Mirabegron: the review of current knowledge of safety and efficacy in the relief of overactive bladder symptoms

Tomasz Aleksiewicz, Kamil Leis, Wojciech Świerczyński, Kacper Miętkiewicz, Katarzyna Litwin, Przemysław Gałązka

Abstract


Mirabegron has been registered as the first strong and selective agonist of the β3 receptor. It is currently used for relief of symptoms of overactive bladder (OAB). That onerous illness involving urgency and detrusor overactivity, that may be accompanied by incontinence, affects approx. 16% of the population. Before registration of Mirabegron, the main pharmacological and non-surgical therapeutic method was the treatment with anti-muscarinic drugs, associated with burdensome adverse effects. Clinical trials on over 10,000 participants demonstrated efficacy and safety of Mirabegron. Besides monotherapy, attempts are being made to use Mirabegron in combined therapy of OAB. The innovative mechanism of action of the drug makes it an attractive option not only in treatment of conditions of the urinary system, but also of metabolic disorders and diseases of the cardiovascular system. This article provides a review of the current knowledge and recent reports regarding Mirabegron - an alternative in treatment of the common and onerous disease of overactive bladder.

Keywords


mirabegron; overactive bladder; review

Full Text:

PDF

References


European Medicines Agency. Betmiga: Product Information. 2013 Jan 15 [updated 2017 Nov 15, cited 2018 Jun 18]. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002388/WC500137309.pdf

Wagg A, Diles D, Berner T. Treatment patterns for patients on overactive bladder therapy: A retrospective statistical analysis using Canadian claims data. JHEOR 2015;3:43-55.

Tubaro A. Defining overactive bladder: epidemiology and burden of disease. Urology 2004; 64: 2–6.

Cypess, A. M., Weiner, L. S., Roberts-Toler, C., Elía, E. F., Kessler, S. H., Kahn, P. A., ... & Kolodny, G. M. (2015). Activation of human brown adipose tissue by a β3-adrenergic receptor agonist. Cell metabolism, 21(1), 33-38.

Bundgaard, H., Axelsson, A., Hartvig Thomsen, J., Sørgaard, M., Kofoed, K. F., Hasselbalch, R., ... & Køber, L. (2017). The first‐in‐man randomized trial of a beta3 adrenoceptor agonist in chronic heart failure: the BEAT‐HF trial. European journal of heart failure, 19(4), 566-575.

Herschorn, S., Chapple, C. R., Abrams, P., Arlandis, S., Mitcheson, D., Lee, K. S., ... & Robinson, D. (2017). Efficacy and safety of combinations of mirabegron and solifenacin compared with monotherapy and placebo in patients with overactive bladder (SYNERGY study). BJU international, 120(4), 562-575.

Abrams, P., Kelleher, C., Staskin, D., Rechberger, T., Kay, R., Martina, R., ... & Ridder, A. (2015). 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). European urology, 67(3), 577-588.

Adrian Wagg (2018): Choosing oral drug therapy for overactive bladder in older people, Expert Opinion on Pharmacotherapy, DOI: 10.1080/14656566.2018.1502270

Karl-Erik Andersson, et al.The efficacy of mirabegron in the treatment of urgency and the potential utility of combination therapy. Therapeutic Advances in Urolog. 2018.

White N, Iglesia CB. Overactive bladder. Elserviel. 2016

Gormley EA et al. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment. Elserviel. 2015.

Robinson D et al. A drug safety evaluation of mirabegron in the management of overactive bladder. Expert Opinion on Drug Safty. 2015.

Aditya S, Mathur SK. Mirabegron: A first-in-class beta-3 agonist for overactive bladder. J Mahatma Gandhi InstMedSci 2015;20:128-33

Krauwinkel W et al. The effect of mirabegron, a potent and selective b3 -adrenoceptoragonist, on the pharmacokinetics of CYP2D6 substratesdesipramine and metoprolol. European Journal of Drug Metabolism and Pharmacokinetics. 2014.

Dehvari, N., da Silva Junior, E. D., Bengtsson, T., & Hutchinson, D. S. (2017). Mirabegron: potential off target effects and uses beyond the bladder. British journal of pharmacology.

Yoshimura, N., & Chancellor, M. B. (2003). Neurophysiology of lower urinary tract function and dysfunction. Reviews in urology, 5(Suppl 8), S3.

Alexandre, E. C., Kiguti, L. R., Calmasini, F. B., Silva, F. H., da Silva, K. P., Ferreira, R., ... & Antunes, E. (2016). Mirabegron relaxes urethral smooth muscle by a dual mechanism involving β3‐adrenoceptor activation and α1‐adrenoceptor blockade. British journal of pharmacology, 173(3), 415-428.

Chapple, C. R., Nitti, V. W., Khullar, V., Wyndaele, J. J., Herschorn, S., van Kerrebroeck, P., ... & Siddiqui, E. (2014). Onset of action of the β3-adrenoceptor agonist, mirabegron, in Phase II and III clinical trials in patients with overactive bladder. World journal of urology, 32(6), 1565-1572.

