Double‐blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease
Identifieur interne : 002C03 ( Main/Merge ); précédent : 002C02; suivant : 002C04Double‐blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease
Auteurs : Robert A. Hauser [États-Unis] ; Michel Panisset [Canada] ; Giovanni Abbruzzese [Italie] ; Linda Mancione [États-Unis] ; Nalina Dronamraju [États-Unis] ; Algirdas Kakarieka [Suisse]Source :
- Movement Disorders [ 0885-3185 ] ; 2009-03-15.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Antiparkinson Agents (therapeutic use), Carbidopa (therapeutic use), Catechols (therapeutic use), Double-Blind Method, Drug Therapy, Combination, Female, Humans, Levodopa (therapeutic use), Male, Middle Aged, Nitriles (therapeutic use), Outcome Assessment (Health Care) (methods), Parkinson Disease (drug therapy), Parkinson's disease, Severity of Illness Index, Stalevo, UPDRS, entacapone, levodopa, treatment.
- MESH :
- chemical , therapeutic use : Antiparkinson Agents, Carbidopa, Catechols, Levodopa, Nitriles.
- drug therapy : Parkinson Disease.
- methods : Outcome Assessment (Health Care).
- Adult, Aged, Aged, 80 and over, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Severity of Illness Index.
Abstract
We performed a 39‐week, randomized, double‐blind, multicenter study to compare the efficacy, safety, and tolerability of levodopa/carbidopa/entacapone (LCE, Stalevo) with levodopa/carbidopa (LC, Sinemet IR) in patients with early Parkinson's disease (PD). Four hundred twenty‐three patients with early PD warranting levodopa were randomly assigned to treatment with LCE 100/25/200 or LC 100/25 three‐times daily. The adjusted mean difference in total Unified Parkinson's disease Rating Scale (UPDRS) Parts II and III between groups using the analysis of covariance model (prespecified primary outcome measure) was 1.7 (standard error = 0.84) points favoring LCE (P = 0.045). Significantly greater improvement with LCE compared with LC was also observed in UPDRS Part II activities of daily living (ADL) scores (P = 0.025), Schwab and England ADL scores (blinded rater, P = 0.003; subject, P = 0.006) and subject‐reported Clinical Global Impression (CGI) scores (P = 0.047). There was no significant difference in UPDRS Part III or investigator‐rated CGI scores. Wearing‐off was observed in 29 (13.9%) subjects in the LCE group and 43 (20.0%) in the LC group (P = 0.099). Dyskinesia was observed in 11 (5.3%) subjects in the LCE group and 16 (7.4%) in the LC group (P = 0.367). Nausea and diarrhea were reported more frequently in the LCE group. LCE provided greater symptomatic benefit than LC and did not increase motor complications. © 2008 Movement Disorder Society
Url:
DOI: 10.1002/mds.22343
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Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2009-03-15">2009-03-15</date><biblScope unit="vol">24</biblScope><biblScope unit="issue">4</biblScope><biblScope unit="page" from="541">541</biblScope><biblScope unit="page" to="550">550</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">040A5F110A6A28ADFF13CCEDF4A94E8B38A8CF05</idno><idno type="DOI">10.1002/mds.22343</idno><idno type="ArticleID">MDS22343</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Antiparkinson Agents (therapeutic use)</term><term>Carbidopa (therapeutic use)</term><term>Catechols (therapeutic use)</term><term>Double-Blind Method</term><term>Drug Therapy, Combination</term><term>Female</term><term>Humans</term><term>Levodopa (therapeutic use)</term><term>Male</term><term>Middle Aged</term><term>Nitriles (therapeutic use)</term><term>Outcome Assessment (Health Care) (methods)</term><term>Parkinson Disease (drug therapy)</term><term>Parkinson's disease</term><term>Severity of Illness Index</term><term>Stalevo</term><term>UPDRS</term><term>entacapone</term><term>levodopa</term><term>treatment</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</term><term>Carbidopa</term><term>Catechols</term><term>Levodopa</term><term>Nitriles</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Outcome Assessment (Health Care)</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Double-Blind Method</term><term>Drug Therapy, Combination</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Severity of Illness Index</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">We performed a 39‐week, randomized, double‐blind, multicenter study to compare the efficacy, safety, and tolerability