Combined medical treatment using dutasteride and tamsulosin for lower urinary tract symptoms suggestive of benign prostatic hyperplasia

Expert Opinion on Pharmacotherapy

Volumn 11, Issue 15, 2010, Pages 2535-2547

  Djavan, Bob ^a   Handl, Markus Johannes ^a   Dianat, Saeid ^a  

^a NEW YORK UNIVERSITY   (United States)

Author keywords

Benign prostate hyperplasia; Combination therapy; Dutasteride; Lower urinary tract symptoms; Tamsulosin

Indexed keywords

4 [3 [3 [BIS(4 ISOBUTYLPHENYL)METHYLAMINO]BENZOYL] 1H INDOL 1 YL]BUTYRIC ACID; ALFUZOSIN; ANDROSTANOLONE; DOXAZOSIN; DUODART; DUTASTERIDE; FINASTERIDE; NAFTOPIDIL; PROSTATE SPECIFIC ANTIGEN; SILODOSIN; TAMSULOSIN; TERAZOSIN; UNCLASSIFIED DRUG;

BLADDER NECK STENOSIS; BREAST TENDERNESS; CANCER PREVENTION; CLINICAL TRIAL; DIZZINESS; DRUG ABSORPTION; DRUG DELIVERY SYSTEM; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG ELIMINATION; DRUG EXCRETION; DRUG FORMULATION; DRUG MECHANISM; DRUG METABOLISM; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; EJACULATION; EJACULATION DISORDER; ERECTILE DYSFUNCTION; GYNECOMASTIA; HUMAN; IMPOTENCE; INTRAOPERATIVE FLOPPY IRIS SYNDROME; IRIS DISEASE; LIBIDO; LIBIDO DISORDER; LOWER URINARY TRACT SYMPTOM; MASTALGIA; POSTMARKETING SURVEILLANCE; PRESYNCOPE; PROSTATE CANCER; PROSTATE HYPERTROPHY; QUALITY OF LIFE; RETROGRADE EJACULATION; REVIEW; SEXUAL DYSFUNCTION; SIDE EFFECT; SPERM; STRUCTURE ACTIVITY RELATION; SYNCOPE; URINE RETENTION; VASCULAR DISEASE;

ANIMALS; AZASTEROIDS; DRUG THERAPY, COMBINATION; HUMANS; MALE; PROSTATIC HYPERPLASIA; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SULFONAMIDES; TREATMENT OUTCOME;

EID: 77957024031     PISSN: 14656566     EISSN: None     Source Type: Journal    
DOI: 10.1517/14656566.2010.516901     Document Type: Review

References (76)

