La maladie de Parkinson au Canada (serveur d'exploration)

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Rivastigmine for dementia associated with Parkinson's disease

Identifieur interne : 000269 ( France/Analysis ); précédent : 000268; suivant : 000270

Rivastigmine for dementia associated with Parkinson's disease

Auteurs : Murat Emre [Turquie] ; Dag Aarsland [Norvège] ; Albeao Albanese [Italie] ; E. Jane Byrne [Royaume-Uni] ; Günther Deuschl [Allemagne] ; Peter P. De Deyn [Belgique] ; Franck Durif [France] ; Jaime Kulisevsky [Espagne] ; Teus Van Laar [Pays-Bas] ; Andrew Lees [Royaume-Uni] ; Werner Poewe [Autriche] ; Alain Robillard [Canada] ; Mario M. Rosa [Portugal] ; Erik Wolters [Pays-Bas] ; Peter Quarg [Suisse] ; Sibel Tekin [États-Unis] ; Roger Lane [États-Unis]

Source :

RBID : Pascal:05-0025297

Descripteurs français

English descriptors

Abstract

BACKGROUND Cholinergic deficits are prominent in patients who have dementia associated with Parkinson's disease. We investigated the effects of the dual cholinesterase inhibitor rivastigmine in such patients. METHODS Patients in whom mild-to-moderate dementia developed at least 2 years after they received a clinical diagnosis of Parkinson's disease were randomly assigned to receive placebo or 3 to 12 mg of rivastigmine per day for 24 weeks. Primary efficacy variables were the scores for the cognitive subscale ofthe Alzheimer's Disease Assessment Scale (ADAS-cog) and Alzheimer's Disease Cooperative Study-Clinician's Global Impression of Change (ADCS-CGIC). Secondary clinical outcomes were the scores for the Alzheimer's Disease Cooperative Study-Activities of Daily Living, the 10-item Neuropsychiatric Inventory, the Mini-Mental State Examination, Cognitive Drug Research power of attention tests, the Verbal Fluency test, and the Ten Point Clock-Drawing test. RESULTS A total of 541 patients were enrolled, and 410 completed the study. The outcomes were better among patients treated with rivastigmine than among those who received placebo; however, the differences between these two groups were moderate and similar to those reported in trials of rivastigmine for Alzheimer's disease. Rivastigmine-treated patients had a mean improvement of2.1 points in the score for the 70-point ADAS-cog, from a baseline score of 23.8, as compared with a 0.7-point worsening in the placebo group, from a baseline score of 24.3 (P<0.001). Clinically meaningful improvements in the scores for the ADCS-CGIC were observed in 19.8 percent of patients in the rivastigmine group and 14.5 percent ofthose in the placebo group, and clinically meaningful worsening was observed in 13.0 percent and 23.1 percent, respectively (mean score at 24 weeks, 3.8 and 4.3, respectively; P=0.007). Significantly better outcomes were seen with rivastigmine with respect to all secondary efficacy variables. The most frequent adverse events were nausea (affecting 29.0 percent of patients in the rivastigmine group and 11.2 percent of those in the placebo group, P<0.001), vomiting (16.6 and 1.7 percent, P<0.001), and tremor (10.2 and 3.9 percent, P=:0.01). CONCLUSIONS In this placebo-controlled study, rivastigmine was associated with moderate improvements in dementia associated with Parkinson's disease but also with higher rates of nausea, vomiting, and tremor.


