Double-Blind Trial of Levodopa/Carbidopa/Entacapone Versus Levodopa/Carbidopa in Early Parkinson's Disease
Identifieur interne : 000475 ( PascalFrancis/Checkpoint ); précédent : 000474; suivant : 000476Double-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.
Descripteurs français
- Pascal (Inist)
English descriptors
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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.
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">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"><inist:fA14 i1="01"><s1>Parkinson's Disease and Movement Disorders Center of Excellence, University of South Florida</s1><s2>Tampa, FL</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Tampa</settlement><region type="state">Floride</region></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"><inist:fA14 i1="02"><s1>André-Barbeau Movement Disorders Unit, Department of Medicine (Neurology), University of Montreal</s1><s2>Quebec</s2><s3>CAN</s3><sZ>2 aut.</sZ></inist:fA14><country>Canada</country><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"><inist:fA14 i1="03"><s1>Department of Neurological Sciences, Movement Disorder Unit, University of Genoa</s1><s2>Genoa</s2><s3>ITA</s3><sZ>3 aut.</sZ></inist:fA14><country>Italie</country><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="1"><inist:fA14 i1="04"><s1>Novartis Pharmaceuticals</s1><s2>East Hanover, NJ</s2><s3>USA</s3><sZ>4 aut.</sZ><sZ>5 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Novartis Pharmaceuticals</wicri:noRegion></affiliation></author><author><name sortKey="Dronamraju, Nalina" sort="Dronamraju, Nalina" uniqKey="Dronamraju N" first="Nalina" last="Dronamraju">Nalina Dronamraju</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Novartis Pharmaceuticals</s1><s2>East Hanover, NJ</s2><s3>USA</s3><sZ>4 aut.</sZ><sZ>5 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Novartis Pharmaceuticals</wicri:noRegion></affiliation></author><author><name sortKey="Kakarieka, Algirdas" sort="Kakarieka, Algirdas" uniqKey="Kakarieka A" first="Algirdas" last="Kakarieka">Algirdas Kakarieka</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Novartis Pharma AG</s1><s2>Basel</s2><s3>CHE</s3><sZ>6 aut.</sZ></inist:fA14><country>Suisse</country><wicri:noRegion>Novartis Pharma AG</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">09-0171610</idno><date when="2009">2009</date><idno type="stanalyst">PASCAL 09-0171610 INIST</idno><idno type="RBID">Pascal:09-0171610</idno><idno type="wicri:Area/PascalFrancis/Corpus">000557</idno><idno type="wicri:Area/PascalFrancis/Curation">000735</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000475</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">000475</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">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"><inist:fA14 i1="01"><s1>Parkinson's Disease and Movement Disorders Center of Excellence, University of South Florida</s1><s2>Tampa, FL</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Tampa</settlement><region type="state">Floride</region></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"><inist:fA14 i1="02"><s1>André-Barbeau Movement Disorders Unit, Department of Medicine (Neurology), University of Montreal</s1><s2>Quebec</s2><s3>CAN</s3><sZ>2 aut.</sZ></inist:fA14><country>Canada</country><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"><inist:fA14 i1="03"><s1>Department of Neurological Sciences, Movement Disorder Unit, University of Genoa</s1><s2>Genoa</s2><s3>ITA</s3><sZ>3 aut.</sZ></inist:fA14><country>Italie</country><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="1"><inist:fA14 i1="04"><s1>Novartis Pharmaceuticals</s1><s2>East Hanover, NJ</s2><s3>USA</s3><sZ>4 aut.