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Efficacy of donepezil on behavioral symptoms in patients with moderate to severe Alzheimer's disease

Identifieur interne : 00B750 ( Main/Exploration ); précédent : 00B749; suivant : 00B751

Efficacy of donepezil on behavioral symptoms in patients with moderate to severe Alzheimer's disease

Auteurs : Serge Gauthier [Canada] ; Howard Feldman [Canada] ; Jane Hecker [Australie] ; Bruno Vellas [France] ; David Ames [Australie] ; Ponni Subbiah [États-Unis] ; Edward Whalen [États-Unis] ; Birol Emir [États-Unis]

Source :

RBID : Pascal:03-0199610

Descripteurs français

English descriptors

Abstract

Objective: This subanalysis of a large, double-blind, placebo-controlled trial examined the prevalence of behavioral symptoms in moderate to severe Alzheimer's disease (AD), and the effect of treatment with donepezil. Methods: Two hundred ninety patients with moderate to severe AD (standardized Mini-Mental State Examination scores 5-17) were randomized to receive 24 weeks of once-daily doses of donepezil 5 mg/day for 28 days, and 10 mg/day thereafter per the clinician's judgment (n = 144), or placebo (n = 146). The outcome measure of interest was the 12-item Neuropsychiatric Inventory (NPI). Results: Baseline demographics were similar between the treatment groups. Least squares mean (± SE) baseline NPI 12-item total scores were 19.55 ± 1.48 and 19.30 ± 1.45, respectively. At baseline, the most common symptoms were apathy/indifference (67%), aberrant motor behavior (53%), depression/dysphoria (52%), anxiety (49%), and agitation/aggression (45%). NPI individual item change from baseline scores at Week 24 using a last observation carried forward (LOCF) analysis showed benefits with donepezil treatment compared with placebo for all items, with significant treatment differences for depression/dysphoria, anxiety, and apathy/indifference (p <.05). Symptoms present at baseline that improved significantly for donepezil- compared with placebo-treated patients at Week 24 LOCF included anxiety, apathy/indifference, and irritability/lability (p <.05). When patients who were not receiving psychoactive medications at baseline were analyzed separately, significant improvements in NPI 12-item total score were observed with donepezil compared with placebo at most visits and at Week 24 LOCF (p <.05). Conclusions: Behavioral symptoms of the magnitude observed in this moderate to severe AD population improved with donepezil.


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Le document en format XML

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<term>Alzheimer disease</term>
<term>Behavioral disorder</term>
<term>Chemotherapy</term>
<term>Donepezil</term>
<term>Elderly</term>
<term>Mental disorder</term>
<term>Piperidine derivatives</term>
<term>Psychotropic</term>
<term>Treatment efficiency</term>
</keywords>
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<term>Démence Alzheimer</term>
<term>Donépézil</term>
<term>Trouble comportement</term>
<term>Psychotrope</term>
<term>Chimiothérapie</term>
<term>Trouble psychiatrique</term>
<term>Efficacité traitement</term>
<term>Personne âgée</term>
<term>Pipéridine dérivé</term>
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<div type="abstract" xml:lang="en">Objective: This subanalysis of a large, double-blind, placebo-controlled trial examined the prevalence of behavioral symptoms in moderate to severe Alzheimer's disease (AD), and the effect of treatment with donepezil. Methods: Two hundred ninety patients with moderate to severe AD (standardized Mini-Mental State Examination scores 5-17) were randomized to receive 24 weeks of once-daily doses of donepezil 5 mg/day for 28 days, and 10 mg/day thereafter per the clinician's judgment (n = 144), or placebo (n = 146). The outcome measure of interest was the 12-item Neuropsychiatric Inventory (NPI). Results: Baseline demographics were similar between the treatment groups. Least squares mean (± SE) baseline NPI 12-item total scores were 19.55 ± 1.48 and 19.30 ± 1.45, respectively. At baseline, the most common symptoms were apathy/indifference (67%), aberrant motor behavior (53%), depression/dysphoria (52%), anxiety (49%), and agitation/aggression (45%). NPI individual item change from baseline scores at Week 24 using a last observation carried forward (LOCF) analysis showed benefits with donepezil treatment compared with placebo for all items, with significant treatment differences for depression/dysphoria, anxiety, and apathy/indifference (p <.05). Symptoms present at baseline that improved significantly for donepezil- compared with placebo-treated patients at Week 24 LOCF included anxiety, apathy/indifference, and irritability/lability (p <.05). When patients who were not receiving psychoactive medications at baseline were analyzed separately, significant improvements in NPI 12-item total score were observed with donepezil compared with placebo at most visits and at Week 24 LOCF (p <.05). Conclusions: Behavioral symptoms of the magnitude observed in this moderate to severe AD population improved with donepezil.</div>
</front>
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<name sortKey="Vellas, Bruno" sort="Vellas, Bruno" uniqKey="Vellas B" first="Bruno" last="Vellas">Bruno Vellas</name>
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<name sortKey="Emir, Birol" sort="Emir, Birol" uniqKey="Emir B" first="Birol" last="Emir">Birol Emir</name>
<name sortKey="Whalen, Edward" sort="Whalen, Edward" uniqKey="Whalen E" first="Edward" last="Whalen">Edward Whalen</name>
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