520 THE BETA-3 ADRENOCEPTOR AGONIST SOLABEGRON IS EFFECTIVE AND SAFE FOR IMPROVING SYMPTOMS OF OVERACTIVE BLADDER (2012)

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Incontinence - Evaluation & Therapy I1 Apr 2012520 THE BETA-3 ADRENOCEPTOR AGONIST SOLABEGRON IS EFFECTIVE AND SAFE FOR IMPROVING SYMPTOMS OF OVERACTIVE BLADDER Martin Michel, Alexander Von Keitz, and Eliot Ohlstein Martin MichelMartin Michel Amsterdam, Netherlands More articles by this author , Alexander Von KeitzAlexander Von Keitz Marburg, Germany More articles by this author , and Eliot OhlsteinEliot Ohlstein Malvern, PA More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.02.592AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Solabegron, a novel beta-3 adrenoceptor agonist with high affinity and selectivity, is in clinical development for the treatment of patients with overactive bladder. A phase II multi-center, randomized, double-blind, placebo-controlled, parallel group study was performed to evaluate the safety and efficacy of oral solabegron in women with over active bladder symptoms. METHODS 258 women were enrolled to receive solabegron 50 mg, 125 mg, or matching placebo twice daily for 8 weeks. Based on a 3-day electronic diary, patients with > 8 micturitions/24 hr, and >1 incontinence episodes/24 hr and > 1 urgency episodes/24 hr were randomized to double-blind treatment. Percent change from baseline to 8 weeks in the number of incontinence episodes/24 hr was the primary endpoint. RESULTS In this patient population the mean baseline for incontinence episodes was 4.5 episodes/24hr. For the primary endpoint, solabegron (125 mg) produced a statistical significant 65% adjusted mean reduction from baseline in incontinence episodes and an adjusted mean difference from placebo of 21% (p=0.025). The median reduction in incontinence episodes was 75% from baseline. Solabegron produced an adjusted mean reduction from placebo in incontinence episodes for both the 50 mg (23%; p=0.03) and 125 mg (32%; p=0.003) treatment groups after 4 weeks of treatment. At the 125 mg dose there was a significant reduction in the number of micturitions at week 4 (−0.7; p=0.05) and week 8 (−0.8; p=0.036). There was a marked and significant increase in the volume voided per micturition at week 8 for the solabegron 125mg treatment group (+27%; p<0.001). The extent of the solabegron response was similar in patients with or without the Trp64Arg polymorphism of the beta-3 adrenoceptor. Solabegron was safe and well-tolerated. There were no significant differences in AEs between placebo and the solabegron treatment groups. The most common AE's across the placebo and treatment groups were headache (8%, 8%), nasopharingitis (11%, 6%) and dry mouth (4%, 1%), respectively. There were no significant changes in clinical chemistry, hematology or ECG parameters. Urinary retention was not observed. There were no significant treatment differences for mean changes in ambulatory SBP, DBP, MAP or heart rate during 24 hr measurement. CONCLUSIONS The results of this phase 2 clinical study demonstrate that solabegron is efficacious, safe and well-tolerated in the treatment of patients with OAB. © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 187Issue 4SApril 2012Page: e213-e214 Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.MetricsAuthor Information Martin Michel Amsterdam, Netherlands More articles by this author Alexander Von Keitz Marburg, Germany More articles by this author Eliot Ohlstein Malvern, PA More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...