Urology
Volume 61, Issue 4, Supplement 1 , Pages 8-14 , April 2003

Sustained efficacy and tolerability of vardenafil, a highly potent selective phosphodiesterase type 5 inhibitor, in men with erectile dysfunction: results of a randomized, double-blind, 26-week placebo-controlled pivotal trial

  • Wayne J.G. Hellstrom

      Affiliations

    • Department of Urology, Tulane University Medical Center, New Orleans, Louisiana, USA (WJGH)
    • Corresponding Author InformationReprint requests: Wayne J.G. Hellstrom, MD, Tulane University Medical Center, Department of Urology, 1430 Tulane Avenue, New Orleans, Louisiana 70112, USA.
    • ,
  • Marc Gittelman

      Affiliations

    • South Florida Medical Research, Aventura, Florida, USA (MG)
    • ,
  • Gary Karlin

      Affiliations

    • Lawrenceville Urology, Lawrenceville, New Jersey, USA (GK)
    • ,
  • Thomas Segerson

      Affiliations

    • Bayer Corporation, Pharmaceutical Division, West Haven, Connecticut, USA (TS, MT, TT)
    • ,
  • Marc Thibonnier

      Affiliations

    • Bayer Corporation, Pharmaceutical Division, West Haven, Connecticut, USA (TS, MT, TT)
    • ,
  • Terry Taylor

      Affiliations

    • Bayer Corporation, Pharmaceutical Division, West Haven, Connecticut, USA (TS, MT, TT)
    • ,
  • Harin Padma-Nathan

      Affiliations

    • Male Clinic, Beverly Hills, California, USA (HP-N)
    • ,
  • the Vardenafil Study Group

References 

  1. 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
  2. Derouet H, Zehl U. Treatment of erectile dysfunction with vacuum pumps. Urologe A. 1993;32:312–315
  3. Padma-Nathan H, Hellstrom WJ, Kaiser FE, et al.  Treatment of men with erectile dysfunction with transurethral alprostadil (Medicated Urethral System for Erection (MUSE) Study Group). N Engl J Med. 1997;336:1–7
  4. Purvis K, Egdetveit I, Christiansen E. Intracavernosal therapy for erectile failure-impact of treatment and reasons for drop-out and dissatisfaction. Int J Impot Res. 1999;11:287–299
  5. Lue T, Goldstein I, Traish A. Comparison of oral and intracavernosal vasoactive agents in penile erection. Int J Impot Res. 2000;12(suppl 1):S81–S88
  6. Montague DK, Angermeier KW. Future considerations (advances in the surgical management of erectile dysfunction). Int J Impot Res. 2000;12(suppl 1):S140–S143
  7. Burnett AL. Oral pharmacotherapy for erectile dysfunction (current perspectives). Urology. 1999;54:392–400
  8. Goldstein I, Lue TF, Padma-Nathan H, et al.  Oral sildenafil in the treatment of erectile dysfunction (Sildenafil Study Group). N Engl J Med. 1998;338:1397–1404
  9. Lyseng-Williamson KA, Wagstaff AJ. Management of erectile dysfunction (defining the role of sildenafil). Dis Manage Health Outcomes. 2002;10:431–452
  10. Lue TF. Erectile dysfunction. N Engl J Med. 2000;342:1802–1813
  11. Seftel A. Challenges in oral therapy for erectile dysfunction. J Androl. 2002;23:729–736
  12. Ormrod D, Easthope SE, Figgitt DP. Vardenafil. Drugs Aging. 2002;19:217–227
  13. 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
  14. Gbekor E, Betehell S, Fawcett L, et al.  Phosphodiesterase-5 inhibitor profiles against all human phosphodiesterase families (implications for use as pharmacological tools). J Urol. 2002;167:246
  15. Kim N, Huang Y-H, Goldstein I, et al.  Inhibition of cGMP hydrolysis in human corpus cavernosum smooth muscle cells by vardenafil, a novel phosphodiesterase type-5-selective inhibitor. Life Sci. 2001;69:2249–2256
  16. Hellstrom W, 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
  17. Goldstein I, Young J, Fischer J, et al.  Vardenafil, a new highly selective PDE5 inhibitor, significantly improved all IIEF domains and showed a favorable safety profile in patients with impaired erectile function and diabetes mellitus. Int J Impot Res. 2001;13(suppl 5):S64
  18. Brock G, Taylor T, Seger M  for the Vardenafil PROSPECT Group . Efficacy and tolerability of vardenafil in men with erectile dysfunction following radical prostatectomy. Eur Urol. 2002;1:152
  19. Cappelleri JC, Rosen RC, Smith MD, et al.  Diagnostic evaluation of the erectile function domain of the International Index of Erectile Function. Urology. 1999;54:346–351

☆ This study was funded by Bayer Corporation, Pharmaceutical DivisionWayne J. G. Hellstrom, Marc Gittelman, Gary Karlin, and Harin Padma-Nathan are study investigators funded by the sponsor.

PII: S0090-4295(03)00115-8

doi: 10.1016/S0090-4295(03)00115-8

Urology
Volume 61, Issue 4, Supplement 1 , Pages 8-14 , April 2003

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