibitors for erectile dysfunction. Curr Opin Urol. 2004;14:357–359
  9. Guay AT, Spark RF, Bansal S, et al. The American Association of Clinical Endocrinologists. Male Sexual Dysfunction Task Force. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the evaluation and treatment of male sexual dysfunction: a couple's problem-2003 update. Endocr Pract 2003;9:77–95.
  10. Hellstrom WJG, Gittelman M, Karlin G, et al. on behalf of the Vardenafil Study Group 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
  11. Hatzichristou D, Montorsi F, Buvat J, Laferriere N, Bandel T-J, Porst H for the European Vardenafil Study Group. The efficacy and safety of flexible-dose vardenafil (Levitra®) in a broad population of European men. Eur Urol. 2004;45:634–641
  12. Brock G, Nehra A, Lipshultz LI, et al. Safety and efficacy of vardenafil for the treatment of men with erectile dysfunction after radical retropubic prostatectomy. J Urol. 2003;170:1278–1283
  13. 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;26:777–783
  14. Carson CC, Hatzichristou DG, Carrier S, et al. for the Patient Response with Vardenafil in Sildenafil Non-Responders (PROVEN) Study Group Erectile response with vardenafil in sildenafil nonresponders: a multicentre, double-blind, 12-week, flexible-dose, placebo-controlled erectile dysfunction clinical trial. BJU Int. 2004;94:1301–1309
  15. Stief C, Porst H, Sáenz de Tejada I, Ulbrich E, Beneke M for the Vardenafil Study Group. Sustained efficacy and tolerability with vardenafil over 2 years of treatment in men with erectile dysfunction. Int J Clin Pract. 2004;58:230–239
  16. Potempa A-J, Ulbrich E, Bernard I, Beneke M on behalf of the Vardenafil Study Group. Efficacy of vardenafil in men with erectile dysfunction: a flexible dose community practice study. Eur Urol. 2004;46:73–79
  17. Montorsi F, Salonia A, Briganti A, et al. Vardenafil for the treatment of erectile dysfunction: a critical review of the literature based on personal clinical experience. Eur Urol. 2005;47:612–621
  18. Fisher W, Eardley I, Rosen R, Niederberger C, Sand M. Sexual ecology of men with ED: Timing, periodicity and predictability of sexual activity of men in the MALES 2004 Study. J Sex Med. 2005;2:19
  19. Fisher WA, Rosen RC, Eardley I, Sand M, Goldstein I. Sexual experience of female partners of men with erectile dysfunction: the Female Experience of Men's Attitudes to Life Events and Sexuality (FEMALES) study. J Sex Med. 2005;2:675–684
  20. Valiquette L, Montorsi F, Hellstrom WJG, et al. for the Vardenafil Study Group Penetration and maintenance of erection with vardenafil: a time-from-dosing analysis. Can J Urol. 2005;12:2687–2698
  21. Montorsi F, Padma-Nathan H, Buvat J, et al. for the Vardenafil Study Group 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;1:168–178
  22. Wincze J, Rosen R, Carson C, et al. Erection quality scale: initial scale development and validation. Urology. 2004;64:351–356
  23. Fisher WA, Rosen RC, Mollen M, et al. for the Vardenafil Study Group Improving the sexual quality of life of couples affected by erectile dysfunction: a double-blind, randomized, placebo-controlled trial of vardenafil. J Sex Med. 2005;2:699–708
  24. Valiquette L, Young J, Moncada I, et al. for the Vardenafil Study Group Sustained efficacy and safety of vardenafil for treatment of erectile dysfunction: a randomized, double-blind, placebo-controlled study. Mayo Clin Proc. 2005;80:1291–1297
  25. Cappelleri JC, Siegel RL, Osterloh IH, Rosen RC. Relationship between patient self-assessment of erectile function and the erectile function domain of the international index of erectile function. Urology. 2000;56:477–481
  26. Porst H, Lunglmayr G. Deutsch-Osterreichische STEADY-Studiengruppe. [Efficacy and tolerability of vardenafil within the time window of 6 hours after administration and beyond]. MMW Fortschr Med. 2005;147:43
  27. Sotomayor M, van Ahlen H, Salonia A, et al. Vardenafil on demand compared with tadalafil administered 24 hours before sexual intercourse in patients with ED. XVII World Congress of Sexology, Montreal, Canada, 10–15 July 2005.
  28. Corbin JD, Francis SH. Pharmacology of phosphodiesterase-5 inhibitors. Int J Clin Pract. 2002;56:453–459
  29. Blount MA, Beasley A, Zoraghi R, et al. Binding of tritiated sildenafil, tadalafil, or vardenafil to the phosphodiesterase-5 catalytic site displays potency, specificity, heterogeneity, and cGMP stimulation. Mol Pharmacol. 2004;66:144–152
  30. Bischoff E. Vardenafil preclinical trial data: potency, pharmacodynamics, pharmacokinetics, and adverse events. Int J Impot Res. 2004;16:S34–S37

PII: S0302-2838(06)00651-8

doi: 10.1016/j.eururo.2006.05.036

European Urology
Volume 50, Issue 5 , Pages 1086-1095 , November 2006

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