Effectiveness of tadalafil 5mg once daily in the treatment of men with lower urinary tract symptoms suggestive to benign prostatic hyperplasia with or without erectile dysfunction: Results from naturalistic observational tadalutsed study

Journal of Sexual Medicine

Volumn 11, Issue 2, 2014, Pages 498-505

  Bechara, Amado ^a   Casabe, Adolfo ^b   Rodriguez Baigorri, Gustavo ^c   Cobreros, Christian ^d  

^a HOSPITAL DURAND   (Argentina)

^b The Middlesex Hospital   (Argentina)

^c Tornu Hospital   (Argentina)

^d Instituto Urológico de Buenos Aires   (Argentina)

Author keywords

Benign Prostatic Hyperplasia; Erectile Dysfunction; IIEF; IPSS; Lower Urinary Tract Symptoms; Phosphodiesterase 5 Inhibitor; Tadalafil

Indexed keywords

TADALAFIL; CARBOLINE DERIVATIVE; PHOSPHODIESTERASE V INHIBITOR;

ADULT; AGED; ARTICLE; BACKACHE; DRUG EFFICACY; DRUG SAFETY; DYSPEPSIA; ERECTILE DYSFUNCTION; HEADACHE; HEART PALPITATION; HUMAN; LOWER URINARY TRACT SYMPTOM; MAJOR CLINICAL STUDY; MALE; MEDICAL PRACTICE; MULTICENTER STUDY; OBSERVATIONAL STUDY; PRIORITY JOURNAL; PROSTATE HYPERTROPHY; QUALITY OF LIFE; QUESTIONNAIRE; SCORING SYSTEM; SEXUAL BEHAVIOR; TREATMENT OUTCOME; DOUBLE BLIND PROCEDURE; DRUG ADMINISTRATION; INTERNATIONAL INDEX OF ERECTILE FUNCTION; IPSS; MIDDLE AGED; PROSPECTIVE STUDY; VERY ELDERLY;

BENIGN PROSTATIC HYPERPLASIA; ERECTILE DYSFUNCTION; IIEF; IPSS; LOWER URINARY TRACT SYMPTOMS; PHOSPHODIESTERASE 5 INHIBITOR; TADALAFIL;

AGED; AGED, 80 AND OVER; CARBOLINES; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; ERECTILE DYSFUNCTION; HUMANS; LOWER URINARY TRACT SYMPTOMS; MALE; MIDDLE AGED; PHOSPHODIESTERASE 5 INHIBITORS; PROSPECTIVE STUDIES; PROSTATIC HYPERPLASIA; QUESTIONNAIRES; TREATMENT OUTCOME;

EID: 84899481482     PISSN: 17436095     EISSN: 17436109     Source Type: Journal    
DOI: 10.1111/jsm.12386     Document Type: Article

References (41)

