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BMC Urology
Published in: BMC Urology 1/2018

Open Access 01-12-2018 | Research article

A retrospective study of treatment persistence and adherence to mirabegron versus antimuscarinics, for the treatment of overactive bladder in Spain

Authors: Jameel Nazir, Zalmai Hakimi, Florent Guelfucci, Amine Khemiri, Francis Fatoye, Ana María Mora Blázquez, Marta Hernández González

Published in: BMC Urology | Issue 1/2018

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Abstract

Background

Persistence on-treatment with antimuscarinics in patients with overactive bladder (OAB) is reported to be sub-optimal. This retrospective, longitudinal, observational cohort study assessed treatment persistence with β3-adrenoceptor agonists (i.e. mirabegron) and antimuscarinics, both classes of OAB pharmacotherapy, in patients with OAB in Spain.

Methods

Adults who received mirabegron or an antimuscarinic in routine clinical practice (1 June–31 October 2014), were identified from anonymised prescription data within the Spanish Cegedim Electronic Medical Records database. The primary endpoint, treatment persistence (time to treatment discontinuation [TTD] and the proportion of patients remaining on-treatment after 12 months), was unadjusted for potential confounders. Multivariate Cox regression models of persistence, adjusted for baseline characteristics, were used to compare differences in treatment groups. Adjusted subgroup analyses (target OAB drug, age, treatment status and sex) and sensitivity analyses (extending the time used to define treatment discontinuation from 30 days [base-case] to 45, 60 or 90 days without prescription renewal) were also performed.

Results

Overall, 1798 patients received mirabegron (N = 1169) or an antimuscarinic (N = 629); the mean age was 66.42 years. Median TTD was longer for mirabegron versus antimuscarinics (90 vs 56 days) and a higher proportion of patients who received mirabegron were persistent after 12 months (20.2% vs 10.2%); multivariate analyses indicated significantly greater persistence with mirabegron versus antimuscarinics (hazard ratio [HR]: 1.52; 95% confidence interval [CI]: 1.37–1.70; p < 0.001). Significant differences were also observed in subgroup analyses of mirabegron versus individual antimuscarinics (median TTD: 90 vs [range] 28–60 days; HR range: 1.21–2.17; p ≤ 0.013) and in all other subgroups assessed (p < 0.001). Sensitivity analysis showed that the median TTD for mirabegron increased by up to 31 days, and was significantly longer versus antimuscarinics across all adjusted periods (HR range: 1.43–1.53; all p < 0.001).

