AUA 2017: Long-term combination treatment with solifenacin and mirabegron is effective and well-tolerated in patients with overactive bladder

Boston, MA ( randomized controlled trial parallel group, active-controlled multicenter study to evaluate the safety of long-term combination treatment of solifenacin 5 mg (Soli) and mirabegron 50 mg (Mira) compared with each monotherapy.

Primary objective was for safety, frequency of adverse events.  Secondary objectives involved efficacy as in the change from baseline to end of treatment in the mean number of UI episodes/24 hr and micturition/ 24 hr.  Mean voided volume per micturition, OAB-q Symptom Bother Score and TS-VAS were additional variables.   1,819 patients were enrolled and were randomized in a 12-week double-blind treatment course to 3 arms: 1) combination Soli + Mira or 2) Soli alone, or 3) Mira alone.  All treatments were generally well-tolerated.  Slight increase frequency of overall AEs in the combination group (Combination + Soli alone=dry mouth; Mira=Nasopharyngitis). Efficacy indicated that clear and clinically relevant improvements with combination compared with each monotherapy.  Also, combination treatment did not reveal any new safety concerns.  

Presented by: Christian Gratzke, MD, University of Munich

Written by: Diane K. Newman, DNP, FAAN, BCB-PMD, Perelman School of Medicine, University of Pennsylvania

at the 2017 AUA Annual Meeting - May 12 - 16, 2017 – Boston, Massachusetts, USA