of levodopa/carbidopa/entacapone (LCE, Stalevo) with levodopa/carbidopa (LC, Sinemet IR) in patients with early Parkinson's disease (PD). Four hundred twenty‐three patients with early PD warranting levodopa were randomly assigned to treatment with LCE 100/25/200 or LC 100/25 three‐times daily. The adjusted mean difference in total Unified Parkinson's disease Rating Scale (UPDRS) Parts II and III between groups using the analysis of covariance model (prespecified primary outcome measure) was 1.7 (standard error = 0.84) points favoring LCE (P = 0.045). Significantly greater improvement with LCE compared with LC was also observed in UPDRS Part II activities of daily living (ADL) scores (P = 0.025), Schwab and England ADL scores (blinded rater, P = 0.003; subject, P = 0.006) and subject‐reported Clinical Global Impression (CGI) scores (P = 0.047). There was no significant difference in UPDRS Part III or investigator‐rated CGI scores. Wearing‐off was observed in 29 (13.9%) subjects in the LCE group and 43 (20.0%) in the LC group (P = 0.099). Dyskinesia was observed in 11 (5.3%) subjects in the LCE group and 16 (7.4%) in the LC group (P = 0.367). Nausea and diarrhea were reported more frequently in the LCE group. LCE provided greater symptomatic benefit than LC and did not increase motor complications. © 2008 Movement Disorder Society</div></front></TEI><double doi="10.1002/mds.22343"><ISTEX><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Double‐blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease</title><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name></author><author><name sortKey="Panisset, Michel" sort="Panisset, Michel" uniqKey="Panisset M" first="Michel" last="Panisset">Michel Panisset</name></author><author><name sortKey="Abbruzzese, Giovanni" sort="Abbruzzese, Giovanni" uniqKey="Abbruzzese G" first="Giovanni" last="Abbruzzese">Giovanni Abbruzzese</name></author><author><name sortKey="Mancione, Linda" sort="Mancione, Linda" uniqKey="Mancione L" first="Linda" last="Mancione">Linda Mancione</name></author><author><name sortKey="Dronamraju, Nalina" sort="Dronamraju, Nalina" uniqKey="Dronamraju N" first="Nalina" last="Dronamraju">Nalina Dronamraju</name></author><author><name sortKey="Kakarieka, Algirdas" sort="Kakarieka, Algirdas" uniqKey="Kakarieka A" first="Algirdas" last="Kakarieka">Algirdas Kakarieka</name></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:040A5F110A6A28ADFF13CCEDF4A94E8B38A8CF05</idno><date when="2009" year="2009">2009</date><idno type="doi">10.1002/mds.22343</idno><idno type="url">https://api.istex.fr/document/040A5F110A6A28ADFF13CCEDF4A94E8B38A8CF05/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">000369</idno><idno type="wicri:Area/Istex/Curation">000369</idno><idno type="wicri:Area/Istex/Checkpoint">000F44</idno><idno type="wicri:doubleKey">0885-3185:2009:Hauser R:double:blind:trial</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Double‐blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease</title><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name><affiliation wicri:level="4"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Parkinson's Disease and Movement Disorders Center of Excellence, University of South Florida, Tampa, FL</wicri:regionArea><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation></author><author><name sortKey="Panisset, Michel" sort="Panisset, Michel" uniqKey="Panisset M" first="Michel" last="Panisset">Michel Panisset</name><affiliation wicri:level="1"><country xml:lang="fr">Canada</country><wicri:regionArea>André‐Barbeau Movement Disorders Unit, Department of Medicine (Neurology), University of Montreal, Quebec</wicri:regionArea><wicri:noRegion>Quebec</wicri:noRegion></affiliation></author><author><name sortKey="Abbruzzese, Giovanni" sort="Abbruzzese, Giovanni" uniqKey="Abbruzzese G" first="Giovanni" last="Abbruzzese">Giovanni Abbruzzese</name><affiliation wicri:level="1"><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Neurological Sciences, Movement Disorder Unit, University of Genoa, Genoa</wicri:regionArea><wicri:noRegion>Genoa</wicri:noRegion></affiliation></author><author><name sortKey="Mancione, Linda" sort="Mancione, Linda" uniqKey="Mancione L" first="Linda" last="Mancione">Linda Mancione</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals, East Hanover, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Dronamraju, Nalina" sort="Dronamraju, Nalina" uniqKey="Dronamraju