Exploratory pilot study assessing the risk of cognitive impairment or sedation in the elderly following single doses of solifenacin 10 mg
- 11 September 2009
- journal article
- research article
- Published by Informa Healthcare in Expert Opinion on Drug Safety
- Vol. 8 (6), 615-626
- https://doi.org/10.1517/14740330903260790
Abstract
To assess the cognitive effects of single doses of solifenacin 10 mg compared with placebo (primary objective) and oxybutynin immediate release (IR) 10 mg (secondary objective) in elderly subjects. Single-centre, randomised, double-blind, placebo-controlled study in 12 healthy elderly volunteers, with three crossover periods separated by two 14-day washout periods. Each sequence consisted of a single dose of solifenacin 10 mg in one period, oxybutynin IR 10 mg in another and placebo in another. Aspects of attention, information processing, working memory, episodic memory and self-rated mood and alertness were tested using the validated Cognitive Drug Research computerised assessment system. There was no evidence from absolute mean values or changes from baseline to suggest that solifenacin 10 mg impaired cognition or self-ratings of mood and alertness versus placebo. Post-hoc ANCOVA showed no statistically significant cognitive deterioration with solifenacin versus placebo, when measured at a time point closest to the probable C(max) of solifenacin. Oxybutynin was associated with statistically significant impairments in several measures of cognitive function at a time point corresponding with its probable C(max). In this pilot study, single 10 mg doses of solifenacin did not show any clear propensity to impair cognitive function in a healthy elderly population.Keywords
This publication has 28 references indexed in Scilit:
- Population-Based Survey of Urinary Incontinence, Overactive Bladder, and Other Lower Urinary Tract Symptoms in Five Countries: Results of the EPIC StudyEuropean Urology, 2006
- Differential Effects of the Antimuscarinic Agents Darifenacin and Oxybutynin ER on Memory in Older SubjectsEuropean Urology, 2006
- Reviewing the ICS 2002 terminology report: The ongoing debateNeurourology and Urodynamics, 2006
- The role of urinary urgency and its measurement in the overactive bladder symptom syndrome: current concepts and future prospectsBJU International, 2005
- Prevalence and burden of overactive bladder in the United StatesWorld Journal of Urology, 2003
- Selective cognitive dysfunction in acetylcholine M1 muscarinic receptor mutant miceNature Neuroscience, 2002
- The standardisation of terminology of lower urinary tract function: Report from the standardisation sub‐committee of the International Continence SocietyNeurourology and Urodynamics, 2002
- How widespread are the symptoms of an overactive bladder and how are they managed? A population‐based prevalence studyBJU International, 2001
- Identification of Medications That Cause Cognitive Impairment in Older People: The Case of Oxybutynin ChlorideJournal of the American Geriatrics Society, 1998
- Lesson of the week: Oxybutynin and cognitive dysfunctionBMJ, 1997