| |
Urinary Incontinence
|
|
| |
|
|
| |
|
|
|
|
|
my personal edition > urinary incontinence > news
E-Mail this DGDispatch to a colleague
DGDispatch
Solifenacin Appears to Cut Urgency Episodes: Presented at ICS
By Jill Stein
PARIS, FRANCE -- August 25, 2004 -- Treatment with the once-daily oral antimuscarinic agent solifenacin succinate significantly reduces urgency in patients with overactive bladder, according to results released here on August 25th at the Joint Meeting of the International Continence Society and International UroGynecological Association.
Christopher Chapple, MD, Consultant Urologist, Royal Hallamshire Hospital, Sheffield, United Kingdom, presented findings from a pooled analysis of two similarly designed 12-week, phase III studies that evaluated solifenacin at 5 mg and 10 mg once daily.
The trials included patients who reported eight or more episodes of micturition per 24 hours and either one or more episodes of incontinence or urgency per 24 hours.
Dr. Chapple presented results of an analysis that examined reductions in the number of urgency episodes per 24 hours. Efficacy outcomes were based on 3-day micturition diaries in which each urgency episode was recorded as an independent event and collected at baseline, 4, 8, and 12 weeks.
Overall, 1624 patients who reported urgency episodes at baseline were included in the analysis.
Results showed that the changes from the start of the trial to end point in mean number of urgency episodes over 24 hours were -2.9 for the 5 mg dose of solifenacin and -3.0 for the 10 mg dose compared with -1.7 for placebo.
The adjusted mean treatment effects with baseline as a covariate were -0.99 and -1.21 episodes of urgency for the solifenacin 5 mg and 10 mg once-daily treatment arms, respectively (P <.001 for both dosage groups in the pooled analysis).
A total of 62% and 66% of patients who received 5 mg and 10 mg once daily, respectively, reported a 50% or greater reduction in the number of urgency episodes at study end point in contrast to 50% of patients who received placebo (P <.001 versus placebo for both dosage groups in the pooled analysis).
At the end of the study, 29% of patients on solifenacin 5 mg once daily, 32% on solifenacin 10 mg once daily, and 23% of placebo patients reported no episodes of urgency. The percentage of patients who reported no urgency episodes at this time point was significant relative to placebo with the 10 mg solifenacin dose (P <.01).
Reductions in the number of urgency episodes were assessed in the cohort of patients that reported incontinence at baseline. The adjusted mean treatment effects (active-placebo differences) in patients who reported incontinence were -1.02 and -1.31 episodes of urgency per 24 hours for the solifenacin 5 mg and 10 mg once-daily treatment arms, respectively (P <.001 for both dosage groups).
"Since urgency is a defining symptom of overactive bladder, drugs such as solifenacin that have demonstrated a significant impact on urgency episodes are likely to provide therapeutic benefit," Dr. Chapple said.
The study was supported by Yamanouchi Co., Ltd., Tokyo, Japan.
[Abstract title: " Solifenacin Provided Statistically Significant and Clinically Relevant Reductions in Urgency, a Defining Symptom of Overactive Bladder." Abstract 276]
All contents Copyright (c) 1995-2009 Doctor's Guide Publishing Limited. All rights reserved.
|
