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


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.
Sand
Peter K
PK
Division of Urogynecology and Reconstructive Pelvic Surgery, NorthShore University HealthSystem, University of Chicago, Pritzker School of Medicine, Evanston, IL, USA. psand@northshore.org
Johnson Ii
Theodore M
TM
Rovner
Eric S
ES
Ellsworth
Pamela I
PI
Oefelein
Michael G
MG
Staskin
David R
DR
D000368:Aged; D000369:Aged, 80 and over; D001561:Benzilates; D003692:Delayed-Action Preparations; D004812:Epidemiologic Methods; D005260:Female; D006801:Humans; D008297:Male; D018727:Muscarinic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D009662:Nortropanes / Q000009:adverse effects / Q000627:therapeutic use*; D017060:Patient Satisfaction; D011788:Quality of Life; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*
D001561:Benzilates; D003692:Delayed-Action Preparations; D018727:Muscarinic Antagonists; D009662:Nortropanes; C003330:trospium chloride