How to Choose Appropriate Medication for Overactive Bladder: Findings from the Largest Integrated Clinical Trial Database Analysis of Mirabegron Studies

Overview

Journal Tzu Chi Med J

Specialty General Medicine

Date 2022 Mar 2

PMID 35233352

Authors

Hann-Chorng Kuo

Affiliations

Soon will be listed here.

Abstract

Medical treatment of overactive bladder (OAB) includes antimuscarinic agents, beta-3 adrenoceptor agonist (mirabegron), or combination with both drugs. Recently, a meta-analysis reported the integrated clinical trial data from 10 phase 2-4, double-blind, 12-week mirabegron monotherapy studies. The results confirmed that mirabegron is as effective as the previously used antimuscarinic agent to treat OAB. The treatment-emergent adverse events were similar across subgroups. This article comments on this largest integrated clinical trial data analysis, and reviews the recently published literature and tries to reveal how to choose the appropriate medication for OAB. For OAB patients, starting from antimuscarinic agent is feasible. However, if the patients have risk of cognitive dysfunction, a history of constipation, dry mouth, and urinary retention, starting with mirabegron 50 mg might be more safe and appropriate. In the elderly patients with low detrusor contractility, with central nervous system lesion, and men with benign prostatic hyperplasia, starting from 25 mg mirabegron is recommended. If the treatment result is not satisfactory to the 25 mg mirabegron, increase dose to 50 mg mirabegron is appropriate. In patients who have failed from the first OAB medication either with antimuscarinics or mirabegron 50 mg, the exchange of the OAB medication to each other should be tried first. If the treatment result is still not satisfactory, a combination of antimuscarinics and mirabegron is recommended.

Citing Articles

Examining the safety of mirabegron: an analysis of real-world pharmacovigilance data from the US FDA adverse event reporting system (FAERS) database.

Wang J, Zhang A, Ye M, Zhang C Front Pharmacol. 2024; 15:1376535.

PMID: 38562462 PMC: 10982368. DOI: 10.3389/fphar.2024.1376535.

Urinary beta 3-adrenoceptor as a diagnostic biomarker for overactive bladder in women.

Liang C, Hsieh W, Lo T, Huang T, Chou Y, Huang J Sci Rep. 2023; 13(1):19368.

PMID: 37938600 PMC: 10632490. DOI: 10.1038/s41598-023-46786-6.

Discriminating Different Bladder and Bladder Outlet Dysfunctions by Urinary Biomarkers in Women with Frequency-Urgency Syndrome.

Jhang J, Jiang Y, Kuo H Biomedicines. 2023; 11(3).

PMID: 36979652 PMC: 10045187. DOI: 10.3390/biomedicines11030673.

The clinical application of intravesical botulinum toxin A injection in patients with overactive bladder and interstitial cystitis.

Jiang Y, Jhang J, Kuo H Tzu Chi Med J. 2023; 35(1):31-37.

PMID: 36866354 PMC: 9972932. DOI: 10.4103/tcmj.tcmj_313_21.

References

Herschorn S, Chapple C, Snijder R, Siddiqui E, Cardozo L . Could Reduced Fluid Intake Cause the Placebo Effect Seen in Overactive Bladder Clinical Trials? Analysis of a Large Solifenacin Integrated Database. Urology. 2017; 106:55-59. DOI: 10.1016/j.urology.2017.04.016. View

Yamaguchi O, Nishizawa O, Takeda M, Yokoyama O, Homma Y, Kakizaki H . Clinical guidelines for overactive bladder. Int J Urol. 2009; 16(2):126-42. DOI: 10.1111/j.1442-2042.2008.02177.x. View

Chapple C, Cruz F, Cardozo L, Staskin D, Herschorn S, Choudhury N . Safety and Efficacy of Mirabegron: Analysis of a Large Integrated Clinical Trial Database of Patients with Overactive Bladder Receiving Mirabegron, Antimuscarinics, or Placebo. Eur Urol. 2019; 77(1):119-128. DOI: 10.1016/j.eururo.2019.09.024. View

Yamaguchi O . Beta3-adrenoceptors in human detrusor muscle. Urology. 2002; 59(5 Suppl 1):25-9. DOI: 10.1016/s0090-4295(01)01635-1. View

Liao C, Kuo H . High satisfaction with direct switching from antimuscarinics to mirabegron in patients receiving stable antimuscarinic treatment. Medicine (Baltimore). 2016; 95(45):e4962. PMC: 5106046. DOI: 10.1097/MD.0000000000004962. View

Khullar V, Amarenco G, Angulo J, Cambronero J, Hoye K, Milsom I . Efficacy and tolerability of mirabegron, a β(3)-adrenoceptor agonist, in patients with overactive bladder: results from a randomised European-Australian phase 3 trial. Eur Urol. 2012; 63(2):283-95. DOI: 10.1016/j.eururo.2012.10.016. View

