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. 2015 Aug;7(4):167-79.
doi: 10.1177/1756287215589250.

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

Jose E Batista  1 , Heinz Kölbl  2 , Sender Herschorn  3 , Tomasz Rechberger  4 , Javier Cambronero  5 , Michael Halaska  6 , Alex Coppell  7 , Mathilde Kaper  8 , Moses Huang  7 , Emad Siddiqui  7 ; BEYOND study group
Affiliations

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

Jose E Batista et al. Ther Adv Urol. 2015 Aug.

Abstract

Objective: To compare the efficacy and safety of mirabegron 50 mg and solifenacin 5 mg in overactive bladder (OAB) patients dissatisfied with previous antimuscarinic treatment due to lack of efficacy.

Patients and methods: This randomized, double-blind, phase IIIb, noninferiority study, enrolled male and female patients aged ⩾18 years old, with symptoms of OAB for ⩾3 months, who were dissatisfied with their previous antimuscarinic drug due to lack of efficacy. A total of 1887 patients were randomized to receive mirabegron 50 mg (n = 943) or solifenacin 5 mg (n = 944) daily for 12 weeks. The primary efficacy endpoint was change from baseline to end of treatment in mean number of micturitions/24 h. Noninferiority was confirmed if the lower limit of the two-sided 95% confidence interval (CI) for the treatment difference between solifenacin and mirabegron was > -0.20. Secondary efficacy endpoints, which included change from baseline in mean number of incontinence episodes/24 h, urgency incontinence episodes/24 h, urgency episodes (grade 3 or 4)/24 h and nocturia episodes/24 h, were analyzed using analysis of covariance.

Results: For the primary endpoint, adjusted mean treatment difference (95% CI) in mean number of micturitions/24 h was -0.18 (-0.42, 0.06) and therefore noninferiority of mirabegron to solifenacin was not demonstrated. Both treatments demonstrated clinically meaningful reductions in efficacy variables and were well tolerated, with a lower incidence of dry mouth with mirabegron.

Conclusions: Noninferiority of mirabegron compared with solifenacin for reduction in micturition frequency could not be demonstrated in this population of OAB patients who were dissatisfied with previous antimuscarinic therapy due to lack of efficacy. Both mirabegron and solifenacin improved key OAB symptoms with no statistically significant differences observed between the two treatments. Both drugs were well tolerated.

Keywords: mirabegron; noninferiority; overactive bladder; solifenacin.

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Conflict of interest statement

Conflict of interest statement: M. Huang, E.S. and M.K. are paid employees of Astellas. A.C. is employed as a contractor for Astellas and received consultancy fees from Astellas for his contribution to the study. S.H. received grants from Sunnybrook Research Institute during the conduct of the study, and grants and personal fees from Astellas, Pfizer and Allergan outside the submitted work. J.E.B. and J.C. received fees from Astellas for their roles as study investigators. T.R. received consultancy fees and payment for his role as study investigator from Astellas. H.K. and M. Halaska report no conflicts of interest in preparing this article.

Figures

Figure 1.
Figure 1.
Study design.
Figure 2.
Figure 2.
Possible scenarios for demonstrating noninferiority and superiority between mirabegron and solifenacin. CI, confidence interval.
Figure 3.
Figure 3.
Patient disposition.
Figure 4.
Figure 4.
(a) Adjusted change from baseline to EoT in primary efficacy variable (mean number of micturitions/24 h [PPS]). (b) Treatment difference for change from baseline to EoT in mean number of micturitions/24 h. CI, confidence interval; EoT, end of treatment; PPS, Per Protocol Set.
Figure 5.
Figure 5.
Adjusted change from baseline to EoT in the primary efficacy variable (secondary analysis in FAS) and secondary efficacy variables [mean number of incontinence episodes/24 h (FAS-I), urgency incontinence episodes/24 h (FAS-I), urgency (grade 3 or 4)/24 h and nocturia episodes/24 h (both FAS)]. ANCOVA, analysis of covariance; EoT, end of treatment; FAS, Full Analysis Set; FAS-I, Full Analysis Set-Incontinence.
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