A proof‐of‐concept study: Mirabegron, a new therapy for overactive bladder. Issue 8 (19th February 2013)

• Record Type: Journal Article
• Authors: Chapple, Christopher R.; Amarenco, Gerard; López Aramburu, Miguel A.; Everaert, Karel; Liehne, Josef; Lucas, Malcolm; Vik, Viktor; Ridder, Arwin; Snijder, Robert; Yamaguchi, Osamu
• Is Part Of: Neurourology and urodynamics. Volume 32:Issue 8(2013:Nov.)
• Page Start: 1116
• Page End: 1122
• Publication Date: 2013-02-19
• Subjects: Urinary organs -- Periodicals; Urodynamics -- Periodicals; Urology -- Periodicals; 616.6
• DOI: 10.1002/nau.22373
• Languages: English
• ISSNs: 0733-2467

Abstract

<abstract abstract-type="main" xml:lang="en"> <title>Abstract</title> <sec id="nau22373-sec-0001" sec-type="section"> <title>Aims</title> <p>To evaluate the potential of mirabegron, a selective β3‐adrenoceptor agonist, for treatment of overactive bladder (OAB) symptoms.</p> </sec> <sec id="nau22373-sec-0002" sec-type="section"> <title>Methods</title> <p>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.</p> </sec> <sec id="nau22373-sec-0003" sec-type="section"> <title>Results</title> <p>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 <italic>P</italic> ≤ 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.</p> </sec> <sec id="nau22373-sec-0004" sec-type="section"> <title>Conclusions</title> <p>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. <italic>Neurourol. Urodynam. 32:1116–1122, 2013</italic>. © 2013 Wiley Periodicals, Inc.</p> </sec> </abstract>