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Review

Mirabegron in the Treatment of Overactive Bladder: Safety and Efficacy in the Very Elderly Patient

ORCID Icon, ORCID Icon & ORCID Icon
Pages 575-581 | Published online: 23 Apr 2020

References

  • Irwin DE, Milsom I, Hunskaar S, et al. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006;50(6):1306–14; discussion 1314–5. doi:10.1016/j.eururo.2006.09.019
  • Donaldson MM, Thompson JR, Matthews RJ, et al. The natural history of overactive bladder and stress urinary incontinence in older women in the community: a 3-year prospective cohort study. Neurourol Urodyn. 2006;25(7):709–716. doi:10.1002/nau.2023516998862
  • Milsom I, Abrams P, Cardozo L, et al. How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001;87(9):760–766. doi:10.1046/j.1464-410x.2001.02228.x11412210
  • Wagg A, Gibson W, Ostaszkiewicz J, et al. Urinary incontinence in frail elderly persons: report from the 5th International Consultation on Incontinence. Neurourol Urodyn. 2015;34(5):398–406. doi:10.1002/nau.2260224700771
  • Abrams P, Artibani W, Cardozo L, et al. Reviewing the ICS 2002 terminology report: the ongoing debate. Neurourol Urodyn. 2009;28(4):287. doi:10.1002/nau.2073719350662
  • Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167–178. doi:10.1002/nau.1005211857671
  • de Groat WC. The urothelium in overactive bladder: passive bystander or active participant? Urology. 2004;64(6 Suppl 1):7–11. doi:10.1016/j.urology.2004.08.06315621221
  • Brading AF. A myogenic basis for the overactive bladder. Urology. 1997;50(6A Suppl):57–67; discussion 68–73. doi:10.1016/S0090-4295(97)00591-8
  • Sakakibara R, Panicker J, Fowler CJ, et al. Is overactive bladder a brain disease? The pathophysiological role of cerebral white matter in the elderly. Int J Urol. 2014;21(1):33–38. doi:10.1111/iju.12288
  • Gibson W, Wagg A. Incontinence in the elderly, ‘normal’ ageing, or unaddressed pathology? Nat Rev Urol. 2017;14(7):440–448. doi:10.1038/nrurol.2017.5328401955
  • Gary B, Perera S, Murrin A, Aizenstein H, Tadic S. White matter hyperintensity burden and depression are associated with severity and impact of urgency urinary incontinence in functional, community-dwelling older women. Neurourol Urodyn. 2013;32(6):798–799.
  • NICE UK. Urinary Incontinence: The Management of Urinary Incontinence in Women (CG40); 2006.
  • UK NICE. GC 97: the management of lower urinary tract symptoms in men; 2010 Available from: http://www.nice.org.uk/CG97. Accessed 327, 2020.
  • Corcos J, Przydacz M, Campeau L, et al. CUA guideline on adult overactive bladder. Can Urol Assoc J. 2017;11(5):E142–E173. doi:10.5489/cuaj.458628503229
  • Wagg A. Treating overactive bladder in the elderly. Can Urol Assoc J. 2011;5(5 Suppl 2):S149–51. doi:10.5489/cuaj.1118821989530
  • Wagner TH, Hu TW, Bentkover J, et al. Health-related consequences of overactive bladder. Am J Manag Care. 2002;8(19 Suppl):S598–607.12516954
  • Gibson W, Hunter KF, Camicioli R, et al. The association between lower urinary tract symptoms and falls: forming a theoretical model for a research agenda. Neurourol Urodyn. 2018;37(1):501–509. doi:10.1002/nau.2329528471525
  • Coyne KS, Sexton CC, Irwin DE, et al. The impact of overactive bladder, incontinence and other lower urinary tract symptoms on quality of life, work productivity, sexuality and emotional well-being in men and women: results from the EPIC study. BJU Int. 2008;101(11):1388–1395. doi:10.1111/j.1464-410X.2008.07601.x18454794
  • Thom DH, Haan MN, Van Den Eeden SK. Medically recognized urinary incontinence and risks of hospitalization, nursing home admission and mortality. Age Ageing. 1997;26(5):367–374. doi:10.1093/ageing/26.5.3679351481
  • Teunissen D, van Weel C, Lagro-Janssen T. Urinary incontinence in older people living in the community: examining help-seeking behaviour. Br J Gen Pract. 2005;55(519):776–782.16212853
  • Shaw C, Tansey R, Jackson C, Hyde C, Allan R. Barriers to help seeking in people with urinary symptoms. Fam Pract. 2001;18(1):48–52. doi:10.1093/fampra/18.1.4811145628
