Long-term safety of rivastigmine in parkinson disease dementia: an open-label, randomized study.
Identifieur interne : 000608 ( PubMed/Curation ); précédent : 000607; suivant : 000609Long-term safety of rivastigmine in parkinson disease dementia: an open-label, randomized study.
Auteurs : Murat Emre [États-Unis] ; Werner Poewe ; Peter Paul De Deyn ; Paolo Barone ; Jaime Kulisevsky ; Emmanuelle Pourcher ; Teus Van Laar ; Alexander Storch ; Federico Micheli ; David Burn ; Frank Durif ; Rajesh Pahwa ; Francesca Callegari ; Nadia Tenenbaum ; Christine StrohmaierSource :
- Clinical neuropharmacology [ 1537-162X ]
English descriptors
- KwdEn :
- Aged, Aged, 80 and over, Analysis of Variance, Dementia (drug therapy), Dementia (etiology), Drug Carriers, Drug Delivery Systems, Female, Humans, International Cooperation, Longitudinal Studies, Male, Middle Aged, Neuroprotective Agents (therapeutic use), Outcome Assessment (Health Care), Parkinson Disease (complications), Parkinson Disease (drug therapy), Parkinson Disease (psychology), Patient Compliance, Phenylcarbamates (therapeutic use), Quality of Life, Rivastigmine, Time Factors, Transdermal Patch, Treatment Outcome.
- MESH :
- chemical , therapeutic use : Neuroprotective Agents, Phenylcarbamates.
- chemical : Drug Carriers, Rivastigmine.
- complications : Parkinson Disease.
- drug therapy : Dementia, Parkinson Disease.
- etiology : Dementia.
- psychology : Parkinson Disease.
- Aged, Aged, 80 and over, Analysis of Variance, Drug Delivery Systems, Female, Humans, International Cooperation, Longitudinal Studies, Male, Middle Aged, Outcome Assessment (Health Care), Patient Compliance, Quality of Life, Time Factors, Transdermal Patch, Treatment Outcome.
Abstract
This study investigated the long-term safety of rivastigmine (12 mg/d capsules, 9.5 mg/24 h patch) and effects on motor symptoms in patients with mild-to-moderately severe Parkinson disease dementia.
DOI: 10.1097/WNF.0000000000000010
PubMed: 24434526
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sortKey="Emre, Murat" sort="Emre, Murat" uniqKey="Emre M" first="Murat" last="Emre">Murat Emre</name><affiliation wicri:level="2"><nlm:affiliation>*Department of Neurology, Behavioural Neurology and Movement Disorders Unit, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey; †Department of Neurology, Medical University Innsbruck, Innsbruck, Austria; ‡Middelheim Hospital, Institute Born-Bunge, University of Antwerp, Antwerp, Belgium; §Department of Neurology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands; ║Neurodegenerative Diseases Centre, Department of Medicine, University of Salerno, Italy; ¶Department of Neurology, Movement Disorders Unit, Hospital de Sant Pau (IIB-Sant Pau) and CIBERNED, Universitat Autònoma de Barcelona, Barcelona, Spain; #Québec Memory and Motor Skills Disorders Research Center, Clinique Sainte Anne, Québec, Canada; **Division of Neurodegenerative Diseases, Department of Neurology, Dresden University of Technology, Dresden, Germany; ††Department of Neurology, Hospital de Clinicas, University of Buenos Aires, Argentina; ‡‡Institute for Ageing and Health, Newcastle University, Newcastle upon Tyne, United Kingdom; §§Service De Neurologie CHU, Clermont-Ferrand, France; ║║Parkinson's Disease and Movement Disorder Center, University of Kansas Medical Center, Kansas City, KS; ¶¶Novartis Pharma AG, Basel, Switzerland; and ##Novartis Pharmaceuticals Corporation, East Hanover, NJ.