title: Mirabegron as Add-On Treatment to Solifenacin in Patients with Incontinent Overactive Bladder and an Inadequate Response to Solifenacin Monotherapy: Responder Analyses and Patient-Reported Outcomes from the BESIDE Study [corrected].
abstract: We investigated improvements in overactive bladder and patient reported outcomes in patients with overactive bladder and refractory incontinence treated with mirabegron 50 mg plus solifenacin 5 mg vs solifenacin 5 or 10 mg.
  
  
  
  Patients with overactive bladder who were incontinent despite 4 weeks of single-blind daily solifenacin 5 mg were randomized 1:1:1 to a double-blind daily combination of mirabegron 50 mg/solifenacin 5 mg, or solifenacin 5 or 10 mg for 12 weeks. The mirabegron dose was increased from 25 to 50 mg after week 4. Symptom bother, health related quality of life and patient perception of bladder condition were assessed by OAB-q (Overactive Bladder Questionnaire) and the PPBC (Patient Perception of Bladder Condition) questionnaire, respectively. Responder rates were based on a 50% reduction in daily incontinence, zero incontinence episodes and fewer than 8 micturitions per 24 hours with minimal important differences in OAB-q and PPBC.
  
  
  
  Overall 2,174 patients with a median age of 59 years were randomized, including 727 to the combination, 728 to solifenacin 5 mg and 719 to solifenacin 10 mg. Symptom bother, total health related quality of life and its subscales (coping, concern and social), and PPBC were significantly improved with combination vs solifenacin monotherapy (p <0.05). The odds of achieving clinically meaningful improvements in incontinence, micturition frequency, symptom bother, health related quality of life and PPBC were significantly higher for combination than solifenacin monotherapy. The odds of becoming continent was 47% and 28% higher for combination vs solifenacin 5 and 10 mg (OR 1.47, 95% CI 1.17-1.84, p = 0.001 and OR 1.28; 95% CI 1.02-1.61, p = 0.033, respectively).
  
  
  
  Significantly more patients on the combination achieved clinically meaningful improvements in incontinence and micturition frequency. Improvements were accompanied by similar improvements in PPBC, symptom bother and health related quality of life.
authors.affiliation: Alliance Urology Specialists, Greensboro, North Carolina. Electronic address: smacdiarmid@allianceurology.com.
authors.forename: Scott
authors.initials: S
authors.lastname: MacDiarmid
authors.affiliation: Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russia.
authors.forename: Salman
authors.initials: S
authors.lastname: Al-Shukri
authors.affiliation: Humber River Hospital, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Jack
authors.initials: J
authors.lastname: Barkin
authors.affiliation: Karolinska University Hospital, Huddinge, Stockholm, Sweden.
authors.forename: Aino
authors.initials: A
authors.lastname: Fianu-Jonasson
authors.affiliation: Rouen University Hospital, Rouen, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Grise
authors.affiliation: Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Sender
authors.initials: S
authors.lastname: Herschorn
authors.affiliation: Astellas Pharma Europe Ltd., Chertsey, Surrey.
authors.forename: Tahir
authors.initials: T
authors.lastname: Saleem
authors.affiliation: Astellas Pharma Europe Ltd., Chertsey, Surrey.
authors.forename: Moses
authors.initials: M
authors.lastname: Huang
authors.affiliation: Astellas Pharma Europe Ltd., Chertsey, Surrey.
authors.forename: Emad
authors.initials: E
authors.lastname: Siddiqui
authors.affiliation: Astellas Pharma Global Development, Leiden, The Netherlands.
authors.forename: Matthias
authors.initials: M
authors.lastname: Stölzel
authors.affiliation: Astellas Pharma Europe Ltd., Chertsey, Surrey.
authors.forename: Claire
authors.initials: C
authors.lastname: Hemsted
authors.affiliation: Astellas Pharma Europe Ltd., Chertsey, Surrey.
authors.forename: Jameel
authors.initials: J
authors.lastname: Nazir
authors.affiliation: Astellas Pharma Europe Ltd., Chertsey, Surrey.
authors.forename: Zalmai
authors.initials: Z
authors.lastname: Hakimi
authors.affiliation: University of Bristol and Bristol Urological Institute, Bristol, United Kingdom.
authors.forename: Marcus J
authors.initials: MJ
authors.lastname: Drake
mesh_terms: D000083:Acetanilides / Q000008:administration & dosage*; D000293:Adolescent; D058667:Adrenergic beta-3 Receptor Agonists / Q000008:administration & dosage; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage; D011788:Quality of Life; D000069464:Solifenacin Succinate / Q000008:administration & dosage*; D013844:Thiazoles / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D014549:Urinary Incontinence / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D014563:Urodynamics / Q000187:drug effects*; D055815:Young Adult
chemical_list: D000083:Acetanilides; D058667:Adrenergic beta-3 Receptor Agonists; D018727:Muscarinic Antagonists; D013844:Thiazoles; D000069464:Solifenacin Succinate; C520025:mirabegron
keywords: mirabegron; quality of life; solifenacin succinate; urinary bladder, overactive; urinary incontinence