Efficacy of donepezil on behavioral symptoms in patients with moderate to severe Alzheimer's disease
Identifieur interne : 005453 ( PascalFrancis/Checkpoint ); précédent : 005452; suivant : 005454Efficacy 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 :
- International psychogeriatrics [ 1041-6102 ] ; 2002.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Personne âgée.
English descriptors
- KwdEn :
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.
Affiliations:
- Australie, Canada, France, États-Unis
- Midi-Pyrénées, Occitanie (région administrative), Victoria (État)
- Melbourne, Toulouse
- Université de Melbourne
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><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>
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<keywords scheme="Pascal" xml:lang="fr"><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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<front><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>
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<s5>21</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Elderly</s0>
<s5>21</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Anciano</s0>
<s5>21</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Pipéridine dérivé</s0>
<s5>27</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Piperidine derivatives</s0>
<s5>27</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Piperidina derivado</s0>
<s5>27</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Homme</s0>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Human</s0>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Hombre</s0>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Système nerveux pathologie</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Nervous system diseases</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Sistema nervioso patología</s0>
<s5>37</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Système nerveux central pathologie</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Central nervous system disease</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Sistema nervosio central patología</s0>
<s5>38</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Encéphale pathologie</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Cerebral disorder</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Encéfalo patología</s0>
<s5>39</s5>
</fC07>
<fC07 i1="05" i2="X" l="FRE"><s0>Maladie dégénérative</s0>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG"><s0>Degenerative disease</s0>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA"><s0>Enfermedad degenerativa</s0>
<s5>40</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE"><s0>Anticholinestérasique</s0>
<s5>41</s5>
</fC07>
<fC07 i1="06" i2="X" l="ENG"><s0>Anticholinesterase agent</s0>
<s5>41</s5>
</fC07>
<fC07 i1="06" i2="X" l="SPA"><s0>Anticolinesterasa agente</s0>
<s5>41</s5>
</fC07>
<fC07 i1="07" i2="X" l="FRE"><s0>Nootrope</s0>
<s5>42</s5>
</fC07>
<fC07 i1="07" i2="X" l="ENG"><s0>Nootropic agent</s0>
<s5>42</s5>
</fC07>
<fC07 i1="07" i2="X" l="SPA"><s0>Nootropo</s0>
<s5>42</s5>
</fC07>
<fC07 i1="08" i2="X" l="FRE"><s0>Antialzheimer</s0>
<s2>FR</s2>
<s5>43</s5>
</fC07>
<fC07 i1="08" i2="X" l="ENG"><s0>Antialzheimer agent</s0>
<s2>FR</s2>
<s5>43</s5>
</fC07>
<fC07 i1="08" i2="X" l="SPA"><s0>Antialzheimer</s0>
<s2>FR</s2>
<s5>43</s5>
</fC07>
<fN21><s1>118</s1>
</fN21>
<fN82><s1>PSI</s1>
</fN82>
</pA>
</standard>
</inist>
<affiliations><list><country><li>Australie</li>
<li>Canada</li>
<li>France</li>
<li>États-Unis</li>
</country>
<region><li>Midi-Pyrénées</li>
<li>Occitanie (région administrative)</li>
<li>Victoria (État)</li>
</region>
<settlement><li>Melbourne</li>
<li>Toulouse</li>
</settlement>
<orgName><li>Université de Melbourne</li>
</orgName>
</list>
<tree><country name="Canada"><noRegion><name sortKey="Gauthier, Serge" sort="Gauthier, Serge" uniqKey="Gauthier S" first="Serge" last="Gauthier">Serge Gauthier</name>
</noRegion>
<name sortKey="Feldman, Howard" sort="Feldman, Howard" uniqKey="Feldman H" first="Howard" last="Feldman">Howard Feldman</name>
</country>
<country name="Australie"><noRegion><name sortKey="Hecker, Jane" sort="Hecker, Jane" uniqKey="Hecker J" first="Jane" last="Hecker">Jane Hecker</name>
</noRegion>
<name sortKey="Ames, David" sort="Ames, David" uniqKey="Ames D" first="David" last="Ames">David Ames</name>
</country>
<country name="France"><region name="Occitanie (région administrative)"><name sortKey="Vellas, Bruno" sort="Vellas, Bruno" uniqKey="Vellas B" first="Bruno" last="Vellas">Bruno Vellas</name>
</region>
</country>
<country name="États-Unis"><noRegion><name sortKey="Subbiah, Ponni" sort="Subbiah, Ponni" uniqKey="Subbiah P" first="Ponni" last="Subbiah">Ponni Subbiah</name>
</noRegion>
<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>
</country>
</tree>
</affiliations>
</record>
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