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">New Jersey</region></placeName><wicri:cityArea>*Department of Neurology, Behavioural Neurology and Movement Disorders Unit, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey; †Department of Neurology, Medical University Innsbruck, Innsbruck, Austria; ‡Middelheim Hospital, Institute Born-Bunge, University of Antwerp, Antwerp, Belgium; §Department of Neurology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands; ║Neurodegenerative Diseases Centre, Department of Medicine, University of Salerno, Italy; ¶Department of Neurology, Movement Disorders Unit, Hospital de Sant Pau (IIB-Sant Pau) and CIBERNED, Universitat Autònoma de Barcelona, Barcelona, Spain; #Québec Memory and Motor Skills Disorders Research Center, Clinique Sainte Anne, Québec, Canada; **Division of Neurodegenerative Diseases, Department of Neurology, Dresden University of Technology, Dresden, Germany; ††Department of Neurology, Hospital de Clinicas, University of Buenos Aires, Argentina; ‡‡Institute for Ageing and Health, Newcastle University, Newcastle upon Tyne, United Kingdom; §§Service De Neurologie CHU, Clermont-Ferrand, France; ║║Parkinson's Disease and Movement Disorder Center, University of Kansas Medical Center, Kansas City, KS; ¶¶Novartis Pharma AG, Basel, Switzerland; and ##Novartis Pharmaceuticals Corporation, East Hanover</wicri:cityArea></affiliation></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name></author><author><name sortKey="De Deyn, Peter Paul" sort="De Deyn, Peter Paul" uniqKey="De Deyn P" first="Peter Paul" last="De Deyn">Peter Paul De Deyn</name></author><author><name sortKey="Barone, Paolo" sort="Barone, Paolo" uniqKey="Barone P" first="Paolo" last="Barone">Paolo Barone</name></author><author><name sortKey="Kulisevsky, Jaime" sort="Kulisevsky, Jaime" uniqKey="Kulisevsky J" first="Jaime" last="Kulisevsky">Jaime Kulisevsky</name></author><author><name sortKey="Pourcher, Emmanuelle" sort="Pourcher, Emmanuelle" uniqKey="Pourcher E" first="Emmanuelle" last="Pourcher">Emmanuelle Pourcher</name></author><author><name sortKey="Van Laar, Teus" sort="Van Laar, Teus" uniqKey="Van Laar T" first="Teus" last="Van Laar">Teus Van Laar</name></author><author><name sortKey="Storch, Alexander" sort="Storch, Alexander" uniqKey="Storch A" first="Alexander" last="Storch">Alexander Storch</name></author><author><name sortKey="Micheli, Federico" sort="Micheli, Federico" uniqKey="Micheli F" first="Federico" last="Micheli">Federico Micheli</name></author><author><name sortKey="Burn, David" sort="Burn, David" uniqKey="Burn D" first="David" last="Burn">David Burn</name></author><author><name sortKey="Durif, Frank" sort="Durif, Frank" uniqKey="Durif F" first="Frank" last="Durif">Frank Durif</name></author><author><name sortKey="Pahwa, Rajesh" sort="Pahwa, Rajesh" uniqKey="Pahwa R" first="Rajesh" last="Pahwa">Rajesh Pahwa</name></author><author><name sortKey="Callegari, Francesca" sort="Callegari, Francesca" uniqKey="Callegari F" first="Francesca" last="Callegari">Francesca Callegari</name></author><author><name sortKey="Tenenbaum, Nadia" sort="Tenenbaum, Nadia" uniqKey="Tenenbaum N" first="Nadia" last="Tenenbaum">Nadia Tenenbaum</name></author><author><name sortKey="Strohmaier, Christine" sort="Strohmaier, Christine" uniqKey="Strohmaier C" first="Christine" last="Strohmaier">Christine Strohmaier</name></author></analytic><series><title level="j">Clinical neuropharmacology</title><idno type="eISSN">1537-162X</idno></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Aged, 80 and over</term><term>Analysis of Variance</term><term>Dementia (drug therapy)</term><term>Dementia (etiology)</term><term>Drug Carriers</term><term>Drug Delivery Systems</term><term>Female</term><term>Humans</term><term>International Cooperation</term><term>Longitudinal Studies</term><term>Male</term><term>Middle Aged</term><term>Neuroprotective Agents (therapeutic use)</term><term>Outcome Assessment (Health Care)</term><term>Parkinson Disease (complications)</term><term>Parkinson Disease (drug therapy)</term><term>Parkinson Disease (psychology)</term><term>Patient Compliance</term><term>Phenylcarbamates (therapeutic use)</term><term>Quality of Life</term><term>Rivastigmine</term><term>Time Factors</term><term>Transdermal Patch</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Neuroprotective Agents</term><term>Phenylcarbamates</term></keywords><keywords scheme="MESH" type="chemical" xml:lang="en"><term>Drug Carriers</term><term>Rivastigmine</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Dementia</term><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Dementia</term></keywords><keywords