The BESIDE study is a randomized, double-blind, international study designed to evaluate the efficacy and safety of mirabegron as add-on therapy to solifenacin in incontinent OAB patients. Study patients received SOLI 5mg monotherapy for four weeks; subjects with inadequate response to treatment (eg, patients who still experienced one or more incontinence episodes during a three-day diary period) were then randomized to either SOLI 5mg, SOLI 10mg, or SOLI 5mg in combination with MIRA 25mg, which was increased to MIRA 50mg after four weeks. The primary efficacy endpoint was change from baseline to the end of treatment (EoT) in mean number of incontinence episodes/24 hours.
The mean number of daily incontinence episodes was reduced by 1.80 episodes in OAB patients given solifenacin 5mg with mirabegron 50mg as an add-on therapy compared to a reduction of 1.53 episodes seen with SOLI 5mg monotherapy. The difference between the two treatments of approximately 0.26 was statistically significant (P=0.001). The mean number of daily micturitions was reduced by 1.59 micturitions in the ADD-ON group compared to 1.14 micturitions with SOLI 5mg, which was statistically significant (P<0.001). ADD-ON treatment was both non-inferior and superior to SOLI 10mg for daily reduction in micturitions. ADD-ON treatment also was superior to SOLI 5mg and 10mg monotherapy for improvement in urine volume voided per micturition.
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