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Pascal:05-0025297

Le document en format XML

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<title xml:lang="en" level="a">Rivastigmine for dementia associated with Parkinson's disease</title>
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<s1>Istanbul Faculty of Medicine, Istanbul University</s1>
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<country>Turquie</country>
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<name sortKey="Aarsland, Dag" sort="Aarsland, Dag" uniqKey="Aarsland D" first="Dag" last="Aarsland">Dag Aarsland</name>
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<s1>Rogaland Central Hospital</s1>
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<country>Norvège</country>
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<s1>Sant Pau Hospital</s1>
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<name sortKey="Van Laar, Teus" sort="Van Laar, Teus" uniqKey="Van Laar T" first="Teus" last="Van Laar">Teus Van Laar</name>
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<country>Pays-Bas</country>
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<name sortKey="Lees, Andrew" sort="Lees, Andrew" uniqKey="Lees A" first="Andrew" last="Lees">Andrew Lees</name>
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<country>Royaume-Uni</country>
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<settlement type="city">Londres</settlement>
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<orgName type="university">University College de Londres</orgName>
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<name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name>
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</placeName>
<orgName type="university">Université de médecine d'Innsbruck</orgName>
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<name sortKey="Robillard, Alain" sort="Robillard, Alain" uniqKey="Robillard A" first="Alain" last="Robillard">Alain Robillard</name>
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<s1>Hôpital Maisonneuve-Rosemont</s1>
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<country>Canada</country>
<placeName>
<settlement type="city">Montréal</settlement>
<region type="state">Québec</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Rosa, Mario M" sort="Rosa, Mario M" uniqKey="Rosa M" first="Mario M." last="Rosa">Mario M. Rosa</name>
<affiliation wicri:level="1">
<inist:fA14 i1="14">
<s1>Hospital de Santa Maria</s1>
<s2>Lisbon</s2>
<s3>PRT</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>Portugal</country>
<wicri:noRegion>Hospital de Santa Maria</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Wolters, Erik" sort="Wolters, Erik" uniqKey="Wolters E" first="Erik" last="Wolters">Erik Wolters</name>
<affiliation wicri:level="3">
<inist:fA14 i1="15">
<s1>Research Institute for Neurosciences, Vrije Universiteit Medical Center</s1>
<s2>Amsterdam</s2>
<s3>NLD</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>Pays-Bas</country>
<placeName>
<settlement type="city">Amsterdam</settlement>
<region nuts="2" type="province">Hollande-Septentrionale</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Quarg, Peter" sort="Quarg, Peter" uniqKey="Quarg P" first="Peter" last="Quarg">Peter Quarg</name>
<affiliation wicri:level="1">
<inist:fA14 i1="16">
<s1>Novartis Pharma</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Suisse</country>
<wicri:noRegion>Novartis Pharma</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Tekin, Sibel" sort="Tekin, Sibel" uniqKey="Tekin S" first="Sibel" last="Tekin">Sibel Tekin</name>
<affiliation wicri:level="1">
<inist:fA14 i1="17">
<s1>Novartis Pharmaceuticals</s1>
<s2>East Hanover, N.J.</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Novartis Pharmaceuticals</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Lane, Roger" sort="Lane, Roger" uniqKey="Lane R" first="Roger" last="Lane">Roger Lane</name>
<affiliation wicri:level="1">
