Abstract: PNFLBA-09
Sources of Funding: This study was funded by Astellas Pharma Europe B.V.

Introduction

The objective of this Phase III study was to evaluate the safety and efficacy of long-term solifenacin and mirabegron combination (COMBN) treatment compared with solifenacin (SOLI) and mirabegron (MIRA) alone.

Methods

This was a randomized, double-blind, parallel-group study. Adult patients with symptoms of overactive bladder (OAB) for ≥3 m and ≥3 incontinence episodes in 7 d were eligible. After a 2-wk washout period, patients were randomized (4:1:1) to receive COMBN (SOLI 5 mg + MIRA 50 mg), SOLI (5 mg), or MIRA (50 mg) for a duration of 12 m. The primary safety variable was frequency of treatment-emergent adverse events (TEAEs). The change from Baseline to end of treatment (EoT) in mean number of incontinence episodes/24 h and micturitions/24 h were primary efficacy variables. Key secondary efficacy variables were change from Baseline to EoT in mean volume voided per micturition, OAB questionnaire Symptom Bother score, and treatment satisfaction-visual analog scale score. All efficacy variables were evaluated using analysis of covariance models.

Results

In total, 1,819 patients received COMBN (n=1,210), SOLI (n=303), or MIRA (n=306) and all groups had similar demographics. Overall, 856 (47.2%) patients experienced ≥1 TEAE (Table 1). A slightly increased frequency of TEAEs was observed in the COMBN group. The most common TEAEs in each group were dry mouth (COMBN and SOLI) and nasopharyngitis (MIRA). The changes from Baseline to EoT in the mean number of incontinence episodes and micturitions were significantly greater with COMBN treatment compared with SOLI and MIRA (Table 2). COMBN treatment was also significantly superior to SOLI and MIRA for all key secondary efficacy variables.

Conclusions

COMBN (SOLI + MIRA) treatment over 12 m was well tolerated and no new safety concerns were apparent. Clinically relevant improvements in efficacy were observed with COMBN treatment compared with each monotherapy over the 12 m study period.

Funding

This study was funded by Astellas Pharma Europe B.V.