Efficacy and Safety of Mirabegron in Patients with Overactive Bladder and Cardiovascular Comorbidities: A Post Hoc Analysis of Randomised Trials.

BACKGROUND AND

OBJECTIVE

We conducted a post hoc analysis to evaluate the efficacy and safety of mirabegron in patients with overactive bladder (OAB) and cardiovascular risk comorbidity (CRC) using data from an integrated trial database.

METHODS

Eleven phase 2-4 12-wk studies were included. Primary efficacy endpoints were changes from baseline to 12 wk in micturitions/24 h and incontinence episodes/24 h. Safety was assessed in terms of treatment-emergent adverse events (TEAEs) and cardiac TEAEs. Patients were stratified according to whether or not they had CRC, defined as high risk of cardiovascular events, use of antihypertensive medication, or a medical history of type 2 diabetes, hypertension, atrial fibrillation/flutter, coronary artery disease, or a cerebrovascular accident.

KEY FINDINGS AND LIMITATIONS: In total, 5534 patients were included in the full analysis set. Statistically significant decreases in micturition and incontinence episodes were observed following mirabegron treatment, regardless of CRC subgroup, with overall least-squares mean changes from baseline of -2.07 and -1.59, respectively. Mirabegron efficacy was comparable in the groups with and without CRC. The TEAE prevalence was 45.2% overall and 2.5% for cardiac TEAEs. The main limitation is that the studies included were not designed for a post hoc analysis.

CONCLUSIONS AND CLINICAL IMPLICATIONS: No significant differences in mirabegron efficacy were noted between groups with OAB with and without CRC. Low prevalence of cardiac TEAEs was noted, which indicates that mirabegron was well tolerated in both groups.