Cure effect and persistence of treatment with Mirabegron in patients with symptoms of overactive bladder: a multicentre clinical study


Authors: A. Martan 1;  J. Mašata 1;  K. Švabík 1;  T. Hanuš 2;  J. Krhut 3;  R. Zachoval 4
Authors‘ workplace: Gynekologicko-porodnická klinika VFN a 1. LF UK, Praha, přednosta prof. MUDr. A. Martan, DrSc. 1;  Urologická klinika VFN a 1. LF UK, Praha, přednosta prof. MUDr. T. Hanuš, DrSc. 2;  Urologické oddělení FN, Ostravská univerzita, Ostrava, přednosta doc. MUDr. J. Krhut, Ph. D. 3;  Urologické oddělení Thomayerovy nemocnice, Praha, přednosta doc. MUDr. R. Zachoval, Ph. D. 4
Published in: Ceska Gynekol 2017; 82(6): 424-429

Overview

Objective:
The objective of this study was to monitor and evaluate the persistence and cure effect of Mirabegron in patients with overactive bladder syndrome after 18 months of treatment.

Design:
Prospective clinical study.

Settings:
10 gynecological and urological departments in CZE.

Materials and methods:
This is an analysis of a prospective, multicenter monitoring study from May to September 2014. The patients were ≥ 18 years old and had symptoms of OAB for a minimum of three months. Patient check-ups were performed 18 months after the first visit. The dosage of Mirabegron was 50 mg per day in 162 patients, though for 44 of the patients the treatment was changed. During the final check-ups it was ascertained how many patients had discontinued treatment with Mirabegron, at first as a proportion of the whole group of patients and then in relation to gender, age, previous treatment with anticholinergic drugs and changes in the treatment during the study. To evaluate treatment efficacy we employed the TS-VAS and PPBC. During the check-up it was ascertained how many patients had discontinued treatment with Mirabegron, and reasons for this were established. The statistics were calculated using the softwares STATISTICA 12 (Statsoft, USA) and SPSS 20.0 (IBM, v.20.0).

Results:
Prospective monitoring was performed on 206 patients. Their mean age was 62.8 years; mean body mass index for the whole group of patients was 27.3. At the check-up 18 months post-initiation of treatment it emerged that 79 (38.3%) patients had discontinued the treatment. The reasons for discontinuation of treatment were insufficient treatment efficacy (35.4% of patients), while 49.4% cited other reasons (hospitalisation, surgery, gravidity) and 15.2% of patients discontinued therapy because of side effects. The evaluation of treatment persistence with Mirabegron in groups with relation to gender, age and previous treatment with anticholinergic drugs did not establish statistically significant differences. However, there was a statistically significant difference between groups in relation to changes of treatment during study. At the evaluation of the efficacy of the treatment during the check-up 18 months after initiation of treatment the mean TS-VAS was 73.4, a decrease of the scale of bothers evaluated by PPBC before treatment from a mean value of 4.6 to a value of 2.7.

Conclusions:
In our clinical study 18 months treatment persistence with Mirabegron was 61.7%. The reasons were reduced side effects and good cure effect of the drug.

Keywords:
persistence, overactive bladder, Mirabegron


Sources

1. Benner, JS., Nichol, MB., Rovner, ES., et al. Patient – reported reasons for discontinuing overactive bladder medication. BJU Int, 2010, 105, p. 1276–1282.

2. Coelho, A., Antunes-Lopes, T., Gillespi, J., Cruz, F. Beta-3 adrenergic receptor is expressed in acetylcholine-containing nerve fibres of the human urinary bladder: An immunohistochemical study. Neurourol Urodyn, 2017, DOI 10.1002/nau.23224.

3. Coyne, KS., Sexton, CC., Kopp, ZS., et al. The impact of overactive bladder on mental health, work productivity and health-related quality of life in the UK and Sweden: results from EpiLUTS. BJU Int, 2011, 108, p. 1459–1471.

4. Duckett, J., Balachandran, A. Tolerability and persistence in a large, prospective case series of women prescribed mirabegron. Int Urogynecol J, 2016, 27(8), p. 1163–1167.

5. Haab, F., Castro-Diaz, D. Persistence with antimuscarinic therapy in patiens with overactive bladder. Int J Clin Prac, 2005, 59, p. 931–937.

6. Hakimi, Z., Nazir, J., McCrea,C., et al. Clinical and economic impact of mirabegron compared with antimuscarinics for the treatment of overactive bladder in Canada. J Med Econ, 2017, 20(6), p. 614–622.

7. Haylen, BT., de Ridder, D., Freeman, RM., 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), p. 5–26.

8. Herschorn, S., Bakrin, J., Astro-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) adrenoreceptor agonist, mirabegron, in patiens with symptom of overactive bladder. Urology, 2013, 82(2), p. 313–320.

9. 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)-adrenoreceptor agonist, in overactive bladder. Eur Urol, 2013, 63(2), p. 296–305.

