Once-daily administration of trospium chloride extended release provides 24-hr coverage of nocturnal and diurnal symptoms of overactive bladder: An integrated analysis of two phase III trials

• Published in: Neurourology and urodynamics 2011-04, Vol.30 (4), p.563-567
• Main Authors: Ginsberg, David A., Oefelein, Michael G., Ellsworth, Pamela I.
• Format: Article
• Language: English
• Subjects: Benzilates; Delayed-Action Preparations; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; muscarinic antagonists; nocturia; Nortropanes - administration & dosage; Nortropanes - therapeutic use; overactive; Parasympatholytics - administration & dosage; Parasympatholytics - therapeutic use; Treatment Outcome; urinary bladder; Urinary Bladder, Overactive - drug therapy; Urinary Incontinence - drug therapy
• ISSN: 0733-2467; 1520-6777
• DOI: 10.1002/nau.21018

Aims Once‐daily extended release (XR) trospium chloride, which provides therapeutic trospium plasma concentrations over 24 hours, has demonstrated efficacy in treating overactive bladder (OAB) symptoms as evaluated over a 24‐hr period. This analysis examined the effects of trospium XR on diurnal and nocturnal OAB symptoms. Methods Pooled data were analyzed from two identically designed Phase III trials in which patients with OAB were randomized to receive trospium XR 60 mg or placebo once daily in the morning for 12 weeks. Efficacy was assessed using 3‐day urinary diaries. Diurnal events were those occurring from arising from bed in the morning until retiring in the evening; nocturnal events were those occurring from retiring until arising. Results In total, 1,165 patients received trospium XR (N = 578) or placebo (N = 587). At Week 12 comparison of trospium XR versus placebo, a significantly greater mean reduction from baseline in nocturnal voids (−0.8 vs. −0.6; P = 0.006) and diurnal voids (−1.9 vs. −1.4; P