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Trospium chloride once-daily extended release is efficacious and tolerated in elderly subjects (aged ≥ 75 years) with overactive bladder syndrome.

Abstract：

OBJECTIVE:• To evaluate the safety and efficacy of once-daily trospium chloride extended release (ER) in overactive bladder syndrome (OAB) in subjects aged ≥ 75 years. SUBJECTS AND METHODS:• The analysis included subjects ≥ 75 years of age with OAB. • A subgroup analysis of pooled data was performed for subjects aged ≥ 75 years from two randomized, double-blind, multicenter studies of subjects with OAB receiving once-daily trospium 60 mg extended release (ER) or placebo for 12 weeks, followed by 9-month open-label extension periods during which all subjects received trospium ER. A total of 143 of the 1165 subjects from two phase III registration trials who were aged ≥ 75 years (85 trospium ER, 58 placebo; mean age 79 years and ranging up to 90 years; 73% female) were evaluated. • Dual primary efficacy variables were the changes from baseline in the average number of toilet voids per day and urge urinary incontinence episodes per day. RESULTS:• At week 12 of the double-blind period, trospium ER produced greater improvements from baseline than placebo in voiding diary parameters, OAB Patient Global Assessment, and quality of life. • Efficacy and tolerability persisted among subjects receiving open-label trospium ER for up to 1 year. CONCLUSIONS:• Once-daily trospium chloride 60 mg ER demonstrated efficacy vs placebo and was tolerated in subjects aged ≥ 75 years with OAB. • For subjects who continued into the open-label treatment period, efficacy and tolerability were observed for up to 1 year.

journal_name

BJU Int

journal_title

BJU international

authors

Sand PK,Johnson Ii TM,Rovner ES,Ellsworth PI,Oefelein MG,Staskin DR

doi

10.1111/j.1464-410X.2010.09519.x

subject

Has Abstract

pub_date

2011-02-01 00:00:00

pages

612-20

issue

4

eissn

1464-4096

issn

1464-410X

pii

BJU9519

journal_volume

107

pub_type

杂志文章,多中心研究,随机对照试验

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