<inist:fA14 i1="17">
<s1>Novartis Pharmaceuticals</s1>
<s2>East Hanover, N.J.</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Novartis Pharmaceuticals</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series>
<title level="j" type="main">The New England journal of medicine</title>
<title level="j" type="abbreviated">N. Engl. j. med.</title>
<idno type="ISSN">0028-4793</idno>
<imprint>
<date when="2004">2004</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt>
<title level="j" type="main">The New England journal of medicine</title>
<title level="j" type="abbreviated">N. Engl. j. med.</title>
<idno type="ISSN">0028-4793</idno>
</seriesStmt>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Antialzheimer agent</term>
<term>Association</term>
<term>Dementia</term>
<term>Medicine</term>
<term>Nootropic agent</term>
<term>Parkinson disease</term>
<term>Psychotropic</term>
<term>Rivastigmine</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Démence</term>
<term>Rivastigmine</term>
<term>Association</term>
<term>Parkinson maladie</term>
<term>Médecine</term>
<term>Psychotrope</term>
<term>Antialzheimer</term>
<term>Nootrope</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr">
<term>Association</term>
<term>Médecine</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">BACKGROUND Cholinergic deficits are prominent in patients who have dementia associated with Parkinson's disease. We investigated the effects of the dual cholinesterase inhibitor rivastigmine in such patients. METHODS Patients in whom mild-to-moderate dementia developed at least 2 years after they received a clinical diagnosis of Parkinson's disease were randomly assigned to receive placebo or 3 to 12 mg of rivastigmine per day for 24 weeks. Primary efficacy variables were the scores for the cognitive subscale ofthe Alzheimer's Disease Assessment Scale (ADAS-cog) and Alzheimer's Disease Cooperative Study-Clinician's Global Impression of Change (ADCS-CGIC). Secondary clinical outcomes were the scores for the Alzheimer's Disease Cooperative Study-Activities of Daily Living, the 10-item Neuropsychiatric Inventory, the Mini-Mental State Examination, Cognitive Drug Research power of attention tests, the Verbal Fluency test, and the Ten Point Clock-Drawing test. RESULTS A total of 541 patients were enrolled, and 410 completed the study. The outcomes were better among patients treated with rivastigmine than among those who received placebo; however, the differences between these two groups were moderate and similar to those reported in trials of rivastigmine for Alzheimer's disease. Rivastigmine-treated patients had a mean improvement of2.1 points in the score for the 70-point ADAS-cog, from a baseline score of 23.8, as compared with a 0.7-point worsening in the placebo group, from a baseline score of 24.3 (P<0.001). Clinically meaningful improvements in the scores for the ADCS-CGIC were observed in 19.8 percent of patients in the rivastigmine group and 14.5 percent ofthose in the placebo group, and clinically meaningful worsening was observed in 13.0 percent and 23.1 percent, respectively (mean score at 24 weeks, 3.8 and 4.3, respectively; P=0.007). Significantly better outcomes were seen with rivastigmine with respect to all secondary efficacy variables. The most frequent adverse events were nausea (affecting 29.0 percent of patients in the rivastigmine group and 11.2 percent of those in the placebo group, P<0.001), vomiting (16.6 and 1.7 percent, P<0.001), and tremor (10.2 and 3.9 percent, P=:0.01). CONCLUSIONS In this placebo-controlled study, rivastigmine was associated with moderate improvements in dementia associated with Parkinson's disease but also with higher rates of nausea, vomiting, and tremor.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Allemagne</li>
<li>Autriche</li>
<li>Belgique</li>
<li>Canada</li>
<li>Espagne</li>
<li>France</li>
<li>Italie</li>
<li>Norvège</li>
<li>Pays-Bas</li>
<li>Portugal</li>
<li>Royaume-Uni</li>
<li>Suisse</li>
<li>Turquie</li>
