A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder

Summary

The purpose of this study was to examine how well the combination of two medicines (solifenacin succinate and mirabegron) worked compared to each medicine alone in the treatment of bladder problems, and how safe they were for long term use.

Timeline

Start

2014-03-17

Primary completion

2016-09-08

Completion

2016-09-08

Outcome

Met primary endpoint

registry analysis (superiority test); Mirabegron 50 mg vs Solifenacin 5 mg + Mirabegron 50 mg; p <0.001; Least Squares Mean Difference -0.45 (95% CI -0.69 to -0.21) NCT02045862 ↗

registry analysis (superiority test); Mirabegron 50 mg vs Solifenacin 5 mg + Mirabegron 50 mg; p <0.001; Least Squares Mean Difference -0.48 (95% CI -0.77 to -0.20) NCT02045862 ↗

paper Combination therapy was statistically superior to mirabegron and solifenacin for the number of incontinence episodes PMID 29866467 ↗

paper Combination therapy was statistically superior to mirabegron and solifenacin for the number of incontinence episodes (vs mirabegron: adjusted mean difference [AMD] -0.5, 95% confidence interval [CI] -0.7 to -0.2, p<0.001; PMID 29866467 ↗

Publications

• Gratzke C, van Maanen R, Chapple C, Abrams P, Herschorn S, Robinson D, Ridder A, Stoelzel M, Paireddy A, Yoon SJ, Al-Shukri S, Rechberger T, Mueller ER. Long-term Safety and Efficacy of Mirabegron and Solifenacin in Combination Compared with Monotherapy in Patients with Overactive Bladder: A Randomised, Multicentre Phase 3 Study (SYNERGY II). Eur Urol. 2018 Oct;74(4):501-509. doi: 10.1016/j.eururo.2018.05.005. Epub 2018 Jun 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mirabegron	Other / unclassified	50 mg	Oral
Subject	Solifenacin	Small molecule	5 mg	Oral

Indications