Patient-reported outcomes from SYNERGY, a randomized, double-blind, multicenter study evaluating combinations of mirabegron and solifenacin compared with monotherapy and placebo in OAB patients

To evaluate patient-reported outcomes (PROs) of combinations of solifenacin and mirabegron compared with solifenacin and mirabegron monotherapy and with placebo in patients with overactive bladder (OAB) from the SYNERGY trial.

Following a 4-week placebo run-in, period patients (≥18 years) with OAB were randomized 2:2:1:1:1:1 to receive solifenacin 5 mg + mirabegron 25 mg (combination 5 + 25 mg), solifenacin 5 mg + mirabegron 50 mg, (combination 5 + 50 mg), solifenacin 5 mg, mirabegron 25 mg, mirabegron 50 mg or placebo for 12 weeks, followed by a 2-week washout period. At each visit, PROs related to quality of life, symptom bother, and treatment satisfaction were assessed, including OAB-q Symptom Bother score, health-related quality of life (HRQOL) Total score, treatment satisfaction-visual analogue scale (TS-VAS), and patient perception of bladder condition (PPBC) questionnaires.

Overall, 3527 patients were randomized into the study, with 3494 receiving double-blind treatment. At end of treatment (EoT), both combination groups showed greater improvements in OAB-q Symptom Bother score compared with the monotherapy groups (nominal P < 0.001). Statistically significant improvements in HRQOL Total scores were observed in the combination groups versus monotherapy groups (P ≤ 0.002). For both combination groups, the OAB-q Symptom Bother score responder rates at EoT were statistically significantly higher versus mirabegron monotherapy (P < 0.05). The mean adjusted changes from baseline to EoT for PPBC were greater in the combination groups compared with monotherapy groups.

PROs showed that combination therapy provided clear improvements and an additive effect for many HRQOL parameters, including OAB-q Symptom Bother score, HRQOL Total score, and PPBC.

Neurourology and urodynamics. 2017 Jul 13 [Epub ahead of print]

Dudley Robinson, Con Kelleher, David Staskin, Elizabeth R Mueller, Christian Falconer, Jianye Wang, Arwin Ridder, Matthias Stoelzel, Asha Paireddy, Rob van Maanen, Zalmai Hakimi, Sender Herschorn

King's College Hospital, London, UK., Guy's and St Thomas' Hospital, London, UK., Tufts University School of Medicine, Boston, Massachusetts., Loyola University Chicago, Stritch School of Medicine, Maywood, Illinois., Karolinska Institute, Stockholm, Sweden., Beijing Hospital, Beijing, China., Astellas Pharma Global Development, Leiden, Netherlands., Astellas Pharma Europe Ltd, Surrey, UK., Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.