<li>États-Unis</li>
</country>
<region>
<li>Angleterre</li>
<li>Auvergne (région administrative)</li>
<li>Auvergne-Rhône-Alpes</li>
<li>Catalogne</li>
<li>Grand Londres</li>
<li>Grand Manchester</li>
<li>Groningue (province)</li>
<li>Hollande-Septentrionale</li>
<li>Lombardie</li>
<li>Province d'Anvers</li>
<li>Québec</li>
<li>Région flamande</li>
<li>Schleswig-Holstein</li>
<li>Tyrol (Land)</li>
</region>
<settlement>
<li>Amsterdam</li>
<li>Anvers</li>
<li>Barcelone</li>
<li>Clermont-Ferrand</li>
<li>Groningue</li>
<li>Innsbruck</li>
<li>Kiel</li>
<li>Londres</li>
<li>Manchester</li>
<li>Milan</li>
<li>Montréal</li>
</settlement>
<orgName>
<li>University College de Londres</li>
<li>Université d'Anvers</li>
<li>Université de Manchester</li>
<li>Université de médecine d'Innsbruck</li>
</orgName>
</list>
<tree>
<country name="Turquie">
<noRegion>
<name sortKey="Emre, Murat" sort="Emre, Murat" uniqKey="Emre M" first="Murat" last="Emre">Murat Emre</name>
</noRegion>
</country>
<country name="Norvège">
<noRegion>
<name sortKey="Aarsland, Dag" sort="Aarsland, Dag" uniqKey="Aarsland D" first="Dag" last="Aarsland">Dag Aarsland</name>
</noRegion>
<name sortKey="Aarsland, Dag" sort="Aarsland, Dag" uniqKey="Aarsland D" first="Dag" last="Aarsland">Dag Aarsland</name>
</country>
<country name="Italie">
<region name="Lombardie">
<name sortKey="Albanese, Albeao" sort="Albanese, Albeao" uniqKey="Albanese A" first="Albeao" last="Albanese">Albeao Albanese</name>
</region>
</country>
<country name="Royaume-Uni">
<region name="Angleterre">
<name sortKey="Byrne, E Jane" sort="Byrne, E Jane" uniqKey="Byrne E" first="E. Jane" last="Byrne">E. Jane Byrne</name>
</region>
<name sortKey="Lees, Andrew" sort="Lees, Andrew" uniqKey="Lees A" first="Andrew" last="Lees">Andrew Lees</name>
</country>
<country name="Allemagne">
<region name="Schleswig-Holstein">
<name sortKey="Deuschl, Gunther" sort="Deuschl, Gunther" uniqKey="Deuschl G" first="Günther" last="Deuschl">Günther Deuschl</name>
</region>
</country>
<country name="Belgique">
<region name="Région flamande">
<name sortKey="De Deyn, Peter P" sort="De Deyn, Peter P" uniqKey="De Deyn P" first="Peter P." last="De Deyn">Peter P. De Deyn</name>
</region>
</country>
<country name="France">
<region name="Auvergne-Rhône-Alpes">
<name sortKey="Durif, Franck" sort="Durif, Franck" uniqKey="Durif F" first="Franck" last="Durif">Franck Durif</name>
</region>
</country>
<country name="Espagne">
<region name="Catalogne">
<name sortKey="Kulisevsky, Jaime" sort="Kulisevsky, Jaime" uniqKey="Kulisevsky J" first="Jaime" last="Kulisevsky">Jaime Kulisevsky</name>
</region>
</country>
<country name="Pays-Bas">
<region name="Groningue (province)">
<name sortKey="Van Laar, Teus" sort="Van Laar, Teus" uniqKey="Van Laar T" first="Teus" last="Van Laar">Teus Van Laar</name>
</region>
<name sortKey="Wolters, Erik" sort="Wolters, Erik" uniqKey="Wolters E" first="Erik" last="Wolters">Erik Wolters</name>
</country>
<country name="Autriche">
<region name="Tyrol (Land)">
<name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name>
</region>
</country>
<country name="Canada">
<region name="Québec">
<name sortKey="Robillard, Alain" sort="Robillard, Alain" uniqKey="Robillard A" first="Alain" last="Robillard">Alain Robillard</name>
</region>
</country>
<country name="Portugal">
<noRegion>
<name sortKey="Rosa, Mario M" sort="Rosa, Mario M" uniqKey="Rosa M" first="Mario M." last="Rosa">Mario M. Rosa</name>
</noRegion>
</country>
<country name="Suisse">
<noRegion>
<name sortKey="Quarg, Peter" sort="Quarg, Peter" uniqKey="Quarg P" first="Peter" last="Quarg">Peter Quarg</name>
</noRegion>
</country>
<country name="États-Unis">
<noRegion>
<name sortKey="Tekin, Sibel" sort="Tekin, Sibel" uniqKey="Tekin S" first="Sibel" last="Tekin">Sibel Tekin</name>
</noRegion>
<name sortKey="Lane, Roger" sort="Lane, Roger" uniqKey="Lane R" first="Roger" last="Lane">Roger Lane</name>
</country>
</tree>
</affiliations>
</record>

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