Leon L, Hoffman B, Gardner S, Laping N, Evans C, Lashinger E . Effects of the beta 3-adrenergic receptor agonist disodium 5-[(2R)-2-[[(2R)-2-(3-chlorophenyl)-2-hydroxyethyl]amino]propyl]-1,3-benzodioxole-2,2-dicarboxylate (CL-316243) on bladder micturition reflex in spontaneously hypertensive rats. J Pharmacol Exp Ther. 2008; 326(1):178-85. DOI: 10.1124/jpet.108.138651. View

Lee S, Malhotra B, Creanga D, Carlsson M, Glue P . A meta-analysis of the placebo response in antimuscarinic drug trials for overactive bladder. BMC Med Res Methodol. 2009; 9:55. PMC: 2722668. DOI: 10.1186/1471-2288-9-55. View

Lee Y, Kuo H . Safety and therapeutic efficacy of mirabegron 25 mg in older patients with overactive bladder and multiple comorbidities. Geriatr Gerontol Int. 2018; 18(9):1330-1333. DOI: 10.1111/ggi.13465. View

10.

Kelleher C, Hakimi Z, Zur R, Siddiqui E, Maman K, Aballea S . Efficacy and Tolerability of Mirabegron Compared with Antimuscarinic Monotherapy or Combination Therapies for Overactive Bladder: A Systematic Review and Network Meta-analysis. Eur Urol. 2018; 74(3):324-333. DOI: 10.1016/j.eururo.2018.03.020. View

11.

Andersson K . Prospective pharmacologic therapies for the overactive bladder. Ther Adv Urol. 2011; 1(2):71-83. PMC: 3126054. DOI: 10.1177/1756287209103937. View

12.

Lee C, Kuo H . Efficacy and safety of mirabegron, a β -adrenoceptor agonist, in patients with detrusor hyperactivity and impaired contractility. Low Urin Tract Symptoms. 2018; 11(2):O93-O97. DOI: 10.1111/luts.12224. View

13.

Yamaguchi O, Marui E, Kakizaki H, Homma Y, Igawa Y, Takeda M . Phase III, randomised, double-blind, placebo-controlled study of the β3-adrenoceptor agonist mirabegron, 50 mg once daily, in Japanese patients with overactive bladder. BJU Int. 2014; 113(6):951-60. DOI: 10.1111/bju.12649. View

14.

Kuo H, Lee K, Na Y, Sood R, Nakaji S, Kubota Y . Results of a randomized, double-blind, parallel-group, placebo- and active-controlled, multicenter study of mirabegron, a β3-adrenoceptor agonist, in patients with overactive bladder in Asia. Neurourol Urodyn. 2014; 34(7):685-92. DOI: 10.1002/nau.22645. View

15.

Nitti V, Auerbach S, Martin N, Calhoun A, Lee M, Herschorn S . Results of a randomized phase III trial of mirabegron in patients with overactive bladder. J Urol. 2012; 189(4):1388-95. DOI: 10.1016/j.juro.2012.10.017. View

16.

Aizawa N, Igawa Y, Nishizawa O, Wyndaele J . Effects of CL316,243, a beta 3-adrenoceptor agonist, and intravesical prostaglandin E2 on the primary bladder afferent activity of the rat. Neurourol Urodyn. 2009; 29(5):771-6. DOI: 10.1002/nau.20826. View

17.

Sexton C, Notte S, Maroulis C, Dmochowski R, Cardozo L, Subramanian D . Persistence and adherence in the treatment of overactive bladder syndrome with anticholinergic therapy: a systematic review of the literature. Int J Clin Pract. 2011; 65(5):567-85. DOI: 10.1111/j.1742-1241.2010.02626.x. View

18.

Gray S, Hanlon J . Anticholinergic medication use and dementia: latest evidence and clinical implications. Ther Adv Drug Saf. 2016; 7(5):217-224. PMC: 5014048. DOI: 10.1177/2042098616658399. View

19.

Kay G, Abou-Donia M, Messer Jr W, Murphy D, Tsao J, Ouslander J . Antimuscarinic drugs for overactive bladder and their potential effects on cognitive function in older patients. J Am Geriatr Soc. 2006; 53(12):2195-201. DOI: 10.1111/j.1532-5415.2005.00537.x. View

20.

DSouza A, Smith M, Miller L, Doyle J, Ariely R . Persistence, adherence, and switch rates among extended-release and immediate-release overactive bladder medications in a regional managed care plan. J Manag Care Pharm. 2008; 14(3):291-301. PMC: 10438114. DOI: 10.18553/jmcp.2008.14.3.291. View