Long-Term Safety and Efficacy of Mirabegron and Solifenacin in Combination Compared with Monotherapy in Patients with Overactive Bladder: SYNERGY II Study

The SYNERGY II study, conducted from March 2014 to September 2016, evaluated the long-term safety and efficacy of a combination therapy of solifenacin 5 mg and mirabegron 50 mg compared to monotherapy in patients with overactive bladder (OAB). The study was a phase III, multinational, randomized, double-blind, parallel group, multicentre study, with 1829 patients randomized to double-blind treatment. The main objective was safety, measured with treatment emergent adverse events (TEAE), and efficacy was measured as evolution from the beginning to the end of treatment, in the median number of incontinence episodes/24h and urinary frequency/24 h. The study found that the combination therapy was statistically superior to mirabegron and solifenacin regarding incontinence episodes and urinary frequency. The study concluded that the combination therapy of mirabegron and solifenacin demonstrated safety and efficacy for more than 12 months in patients with "wet" OAB, supporting the results of previous studies with shorter duration.