  • Thompson IM, Lauvetz R. Oxybutynin in bladder spasm, neurogenic bladder, and enuresis. Urology. 1976;8(5):452–454. doi:10.1016/0090-4295(76)90273-9790746
  • Riva D, Casolati E. Oxybutynin chloride in the treatment of female idiopathic bladder instability. Results from double blind treatment. Clin Exp Obstet Gynecol. 1984;11(1–2):37–42.6370504
  • Thuroff JW, Bunke B, Ebner A, et al. Randomized, double-blind, multicenter trial on treatment of frequency, urgency and incontinence related to detrusor hyperactivity: oxybutynin versus propantheline versus placebo. J Urol. 1991;145(4):813–6; discussion 816–7. doi:10.1016/S0022-5347(17)38459-8
  • Yoo DS, Han JY, Lee KS, Choo MS. Prescription pattern of oxybutynin ER in patients with overactive bladder in real life practice: a multicentre, open-label, prospective observational study. Int J Clin Pract. 2012;66(2):132–138. doi:10.1111/j.1742-1241.2011.02838.x22188444
  • Chapple CR, Rechberger T, Al-Shukri S, et al. Randomized, double-blind placebo- and tolterodine-controlled trial of the once-daily antimuscarinic agent solifenacin in patients with symptomatic overactive bladder. BJU Int. 2004;93(3):303–310. doi:10.1111/j.1464-410X.2004.04606.x14764127
  • Chapple C, Steers W, Norton P, et al. A pooled analysis of three phase III studies to investigate the efficacy, tolerability and safety of darifenacin, a muscarinic M3 selective receptor antagonist, in the treatment of overactive bladder. BJU Int. 2005;95(7):993–1001. doi:10.1111/j.1464-410X.2005.05454.x15839920
  • Chapple C, Van Kerrebroeck P, Tubaro A, et al. Clinical efficacy, safety, and tolerability of once-daily fesoterodine in subjects with overactive bladder. Eur Urol. 2007;52(4):1204–1212. doi:10.1016/j.eururo.2007.07.00917651893
  • Sexton CC, Notte SM, Maroulis C, et al. 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):567–585. doi:10.1111/j.1742-1241.2010.02626.x21489081
  • Boustani M, Campbell N, Munger S, Maidment I, Fox C. Impact of anticholinergics on the aging brain: a review and practical application. Aging Health. 2008;4(3):311–320. doi:10.2217/1745509X.4.3.311
  • Gibson W, Athanasopoulos A, Goldman H, et al. Are we shortchanging frail older people when it comes to the pharmacological treatment of urgency urinary incontinence? Int J Clin Pract. 2014;68(9):1165–1173. doi:10.1111/ijcp.1244725196247
  • Bottiggi KA, Salazar JC, Yu L, et al. Long-term cognitive impact of anticholinergic medications in older adults. Am J Geriatr Psychiatry. 2006;14(11):980–984. doi:10.1097/01.JGP.0000224619.87681.7117068321
  • Campbell N, Boustani M, Limbil T, et al. The cognitive impact of anticholinergics: a clinical review. Clin Interv Aging. 2009;4:225–233. doi:10.2147/cia.S535819554093
  • Stuhec M. Solifenacin-induced delirium and hallucinations. Gen Hosp Psychiatry. 2013;35(6):682 e3–4. doi:10.1016/j.genhosppsych.2013.06.002
  • Tsao JW, Heilman KM. Transient memory impairment and hallucinations associated with tolterodine use. N Engl J Med. 2003;349(23):2274–2275. doi:10.1056/NEJM20031204349232514657444
  • Wagg A, Khullar V, Michel MC, et al. Long-term safety, tolerability and efficacy of flexible-dose fesoterodine in elderly patients with overactive bladder: open-label extension of the SOFIA trial. Neurourol Urodyn. 2014;33(1):106–114.23460503
  • Wagg A, Dale M, Tretter R, Stow B, Compion G. Randomised, multicentre, placebo-controlled, double-blind crossover study investigating the effect of solifenacin and oxybutynin in elderly people with mild cognitive impairment: the SENIOR study. Eur Urol. 2013;64(1):74–81. doi:10.1016/j.eururo.2013.01.00223332882
  • Staskin D, Kay G, Tannenbaum C, et al. Trospium chloride has no effect on memory testing and is assay undetectable in the central nervous system of older patients with overactive bladder. Int J Clin Pract. 2010;64(9):1294–1300. doi:10.1111/j.1742-1241.2010.02433.x20561092
  • Michel MC. β-Adrenergic receptor subtypes in the urinary tract. Handb Exp Pharmacol. 2011;202:307–318.
