You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Non-neurogenic Voiding Dysfunction1 Apr 20131958 COMBINATION TREATMENT WITH MIRABEGRON AND SOLIFENACIN IN PATIENTS WITH OVERACTIVE BLADDER (OAB) - EFFICACY RESULTS FROM A PHASE 2 STUDY (SYMPHONY) Paul Abrams, Con Kelleher, David Staskin, Richard Kay, Reynaldo Vilmo Martina, Donald Newgreen, Asha Paireddy, Rob van Maanen, and Arwin Ridder Paul AbramsPaul Abrams Bristol, United Kingdom More articles by this author , Con KelleherCon Kelleher London, United Kingdom More articles by this author , David StaskinDavid Staskin New York, NY More articles by this author , Richard KayRichard Kay Bakewell, United Kingdom More articles by this author , Reynaldo Vilmo MartinaReynaldo Vilmo Martina Leiderdorp, Netherlands More articles by this author , Donald NewgreenDonald Newgreen Leiderdorp, Netherlands More articles by this author , Asha PaireddyAsha Paireddy Leiderdorp, Netherlands More articles by this author , Rob van MaanenRob van Maanen Leiderdorp, Netherlands More articles by this author , and Arwin RidderArwin Ridder Leiderdorp, Netherlands More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.2377AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The primary objective of the current study was to assess the efficacy and safety of combination therapy with the selective β-3 adrenoceptor agonist, mirabegron (M), and a muscarinic receptor antagonist, solifenacin (S), compared with solifenacin monotherapy. METHODS This factorial design, multi-center, randomized, double-blind, parallel-group, placebo and monotherapy controlled trial enrolled patients ≥18 years with symptoms of OAB for ≥3 months. Following a 2-week, single-blind placebo run-in and based on a 3-day micturition diary, patients with ≥8 micturitions/24 h and ≥3 urgency episodes/72 h (with or without incontinence) were randomized to receive 1of 6 combinations of M (25 or 50 mg) and S (2.5, 5 or 10 mg), monotherapy with M (25 or 50 mg) or S (2.5, 5 or 10 mg), or placebo once daily for 12 weeks. The primary efficacy variable was change from baseline to end of treatment in mean volume voided (MVV) per micturition. The key secondary variables were change from baseline to end of treatment in micturition frequency (MF) and incontinence episode frequency (IEF) per 24 h. Efficacy was assessed according to electronic patient micturition diaries. RESULTS 1307 patients were randomized and received study drug. Mean age was 54.8 years, 66.1% were female, 61.1% had urgency and frequency without incontinence, 25.0 % had urgency incontinence, and 13.9% had urgency predominant mixed incontinence. For all combinations including 5 or 10 mg solifenacin, the mean change from baseline in MVV per micturition was statistically significantly greater than with S 5 mg (Table). The combinations 5 + 50, 10 + 25 and 10 + 50 showed statistically significant differences vs S 5 in MF per 24h: -0.80 (p=0.007), -0.88, (p=0.016), and -0.98 (p=0.007), respectively. All treatment groups demonstrated a reduction in IEF. However, due to the low percentage of incontinent patients, meaningful inter-treatment group comparisons on this parameter are not possible. CONCLUSIONS In this 12-week study, mirabegron combination therapy with solifenacin (>5 mg) demonstrated greater efficacy than solifenacin 5 mg alone on MVV and MF. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e803 Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Paul Abrams Bristol, United Kingdom More articles by this author Con Kelleher London, United Kingdom More articles by this author David Staskin New York, NY More articles by this author Richard Kay Bakewell, United Kingdom More articles by this author Reynaldo Vilmo Martina Leiderdorp, Netherlands More articles by this author Donald Newgreen Leiderdorp, Netherlands More articles by this author Asha Paireddy Leiderdorp, Netherlands More articles by this author Rob van Maanen Leiderdorp, Netherlands More articles by this author Arwin Ridder Leiderdorp, Netherlands More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...