Chapple CR, Kaplan SA, Mitcheson D 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: 296–305.

Chapple CR, Amarenco G, López Aramburu MA, Everaert K, Liehne J, Lucas M, Vik V, Ridder A, Snijder R, Yamaguchi O; BLOSSOM Investigator Group. A proof-of-concept study: mirabegron, a new therapy for overactive bladder. Neurourol Urodyn. 2013 Nov;32(8):1116-22. doi: 10.1002/nau.22373. Epub 2013 Feb 19

Chapple CR, Dvorak V, Radziszewski P et al. A phase II dose-ranging study of mirabegron in patients with overactive bladder. Int. Urogynecol. J. 2013; 24: 1447–58.

Kuo HC, Lee KS, Na Y et al. Results of a randomized, double-blind, parallel-group, placebo- and active-controlled, multicenter study of mirabegron, a beta3-adrenoceptor agonist, in patients with overactive bladder in Asia. Neurourol. Urodyn. 2015; 34: 685–92.

Kelleher, C., Hakimi, Z., Zur, R., Siddiqui, E., Maman, K., Aballéa, S., ... & Chapple, C. (2018). Efficacy and tolerability of mirabegron compared with antimuscarinic monotherapy or combination therapies for overactive bladder: a systematic review and network meta-analysis. European Urology.

Khullar, V., Amarenco, G., Angulo, J. C., Blauwet, M. B., Nazir, J., Odeyemi, I. A., & Hakimi, Z. (2016). Patient‐reported outcomes with the β3‐adrenoceptor agonist mirabegron in a phase III trial in patients with overactive bladder. Neurourology and urodynamics, 35(8), 987-994.

Warren, K., Burden, H., & Abrams, P. (2016). Mirabegron in overactive bladder patients: efficacy review and update on drug safety. Therapeutic advances in drug safety, 7(5), 204-216.

Rosa, G. M., Ferrero, S., Nitti, V. W., Wagg, A., Saleem, T., & Chapple, C. R. (2016). Cardiovascular safety of β3-adrenoceptor agonists for the treatment of patients with overactive bladder syndrome. European urology, 69(2), 311-323.

Sebastianelli, A., Russo, G. I., Kaplan, S. A., McVary, K. T., Moncada, I., Gravas, S., ... & Gacci, M. (2018). Systematic review and meta‐analysis on the efficacy and tolerability of mirabegron for the treatment of storage lower urinary tract symptoms/overactive bladder: Comparison with placebo and tolterodine. International Journal of Urology, 25(3), 196-205.

Yamaguchi, O., Marui, E., Igawa, Y., Takeda, M., Nishizawa, O., Ikeda, Y., & Ohkawa, S. (2015). Efficacy and Safety of the Selective β3‐Adrenoceptor Agonist Mirabegron in J apanese Patients with Overactive Bladder: A Randomized, Double‐Blind, Placebo‐Controlled, Dose‐Finding Study. LUTS: Lower Urinary Tract Symptoms, 7(2), 84-92.

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.

Herschorn S, Barkin J, Castro-Diaz D et al. A phase III, randomized, doubleblind, parallel-group, placebo-controlled, multicentre study to assess the efficacy and safety of the beta(3) drenoceptor agonist, mirabegron, in patients with symptoms of overactive bladder. Urology 2013; 82: 313–20.

Yamaguchi O, Marui E, Kakizaki H et al. Phase III, randomised, doubleblind, placebo-controlled study of the beta3-adrenoceptor agonist mirabegron, 50 mg once daily, in Japanese patients with overactive bladder. BJU Int. 2014; 113: 951–60.

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: 283–95.

Batista, J. E., Kölbl, H., Herschorn, S., Rechberger, T., Cambronero, J., Halaska, M., ... & BEYOND study group. (2015). The efficacy and safety of mirabegron compared with solifenacin in overactive bladder patients dissatisfied with previous antimuscarinic treatment due to lack of efficacy: results of a noninferiority, randomized, phase IIIb trial. Therapeutic advances in urology, 7(4), 167-179.

Nitti, V. W., Rosenberg, S., Mitcheson, D. H., He, W., Fakhoury, A., & Martin, N. E. (2013). Urodynamics and safety of the β3-adrenoceptor agonist mirabegron in males with lower urinary tract symptoms and bladder outlet obstruction. The Journal of urology, 190(4), 1320-1327.

Wöllner, J., & Pannek, J. (2016). Initial experience with the treatment of neurogenic detrusor overactivity with a new β-3 agonist (mirabegron) in patients with spinal cord injury. Spinal cord, 54(1), 78.

Kinjo, M., Sekiguchi, Y., Yoshimura, Y., & Nutahara, K. (2018). Long‐term persistence with mirabegron versus solifenacin in women with overactive bladder: prospective, randomized trial. LUTS: Lower Urinary Tract Symptoms, 10(2), 148-152.

