Top

Published in:

01-07-2017 | Original Article

Is mirabegron equally as effective when used as first- or second-line therapy in women with overactive bladder?

Authors: Maurizio Serati, Umberto Leone Roberti Maggiore, Paola Sorice, Simona Cantaluppi, Enrico Finazzi Agrò, Fabio Ghezzi, Publication Committee of the Italian Society of Urodynamics

Published in: International Urogynecology Journal | Issue 7/2017

Abstract

Introduction and hypothesis

No previous studies have investigated the efficacy of mirabegron 50 mg as the first-line therapy in OAB patients. Hence, the primary objective of this study was to evaluate the efficacy of mirabegron in treatment-naive patients in comparison with those who had discontinued antimuscarinic therapy because of insufficient efficacy.

Methods

All consecutive women who had pure OAB symptoms (including urgency with or without urgency incontinence and frequency) for at least 3 months were considered for this study. Women were divided into two groups: women without any previous pharmacological treatment for OAB (group 1) and women with a previous history of failed antimuscarinics therapy (group 2).

Results

At 3-month follow-up, the objective results on the basis of the frequency–volume chart showed a significant improvement in both groups. Furthermore, a significant reduction in the Overactive Bladder Questionnaire Short Form (OABq-SF) score and in the Indevus Urgency Severity Scale (IUSS) questionnaire were reported in both groups. However, the improvement in objective and subjective outcomes was superior in group 1 to that in group 2.

Conclusions

Mirabegron is efficacious in improving OAB symptoms in both naïve patients and those who discontinued primary antimuscarinic therapy; however, its efficacy is superior when prescribed as first-line therapy.

Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, et al. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010;21(1):5–26. doi:10.1007/s00192-009-0976-9.CrossRefPubMed

Maggiore ULR, Salvatore S, Alessandri F, Remorgida V, Origoni M, Candiani M, et al. Pharmacokinetics and toxicity of antimuscarinic drugs for overactive bladder treatment in females. Expert Opin Drug Metab Toxicol. 2012;8(11):1387–408. doi:10.1517/17425255.2012.714365.CrossRef

Reynolds WS, McPheeters M, Blume J, Surawicz T, Worley K, Wang L, et al. Comparative effectiveness of anticholinergic therapy for overactive bladder in women: a systematic review and meta-analysis. Obstet Gynecol. 2015;125(6):1423–32. doi:10.1097/AOG.0000000000000851.CrossRefPubMed

Maggiore ULR, Cardozo L, Ferrero S, Sileo F, Cola A, Torella M, et al. Mirabegron in the treatment of overactive bladder. Expert Opin Pharmacother. 2014;15(6):873–87. doi:10.1517/14656566.2014.898752.CrossRef

Chapple CR, Kaplan SA, Mitcheson D, Klecka J, Cummings J, Drogendijk T, et al. Randomized double-blind, active-controlled phase 3 study to assess 12-month safety and efficacy of mirabegron, a beta(3)-adrenoceptor agonist, in overactive bladder. Eur Urol. 2013;63(2):296–305. doi:10.1016/j.eururo.2012.10.048.CrossRefPubMed

Khullar V, Amarenco G, Angulo JC, Cambronero J, Hoye K, Milsom I, 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):283–95. doi:10.1016/j.eururo.2012.10.016.CrossRefPubMed

Thuroff JW, Abrams P, Andersson KE, Artibani W, Chapple CR, Drake MJ, et al. EAU guidelines on urinary incontinence. Eur Urol. 2011;59(3):387–400. doi:10.1016/j.eururo.2010.11.021.CrossRefPubMed

National Institute for Health and Care Excellence (NICE). Mirabegron for treating symptoms of overactive bladder. National Institute for Health and Care Excellence: Clinical Guidelines. London: NICE; 2013.

Herschorn S, Barkin J, Castro-Diaz D, Frankel JM, Espuna-Pons M, Gousse AE, 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):313–20. doi:10.1016/j.urology.2013.02.077.CrossRefPubMed

10.

Nitti VW, Khullar V, van Kerrebroeck P, Herschorn S, Cambronero J, Angulo JC, 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):619–32. doi:10.1111/ijcp.12194.CrossRefPubMedPubMedCentral

11.

Rosa GM, Ferrero S, Nitti VW, Wagg A, Saleem T, Chapple CR. Cardiovascular safety of beta3-adrenoceptor Agonists for the treatment of patients with overactive bladder syndrome. Eur Urol. 2016;69(2):311–23. doi:10.1016/j.eururo.2015.09.007.CrossRefPubMed

12.

Uzun H, Zorba OU. Metabolic syndrome in female patients with overactive bladder. Urology. 2012;79(1):72–5. doi:10.1016/j.urology.2011.08.050.CrossRefPubMed

13.

Bunn F, Kirby M, Pinkney E, Cardozo L, Chapple C, Chester K, et al. Is there a link between overactive bladder and the metabolic syndrome in women? A systematic review of observational studies. Int J Clin Pract. 2015;69(2):199–217. doi:10.1111/ijcp.12518.CrossRefPubMed

14.