10. Chapple, CR., Nazir, J., Hakimi, Z., et al. Persistence and adherence with mirabegron versus antimuscarinic agents in patiens with overactive bladder: A retrospective observational study in UK clinical praktice. Eur Urol, 2017, pii:S0302-2838(17)30062-3.

11. Katoh, T., Kuwamoto, K., Kato, D., Kuroishi, K. Real-world cardiovascular assessment of mirabegron treatment in patients with overactive bladder and concomitant cardiovasculat disease: Results of a Japanese post-marketing study. Int J Urol, 2016, 23, p. 1009–1015.

12. Khullar, V., Amarenco, G., Angulo, JC., et al. Efficacy and tolerability of mirabegron, adrenoreceptor agonist, in patients with overactive bladder: results from a randomised Australian phase 3 trial. Eur Urol, 2013, 63(2), p. 283–295.

13. Kinjo, M., Sekiguchi, Y., Yoshimura, Y., Nutahara, K. Long-term persistence with mirabegron versus solifenacin in women with overactive bladder: prospective, randomized trial. LUTS, 2016, DOI: 10.111/luts.12151.

14. Kobayashi, M., Nukui, A., Kamai, T. Comparative efficaccy and tolerability of antiimuscarinic agents and the selective beta3-adrenoreceptor agonist, mirabegron, for the treatment of overactive bladder: which is more preferable as an initial treatment? LUTS, 2016, DOI: 10.1111/luts. 12153.

15. Linner, L., Schioler, H., Samuelsson, E., et al. Low persistence of anticholinergic drug use in Sweden. Eur J Clin Pharmacol, 2011, 67, p. 535–536.

16. Martan, A., Horčička, L., Hanuš, T., et al. Prevalence žen s hyperaktivním močovým měchýřem v České republice. Čes Gynek, 2011, 76, s. 144–150.

17. Maggiore, ULR., Cardozo, L., Ferrero, S., et al. Mirabegron in the treatment of overactive bladder. Expert Opin Pharmacother, 2014, 15(6), p. 873–887.

18. Morin, F., Blaivas, AS., Naderu, G., et al. Dual therapy for refractory overactive bladder in children: a prospective open-label study. 2017, J Urol, 2017, 197(4), p. 1158–1163.

19. Nabi, G., Cody, JD., Ellis, G., et al. Anticholinergic drugs versus placebo for overactive bladder syndrome in adults. Cochrane Database Syst Rev, 2006, 4, CD003781.

20. Nitti, VW., Khullar, V., van Kerrenbroeck, P., et al. Mirabegron for the treatment of overactive bladder: a prespecified pooled efficacy analysis and pooled safety analysis of three randomized, double-blind, placebo-controlled, phase III studies. Int J Clin Pract, 2013, 67(7), p. 619–632.

21. Pindoria, N., Malde, S., Nowers, J., et al. Persistence with mirabegron therapy for overactive bladder: A real life experience. Neurourol Urodyn, 2017, 36, p. 404–408.

22. Robinson, D., Kelleher, C., Staskin, D., et al. Patient-reported outcomes from SYNERGY, a randomized, double-blind, multicenter study evaluating combinations of mirabegron and solifenacin compared with monotherapy and placebo in OAB patients. Neurourol Urodyn, 2017, DOI:10.1002/nau.23315.

23 Serati, M., Maggiore, ULR., Sorice, P., et al. Is mirabegron equally as effective when used as first- or second-line therapy in women with overactive bladder? Int Urogynecol J, 2017, 28(7), p. 1033–1039.

24. 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, p. 567–585.

25. Shaya, FT., Blume, S., Gu, A., et al. Persistence with overactive bladder pharmacotherapy in a medicaid population. Am J Manag Care, 2005,11 (Suppl.), p. 121–129.

26. Shin, JH., Kim, A., Choo, M., et al. Additional low-dose antimuscarinics can improve overactive bladder symptoms in patients with suboptimal response to beta 3 agonist monotherapy. Investig Clin Urol, 2017, 58, p. 261–266

27. Stewart, WF., Corey, R., Herzog, AR., et al. Prevalence of overactive bladder in women: results from the NOBLE program. Int Urogynaecol J, 2001, 12(3), S66.

28. Wagg, A., Compion, G., Fahey, A., Siddiqui, E. Persistence with prescribed antimuscarinic therapy for overactive bladder: a UK experience. BJU Int, 2012, 110, p. 1767–1774.

29. Wagg, A., Franks, B., Ramos, B., Berner, T. Persistence and adherence with the beta-3 receptor agonist, mirabegron, versus antimuscarinics in overactive bladder: early experience in Canada. Can Urol Assoc J, 2015, 9, p. 343–350.

30. Wagg, A., Nitti, VW., Kelleher, C., et al. Oral pharmacotherapy for overactive bladder in older patiens: mirabegron as a potential alternative to antimuscarinics. Curr Med Res Opinion, 2016, 32, p. 621–638.

Labels
Paediatric gynaecology Gynaecology and obstetrics Reproduction medicine

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