1. Chute CG, Panser LA, Girman CJ, Oesterling JE, Guess HA, Jacobsen SJ, Lieber MM. The prevalence of prostatism: A population-based survey of urinary symptoms. J Urol 1993;150:85-89.
2. Kupelian V, Wei JT, O'Leary MP, Kusek JW, Litman HJ, Link CL, McKinlay JB. Prevalence of lower urinary tract symptoms and effect on quality of life in a racially and ethnically diverse random sample: The Boston Area Community Health (BACH) Survey. Arch Intern Med 2006;166:2381-2387.
3. Jacobsen SJ, Jacobson DJ, Girman CJ, Roberts RO, Rhodes T, Guess HA, Lieber MM. Treatment for benign prostatic hyperplasia among community dwelling men: The Olmsted County Study of Urinary Symptoms and Health Status. J Urol 1999;162:1301-1306.
4. Anderson JB, Roehrborn CG, Schalken JA, Emberton M. The progression of benign prostatic hyperplasia: Examining the evidence and determining the risk. Eur Urol 2001;39:390-399.
5. Roehrborn CG, Boyle P, Bergner D, Gray T, Gittelman M, Shown T, Melman A, Bracken RB, deVere White R, Taylor A, Wang D, Waldstreicher J. Serum prostate-specific antigen and prostate volume predict long-term changes in symptoms and flow rate: Results of a four-year, randomized trial comparing finasteride versus placebo. PLESS Study Group. Urology 1999;54:662-669.
6. American Urological Association Practice Guidelines Committee. AUA guidelines on management of benign prostatic hyperplasia. Linthicum, MD: American Urological Association; 2010.
7. Oelke M, Bachmann A, Descazeaud A, Emberton M, Gravas S, Michel MC, N'Dow J, Nordling J, de la Rosette JJ. Guidelines on the management of male lower urinary tract symptoms (LUTS), incl. benign prostatic obstruction (BPO). Eur Urol 2013;64:118-140.
8. Djavan B, Marberger M. A meta-analysis on the efficacy and tolerability of α1-adrenoceptor antagonists in patients with lower urinary tract symptoms suggestive of benign prostatic obstruction. Eur Urol 1999;36:1-13.
9. Lukacs B, McCarthy C, Grange JC. Long-term quality of life in patients with benign prostatic hypertrophy: Preliminary results of a cohort survey of 7093 patients treated with alpha-1 adrenergic blocker, alfuzosin. QoL BPH Study Group in General Practice. Eur Urol 1993;24(suppl 1):34-40.
10. Lepor H. Long-term evaluation of tamsulosin in benign prostatic hyperplasia: Placebo-controlled, double-blind extension of phase III trial. Tamsulosin Investigator Group. Urology 1998;51:901-906.
11. Debruyne F, Barkin J, van Erps P, Reis M, Tammela TL, Roehrborn C. Efficacy and safety of long-term treatment with the dual 5-alpha-reductase inhibitor dutasteride in men with symptomatic benign prostatic hyperplasia. Eur Urol 2004;46:488-494.
12. Roehrborn CG, Siami P, Barkin J, Damião R, Major-Walker K, Nandy I, Morrill BB, Gagnier RP, Montorsi F; CombAT Study Group. The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT Study. Eur Urol 2010;57:123-131.
13. Kaplan SA, Roehrborn CG, Chancellor M, Carlsson M, Bavendam T, Guan Z. Extended-release tolterodine with or without tamsulosin in men with lower urinary tract symptoms and overactive bladder: Effects on urinary symptoms assessed by the International Prostate Symptom Score. BJU Int 2008;102:1133-1139.
14. McConnell JD, Roehrborn CG, Bautista OM, Andriole GL Jr, Dixon CM, Kusek JW, Lepor H, McVary KT, Nyberg LM Jr, Clarke HS, Crawford ED, Diokno A, Foley JP, Foster HE, Jacobs SC, Kaplan SA, Kreder KJ, Lieber MM, Lucia MS, Miller GJ, Menon M, Milam DF, Ramsdell JW, Schenkman NS, Slawin KM, Smith JA; Medical Therapy of Prostatic Symptoms Research Group. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N Engl J Med 2003;349:2387-2398.
15. Porst H, Kim ED, Casabé AR, Mirone V, Secrest RJ, Xu L, Sundin DP, Viktrup L; LVHJ Study Team. Efficacy and safety of tadalafil once daily in the treatment of men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: Results of an international randomized, double-blind, placebo-controlled trial. Eur Urol 2011;60:1105-1113.
16. Donatucci CF, Brock GB, Goldfischer ER, Pommerville PJ, Elion-Mboussa A, Kissel JD, Viktrup L. Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: A 1-year, open-label extension study. BJU Int 2011;107:1110-1116.
17. Gacci M, Corona G, Salvi M, Vignozzi L, McVary KT, Kaplan SA, Roehrborn CG, Serni S, Mirone V, Carini M, Maggi M. A systematic review and meta-analysis on the use of phosphodiesterase 5 inhibitors alone or in combination with α-blockers for lower urinary tract symptoms due to benign prostatic hyperplasia. Eur Urol 2012;61:994-1003.
18. Egerdie RB, Auerbach S, Roehrborn CG, Costa P, Garza MS, Esler AL, Wong DG, Secrest RJ. Tadalafil 2.5 or 5mg administered once daily for 12 weeks in men with both erectile dysfunction and signs and symptoms of benign prostatic hyperplasia: Results of a randomized, placebo-controlled, double-blind study. J Sex Med 2012;9:271-281.