1. Issa MM, Fenter TC, Black L, et al. An assessment of the diagnosed prevalence of diseases in men 50 years of age or older. Am J Manag Care 2006;12(4 Suppl):S83-9
2. Naslund MJ, Issa MM, Grogg AL, et al. Clinical and economic outcomes in patients treated for enlarged prostate. Am J Manag Care 2006;12(4 Suppl):S111-16
3. Gravas S, Melekos MD. Male lower urinary tract symptoms: how do symptoms guide our choice of treatment? Curr Opin Urol 2009;19(1):49-54
4. Barry MJ, OLeary MP. Advances in benign prostatic hyperplasia. The developmental and clinical utility of symptom scores. Urol Clin North Am 1995;22(2):299-307
5. Chapple CR, Roehrborn CG. A shifted paradigm for the further understanding, evaluation, and treatment of lower urinary tract symptoms in men: focus on the bladder. Eur Urol 2006;49(4):651-658
6. Abrams P, Chapple C, Khoury S, et al. Evaluation and treatment of lower urinary tract symptoms in older men. J Urol 2009;181(4):1779-1787
7. American Urological Association Education and Research I. Chapter 1: AUA Guideline on the Management of Benign Prostatic Hyperplasia: Diagnosis and Treatment Recommendations. Available from: http://www.auanet.org/content/ guidelines-and-quality-care/ clinical-guidelines/main-reports/ bph-management/chapt-1-appendix.pdf [Cited 8 August 2010].
8. Mehdizadeh JL, Leach GE. Role of invasive urodynamic testing in benign prostatic hyperplasia and male lower urinary tract symptoms. Urol Clin North Am 2009;36(4):431-41, v
9. Roehrborn CG. Clinical management of lower urinary tract symptoms with combined medical therapy. BJU Int 2008;102(Suppl 2):13-17
10. Roehrborn CG, Schwinn DA. Alpha1-adrenergic receptors and their inhibitors in lower urinary tract symptoms and benign prostatic hyperplasia. J Urol 2004;171(3):1029-1035
11. Keam SJ, Scott LJ. Dutasteride: a review of its use in the management of prostate disorders. Drugs 2008;68(4):463-485
12. Rittmaster RS, Norman RW, Thomas LN, Rowden G. Evidence for atrophy and apoptosis in the prostates of men given finasteride. J Clin Endocrinol Metab 1996;81(2):814-819
13. Barendrecht MM, Abrams P, Schumacher H, et al. Do alpha1-adrenoceptor antagonists improve lower urinary tract symptoms by reducing bladder outlet resistance? Neurourol Urodyn 2008;27(3):226-230
14. Oelke M, Bachmann A, Descazeaud A, et al. Conservative treatment of non-neurogenic male LUTS. Available from: http://www. uroweb.org/guidelines/ online-guidelines/ [Cited 24 June 2010]
15. Cantrell MA, Bream-Rouwenhorst HR, Hemerson P, Magera JS Jr. Silodosin for benign prostatic hyperplasia. Ann Pharmacother 2010;44(2):302-310
16. Garimella PS, Fink HA, Macdonald R, Wilt TJ. Naftopidil for the treatment of lower urinary tract symptoms compatible with benign prostatic hyperplasia. Cochrane Database Syst Rev 2009;(4):CD007360
17. Aggarwal S, Thareja S, Verma A, et al. An overview on 5alpha-reductase inhibitors. Steroids 2010;75(2):109-153
18. Faragalla J, Bremner J, Brown D, et al. Comparative pharmacophore development for inhibitors of human and rat 5-alpha-reductase. J Mol Graph Model 2003;22(1):83-92
19. Aggarwal S, Thareja S, Bhardwaj TR, Kumar M. 3D-QSAR studies on unsaturated 4-azasteroids as human 5alpha-reductase inhibitors: a self organizing molecular field analysis approach. Eur J Med Chem 2010;45(2):476-481
20. Sawada K, Okada S, Golden P, et al. 4-(1-benzoylindol-3-yl)butyric acids and FK143: novel nonsteroidal inhibitors of steroid 5 alpha-reductase (II). Chem Pharm Bull (Tokyo) 1999;47(4):481-491
21. Michel MC, Korstanje C, Krauwinkel W, Kuipers M. The Pharmacokinetic Profile of Tamsulosin Oral Controlled Absorption System (OCAS®). Eur Urol Suppl 2005;4(2):15-24 (Pubitemid 40125734)
