Persistence in the treatment of overactive bladder (OAB) with Mirabegron in a multicentre clinical study

Česká verzia

Authors: A. Martan ¹ ; J. Mašata ¹; K. Švabík ¹; T. Hanuš ²; J. Krhut ^3,4
Authors place of work: 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, Ostrava, přednosta doc. MUDr. J. Krhut, Ph. D. ³; Katedra chirurgických oborů LF OU, Ostrava, vedoucí MUDr. P. Vávra, Ph. D. ⁴
Published in the journal: Ceska Gynekol 2015; 80(4): 244-248

Summary

Objective:
The objective of this monitoring was to evaluate persistence in the treatment of patients with overactive bladder syndrome (OAB) using mirabegron.

Design:
Prospective clinical study.

Setting:
10 gynecological and urological departments in CZE.

Materials and methods:
This is an analysis of a prospective, multicenter monitoring which started in May 2014 and will continue for 1 year. This monitoring included patients ≥18 years old who have had symptoms of OAB for minimum ≥3 months. The patient check-up was performed 6 months (±2 weeks) after the first visit. The dosage of mirabegron was 50 mg per day. For the evaluation the treatment efficacy we employed the TS-VAS and PPBC. During the check-up it was ascertained how many patients discontinued the treatment with mirabegron, and reasons for this interruption were established. The statistics were calculated using the software SPSS 20.0.

Results:
A prospective monitoring was performed on 206 patients. Their mean age was 62.8 years (range 23-89); mean body mass index for the whole group of patients was 27.3. At the check-up 6 months post-initiation of treatment it emerged that 55/206 (27%) patiens had discontinued the treatment. The reasons for discontinuation of treatment were: 24/55 (43%) insufficient treatment efficacy, 29/55 (53%) other reasons (the main reasons here were hospitalisation, surgery, gravidity) and 2/55 discontinued therapy because of side effects. The side effects were tachycardia, eye irritation, lower abdominal pain and vasculitis, and they were mild in nature. The termination of the study was 7/28 (25%) in the group of patients without previous treatment before mirabegron. Discontinuation of the treatment in the group of patients with previous anticholinergic treatment was 48/178 (27%). At the evaluation of the efficacy of the treatment during the check-up 6 months after initiation of treatment the mean TS-VAS was 77.5, a decrease of the scale of bothers evaluated by PPBC before treatment from a mean value of 3.56 to a value of 1.77.

Conclusions:
Our hypothesis, that persistence in treat-ment with mirabegron would be relatively high due to reduced side effects and better cure effect, was confirmed, and this is the reason for higher rates of persistence in the treatment at 6 months check-up (73%).

Keywords:
persistence, overactive bladder, mirabegron

Zdroje

1. Abrams, P., Cardovo, 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, p.167–178.

2. Basra, RK., Wagg, A., Chapple, C., et al. A review of adherence to drug therapy in patiens with overactive bladder. BJU Int, 2008, 102, p. 774–779.

3. Brostrom, S., Hallas, J. Persistence of antimuscarinic drug use. Eur J Clin Pharmacol, 2009, 65, p. 309–314.

4. European Association of Urology. EAU guidelines on urinary incontinence. 2009. EAU 2011. Available at:http://www.uroweb.org/gls/pdf/Urinary%20Incontinence%202010.pdf. Accessed January 2011.

5. Gulur, DM., Drake, MJ. Management of overactive bladder. Nat Rev Urol, 2010, 7, p. 572–582.

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

7. Chapple, CR. Muscarinic receptor antagonists in the treatment of overactive bladder. Urology, 2000, 55 (Suppl.), p. 33–46.

8. Khullar, V., Amarenco, G., Angulo, JC., et al. Efficacy and tolerability of Mirabegron, a β₃-adrenoceptor agonist, in patiens with overactive bladder: results from a randomised European-Australian Phase 3 Trial. Eur Urol, 2013, 63, p. 283–295.

9. 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.

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

11. Milsom, I., Abrams, P., Cardoso, 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, p. 760–766.

12. 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.

13. Rudy, D., Cline, K., Harris, R., et al. Time to onset of improvement in symptoms of overactive bladder using antimuscarinics treatment. BJU Int, 2006, 97, p. 540–546.

14. 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.

15. 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), p. S66.

16. Stewart, WF., Van Rooyen, JB., Cundiff, GW., et al. Prevalence and burden of overactive bladder in the United States. World J Urol, 2003, 20, p. 327–336.

17. 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.

18. Švabík, K., Krhut, J., Finsterle, V., Martan, A. Perzistence užívání léčby hyperaktivního močového měchýře v České republice. Čes Gynek, 78, 2013, 3, s. 252–256.

19. Tikkinen, KAO., Auvinen, A. Does the imprecise definition of overactive bladder serve commercial rather than patient interests? Eur Urol, 2012, 61, p. 746–748.

20. 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.

21. Yu, YF., Nichol, MB., Yu, AP., Ahn, J. Persistence and adherence of medications for chronic overactive bladder/urinary incontinence in the California medicaid program. Value Health, 2005, 8, p. 495–505.