1959 MIRABEGRON IMPROVES PATIENT-REPORTED OUTCOMES IN PATIENTS WITH OVERACTIVE BLADDER SYNDROME - RESULTS FROM A NORTH-AMERICAN STUDY

Abstract

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Non-Neurogenic Voiding Dysfunction1 Apr 20111959 MIRABEGRON IMPROVES PATIENT-REPORTED OUTCOMES IN PATIENTS WITH OVERACTIVE BLADDER SYNDROME - RESULTS FROM A NORTH-AMERICAN STUDY Victor Nitti, Sender Herschorn, Stephen Auerbach, Nancy Martin, Mary Beth Blauwet, and Thomas Marshall Victor NittiVictor Nitti New York, NY More articles by this author , Sender HerschornSender Herschorn Toronto, Canada More articles by this author , Stephen AuerbachStephen Auerbach Newport Beach, CA More articles by this author , Nancy MartinNancy Martin Deerfield, IL More articles by this author , Mary Beth BlauwetMary Beth Blauwet Deerfield, IL More articles by this author , and Thomas MarshallThomas Marshall Deerfield, IL More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2011.02.2163AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Patient-reported outcome measures (PROs) of symptom bother, health-related quality of life (HRQoL), treatment satisfaction and disease perception are becoming increasingly important in the assessment of treatments for overactive bladder syndrome (OAB). Mirabegron is a selective β3-adrenoreceptor agonist in development for the treatment of OAB. Herein we present PROs from a Phase III trial of mirabegron in the United States and Canada. METHODS This was a 12-week, multicentre, randomized, double-blind, parallel-group, placebo-controlled, Phase III trial. Patients with ≥3 months of OAB symptoms were enrolled into a 2-week, single-blind, placebo run-in. During a 3-day micturition diary period, patients with ≥8 micturitions/24 h and ≥3 urgency episodes (with or without incontinence) were randomized to receive placebo or mirabegron 50 or 100 mg once daily. The co-primary endpoints were the changes in the mean number of incontinence episodes/24 h and the mean number of micturitions/24 h. Additional secondary variables of symptom bother, HRQoL, treatment satisfaction and perception of disease were assessed using the Overactive Bladder Questionnaire (OAB-q), Treatment Satisfaction-Visual Analog Scale (TS-VAS) and Patient Perception of Bladder Condition (PPBC). RESULTS In total, 1328 patients were randomized and received study drug (placebo: n=453; mirabegron 50 mg: n=442; mirabegron 100 mg: n=433). Mean age was 60.1 years, 74.3% were female, 29.7% had urgency incontinence, 38.1% had mixed stress/urgency incontinence (urgency predominant) and 32.2% had frequency without incontinence. At 12 weeks (or final visit), statistically significant reductions in the number of incontinence episodes and micturitions (co-primary endpoints) with mirabegron 50 and 100 mg were also associated with statistically significant improvements in PROs compared with placebo (Table). Adjusted mean⁎ (standard error) change from baseline to final visit Placebo Mirabegron 50 mg Mirabegron 100 mg Co-primary endpoints Number of incontinence episodes/24 h§ −1.13 (0.112) −1.47† (0.114) −1.63† (0.117) Number of micturitions/24 h§ −1.05 (0.132) −1.66† (0.133) −1.75† (0.135) Secondary variables: patient-reported outcomes Treatment satisfaction (TS-VAS)¦ 0.7 (0.16) 1.5‡ (0.16) 2.1‡ (0.16) Symptom bother (OAB-q)§ −10.8 (0.97) −17.0‡ (0.98) −20.2‡ (0.99) HRQoL score (OAB-q)¦ Total 10.7 (0.89) 14.8‡(0.90) 17.3‡(0.90) Coping 12.8 (1.06) 16.9‡ (1.07) 19.1‡ (1.08) Concern 12.7 (1.03) 18.0‡ (1.04) 20.5‡ (1.05) Sleep 9.7 (1.07) 14.6‡ (1.08) 17.5‡ (1.09) Social interaction 6.0 (0.77) 7.4 (0.77) 9.6‡ (0.78) PPBC§ −0.5 (0.05) −0.7‡ (0.05) −0.8‡ (0.05) ⁎ Least squares mean adjusted for baseline, gender and geographical region; p< 0.05 versus placebo † with multiplicity adjustment; ‡ without multiplicity adjustment; § Negative change indicates improvement; ¦ Positive change indicates improvement. CONCLUSIONS In this 12-week, North-American study of patients with OAB, mirabegron 50 and 100 mg provided statistically significant improvements both in efficacy measures of incontinence episodes and micturition frequency, as well as the PROs for patients′ perception of disease, treatment satisfaction, symptom bother and HRQoL compared with placebo. © 2011 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 185Issue 4SApril 2011Page: e784 Advertisement Copyright & Permissions© 2011 by American Urological Association Education and Research, Inc.MetricsAuthor Information Victor Nitti New York, NY More articles by this author Sender Herschorn Toronto, Canada More articles by this author Stephen Auerbach Newport Beach, CA More articles by this author Nancy Martin Deerfield, IL More articles by this author Mary Beth Blauwet Deerfield, IL More articles by this author Thomas Marshall Deerfield, IL More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...