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

Abstract

Funding informationAstellas Pharma Europe B.V Aims: 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. Methods: 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. Results: 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 Alan Wein led the peer-review process as the Associate Editor responsible for the paper.394 |

Factors Associated with Improvements in Patient-Reported Outcomes During Mirabegron or Antimuscarinic Treatment of Overactive Bladder Syndrome: A Registry Study (PERSPECTIVE)

“…This finding is consistent with the improvements in symptom bother and HRQoL that were observed in a prospective, observational study of 862 patients with OAB prescribed mirabegron during routine clinical practice in Europe (BELIEVE) [19]. Other studies have compared PROs for mirabegron and antimuscarinics in the clinical trial setting [20–23]. PRO results from a phase 3 trial demonstrated significant improvements for mirabegron over placebo in OAB-q coping, concern, and HRQoL total score, whereas no significant difference was reported for tolterodine compared with placebo [20].…”

Combination therapy in overactive bladder‐untapped research opportunities: A systematic review of the literature

“…The most often studied OAB combination therapy is an anticholinergic medication with mirabegron (a beta‐3 agonist; nine of 32 studies, 28.2%; Table ) . These studies were all prospectively designed and demonstrate that the combination of a beta‐3 agonist with an anticholinergic improves OAB symptoms.…”

“…The most often studied OAB combination therapy is an anticholinergic medication with mirabegron (a beta-3 agonist; nine of 32 studies, 28.2%; Table 3). 8,9,[14][15][16][17][18][19][20] These studies were all prospectively designed and demonstrate that the combination of a beta-3 agonist with an anticholinergic improves OAB symptoms. The three largest studies are the BESIDE, SYNERGY, and SYMPH-ONY studies which all demonstrate that combination therapy of an anticholinergic with a beta-3 agonist improves urinary frequency, urgency, and urge incontinence in those with OAB compared to monotherapy beta-3 agonist or anticholinergic alone in a statistically significant manner.…”

Development of a flowchart reflecting the current attitude and approach towards idiopathic overactive bladder treatment in Belgium: A Delphi study

“…In line with the AUA flowchart, the Delphi panel would proceed to combination therapy of AC plus β3A for patients who are refractory to monotherapy with either. The strongest evidence for combination therapy comes from the randomized‐controlled SYNERGY 17 and BESIDE 18 trials, both demonstrating the superiority of solifenacin 5 mg plus mirabegron 25 mg or 50 mg compared with monotherapy with solifenacin 5 mg.…”