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.
OBJECTIVE
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 < 0.0001) was noted. At Week 12, the mean percent reduction from baseline with trospium XR versus placebo in nocturnal urge urinary incontinence (UUI) episodes (-60.2% vs. -48.3%; P = 0.003) and mean absolute reduction in diurnal UUI episodes (-2.0 vs. -1.5; P < 0.0001) was significantly greater. Predictors of nocturnal response were duration (weeks) and type of therapy (trospium XR vs. placebo). Reductions in nocturnal toilet voids were accompanied by significant improvements in sleep-related quality of life (QoL) domains.


CONCLUSIONS
Trospium XR significantly improved both nocturnal and diurnal OAB symptoms. Nocturnal improvements were associated with sleep-related QoL benefits. These results indicate that the XR formulation of trospium chloride provides effective 24-hr coverage of OAB symptoms.
University of Southern California Keck School of Medicine, Los Angeles, California, USA. ginsberg@ccnt.usc.edu
David A
DA
Ginsberg
Michael G
MG
Oefelein
Pamela I
PI
Ellsworth
D001561:Benzilates; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D009662:Nortropanes / Q000008:administration & dosage / Q000627:therapeutic use*; D010276:Parasympatholytics / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*; D014549:Urinary Incontinence / Q000188:drug therapy*
D001561:Benzilates; D003692:Delayed-Action Preparations; D009662:Nortropanes; D010276:Parasympatholytics; C003330:trospium chloride