22. Clark RV, Hermann DJ, Cunningham GR, et al. Marked suppression of dihydrotestosterone in men with benign prostatic hyperplasia by dutasteride, a dual 5alpha-reductase inhibitor. J Clin Endocrinol Metab 2004;89(5):2179-2184
23. Djavan B, Milani S, Fong YK. Dutasteride: a novel dual inhibitor of 5alpha-reductase for benign prostatic hyperplasia. Expert Opin Pharmacother 2005;6(2):311-317
24. Franco-Salinas G, de la Rosette JJ, Michel MC. Pharmacokinetics and pharmacodynamics of tamsulosin in its modified-release and oral controlled absorption system formulations. Clin Pharmacokinet 2010;49(3):177-188
25. Highlights of prescribing information for Flomax. Available from: http://bidocs. boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase= renetnt&folderPath=/Prescribing+Information/PIs/Flomax+Caps/Flomax.pdf [Cited 21 June 2010]
26. Michel MC, Korstanje C, Krauwinkel W, et al. Comparison of vascular [alpha]1-adrenoceptor antagonism of tamsulosin in Oral Controlled Absorption System (OCAS) and Modified Release (MR) Formulations. Eur Urol Suppl 2005;4(2):45-52 (Pubitemid 40125736)
27. Yamada S, Kato Y, Okura T, et al. Prediction of alpha1-adrenoceptor occupancy in the human prostate from plasma concentrations of silodosin, tamsulosin and terazosin to treat urinary obstruction in benign prostatic hyperplasia. Biol Pharm Bull 2007;30(7):1237-1241
28. Roehrborn C, Boyle P, Nickel J, et al. Efficacy and safety of a dual inhibitor of 5-alpha-reductase types 1 and 2 (dutasteride) in men with benign prostatic hyperplasia. Urology 2002;60(3):434-441
29. Debruyne F, Barkin J, van Erps P, et al. 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(4):488-494, discussion 95
30. Wurzel R, Ray P, Major-Walker K, et al. The effect of dutasteride on intraprostatic dihydrotestosterone concentrations in men with benign prostatic hyperplasia. Prostate Cancer Prostatic Dis 2007;10(2):149-154
31. Andriole GL, Marberger M, Roehrborn CG. Clinical usefulness of serum prostate specific antigen for the detection of prostate cancer is preserved in men receiving the dual 5alpha-reductase inhibitor dutasteride. J Urol 2006;175(5):1657-1662
32. Thompson IM, Goodman PJ, Tangen CM, et al. The influence of finasteride on the development of prostate cancer. N Engl J Med 2003;349(3):215-224
33. Andriole G, Bostwick D, Brawley O, et al. Chemoprevention of prostate cancer in men at high risk: rationale and design of the reduction by dutasteride of prostate cancer events (REDUCE) trial. J Urol 2004;172(4 Pt 1):1314-1317
34. Andriole GL, Bostwick DG, Brawley OW, et al. Effect of dutasteride on the risk of prostate cancer. N Engl J Med 2010;362(13):1192-1202
35. Barqawi AB, ODonnell CI, Siomos VJ, Hou AH. The effect of short-term dutasteride intake in early-stage prostate cancer: analysis of 148 patients who underwent three-dimensional prostate mapping biopsy. Urology 2010 May 14. [Epub ahead of print]
36. van Hoogdalem EJ, Soeishi Y, Matsushima H, Higuchi S. Disposition of the selective alpha1A-adrenoceptor antagonist tamsulosin in humans: comparison with data from interspecies scaling. J Pharm Sci 1997;86(10):1156-1161
37. Wolzt M, Fabrizii V, Dorner GT, et al. Pharmacokinetics of tamsulosin in subjects with normal and varying degrees of impaired renal function: an open-label single-dose and multiple-dose study. Eur J Clin Pharmacol 1998;54(4):367-373
38. Michel MC, Korstanje C, Krauwinkel W, et al. Cardiovascular safety of the Oral Controlled Absorption System (OCAS) formulation of tamsulosin compared to the Modified Release (MR) formulation. Eur Urol Suppl 2005;4(2):53-60 (Pubitemid 40125737)