Conclusions

Patients with OAB in Spain who received mirabegron experienced longer persistence on-treatment than those who received antimuscarinics and the proportion of patients persistent on-treatment at 12 months with mirabegron was two-times higher versus antimuscarinics. These data may provide strategic insights for clinicians and policy makers involved in the management of OAB.
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Literature
1.
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, et al. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the international continence society. Urology. 2002;61:37–49.CrossRef
2.
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. Neurourol Urodyn. 2010;29:4–20.PubMed
3.
Castro D, Espuna M, Prieto M, Badia X. Prevalence of overactive bladder in Spain: a population-based study. Arch Esp Urol. 2005;58:131–8.CrossRefPubMed
4.
Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, et al. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003;20:327–36.PubMed
5.
Nicolson P, Kopp Z, Chapple CR, Kelleher C. It's just the worry about not being able to control it! A qualitative study of living with overactive bladder. Br J Health Psychol. 2008;13:343–59.CrossRefPubMed
6.
Coyne KS, Sexton CC, Irwin DE, Kopp ZS, Kelleher CJ, Milsom I. 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;101:1388–95.CrossRefPubMed
7.
Irwin DE, Mungapen L, Milsom I, Kopp Z, Reeves P, Kelleher C. The economic impact of overactive bladder syndrome in six western countries. BJU Int. 2009;103:202–9.CrossRefPubMed
8.
9.
10.
Cramer JA, Roy A, Burrell A, Fairchild CJ, Fuldeore MJ, Ollendorf DA, et al. Medication compliance and persistence: terminology and definitions. Value Health. 2008;11:44–7.CrossRefPubMed
11.
Yeaw J, Benner JS, Walt JG, Sian S, Smith DB. Comparing adherence and persistence across 6 chronic medication classes. J Manag Care Pharm. 2009;15:728–40.PubMed
12.
Veenboer PW, Bosch JL. Long-term adherence to antimuscarinic therapy in everyday practice: a systematic review. J Urol. 2014;191:1003–8.CrossRefPubMed
13.
Sexton CC, Notte SM, Maroulis C, Dmochowski RR, Cardozo L, Subramanian D, 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;65:567–85.CrossRefPubMed
14.
Benner JS, Nichol MB, Rovner ES, Jumadilova Z, Alvir J, Hussein M, et al. Patient-reported reasons for discontinuing overactive bladder medication. BJU Int. 2010;105:1276–82.CrossRefPubMed
15.
16.
17.
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;82:313–20.CrossRefPubMed
18.
Nitti VW, 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. 2013;189:1388–95.CrossRefPubMed
19.
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;63:283–95.CrossRefPubMed
20.
Maman K, Aballea S, Nazir J, Desroziers K, Neine ME, Siddiqui E, et al. Comparative efficacy and safety of medical treatments for the management of overactive bladder: a systematic literature review and mixed treatment comparison. Eur Urol. 2014;65:755–65.CrossRefPubMed
21.
Wagg A, Franks B, Ramos B, Berner T. Persistence and adherence with the new beta-3 receptor agonist, mirabegron, versus antimuscarinics in overactive bladder: early experience in Canada. Can Urol Assoc J. 2015;9:343–50.CrossRefPubMedPubMedCentral
22.
Chapple CR, Nazir J, Hakimi Z, Bowditch S, Fatoye F, Guelfucci F, et al. Persistence and adherence with mirabegron versus antimuscarinic agents in patients with overactive bladder: a retrospective observational study in UK clinical practice. Eur Urol. 2017;72:389–99.CrossRefPubMed
23.
Nitti VW, Rovner ES, Franks B, Muma NM, Berner T, Fan A, et al. Persistence with mirabegron versus tolterodine in patients with overactive bladder. Am J Pharm Benefits. 2016;8:e25–33.
24.
25.
Chapple CR, Fianu-Jonsson A, Indig M, Khullar V, Rosa J, Scarpa RM, et al. Treatment outcomes in the STAR study: a subanalysis of solifenacin 5 mg and tolterodine ER 4 mg. Eur Urol. 2007;52:1195–203.CrossRefPubMed
26.
Chapple CR, Khullar V, Gabriel Z, Muston D, Bitoun CE, Weinstein D. The effects of antimuscarinic treatments in overactive bladder: an update of a systematic review and meta-analysis. Eur Urol. 2008;54:543–62.CrossRefPubMed
27.
Corcos J, Przydacz M, Campeau L, Gray G, Hickling D, Honeine C, et al. CUA guideline on adult overactive bladder. Can Urol Assoc J. 2017;11:E142–e73.CrossRefPubMedPubMedCentral
28.
Campbell UB, Stang P, Barron R. Survey assessment of continuation of and satisfaction with pharmacological treatment for urinary incontinence. Value Health. 2008;11:726–32.CrossRefPubMed
29.
Dmochowski RR, Newman DK. Impact of overactive bladder on women in the United States: results of a national survey. Curr Med Res Opin. 2007;23:65–76.CrossRefPubMed
30.
Andy UU, Arya LA, Smith AL, Propert KJ, Bogner HR, Colavita K, et al. Is self-reported adherence associated with clinical outcomes in women treated with anticholinergic medication for overactive bladder? Neurourol Urodyn. 2015;35:738–42.CrossRefPubMedPubMedCentral