Vouri, S. M., Kebodeaux, C. D., Stranges, P. M., & Teshome, B. F. (2017). Adverse events and treatment discontinuations of antimuscarinics for the treatment of overactive bladder in older adults: A systematic review and meta-analysis. Archives of gerontology and geriatrics, 69, 77-96.




DOI: http://dx.doi.org/10.5281/zenodo.1403711

Refbacks

  • There are currently no refbacks.




Copyright (c) 2018 © The Author(s)

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

Journal of Education, Health and Sport formerly Journal of Health Sciences

Declaration on the original version.

Editors indicates that the main version of the magazine is to issue a "electronic".

The journal has had 5 points in Ministry of Science and Higher Education parametric evaluation. § 8. 2) and § 12. 1. 2) 22.02.2019.

1223 Journal of Education, Health and Sport eISSN 2391-8306 7

ISSN 2391-8306 formerly ISSN: 1429-9623 / 2300-665X

Archives 2011 - 2014

PBN 2011 - 2014

https://pbn.nauka.gov.pl/sedno-webapp/search?search&searchCategory=WORK&filter.inJournal=36616

POL-index 2011 - 2014

https://pbn.nauka.gov.pl/polindex-webapp/browse/journal/journal-32a319c5-a850-4f44-ba70-1418a6087655

BASE 2011 - 2014

https://www.base-search.net/Search/Results?lookfor=Journal+of+Health+Sciences+%28Radom%29&type=all&oaboost=1&ling=1&name=&thes=&refid=dcrespl&newsearch=1

http://elibrary.ru/contents.asp?titleid=37467

http://journal.rsw.edu.pl/index.php/JHS/issue/archive

Indexed in Bases, Bazy indeksacyjne: ERIH Plus, Worldcat, PBN/POL-Index, ICI Journals Master List, Directory of Open Access Journals (DOAJ), ZBD, Ulrich's periodicals, Google Scholar, Polska Bibliografia Lekarska

US NLM = 101679844

101679844 - NLM Catalog Result - NCBI

https://www.ncbi.nlm.nih.gov/nlmcatalog/101679844

Find a library that holds this journal: http://worldcat.org/issn/23918306

Journal Language(s): English 

PBN Poland

https://pbn.nauka.gov.pl/sedno-webapp/journals/49068

POL-index

https://pbn.nauka.gov.pl/polindex-webapp/browse/journal/journal-c39c8169-88d2-45db-9e7f-d948ce9981c4

BASE

https://www.base-search.net/Search/Results?join=AND&bool0[]=AND&lookfor0[]=2391-8306&type0[]=all&page=11&l=pl&oaboost=1&refid=dcpagepl

Redaction, Publisher and Editorial Office

Instytut Kultury Fizycznej Uniwersytet Kazimierza Wielkiego w Bydgoszczy, Institute of Physical Education Kazimierz Wielki University in Bydgoszcz, Poland 85-091 Bydgoszcz ul. Sportowa 2  www.ukw.edu.pl Copyright by Instytut Kultury Fizycznej UKW w Bydgoszczy http://ojs.ukw.edu.pl/index.php/johs  Open Access ISSN 2391-8306 formerly ISSN: 1429-9623 / 2300-665X

The journal has been approved for inclusion in ERIH PLUS.

The ERIH PLUS listing of the journal is available at https://dbh.nsd.uib.no/publiseringskanaler/erihplus/periodical/info?id=485984

SIC Science citation index (calculated on the basis of TCI and Page Rank) 0

Russian Impact factor 0.16

Indexed in Index Copernicus Journals Master List.

http://journals.indexcopernicus.com/Journal+of+Education+Health+and+Sport,p24782242,3.html

ICV 2018 = 95.95 ICV 2017 = 91.30 ICV 2016 = 84.69 ICV 2015 = 93.34 ICV 2014 = 89.51 Standardized Value: 8.27 ICV 2013: 7.32 ICV 2012: 6.41 ICV 20115.48

The InfoBase Index IBI Factor for the year 2015 is 3.56 in InfoBase Index.com.

Website: www.infobaseindex.com

Universal Impact Factor 1.78 for year 2012. (http://www.uifactor.org/AppliedJournals.aspx)

Indexed in Polish Scholarly Bibliography (PBN) (PBN Polska Bibliografia Naukowa) (https://pbn.nauka.gov.pl/journals/36616)

is a portal of the Polish Ministry of Science and Higher Education, collecting information on publications of Polish scientists and on Polish and foreign scholarly journals. Polish Scholarly Bibliograhpy is a part of POL-on - System of Information on Higher Education. It is operated by the Interdisciplinary Centre for Mathematical and Computational Modelling, University of Warsaw.

Indexed in Russian Sciences Index Российский индекс научного цитирования (РИНЦ) http://elibrary.ru/contents.asp?titleid=37467

Indexed in Arianta Polish scientific and professional electronic journals Aneta Drabek i Arkadiusz Pulikowski

(http://www1.bg.us.edu.pl/bazy/czasopisma/czasop_full.asp?id=3595)