  • Bhide AA, Digesu GA, Fernando R, Khullar V. Mirabegron - a selective beta3-adrenoreceptor agonist for the treatment of overactive bladder. Res Rep Urol. 2012;4:41–45. doi:10.2147/RRU.S2893024199179
  • Yoshida M, Takeda M, Gotoh M, Nagai S, Kurose T. Vibegron, a novel potent and selective beta3-adrenoreceptor agonist, for the treatment of patients with overactive bladder: a randomized, double-blind, Placebo-controlled Phase 3 Study. Eur Urol. 2018;73(5):783–790. doi:10.1016/j.eururo.2017.12.02229366513
  • Keam SJ. Vibegron: first global approval. Drugs. 2018;78(17):1835–1839. doi:10.1007/s40265-018-1006-330411311
  • Sacco E, Bientinesi R, Tienforti D, et al. Discovery history and clinical development of mirabegron for the treatment of overactive bladder and urinary incontinence. Expert Opin Drug Discov. 2014;9(4):433–448. doi:10.1517/17460441.2014.89292324559030
  • Khullar V, Amarenco G, Angulo JC, et al. Efficacy and tolerability of mirabegron, a beta(3)-adrenoceptor agonist, in patients with overactive bladder: results from a randomised European-Australian phase 3 trial. Eur Urol. 2013;63(2):283–295. doi:10.1016/j.eururo.2012.10.01623182126
  • Nitti VW, Khullar V, van Kerrebroeck P, et al. Mirabegron for the treatment of overactive bladder: a prespecified pooled efficacy analysis and pooled safety analysis of three randomised, double-blind, placebo-controlled, phase III studies. Int J Clin Pract. 2013;67(7):619–632. doi:10.1111/ijcp.1219423692526
  • Herschorn S, Barkin J, Castro-Diaz D, et al. A Phase III, randomized, double-blind, parallel-group, placebo-controlled, multicentre study to assess the efficacy and safety of the beta(3) adrenoceptor agonist, mirabegron, in patients with symptoms of overactive bladder. Urology. 2013;82(2):313–320. doi:10.1016/j.urology.2013.02.07723769122
  • Cui Y, Zong H, Yang C, Yan H, Zhang Y. The efficacy and safety of mirabegron in treating OAB: a systematic review and meta-analysis of phase III trials. Int Urol Nephrol. 2014;46(1):275–284. doi:10.1007/s11255-013-0509-923896942
  • Wagg A, Cardozo L, Nitti VW, et al. The efficacy and tolerability of the beta3-adrenoceptor agonist mirabegron for the treatment of symptoms of overactive bladder in older patients. Age Ageing. 2014;43(5):666–675. doi:10.1093/ageing/afu01724610862
  • Wagg A, Staskin D, Engel E, et al. Efficacy, safety, and tolerability of mirabegron in patients aged ≥65 years with overactive bladder wet: a Phase IV, double-blind, randomised, placebo-controlled study (PILLAR). Eur Urol. 77(2):211–220.31733990
  • Abrams P, Kelleher C, Staskin D, et al. Combination treatment with mirabegron and solifenacin in patients with overactive bladder: efficacy and safety results from a randomised, double-blind, dose-ranging, phase 2 study (Symphony). Eur Urol. 2015;67(3):577–588. doi:10.1016/j.eururo.2014.02.01224612659
  • Herschorn S, Chapple CR, Abrams P, et al. Efficacy and safety of combinations of mirabegron and solifenacin compared with monotherapy and placebo in patients with overactive bladder (SYNERGY study). BJU Int. 2017;120(4):562–575. doi:10.1111/bju.1388228418102
  • Drake MJ, Chapple C, Esen AA, et al. Efficacy and safety of mirabegron add-on therapy to solifenacin in incontinent overactive bladder patients with an inadequate response to initial 4-week solifenacin monotherapy: a randomised double-blind multicentre Phase 3B Study (BESIDE). Eur Urol. 2016;70(1):136–145. doi:10.1016/j.eururo.2016.02.03026965560
  • Gibson W, MacDiarmid S, Huang M, et al. Treating overactive bladder in older patients with a combination of mirabegron and solifenacin: a prespecified analysis from the BESIDE Study. Eur Urol Focus. 2017;3(6):629–638. doi:10.1016/j.euf.2017.08.00828916436
  • Chapple CR, Cruz F, Cardozo L, et al. 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. 77(1):119–128.31635815
  • Gratzke C, van Maanen R, Chapple C, et al. Long-term safety and efficacy of mirabegron and solifenacin in combination compared with monotherapy in patients with overactive bladder: a randomised, multicentre Phase 3 Study (SYNERGY II). Eur Urol. 2018;74(4):501–509. doi:10.1016/j.eururo.2018.05.00529866467
  • Oelke M, Becher K, Castro-Diaz D, et al. Appropriateness of oral drugs for long-term treatment of lower urinary tract symptoms in older persons: results of a systematic literature review and international consensus validation process (LUTS-FORTA 2014). Age Ageing. 2015;44(5):745–755. doi:10.1093/ageing/afv07726104505
  • Chapple CR, Mironska E, Wagg A, et al. Multicriteria decision analysis applied to the clinical use of pharmacotherapy for overactive bladder symptom complex. Eur Urol Focus. 2019. doi:10.1016/j.euf.2019.09.020