N" first="Nalina" last="Dronamraju">Nalina Dronamraju</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Novartis Pharmaceuticals, East Hanover, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Kakarieka, Algirdas" sort="Kakarieka, Algirdas" uniqKey="Kakarieka A" first="Algirdas" last="Kakarieka">Algirdas Kakarieka</name><affiliation wicri:level="1"><country xml:lang="fr">Suisse</country><wicri:regionArea>Novartis Pharma AG, Basel</wicri:regionArea><wicri:noRegion>Basel</wicri:noRegion></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2009-03-15">2009-03-15</date><biblScope unit="vol">24</biblScope><biblScope unit="issue">4</biblScope><biblScope unit="page" from="541">541</biblScope><biblScope unit="page" to="550">550</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">040A5F110A6A28ADFF13CCEDF4A94E8B38A8CF05</idno><idno type="DOI">10.1002/mds.22343</idno><idno type="ArticleID">MDS22343</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Parkinson's disease</term><term>Stalevo</term><term>UPDRS</term><term>entacapone</term><term>levodopa</term><term>treatment</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">We performed a 39‐week, randomized, double‐blind, multicenter study to compare the efficacy, safety, and tolerability of levodopa/carbidopa/entacapone (LCE, Stalevo) with levodopa/carbidopa (LC, Sinemet IR) in patients with early Parkinson's disease (PD). Four hundred twenty‐three patients with early PD warranting levodopa were randomly assigned to treatment with LCE 100/25/200 or LC 100/25 three‐times daily. The adjusted mean difference in total Unified Parkinson's disease Rating Scale (UPDRS) Parts II and III between groups using the analysis of covariance model (prespecified primary outcome measure) was 1.7 (standard error = 0.84) points favoring LCE (P = 0.045). Significantly greater improvement with LCE compared with LC was also observed in UPDRS Part II activities of daily living (ADL) scores (P = 0.025), Schwab and England ADL scores (blinded rater, P = 0.003; subject, P = 0.006) and subject‐reported Clinical Global Impression (CGI) scores (P = 0.047). There was no significant difference in UPDRS Part III or investigator‐rated CGI scores. Wearing‐off was observed in 29 (13.9%) subjects in the LCE group and 43 (20.0%) in the LC group (P = 0.099). Dyskinesia was observed in 11 (5.3%) subjects in the LCE group and 16 (7.4%) in the LC group (P = 0.367). Nausea and diarrhea were reported more frequently in the LCE group. LCE provided greater symptomatic benefit than LC and did not increase motor complications. © 2008 Movement Disorder Society</div></front></TEI></ISTEX><PubMed><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Double-blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease.</title><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name><affiliation wicri:level="4"><nlm:affiliation>Parkinson's Disease and Movement Disorders Center of Excellence, University of South Florida, 4 Columbia Drive, Suite 410, Tampa, FL 33606, USA. rhauser@health.usf.edu</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Parkinson's Disease and Movement Disorders Center of Excellence, University of South Florida, 4 Columbia Drive, Suite 410, Tampa, FL 33606</wicri:regionArea><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation></author><author><name sortKey="Panisset, Michel" sort="Panisset, Michel" uniqKey="Panisset M" first="Michel" last="Panisset">Michel Panisset</name></author><author><name sortKey="Abbruzzese, Giovanni" sort="Abbruzzese, Giovanni" uniqKey="Abbruzzese G" first="Giovanni" last="Abbruzzese">Giovanni Abbruzzese</name></author><author><name sortKey="Mancione, Linda" sort="Mancione, Linda" uniqKey="Mancione L" first="Linda" last="Mancione">Linda Mancione</name></author><author><name sortKey="Dronamraju, Nalina" sort="Dronamraju, Nalina" uniqKey="Dronamraju N" first="Nalina" last="Dronamraju">Nalina Dronamraju</name></author><author><name sortKey="Kakarieka, Algirdas" sort="Kakarieka, Algirdas" uniqKey="Kakarieka A" first="Algirdas" last="Kakarieka">Algirdas Kakarieka</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2009">2009</date><idno type="doi">10.1002/mds.22343</idno><idno type="RBID">pubmed:19058133</idno><idno type="pmid">19058133</idno><idno type="wicri:Area/PubMed/Corpus">001F15</idno><idno type="wicri:Area/PubMed/Curation">001F15</idno><idno type="wicri:Area/PubMed/Checkpoint">001E45</idno><idno type="wicri:Area/Ncbi/Merge">002450</idno><idno type="wicri:Area/Ncbi/Curation">002450</idno><idno type="wicri:Area/Ncbi/Checkpoint">002450</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Double-blind trial of levodopa/carbidopa/entacapone versus levodopa/carbidopa in early Parkinson's disease.