title: A proof-of-concept study: mirabegron, a new therapy for overactive bladder.
abstract: OBJECTIVE
  To evaluate the potential of mirabegron, a selective β3-adrenoceptor agonist, for treatment of overactive bladder (OAB) symptoms.
  
  
  METHODS
  A multicenter, randomized, double-blind, double-dummy, parallel group, placebo and active-controlled, Phase 2, proof-of-concept study was conducted. Eligible patients (n = 314) were enrolled into a single-blind, 2-week placebo run-in period followed by a randomized, double-blind, placebo-controlled treatment period. Patients received mirabegron 100 or 150 mg twice-daily (BID), placebo or tolterodine 4 mg extended release (ER) once-daily for 4 weeks. Primary endpoint was change from baseline to end-of-treatment in mean number of micturition episodes per 24 hr. Secondary endpoints included changes in mean volume voided per micturition; mean number of urinary incontinence, urgency urinary incontinence, and urgency episodes per 24 hr; severity of urgency; nocturia, and quality of life measures. Safety parameters included adverse events, laboratory tests, electrocardiogram parameters and post-void residual volume.
  
  
  RESULTS
  Mirabegron 100 and 150 mg BID resulted in a statistically significant improvement versus placebo in mean change from baseline to end-of-treatment in the primary endpoint of micturition frequency (2.2 micturitions/24 hr vs. 1.2 micturitions/24 hr for both doses, adjusted P ≤ 0.01 for both comparisons). Mirabegron had a statistically significant effect versus placebo for most secondary endpoints, including quality of life variables. Despite a small increase in pulse rate, mirabegron demonstrated good safety and tolerability.
  
  
  CONCLUSIONS
  Mirabegron was efficacious and well tolerated in patients with OAB symptoms and heralds the first of a new class of oral pharmacological therapy for OAB for more than 30 years.
authors: Department of Urology, Royal Hallamshire Hospital, Sheffield Teaching Hospitals, Sheffield, UK.
authors: Christopher R
authors: CR
authors: Chapple
authors: Gerard
authors: G
authors: Amarenco
authors: Miguel A
authors: MA
authors: López Aramburu
authors: Karel
authors: K
authors: Everaert
authors: Josef
authors: J
authors: Liehne
authors: Malcolm
authors: M
authors: Lucas
authors: Viktor
authors: V
authors: Vik
authors: Arwin
authors: A
authors: Ridder
authors: Robert
authors: R
authors: Snijder
authors: Osamu
authors: O
authors: Yamaguchi
mesh_terms: D000083:Acetanilides / Q000494:pharmacology / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D053158:Nocturia / Q000188:drug therapy*; D011788:Quality of Life; D013844:Thiazoles / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*; D014554:Urination / Q000187:drug effects*; D064804:Urological Agents / Q000494:pharmacology / Q000627:therapeutic use*
chemical_list: D000083:Acetanilides; D013844:Thiazoles; D064804:Urological Agents; C520025:mirabegron
keywords: overactive bladder; phase 2 study; β3-adrenoceptor agonist