</sZ><sZ>5 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Novartis Pharmaceuticals</wicri:noRegion></affiliation></author><author><name sortKey="Dronamraju, Nalina" sort="Dronamraju, Nalina" uniqKey="Dronamraju N" first="Nalina" last="Dronamraju">Nalina Dronamraju</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Novartis Pharmaceuticals</s1><s2>East Hanover, NJ</s2><s3>USA</s3><sZ>4 aut.</sZ><sZ>5 aut.</sZ></inist:fA14><country>États-Unis</country><wicri:noRegion>Novartis Pharmaceuticals</wicri:noRegion></affiliation></author><author><name sortKey="Kakarieka, Algirdas" sort="Kakarieka, Algirdas" uniqKey="Kakarieka A" first="Algirdas" last="Kakarieka">Algirdas Kakarieka</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Novartis Pharma AG</s1><s2>Basel</s2><s3>CHE</s3><sZ>6 aut.</sZ></inist:fA14><country>Suisse</country><wicri:noRegion>Novartis Pharma AG</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno><imprint><date when="2009">2009</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Carbidopa</term><term>Comparative study</term><term>Entacapone</term><term>Levodopa</term><term>Nervous system diseases</term><term>Parkinson disease</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Maladie de Parkinson</term><term>Pathologie du système nerveux</term><term>Lévodopa</term><term>Carbidopa</term><term>Entacapone</term><term>Etude comparative</term><term>Traitement</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><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0885-3185</s0></fA01><fA03 i2="1"><s0>Mov. disord.</s0></fA03><fA05><s2>24</s2></fA05><fA06><s2>4</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Double-Blind Trial of Levodopa/Carbidopa/Entacapone Versus Levodopa/Carbidopa in Early Parkinson's Disease</s1></fA08><fA11 i1="01" i2="1"><s1>HAUSER (Robert A.)</s1></fA11><fA11 i1="02" i2="1"><s1>PANISSET (Michel)</s1></fA11><fA11 i1="03" i2="1"><s1>ABBRUZZESE (Giovanni)</s1></fA11><fA11 i1="04" i2="1"><s1>MANCIONE (Linda)</s1></fA11><fA11 i1="05" i2="1"><s1>DRONAMRAJU (Nalina)</s1></fA11><fA11 i1="06" i2="1"><s1>KAKARIEKA (Algirdas)</s1></fA11><fA14 i1="01"><s1>Parkinson's Disease and Movement Disorders Center of Excellence, University of South Florida</s1><s2>Tampa, FL</s2><s3>USA</s3><sZ>1 aut.</sZ></fA14><fA14 i1="02"><s1>André-Barbeau Movement Disorders Unit, Department of Medicine (Neurology), University of Montreal</s1><s2>Quebec</s2><s3>CAN</s3><sZ>2 aut.</sZ></fA14><fA14 i1="03"><s1>Department of Neurological Sciences, Movement Disorder Unit, University of Genoa</s1><s2>Genoa</s2><s3>ITA</s3><sZ>3 aut.</sZ></fA14><fA14 i1="04"><s1>Novartis Pharmaceuticals</s1><s2>East Hanover, NJ</s2><s3>USA</s3><sZ>4 aut.</sZ><sZ>5 aut.</sZ></fA14><fA14 i1="05"><s1>Novartis Pharma AG</s1><s2>Basel</s2><s3>CHE</s3><sZ>6 aut.</sZ></fA14><fA17 i1="01" i2="1"><s1>FIRST-STEP Study Group</s1><s3>INC</s3></fA17><fA20><s1>541-550</s1></fA20><fA21><s1>2009</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>20953</s2><s5>354000187465460080</s5></fA43><fA44><s0>0000</s0><s1>© 2009 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>28 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>09-0171610</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>Movement disorders</s0></fA64><fA66 i1="01"><s0>USA</s0></fA66><fC01 i1="01" l="ENG"><s0>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.