The Journal of Urology
Volume 180, Issue 4 , Pages 1228-1234 , October 2008

Tadalafil Administered Once Daily for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Dose Finding Study

  • Claus G. Roehrborn

      Affiliations

    • Department of Urology, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas
    • Corresponding Author InformationCorrespondence: Department of Urology, University of Texas Southwestern Medical Center at Dallas, 5323 Harry Hines Blvd., Dallas, Texas 75390-9110 (telephone: 214-648-2941; FAX: 214-648-0365)
  • ,
  • Kevin T. McVary

      Affiliations

    • Department of Urology, Northwestern University, Chicago, Illinois
  • ,
  • Albert Elion-Mboussa

      Affiliations

    • Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana
  • ,
  • Lars Viktrup

      Affiliations

    • Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana

Received 9 June 2008

References 

  1. Wei JT, Calhoun E, Jacobsen SJ. Urologic Diseases in America Project: benign prostatic hyperplasia. J Urol. 2005;173:1256
  2. Jacobsen SJ, Jacobson DJ, Girman CJ, Roberts RO, Rhodes T, Guess HA, et al. Natural history of prostatism: risk factors for acute urinary retention. J Urol. 1997;158:481
  3. Sagnier PP, MacFarlane G, Teillac P, Botto H, Richard F, Boyle P. Impact of symptoms of prostatism on level of bother and quality of life of men in the French community. J Urol. 1995;153:669
  4. Norman RW, Nickel JC, Fish D, Pickett SN. ‘Prostate-related symptoms’ in Canadian men 50 years of age or older: prevalence and relationships among symptoms. Br J Urol. 1994;74:542
  5. American Urological Association (AUA) Benign Prostatic Hyperplasia (BPH) Guideline Update Panel: Guideline on the Management of Benign Prostatic Hyperplasia (BPH). American Urological Association 2006. URL:http://www.auanet.org/guidelines/bph.cfm2008;Accessed March 2008
  6. McConnell JD, Roehrborn CG, Bautista OM, Andriole GL, Dixon CM, Kusek JW, et al. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N Engl J Med. 2003;349:2387
  7. McVary KT, McKenna KE. The relationship between erectile dysfunction and lower urinary tract symptoms: epidemiological, clinical, and basic science evidence. Curr Urol Rep. 2004;5:251
  8. Forgue ST, Patterson BE, Bedding AW, Payne CD, Phillips DL, Wrishko RE, et al. Tadalafil pharmacokinetics in healthy subjects. Br J Clin Pharmacol. 2006;61:280
  9. Uckert S, Kuthe A, Jonas U, Stief CG. Characterization and functional relevance of cyclic nucleotide phosphodiesterase isoenzymes of the human prostate. J Urol. 2001;166:2484
  10. Filippi S, Morelli A, Sandner P, Fibbi B, Mancina R, Marini M, et al. Characterization and functional role of androgen-dependent PDE5 activity in the bladder. Endocrinology. 2007;148:1019
  11. Gacci M, Del PG, Macchiarella A, Celso M, Vittori G, Lapini A, et al. Vardenafil improves urodynamic parameters in men with spinal cord injury: results from a single dose, pilot study. J Urol. 2007;178:2040
  12. Azadzoi KM, Babayan RK, Kozlowski R, Siroky MB. Chronic ischemia increases prostatic smooth muscle contraction in the rabbit. J Urol. 2003;170:659
  13. Berger AP, Deibl M, Leonhartsberger N, Bektic J, Horninger W, Fritsche G, et al. Vascular damage as a risk factor for benign prostatic hyperplasia and erectile dysfunction. BJU Int. 2005;96:1073
  14. Pinggera GM, Mitterberger M, Pallwein L, Schuster A, Herwig R, Frauscher F, et al. Alpha-blockers improve chronic ischaemia of the lower urinary tract in patients with lower urinary tract symptoms. BJU Int. 2008;101:319
  15. Andersson KE, Uckert S, Stief C, Hedlund P. Phosphodiesterases (PDEs) and PDE inhibitors for treatment of LUTS. Neurourol Urodyn. 2007;26:928
  16. Ehren I, Iversen H, Jansson O, Adolfsson J, Wiklund NP. Localization of nitric oxide synthase activity in the human lower urinary tract and its correlation with neuroeffector responses. Urology. 1994;44:683
  17. Yoshimura N, Seki S, de Groat WC. Nitric oxide modulates Ca(2+) channels in dorsal root ganglion neurons innervating rat urinary bladder. J Neurophysiol. 2001;86:304
  18. Persson K, Andersson KE. Nitric oxide and relaxation of pig lower urinary tract. Br J Pharmacol. 1992;106:416
  19. McVary KT, Roehrborn CG, Kaminetsky JC, Auerbach SM, Wachs B, Young JM, et al. Tadalafil relieves lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol. 2007;177:1401
  20. StatXact Procs for SAS Users: Statistical Software for Exact Nonparametric Inference (User Manual), version 6. Cambridge, Massachusetts: Cytel Software Corp; 2004;
  21. Barry MJ, Williford WO, Chang Y, Machi M, Jones KM, Walker-Corkery E, et al. Benign prostatic hyperplasia specific health status measures in clinical research: how much change in the American Urological Association symptom index and the benign prostatic hyperplasia impact index is perceptible to patients?. J Urol. 1995;154:1770
  22. Dunn CJ, Matheson A, Faulds DM. Tamsulosin: a review of its pharmacology and therapeutic efficacy in the management of lower urinary tract symptoms. Drugs Aging. 2002;19:135
  23. McVary KT, Monnig W, Camps JL, Young JM, Tseng LJ, van den EG. Sildenafil citrate improves erectile function and urinary symptoms in men with erectile dysfunction and lower urinary tract symptoms associated with benign prostatic hyperplasia: a randomized, double-blind trial. J Urol. 2007;177:1071
  24. Stief CG, Porst H, Neuser D, Beneke M, Ulbrich E. A randomised, placebo-controlled study to assess the efficacy of twice-daily vardenafil in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. Eur Urol. 2008;53:1236
  25. Porst H, Giuliano F, Glina S, Ralph D, Casabe AR, Elion-Mboussa A, et al. Evaluation of the efficacy and safety of once-a-day dosing of tadalafil 5 mg and 10 mg in the treatment of erectile dysfunction: results of a multicenter, randomized, double-blind, placebo-controlled trial. Eur Urol. 2006;50:351
  26. Rajfer J, Aliotta PJ, Steidle CP, Fitch WP, Zhao Y, Yu A. Tadalafil dosed once a day in men with erectile dysfunction: a randomized, double-blind, placebo-controlled study in the US. Int J Impot Res. 2007;19:95

 Study received approval from the institutional review board at each site.

 Supported by Eli Lilly and Co. (CR, KTM).

 Registered on clinicaltrials.gov (registration number NCT00384930).

 For another article on a related topic see page 1551.

PII: S0022-5347(08)01715-1

doi: 10.1016/j.juro.2008.06.079

The Journal of Urology
Volume 180, Issue 4 , Pages 1228-1234 , October 2008