Mirabegron: A review of recent data and its prospects in the management of overactive bladder

Therapeutic Advances in Urology

Volumn 4, Issue 6, 2012, Pages 315-324

  Sacco, Emilio ^a   Bientinesi, Riccardo ^a  

^a FONDAZIONE POLICLINICO UNIVERSITARIO A GEMELLI IRCCS   (Italy)

Author keywords

efficacy; mirabegron; overactive bladder; safety; urinary incontinence; 3 adrenoceptor agonist

Indexed keywords

MIRABEGRON; MUSCARINIC RECEPTOR BLOCKING AGENT; PLACEBO; TOLTERODINE;

ARTHRALGIA; BACKACHE; CONSTIPATION; CYSTITIS; DETRUSOR MUSCLE; DIARRHEA; DIZZINESS; DRUG BIOAVAILABILITY; DRUG EFFICACY; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG MECHANISM; DRUG PROTEIN BINDING; DRUG RECEPTOR BINDING; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; ELECTROCARDIOGRAM; GASTROINTESTINAL SYMPTOM; HUMAN; HYPERTENSION; MUSCLE RELAXATION; NAUSEA; NONHUMAN; OVERACTIVE BLADDER; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PLASMA PROTEIN BINDING; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SIDE EFFECT; SINUSITIS; TACHYCARDIA; TIME TO MAXIMUM PLASMA CONCENTRATION; URINARY TRACT INFECTION; XEROSTOMIA;

EID: 84868257514     PISSN: 17562872     EISSN: 17562880     Source Type: Journal    
DOI: 10.1177/1756287212457114     Document Type: Article

References (35)