39. Matsushima H, Kamimura H, Soeishi Y, et al. Pharmacokinetics and plasma protein binding of tamsulosin hydrochloride in rats, dogs, and humans. Drug Metab Dispos 1998;26(3):240-245
40. Koiso K, Akaza H, Kikuchi K, et al. Pharmacokinetics of tamsulosin hydrochloride in patients with renal impairment: effects of alpha 1-acid glycoprotein. J Clin Pharmacol 1996;36(11):1029-1038
41. Soeishi Y, Matsushima H, Watanabe T, et al. Absorption, metabolism and excretion of tamsulosin hydrochloride in man. Xenobiotica 1996;26(6):637-645
42. Taguchi K, Saitoh M, Sato S, et al. Effects of tamsulosin metabolites at alpha-1 adrenoceptor subtypes. J Pharmacol Exp Ther 1997;280(1):1-5
43. Kamimura H, Oishi S, Matsushima H, et al. Identification of cytochrome P450 isozymes involved in metabolism of the alpha1-adrenoceptor blocker tamsulosin in human liver microsomes. Xenobiotica 1998;28(10):909-922
44. GlaxoSmithKline. Prescribing Information for AVODART Soft Gelatin Capsules, 0.5 mg http://us. gsk.com/products/assets/us-avodart.pdf
45. Kirby RS, Roehrborn C, Boyle P, et al. Efficacy and tolerability of doxazosin and finasteride, alone or in combination, in treatment of symptomatic benign prostatic hyperplasia: the Prospective European Doxazosin and Combination Therapy (PREDICT) trial. Urology 2003;61(1):119-126
46. McConnell JD, Roehrborn CG, Bautista OM, 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(25):2387-2398
47. Gittelman M, Ramsdell J, Young J, McNicholas T. Dutasteride improves objective and subjective disease measures in men with benign prostatic hyperplasia and modest or severe prostate enlargement. J Urol 2006;176(3):1045-1050, discussion 50
48. Roehrborn CG, Siami P, Barkin J, et al. The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study. J Urol 2008;179(2):616-621, discussion 21
49. Roehrborn CG, Siami P, Barkin J, et al. The influence of baseline parameters on changes in international prostate symptom score with dutasteride, tamsulosin, and combination therapy among men with symptomatic benign prostatic hyperplasia and an enlarged prostate: 2-year data from the CombAT study. Eur Urol 2009;55(2):461-471
50. Roehrborn CG, Siami P, Barkin J, et al. 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(1):123-131
51. Montorsi F, Henkel T, Geboers A, et al. Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 4-year data from the CombAT study. Int J Clin Pract 2010;64(8):1042-1051
52. Issa MM, Runken MC, Grogg AL, Shah MB. A large retrospective analysis of acute urinary retention and prostate-related surgery in BPH patients treated with 5-alpha reductase inhibitors: dutasteride versus finasteride. Am J Manag Care 2007;13(Suppl 1):S10-16
53. Fenter TC, Davis EA, Shah MB, Lin PJ. Dutasteride vs finasteride: assessment of differences in acute urinary retention rates and surgical risk outcomes in an elderly population aged ≥ 65 years. Am J Manag Care 2008;14(5 Suppl 2):S154-9
54. Barkin J, Guimaraes M, Jacobi G, et al. Alpha-blocker therapy can be withdrawn in the majority of men following initial combination therapy with the dual 5alpha-reductase inhibitor dutasteride. Eur Urol 2003;44(4):461-466
55. Naslund M, Black L, Eaddy M, Batiste LR. Differences in alpha blocker usage among enlarged prostate patients receiving combination therapy with 5 ARIs. Am J Manag Care 2007;13(Suppl 1):S17-22
56. Nickel JC, Sander S, Moon TD. A meta-analysis of the vascular-related safety profile and efficacy of alpha-adrenergic blockers for symptoms related to benign prostatic hyperplasia. Int J Clin Pract 2008;62(10):1547-1559
57. Blouin MC, Blouin J, Perreault S, et al. Intraoperative floppy-iris syndrome associated with alpha1-adrenoreceptors: comparison of tamsulosin and alfuzosin. J Cataract Refract Surg 2007;33(7):1227-1234