31.
Kim TH, Choo MS, Kim YJ, Koh H, Lee KS. Drug persistence and compliance affect patient-reported outcomes in overactive bladder syndrome. Qual Life Res. 2016;25:2021–9.CrossRefPubMed
32.
Hakimi Z, Nazir J, McCrea C, Berling M, Fatoye F, Ramos B, et al. Clinical and economic impact of mirabegron compared with antimuscarinics for the treatment of overactive bladder in Canada. J Med Econ. 2017;20:614–22.CrossRefPubMed
33.
Nazir J, Berling M, McCrea C, Fatoye F, Bowditch S, Hakimi Z, et al. Economic impact of mirabegron versus antimuscarinics for the treatment of overactive bladder in the UK. PharmacoEconomics - Open. 2017;1:25–36.CrossRefPubMedPubMedCentral
34.
Sicras-Mainar A, Rejas J, Navarro-Artieda R, Aguado-Jodar A, Ruiz-Torrejon A, Ibanez-Nolla J, et al. Antimuscarinic persistence patterns in newly treated patients with overactive bladder: a retrospective comparative analysis. Int Urogynecol J. 2014;25:485–92.CrossRefPubMed
35.
Sicras-Mainar A, Navarro-Artieda R, Ruiz-Torrejon A, Saez-Zafra M, Coll-de Tuero G. Impact of loss of work productivity in patients with overactive bladder treated with antimuscarinics in Spain: study in routine clinical practice conditions. Clin Drug Investig. 2015;35:795–805.CrossRefPubMed
36.
37.
Krall JM, Uthoff VA, Harley JB. A step-up procedure for selecting variables associated with survival. Biometrics. 1975;31:49–57.CrossRefPubMed
38.
Helmreich JE. Regression modeling strategies with applications to linear models, logistic and ordinal regression and survival analysis (2nd Edition). J Stat Softw. 2016;70(Book Review 2).
39.
Freeman R, Foley S, Rosa J, Vicente E, Grill R, Kachlirova Z, et al. Mirabegron improves quality of life, treatment satisfaction and persistence in patients with overactive bladder - a multicentre, non-interventional, real-world, 12-month study. Curr Med Res Opin. 2017:1–9. https://​doi.​org/​10.​1080/​03007995. [Epub ahead of print]
40.
Wagg A, Compion G, Fahey A, Siddiqui E. Persistence with prescribed antimuscarinic therapy for overactive bladder: a UK experience. BJU Int. 2012;110:1767–74.CrossRefPubMed
41.
Errando-Smet C, Muller-Arteaga C, Hernandez M, Lenero E, Roset M. Healthcare resource utilization and cost among males with lower urinary tract symptoms with a predominant storage component in Spain: the epidemiological, cross-sectional MERCURY study. Neurourol Urodyn. 2017; https://​doi.​org/​10.​1002/​nau.​23293. [epub ahead of print]
42.
Subak LL, Johnson C, Whitcomb E, Boban D, Saxton J, Brown JS. Does weight loss improve incontinence in moderately obese women? Int Urogynecol J Pelvic Floor Dysfunct. 2002;13:40–3.CrossRefPubMed
43.
Gozukara YM, Akalan G, Tok EC, Aytan H, Ertunc D. The improvement in pelvic floor symptoms with weight loss in obese women does not correlate with the changes in pelvic anatomy. Int Urogynecol J. 2014;25:1219–25.CrossRefPubMed
44.
Malone-Lee JG, Walsh JB, Maugourd MF. Tolterodine: a safe and effective treatment for older patients with overactive bladder. J Am Geriatr Soc. 2001;49:700–5.CrossRefPubMed
45.
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;67:577–88.CrossRefPubMed
46.
47.
Wagg AS, Foley S, Peters J, Nazir J, Kool-Houweling L, Scrine L. Persistence and adherence with mirabegron vs antimuscarinics in overactive bladder: retrospective analysis of a UK general practice prescription database. Int J Clin Pract. 2017;71
48.
Kalder M, Pantazis K, Dinas K, Albert US, Heilmaier C, Kostev K. Discontinuation of treatment using anticholinergic medications in patients with urinary incontinence. Obstet Gynecol. 2014;124:794–800.CrossRefPubMed
49.
Tran AM, Sand PK, Seitz MJ, Gafni-Kane A, Zhou Y, Botros SM. Does physician specialty affect persistence to pharmacotherapy among patients with overactive bladder syndrome? Int Urogynecol J. 2017;28:409–15.CrossRefPubMed
50.
Shingler SL, Bennett BM, Cramer JA, Towse A, Twelves C, Lloyd AJ. Treatment preference, adherence and outcomes in patients with cancer: literature review and development of a theoretical model. Curr Med Res Opin. 2014;30:2329–41.CrossRefPubMed
51.
Touchette D, Shapiro N. Medication compliance, adherence, and persistence: current status of behavioral and educational interventions to improve outcomes. J Manag Care Pharm. 2008;14:S2–S10.
52.
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;67:619–32.CrossRefPubMedPubMedCentral
53.
Metadata
Title
A retrospective study of treatment persistence and adherence to mirabegron versus antimuscarinics, for the treatment of overactive bladder in Spain
Authors
Jameel Nazir
Zalmai Hakimi
Florent Guelfucci
Amine Khemiri
Francis Fatoye
Ana María Mora Blázquez
Marta Hernández González
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Urology / Issue 1/2018
Electronic ISSN: 1471-2490
DOI
https://doi.org/10.1186/s12894-018-0390-z

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