1. Abrams P. Cardozo L. Fall M. Griffiths D. Rosier P. Ulmsten U. (2002), The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn 21: 167–178.
2. Andersson K. Arner A. (2004) Urinary bladder contraction and relaxation: physiology and pathophysiology. Physiol Rev 84: 935–986.
3. Andersson K. Chapple C. Cardozo L. Cruz F. Hashim H. Michel M.C. (2009) Pharmacological treatment of urinary incontinence. In: Abrams P. Cardozo L. Khoury S. Wein A. (eds), Incontinence, 4th International Consultation on Incontinence. Plymouth, UK: Plymbridge Distributors, pp. 631–699.
4. Birder L. Apodaca G. De Groat W. Kanai A.J. (1998) Adrenergic- and capsaicin-evoked nitric oxide release from urothelium and afferent nerves in urinary bladder. Am J Physiol 275: F226–F229.
5. Chapple C. Kaplan S. Mitcheson H. Klecka J. Cummings J. Drogendijk T. (2012) Randomised, double-blind, active-controlled phase III study to assess the long-term safety and efficacy of mirabegron in overactive bladder (OAB). Eur Urol Suppl 11: e683–e683a.
6. Chapple C. Khullar V. Gabriel Z. Muston D. Bitoun C. Weinstein D. (2008a) The effects of antimuscarinic treatments in overactive bladder: an update of a systematic review and meta-analysis. Eur Urol 54: 543–562.
7. Chapple C. Wyndaele J. Van Kerrebroeck P. Radziszewski P. Dvorak V. Boerrigter P. (2010) Dose-ranging study of once- daily mirabegron (YM178), a novel selective 3-adrenoceptor agonist, in patients with overactive bladder (OAB). Eur Urol Suppl 9: 249.
8. Chapple C. Yamaguchi O. Ridder A. Liehne J. Carl S. Mattiasson A. (2008b) Clinical proof of concept study (Blossom) shows novel b3 adrenoceptor agonist YM178 is effective and well tolerated in the treatment of symptoms of overactive bladder. Eur Urol Suppl 7: 239 (abstract 674).
9. D–Souza A. Smith M. Miller L. Doyle J. Ariely R. (2008) Persistence, adherence, and switch rates among extended-release and immediate- release overactive bladder medications in a regional managed care plan. J Manag Care Pharm 14: 291–301.
10. FDA (2012) Summary of safety and efficacy as basis for Advisory Committee briefing document for mirabegron, 5 April 2012. Division of Reproductive and Urologic Products, Office of New Drugs Center for Drug Evaluation and Research of Food and Drug Administration. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM298284.pdf (accessed 19 July 2012).
11. Fujimura T. Tamura K. Tsutsumi T. Yamamoto T. Nakamura K. Koibuchi Y. (1999) Expression and possible functional role of the beta3-adrenoceptor in human and rat detrusor muscle. J Urol 161: 680–685.
12. Gruneberger A. (1984) Treatment of motor urge incontinence with clenbuterol and flavoxate hydrochloride. Br J Obstetr Gynaecol 91: 275–278.
13. Hicks A. McCafferty G. Riedel E. Aiyar N. Pullen M. Evans C. (2007) GW427353 (solabegron), a novel, selective beta3-adrenergic receptor agonist, evokes bladder relaxation and increases micturition reflex threshold in the dog. J Pharmacol Exp Ther 323: 202–209.
14. Igawa Y. Aizawa N. Homma Y. (2010) Beta3-adrenoceptor agonists: possible role in the treatment of overactive bladder. Korean J Urol 51: 811–818.
15. Irwin D. Milsom I. Hunskaar S. Reilly K. Kopp Z. Herschorn S. (2006) Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol 50: 1306–1314.
16. Kaidoh K. Igawa Y. Takeda H. Yamazaki Y. Akahane S. Miyata H. (2002) Effects of selective β2 and β3-adrenoceptor agonists in detrusor hyperreflexia in conscious cerebral infarcted rats. J Urol 168: 1247–1252.
17. Kanai A. Wyndaele J. Andersson K. Fry C. Ikeda Y. Zabbarova I. (2011) Researching bladder afferents determining the effects of b3-adrenergic receptor agonists and botulinum toxin type-A. Neurourol Urodyn 30: 684–691.
18. Khullar V. Cambronero J. Angulo J. Wooning M. Blauwet M. Dorrepaal C. (2012) Efficacy of mirabegron in patients with and without prior antimuscarinic therapy for overactive bladder (OAB): post-hoc analysis of a prospective, randomised European–Australian phase III trial. Eur Urol Suppl 11: e684–e684a.
19. Khullar V. Cambronero J. Stroberg P. Angulo J. Boerrigter P. Blauwet M. (2011) The efficacy and tolerability of mirabegron in patients with overactive bladder-results from a European–Australian phase III trial. Eur Urol Suppl 10: 278–279.
20. Krauwinkel W. van Gelderen E. Groen M. Schaddelee M. de Koning P. (2010) An open-label crossover study to evaluate the effect of multiple doses of mirabegron on the pharmacokinetics of the CYP2D6 substrate desipramine in healthy subjects. Clin Pharmacol Ther 87(Suppl. 1): abstract PI-43.
21. Limberg B. Andersson K. Aura Kullmann F. Burmer G. de Groat W.C. Rosenbaum J. S. (2010) β-Adrenergic receptor subtype expression in myocyte and non-myocyte cells in human female bladder. Cell Tissue Res 342: 295–306.
22. Lindholm P. Lose G. (1986) Terbutaline (Bricanyl) in the treatment of female urge incontinence. Urol Int 41: 158–160.
23. Milsom I. Abrams P. Cardozo L. Roberts R. Thuroff J. Wein A. (2001), How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int 87: 760–766.
24. Nitti V. Herschorn S. Auerbach S. Ayers M. Lee M. Martin N. (2011) The selective [beta] 3-adrenoreceptor agonist mirabegron is effective and well tolerated in patients with overactive bladder syndrome. J Urol 185: e783–e784.
25. Otsuka A. Shinbo H. Matsumoto R. Kurita Y. Ozono S. (2008) Expression and functional role of beta-adrenoceptors in the human urinary bladder urothelium. Naunyn Schmiedebergs Arch Pharmacol 377: 473–481.
26. Sacco E. Pinto F. Bassi P. (2008), Emerging pharmacological targets in overactive bladder therapy: experimental and clinical evidences. Int Urogynecol J Pelvic Floor Dysfunct 19: 583–598.
27. Sacco E. Tienforti D. D–Addessi A. Pinto F. Racioppi M. Totaro A. (2010) Social, economic, and health utility considerations in the treatment of overactive bladder. J Urol 2: 11–24.
28. Takasu T. Ukai M. Sato S. Matsui T. Nagase I. Maruyama T. (2007). Effect of (R)-2-(2-aminothiazol-4-yl)-4′-{2-[(2-hydroxy-2-phenylethyl)amino]ethyl} acetanilide (YM178), a novel selective beta3-adrenoceptor agonist, on bladder function. J Pharmacol Exp Ther 321: 642–647.
29. Takeda M. Obara K. Mizusawa T. Tomita Y. Arai K. Tsutsui T. (1999) Evidence for beta3-adrenoceptor subtypes in relaxation of the human urinary bladder detrusor: analysis by molecular biological and pharmacological methods. J Pharmacol Exp Ther 288: 1367–1373.
30. Takeda H. Yamazaki Y. Akahane M. Igawa Y. Ajisawa Y. Nishizawa O. (2000) Role of the beta(3)-adrenoceptor in urine storage in the rat: comparison between the selective beta(3)-adrenoceptor agonist, CL316, 243, and various smooth muscle relaxants. J Pharmacol Exp Ther 293: 939–945.
31. Takusagawa S. van Lier J. Suzuki K. Nagata M. Meijer J. Krauwinkel W. (2012) Absorption, metabolism and excretion of [14C]mirabegron (YM178), a potent and selective β3-adrenoceptor agonist, after oral administration to healthy male volunteers. Drug Metab Dispos 40: 815–824.
32. Teijlingen R. Meijer J. Takusagawa S. Gelderen M. Beld C. Usui T. (2012) Development and validation of LC–MS/MS methods for the determination of mirabegron and its metabolites in human plasma and their application to a clinical pharmacokinetic study. J Chromatogr B Analyt Technol Biomed Life Sci 887–888: 102–111.
33. van Gelderen E. Li Q. Meijer J. Schaddelee M. Takusagawa S. Sugawarw T. (2009) An explanatory comparison of the single dose pharmacokinetics of the beta3-adrenoceptor agonist mirabegron in healthy CYP2D6 poor and extensive metabolizers. Clin Pharmacol Ther 85(Suppl. 1): abstract PIII-65.
34. Woods M. Carson N. Norton N. Sheldon J. Argentieri T. (2001) Efficacy of the β3-adrenergic receptor agonist CL-316243 on experimental bladder hyperreflexia and detrusor instability in the rat. J Urol 166: 1142–1147.
35. Yamaguchi O. Chapple C. (2007) b3-Adrenoceptors in urinary bladder. Neurourol Urodyn 26: 752–756.