Hilt EE, McKinley K, Pearce MM, Rosenfeld AB, Zilliox MJ, Mueller ER, et al. Urine is not sterile: use of enhanced urine culture techniques to detect resident bacterial flora in the adult female bladder. J Clin Microbiol. 2014;52(3):871–6. doi:10.1128/JCM.02876-13.CrossRefPubMedPubMedCentral

15.

Karstens L, Asquith M, Davin S, Stauffer P, Fair D, Gregory WT, et al. Does the urinary microbiome play a role in urgency urinary incontinence and its severity? Front Cell Infect Microbiol. 2016;6:78. doi:10.3389/fcimb.2016.00078.CrossRefPubMedPubMedCentral

16.

Schneeweiss J, Koch M, Umek W. The human urinary microbiome and how it relates to urogynecology. Int Urogynecol J. 2016;27(9):1307–12. doi:10.1007/s00192-016-2944-5.CrossRefPubMed

17.

Leone Roberti Maggiore U, Salvatore S, Alessandri F, Remorgida V, Origoni M, Candiani M, et al. Pharmacokinetics and toxicity of antimuscarinic drugs for overactive bladder treatment in females. Expert Opin Drug Metab Toxicol. 2012;8(11):1387–408. doi:10.1517/17425255.2012.714365.CrossRefPubMed

18.

D’Agostino G, Maria Condino A, Calvi P. Involvement of beta3-adrenoceptors in the inhibitory control of cholinergic activity in human bladder: direct evidence by [(3)H]-acetylcholine release experiments in the isolated detrusor. Eur J Pharmacol. 2015;758:115–22. doi:10.1016/j.ejphar.2015.03.074.CrossRefPubMed

19.

Hsiao SM, Liao CH, Lin HH, Kuo HC. Duration of antimuscarinic administration for treatment of overactive bladder before which one can assess efficacy: an analysis of predictive factors. Int Neurourol J. 2015;19(3):171–7. doi:10.5213/inj.2015.19.3.171.CrossRefPubMedPubMedCentral

20.

Korstanje C, Someya A, Hiroshi Y, Noguchi Y, Ukai M, Suzuki M, et al. Additive effects for increased bladder storage function with the antimuscarinic drug solifenacin and the selective b3-adrenoceptor agonist mirabegron in two rat models for in vivo bladder function. 43rd Meeting of the International Continence Society; Barcelona, Spain, 26–30 August 2013.

21.

Abrams P, Kelleher C, Staskin D, Rechberger T, Kay R, Martina R, 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):577–88. doi:10.1016/j.eururo.2014.02.012.CrossRefPubMed

22.

Abrams P, Kelleher C, Staskin D, Kay R, Martan A, Mincik I, et al. Combination treatment with mirabegron and solifenacin in patients with overactive bladder: exploratory responder analyses of efficacy and evaluation of patient-reported outcomes from a randomized, double-blind, factorial, dose-ranging, Phase II study (SYMPHONY). World J Urol. 2016. doi:10.1007/s00345-016-1908-1.PubMed

23.

Drake MJ, Chapple C, Esen AA, Athanasiou S, Cambronero J, Mitcheson D, 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):136–45. doi:10.1016/j.eururo.2016.02.030.CrossRefPubMed

24.

MacDiarmid S, Al-Shukri S, Barkin J, Fianu-Jonasson A, Grise P, Herschorn S, et al. Mirabegron as add-on treatment to solifenacin in patients with incontinent overactive bladder and an inadequate response to solifenacin monotherapy. J Urol. 2016;196(3):809–18. doi:10.1016/j.juro.2016.03.174.CrossRefPubMed

Title: Is mirabegron equally as effective when used as first- or second-line therapy in women with overactive bladder?
Authors: Maurizio Serati
Umberto Leone Roberti Maggiore
Paola Sorice
Simona Cantaluppi
Enrico Finazzi Agrò
Fabio Ghezzi
Publication Committee of the Italian Society of Urodynamics
Publication date: 01-07-2017
Publisher: Springer London
Published in: International Urogynecology Journal / Issue 7/2017
Print ISSN: 0937-3462
Electronic ISSN: 1433-3023
DOI: https://doi.org/10.1007/s00192-016-3219-x

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Is mirabegron equally as effective when used as first- or second-line therapy in women with overactive bladder?

Abstract

Introduction and hypothesis

Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Introduction and hypothesis

Methods

Results

Conclusions

Please log in to get access to this content

Other articles of this Issue 7/2017

Enlightening the mechanisms of POP recurrence after LeFort colpocleisis. Case report and review

Evaluation of isolated urinary stress incontinence according to the type of levator ani muscle lesion using 3/4D transperineal ultrasound 36 months post-partum

Pessary types and discontinuation rates in patients with advanced pelvic organ prolapse

Multicentre randomized trial of the Ajust™ single-incision sling compared to the Align™ transobturator tape sling

Impaired contraction and decreased detrusor innervation in a female rat model of pelvic neuropraxia

Laparoscopic ventral mesh rectopexy for obstructive defecation syndrome: still the way to go?