Patient-reported outcomes with the 3-adrenoceptor agonist mirabegron in a phase III trial in patients with overactive bladder

AimsTo assess patient-reported outcomes (PROs) in patients with overactive bladder (OAB) receiving the novel (3)-adrenoceptor agonist mirabegron. MethodsData from a randomised, double-blind, controlled phase III trial in 1,987 patients aged 18 years with OAB symptoms for 3 months were analysed. Patients received placebo, mirabegron 50 or 100mg/day, or tolterodine extended release (ER) 4mg orally once daily for 12 weeks after a 2-week placebo run-in. Prespecified analysis of PROs (changes in OAB Questionnaire [OAB-q], Patient Perception of Bladder Condition [PPBC], and Work Productivity and Activity Impairment: Specific Health Problem [WPAI-SHP] instrument) in patients treated with mirabegron 50mg/day, tolterodine ER 4mg/day or placebo is reported. Post-hoc analyses of OAB-q, PPBC and the Treatment Satisfaction-Visual Analogue Scale (TS-VAS) in patients who were incontinent at baseline are also reported. ResultsSignificant improvements over placebo in OAB-q coping and concern from baseline to final visit were observed with mirabegron 50mg/day. No significant improvements in these parameters were observed with tolterodine ER 4mg/day. Mirabegron 50mg/day significantly increased the proportion of patients showing a PPBC improvement over placebo. Mirabegron 50mg/day also produced greater improvements in WPAI-SHP presenteeism and greater reductions in absenteeism and overall work impairment than placebo or tolterodine ER 4mg/day. The impact of mirabegron 50mg/day treatment on PROs in the incontinent population appears to be greater than that in the overall OAB population. ConclusionsAt the approved dose of 50mg/day, mirabegron significantly improves OAB patients' perception of disease and quality of life, independent of whether they are incontinent at baseline. Neurourol. Urodynam. 35:987-994, 2016. (c) 2015 The Authors. Neurourology and Urodynamics published by Wiley Periodicals, Inc.