scheme="MESH" qualifier="psychology" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Aged, 80 and over</term><term>Analysis of Variance</term><term>Drug Delivery Systems</term><term>Female</term><term>Humans</term><term>International Cooperation</term><term>Longitudinal Studies</term><term>Male</term><term>Middle Aged</term><term>Outcome Assessment (Health Care)</term><term>Patient Compliance</term><term>Quality of Life</term><term>Time Factors</term><term>Transdermal Patch</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">This study investigated the long-term safety of rivastigmine (12 mg/d capsules, 9.5 mg/24 h patch) and effects on motor symptoms in patients with mild-to-moderately severe Parkinson disease dementia.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">24434526</PMID><DateCreated><Year>2014</Year><Month>01</Month><Day>17</Day></DateCreated><DateCompleted><Year>2014</Year><Month>09</Month><Day>11</Day></DateCompleted><DateRevised><Year>2015</Year><Month>11</Month><Day>19</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1537-162X</ISSN><JournalIssue CitedMedium="Internet"><Volume>37</Volume><Issue>1</Issue><PubDate><MedlineDate>2014 Jan-Feb</MedlineDate></PubDate></JournalIssue><Title>Clinical neuropharmacology</Title><ISOAbbreviation>Clin Neuropharmacol</ISOAbbreviation></Journal><ArticleTitle>Long-term safety of rivastigmine in parkinson disease dementia: an open-label, randomized study.</ArticleTitle><Pagination><MedlinePgn>9-16</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1097/WNF.0000000000000010</ELocationID><Abstract><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">This study investigated the long-term safety of rivastigmine (12 mg/d capsules, 9.5 mg/24 h patch) and effects on motor symptoms in patients with mild-to-moderately severe Parkinson disease dementia.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">This was a 76-week, prospective, open-label, randomized study in patients aged 50 to 85 years. Primary outcomes included incidence of, and discontinuation due to, predefined adverse events (AEs) potentially arising from worsening of Parkinson disease motor symptoms with capsules. Secondary outcomes included frequency of AEs/serious AEs. Efficacy outcomes included Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL), Neuropsychiatric Inventory (NPI-10), and Mattis Dementia Rating Scale (MDRS).</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Five hundred eighty-three patients were randomized to rivastigmine capsules (n = 295) or patch (n = 288). Incidence of predefined AEs was 36.1% for capsules, 31.9% for patch; discontinuation due to worsening of motor symptoms was 4.4% and 2.4%, respectively. Most common AEs were nausea (capsules, 40.5%; patch, 8.3%), tremor (24.5%; 9.7%), fall (17.0%; 20.1%), vomiting (15.3%; 2.8%), and application site erythema (0%; 13.9%). Significant efficacy in favor of capsules was observed at weeks 24 to 76 on MDRS; 24 and 76 on NPI-10; weeks 52 and 76 on ADCS-ADL. In patients with Mini-Mental State Examination (MMSE) greater than 21, no differences in efficacy on MDRS and ADCS-ADL were observed at any time point; significant differences in favor of capsules were maintained in patients with MMSE less than or equal to 21.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">This study supports the long-term safety of rivastigmine in Parkinson disease dementia. The rate of worsening of motor symptoms was in the range expected due to the natural progression of Parkinson disease, no new or unexpected safety issues emerged in the long-term.