19. Roehrborn CG, McVary KT, Elion-Mboussa A, Viktrup L. Tadalafil administered once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia: A dose finding study. J Urol 2008;180:1228-1234.
20. Pocock SJ, Elbourne DR. Randomized trials or observational tribulations? N Engl J Med 2000;342:1907-1909.
21. Black N. Why we need observational studies to evaluate the effectiveness of health care. BMJ 1996;312:1215-1218.
22. Benson K, Hartz AJ. A comparison of observational studies and randomised, controlled trials. N Engl J Med 2000;342:1878-1886.
23. Wayne AR. Evaluating medication effects outside of clinical trials: New-user designs. Am J Epidemiol 2003;158:915-920.
24. Barry MJ, Fowler FJ Jr, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebusk WK, Cockett AT. The American Urological Association Symptom Index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol 1992;148:1549-1557.
25. Badia X, Garcia-Losa M, Dal-Re R. Ten language translation and harmonization of International Prostate Symptom Score: Developing a methodology for multinational clinical trials. Eur Urol 1997;31:129-140.
26. Cappelleri JC, Siegel RL, Glasser DB, Osterloh IH, Rosen RC. Relationship between patient self-assessment of erectile function and the Sexual Health Inventory for Men. Clin Ther 2001;23:1707-1719.
27. Cappelleri JC, Rosen RC. The Sexual Health Inventory for Men (SHIM): A 5-year review of research and clinical experience. Int J Impot Res 2005;17:307-319.
28. Gift AG. Visual analogue scales: Measurement of subjective phenomena. Nurs Res 1989;38:286-288.
29. Gould D, Kelly D, Goldstone L, Gammon J. Examining the validity of pressure ulcer risk assessment scales: Developing and using illustrated patient simulations to collect the data. J Clin Nurs 2001;10:697-706.
30. Gacci M, Sebastianelli A, Salvi M, Vignozzi L, Corona G, McVary KT, Kaplan SA, Oelke M, Maggi M, Carini M. PDE5-Is for the Treatment of Concomitant ED and LUTS/BPH. Curr Bladder Dysfunct Rep 2013;8:150-159.
31. McVary KT, Roehrborn CG, Kaminetsky JC, Auerbach SM, Wachs B, Young JM, Esler A, Sides GD, Denes BS. Tadalafil relieves lower urinary tract symptoms secondary to benign prostatic hyperplasia. J Urol 2007;177:1401-1407.
32. Andersson K, de Groat W, McNary K, Lue T, Maggi M, Roehrborn C, Wyndale J, Melby T, Viktrup L. Tadalafil for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia: Pathophysiology and mechanism of action. Neurourol Urodyn 2011;30:292-301.
33. Broderick G, Brock G, Roehrborn C, Watts S, Elion-Mboussa A, Viktrupen L. Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia in men with or without erectile dysfunction. Urology 2010;75:1452-1459.
34. Porst H, Roehrborn CG, Secrest RJ, Esler A, Viktrup L. Effects of tadalafil on lower urinary tract symptoms secondary to benign prostatic hyperplasia and on erectile dysfunction in sexually active men with both conditions: Analyses of pooled data from four randomized, placebo-controlled tadalafil clinical studies. J Sex Med 2013;10:2044-2052.
35. Rosen R, Altwein J, Boyle P, Kirby RS, Lukacs B, Meuleman E, O'Leary M, Puppo P, Robertson C, Giuliano F. Lower urinary tract symptoms and male sexual dysfunction: The multinational survey of the aging male (MSAM-7). Eur Urol 2003;44:637-649.
36. Moncada I. LUTS: A risk factor for sexual dysfunction in the BPH patient. Eur Urol Supplements 2003;2:3-8.
37. Orabi H, Albersen M, Lue TF. Association of lower urinary tract symptoms and erectile dysfunction: Pathophysiological aspects and implications for clinical management. Int J Impot Res 2011;23:99-108.
38. Oelke M, Giuliano F, Mirone V, Xu L, Cox D, Viktrup L. Monotherapy with tadalafil or tamsulosin similarly improved lower urinary tract symptoms suggestive of benign prostatic hyperplasia in an international, randomised, parallel, placebo-controlled clinical trial. Eur Urol 2012;61:917-925.
39. Bechara A, Romano S, Casabé A, Haime S, Dedola P, Hernández C, Rey H. Comparative efficacy assessment of tamsulosin vs. tamsulosin plus tadalafil in the treatment of LUTS/BPH pilot study. J Sex Med 2008;5:2170-2178.
40. Liguori G, Trombetta C, De Giorgi G, Pomara G, Maio G, Vecchio D, Ocello G, Ollandini G, Bucci S, Belgrano E. Efficacy and safety of combined oral therapy with tadalafil and alfuzosin: An integrated approach to the management of patients with lower urinary tract symptoms and erectile dysfunction. Preliminary report. J Sex Med 2009;6:544-552.
41. Giuliano F, Oelke M, Jungwirth A, Hatzimouratidis K, Watts S, Cox D, Viktrup L. Tadalafil once daily improves ejaculatory function, erectile function, and sexual satisfaction in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia and erectile dysfunction: Results from a randomized, placebo- and tamsulosin-controlled, 12-week double-blind study. J Sex Med 2013;10:857-865.