</title><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name><affiliation wicri:level="4"><nlm:affiliation>Parkinson's Disease and Movement Disorders Center of Excellence, University of South Florida, 4 Columbia Drive, Suite 410, Tampa, FL 33606, USA. rhauser@health.usf.edu</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Parkinson's Disease and Movement Disorders Center of Excellence, University of South Florida, 4 Columbia Drive, Suite 410, Tampa, FL 33606</wicri:regionArea><placeName><region type="state">Floride</region><settlement type="city">Tampa</settlement></placeName><orgName type="university">Université de Floride du Sud</orgName></affiliation></author><author><name sortKey="Panisset, Michel" sort="Panisset, Michel" uniqKey="Panisset M" first="Michel" last="Panisset">Michel Panisset</name></author><author><name sortKey="Abbruzzese, Giovanni" sort="Abbruzzese, Giovanni" uniqKey="Abbruzzese G" first="Giovanni" last="Abbruzzese">Giovanni Abbruzzese</name></author><author><name sortKey="Mancione, Linda" sort="Mancione, Linda" uniqKey="Mancione L" first="Linda" last="Mancione">Linda Mancione</name></author><author><name sortKey="Dronamraju, Nalina" sort="Dronamraju, Nalina" uniqKey="Dronamraju N" first="Nalina" last="Dronamraju">Nalina Dronamraju</name></author><author><name sortKey="Kakarieka, Algirdas" sort="Kakarieka, Algirdas" uniqKey="Kakarieka A" first="Algirdas" last="Kakarieka">Algirdas Kakarieka</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="eISSN">1531-8257</idno><imprint><date when="2009" type="published">2009</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Antiparkinson Agents (therapeutic use)</term><term>Carbidopa (therapeutic use)</term><term>Catechols (therapeutic use)</term><term>Double-Blind Method</term><term>Drug Therapy, Combination</term><term>Female</term><term>Humans</term><term>Levodopa (therapeutic use)</term><term>Male</term><term>Middle Aged</term><term>Nitriles (therapeutic use)</term><term>Outcome Assessment (Health Care) (methods)</term><term>Parkinson Disease (drug therapy)</term><term>Severity of Illness Index</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</term><term>Carbidopa</term><term>Catechols</term><term>Levodopa</term><term>Nitriles</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Outcome Assessment (Health Care)</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Double-Blind Method</term><term>Drug Therapy, Combination</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Severity of Illness Index</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">We performed a 39-week, randomized, double-blind, multicenter study to compare the efficacy, safety, and tolerability of levodopa/carbidopa/entacapone (LCE, Stalevo) with levodopa/carbidopa (LC, Sinemet IR) in patients with early Parkinson's disease (PD). Four hundred twenty-three patients with early PD warranting levodopa were randomly assigned to treatment with LCE 100/25/200 or LC 100/25 three-times daily. The adjusted mean difference in total Unified Parkinson's disease Rating Scale (UPDRS) Parts II and III between groups using the analysis of covariance model (prespecified primary outcome measure) was 1.7 (standard error = 0.84) points favoring LCE (P = 0.045). Significantly greater improvement with LCE compared with LC was also observed in UPDRS Part II activities of daily living (ADL) scores (P = 0.025), Schwab and England ADL scores (blinded rater, P = 0.003; subject, P = 0.006) and subject-reported Clinical Global Impression (CGI) scores (P = 0.047). There was no significant difference in UPDRS Part III or investigator-rated CGI scores. Wearing-off was observed in 29 (13.9%) subjects in the LCE group and 43 (20.0%) in the LC group (P = 0.099). Dyskinesia was observed in 11 (5.3%) subjects in the LCE group and 16 (7.4%) in the LC group (P = 0.367). Nausea and diarrhea were reported more frequently in the LCE group. LCE provided greater symptomatic benefit than LC and did not increase motor complications.</div></front></TEI></PubMed></double></record>Pour manipuler ce document sous Unix (Dilib)
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