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Emre</LastName><ForeName>Murat</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>*Department of Neurology, Behavioural Neurology and Movement Disorders Unit, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey; †Department of Neurology, Medical University Innsbruck, Innsbruck, Austria; ‡Middelheim Hospital, Institute Born-Bunge, University of Antwerp, Antwerp, Belgium; §Department of Neurology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands; ║Neurodegenerative Diseases Centre, Department of Medicine, University of Salerno, Italy; ¶Department of Neurology, Movement Disorders Unit, Hospital de Sant Pau (IIB-Sant Pau) and CIBERNED, Universitat Autònoma de Barcelona, Barcelona, Spain; #Québec Memory and Motor Skills Disorders Research Center, Clinique Sainte Anne, Québec, Canada; **Division of Neurodegenerative Diseases, Department of Neurology, Dresden University of Technology, Dresden, Germany; ††Department of Neurology, Hospital de Clinicas, University of Buenos Aires, Argentina; ‡‡Institute for Ageing and Health, Newcastle University, Newcastle upon Tyne, United Kingdom; §§Service De Neurologie CHU, Clermont-Ferrand, France; ║║Parkinson's Disease and Movement Disorder Center, University of Kansas Medical Center, Kansas City, KS; ¶¶Novartis Pharma AG, Basel, Switzerland; and ##Novartis Pharmaceuticals Corporation, East Hanover, NJ.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Poewe</LastName><ForeName>Werner</ForeName><Initials>W</Initials></Author><Author ValidYN="Y"><LastName>De Deyn</LastName><ForeName>Peter Paul</ForeName><Initials>PP</Initials></Author><Author ValidYN="Y"><LastName>Barone</LastName><ForeName>Paolo</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Kulisevsky</LastName><ForeName>Jaime</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Pourcher</LastName><ForeName>Emmanuelle</ForeName><Initials>E</Initials></Author><Author ValidYN="Y"><LastName>van Laar</LastName><ForeName>Teus</ForeName><Initials>T</Initials></Author><Author ValidYN="Y"><LastName>Storch</LastName><ForeName>Alexander</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Micheli</LastName><ForeName>Federico</ForeName><Initials>F</Initials></Author><Author ValidYN="Y"><LastName>Burn</LastName><ForeName>David</ForeName><Initials>D</Initials></Author><Author ValidYN="Y"><LastName>Durif</LastName><ForeName>Frank</ForeName><Initials>F</Initials></Author><Author ValidYN="Y"><LastName>Pahwa</LastName><ForeName>Rajesh</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Callegari</LastName><ForeName>Francesca</ForeName><Initials>F</Initials></Author><Author ValidYN="Y"><LastName>Tenenbaum</LastName><ForeName>Nadia</ForeName><Initials>N</Initials></Author><Author ValidYN="Y"><LastName>Strohmaier</LastName><ForeName>Christine</ForeName><Initials>C</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Clin Neuropharmacol</MedlineTA><NlmUniqueID>7607910</NlmUniqueID><ISSNLinking>0362-5664</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D004337">Drug 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UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D017063" MajorTopicYN="N">Outcome Assessment (Health Care)</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D010300" MajorTopicYN="N">Parkinson Disease</DescriptorName><QualifierName UI="Q000150" MajorTopicYN="N">complications</QualifierName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000523" MajorTopicYN="N">psychology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D010349" MajorTopicYN="N">Patient Compliance</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D048448" MajorTopicYN="N">Phenylcarbamates</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011788" MajorTopicYN="N">Quality of Life</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000068836" MajorTopicYN="N">Rivastigmine</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D013997" MajorTopicYN="N">Time Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D057968" MajorTopicYN="N">Transdermal Patch</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2014</Year><Month>1</Month><Day>18</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2014</Year><Month>1</Month><Day>18</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2014</Year><Month>9</Month><Day>12</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">24434526</ArticleId><ArticleId 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