title: The effect of mirabegron on patient-related outcomes in patients with overactive bladder: the results of post hoc correlation and responder analyses using pooled data from three randomized Phase III trials.
abstract: OBJECTIVE
  To understand how improvements in the symptoms of overactive bladder (OAB) seen with the β3-adrenoceptor agonist mirabegron 50 mg, correlate with patient experience as measured by validated and standard patient-reported outcomes (PROs), and to identify whether there is overall directional consistency in the responsiveness of PROs to treatment effect.
  
  
  METHODS
  In a post hoc analysis of pooled data from three randomized, double-blind, placebo-controlled, 12-week Phase III trials of mirabegron 50 mg once daily, responder rates for incontinence frequency (≥50 % reduction in incontinence episodes/24 h from baseline to final visit), micturition frequency (≤8 micturitions/24 h at final visit), and PROs [minimally important differences in patient perception of bladder condition (PPBC) and subsets of the overactive bladder questionnaire (OAB-q) measuring total health-related quality of life (HRQoL), and symptom bother] were evaluated individually and in combination.
  
  
  RESULTS
  Mirabegron 50 mg demonstrated greater improvement from baseline to final visit than placebo for each of the responder analyses, whether for individual objective and subjective outcomes or combinations thereof. These improvements versus placebo were statistically significant for all double and triple responder analyses and for all single responder analyses except PPBC. PRO measurements showed directional consistency and significant correlations, and there were also significant correlations between objective and subjective measures of efficacy.
  
  
  CONCLUSIONS
  The improvements in objective measures seen with mirabegron 50 mg translate into a meaningful clinical benefit as evident by the directional consistency seen in HRQoL measures of benefit.
authors: Department of Urology, University Hospital of the Canary Islands, Ofra s/n. La Cuesta-38320-La Laguna, Santa Cruz de Tenerife, Spain, davidmanuelcastrodiaz@gmail.com.
authors: D
authors: D
authors: Castro-Diaz
authors: C R
authors: CR
authors: Chapple
authors: Z
authors: Z
authors: Hakimi
authors: M B
authors: MB
authors: Blauwet
authors: L
authors: L
authors: Delgado-Herrera
authors: W
authors: W
authors: Lau
authors: S
authors: S
authors: Mujais
mesh_terms: D000083:Acetanilides / Q000627:therapeutic use*; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013844:Thiazoles / Q000627:therapeutic use*; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*; D014549:Urinary Incontinence; D064804:Urological Agents / Q000627:therapeutic use*
chemical_list: D000083:Acetanilides; D013844:Thiazoles; D064804:Urological Agents; C520025:mirabegron