</s0></fC01><fC02 i1="01" i2="X"><s0>002B17</s0></fC02><fC02 i1="02" i2="X"><s0>002B17G</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Maladie de Parkinson</s0><s2>NM</s2><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Parkinson disease</s0><s2>NM</s2><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Parkinson enfermedad</s0><s2>NM</s2><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Pathologie du système nerveux</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Nervous system diseases</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Sistema nervioso patología</s0><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Lévodopa</s0><s2>NK</s2><s2>FR</s2><s5>09</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Levodopa</s0><s2>NK</s2><s2>FR</s2><s5>09</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Levodopa</s0><s2>NK</s2><s2>FR</s2><s5>09</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Carbidopa</s0><s2>NK</s2><s2>FR</s2><s5>10</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Carbidopa</s0><s2>NK</s2><s2>FR</s2><s5>10</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Carbidopa</s0><s2>NK</s2><s2>FR</s2><s5>10</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Entacapone</s0><s2>NK</s2><s2>FR</s2><s5>11</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>Entacapone</s0><s2>NK</s2><s2>FR</s2><s5>11</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Entacapona</s0><s2>NK</s2><s2>FR</s2><s5>11</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Etude comparative</s0><s5>12</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Comparative study</s0><s5>12</s5></fC03><fC03 i1="06" i2="X" l="SPA"><s0>Estudio comparativo</s0><s5>12</s5></fC03><fC03 i1="07" i2="X" l="FRE"><s0>Traitement</s0><s5>13</s5></fC03><fC03 i1="07" i2="X" l="ENG"><s0>Treatment</s0><s5>13</s5></fC03><fC03 i1="07" i2="X" l="SPA"><s0>Tratamiento</s0><s5>13</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Pathologie de l'encéphale</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Cerebral disorder</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Encéfalo patología</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="FRE"><s0>Syndrome extrapyramidal</s0><s5>38</s5></fC07><fC07 i1="02" i2="X" l="ENG"><s0>Extrapyramidal syndrome</s0><s5>38</s5></fC07><fC07 i1="02" i2="X" l="SPA"><s0>Extrapiramidal síndrome</s0><s5>38</s5></fC07><fC07 i1="03" i2="X" l="FRE"><s0>Maladie dégénérative</s0><s5>39</s5></fC07><fC07 i1="03" i2="X" l="ENG"><s0>Degenerative disease</s0><s5>39</s5></fC07><fC07 i1="03" i2="X" l="SPA"><s0>Enfermedad degenerativa</s0><s5>39</s5></fC07><fC07 i1="04" i2="X" l="FRE"><s0>Pathologie du système nerveux central</s0><s5>40</s5></fC07><fC07 i1="04" i2="X" l="ENG"><s0>Central nervous system disease</s0><s5>40</s5></fC07><fC07 i1="04" i2="X" l="SPA"><s0>Sistema nervosio central patología</s0><s5>40</s5></fC07><fN21><s1>124</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard></inist><affiliations><list><country><li>Canada</li><li>Italie</li><li>Suisse</li><li>États-Unis</li></country><region><li>Floride</li></region><settlement><li>Tampa</li></settlement><orgName><li>Université de Floride du Sud</li></orgName></list><tree><country name="États-Unis"><region name="Floride"><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name></region><name sortKey="Dronamraju, Nalina" sort="Dronamraju, Nalina" uniqKey="Dronamraju N" first="Nalina" last="Dronamraju">Nalina Dronamraju</name><name sortKey="Mancione, Linda" sort="Mancione, Linda" uniqKey="Mancione L" first="Linda" last="Mancione">Linda Mancione</name></country><country name="Canada"><noRegion><name sortKey="Panisset, Michel" sort="Panisset, Michel" uniqKey="Panisset M" first="Michel" last="Panisset">Michel Panisset</name></noRegion></country><country name="Italie"><noRegion><name sortKey="Abbruzzese, Giovanni" sort="Abbruzzese, Giovanni" uniqKey="Abbruzzese G" first="Giovanni" last="Abbruzzese">Giovanni Abbruzzese</name></noRegion></country><country name="Suisse"><noRegion><name sortKey="Kakarieka, Algirdas" sort="Kakarieka, Algirdas" uniqKey="Kakarieka A" first="Algirdas" last="Kakarieka">Algirdas Kakarieka</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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