58. Oelke M, Bachmann A, Descazeaud A, et al. Guidelines on Conservative Treatment of Non-neurogenic Male LUTS. Available from: http://www. uroweb.org/?id=218&gid=7 [Cited 29 July 2010]
59. van Dijk MM, de la Rosette JJ, Michel MC. Effects of alpha(1)- adrenoceptor antagonists on male sexual function. Drugs 2006;66(3):287-301
60. Nordling J. Efficacy and safety of two doses (10 and 15 mg) of alfuzosin or tamsulosin (0.4 mg) once daily for treating symptomatic benign prostatic hyperplasia. BJU Int 2005;95(7):1006-1012
61. Hofner K, Claes H, De Reijke TM, et al. Tamsulosin 0.4 mg once daily: effect on sexual function in patients with lower urinary tract symptoms suggestive of benign prostatic obstruction. Eur Urol 1999;36(4):335-341
62. Djavan B, Marberger M. A meta-analysis on the efficacy and tolerability of alpha1-adrenoceptor antagonists in patients with lower urinary tract symptoms suggestive of benign prostatic obstruction. Eur Urol 1999;36(1):1-13
63. Djavan B, Chapple C, Milani S, Marberger M. State of the art on the efficacy and tolerability of alpha1-adrenoceptor antagonists in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Urology 2004;64(6):1081-1088 (Pubitemid 39647042)
64. Roehrborn CG, Van Kerrebroeck P, Nordling J. Safety and efficacy of alfuzosin 10 mg once-daily in the treatment of lower urinary tract symptoms and clinical benign prostatic hyperplasia: a pooled analysis of three double-blind, placebo-controlled studies. BJU Int 2003;92(3):257-261
65. Clifford GM, Farmer RD. Medical therapy for benign prostatic hyperplasia: a review of the literature. Eur Urol 2000;38(1):2-19
66. Montorsi F, Moncada I. Safety and Tolerability of Treatment for BPH. Eur Urol Suppl 2006;5(20):1004-1012
67. Dutasteride/Tamsulosin Combination for BPH Approved in Europe http:// www.gsk.com/media/pressreleases/2010/ 2010-pressrelease-10036.htm
68. TM, a fixed-dose combination of dutasteride and tamsulosin, for symptomatic BPH in men with an enlarged prostate http:// www.drugs.com/newdrugs/fda-approvesjalyn- fixed-combination- dutasteridetamsulosin- symptomatic-bph-menenlarged- prostate-2183.html
69. 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(6):901-906
70. Lepor H. Phase III multicenter placebo-controlled study of tamsulosin in benign prostatic hyperplasia. Tamsulosin Investigator Group. Urology 1998;51(6):892-900
71. Narayan P, Tewari A. A second phase III multicenter placebo controlled study of 2 dosages of modified release tamsulosin in patients with symptoms of benign prostatic hyperplasia. United States 93-01 Study Group. J Urol 1998;160(5):1701-1706
72. Roehrborn CG, Marks LS, Fenter T, et al. Efficacy and safety of dutasteride in the four-year treatment of men with benign prostatic hyperplasia. Urology 2004;63(4):709-715
73. Roehrborn CG, Bruskewitz R, Nickel JC, et al. Sustained decrease in incidence of acute urinary retention and surgery with finasteride for 6 years in men with benign prostatic hyperplasia. J Urol 2004;171(3):1194-1198
74. Lepor H, Williford WO, Barry MJ, et al. The efficacy of terazosin, finasteride, or both in benign prostatic hyperplasia. Veterans Affairs Cooperative Studies Benign Prostatic Hyperplasia Study Group. N Engl J Med 1996;335(8):533-539
75. Debruyne FM, Jardin A, Colloi D, et al. Sustained-release alfuzosin, finasteride and the combination of both in the treatment of benign prostatic hyperplasia. European ALFIN Study Group. Eur Urol 1998;34(3):169-175
76. Kirby RS. A randomized, double-blind crossover study of tamsulosin and controlled-release doxazosin in patients with benign prostatic hyperplasia. BJU Int 2003;91(1):41-44