Efficacy and tolerability of entacapone as adjunctive therapy to levodopa in patients with Parkinson's Disease and end-of-dose deterioration in daily medical practice : An open, multicenter study
Identifieur interne : 003833 ( Main/Curation ); précédent : 003832; suivant : 003834Efficacy and tolerability of entacapone as adjunctive therapy to levodopa in patients with Parkinson's Disease and end-of-dose deterioration in daily medical practice : An open, multicenter study
Auteurs : F. Durif [France] ; I. Devaux [France] ; J.-J. Pere [France] ; J.-C. Delumeau [Suisse] ; I. Bourdeix [France]Source :
- European neurology [ 0014-3022 ] ; 2001.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Antiparkinson Agents (administration & dosage), Antiparkinson Agents (adverse effects), Antiparkinson agent, Catechol O-Methyltransferase Inhibitors, Catechols (administration & dosage), Catechols (adverse effects), Chemotherapy, Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Therapy, Combination, Entacapone, Female, Human, Humans, Levodopa, Levodopa (administration & dosage), Levodopa (adverse effects), Male, Middle Aged, Neurologic Examination, Nitriles, Parkinson Disease (drug therapy), Parkinson disease, Prospective Studies, Quality of life, Tolerance, Treatment Outcome, Treatment efficiency.
- MESH :
- chemical , administration & dosage : Antiparkinson Agents, Catechols, Levodopa.
- chemical , adverse effects : Antiparkinson Agents, Catechols, Levodopa.
- drug therapy : Parkinson Disease.
- Adult, Aged, Aged, 80 and over, Catechol O-Methyltransferase Inhibitors, Dose-Response Relationship, Drug, Drug Administration Schedule, Drug Therapy, Combination, Female, Humans, Male, Middle Aged, Neurologic Examination, Nitriles, Prospective Studies, Treatment Outcome.
Abstract
Entacapone is a potent, reversible and orally active inhibitor of catechol-O-methyltransferase. This open multicenter study evaluated the efficacy, safety and tolerability of entacapone as adjunct therapy to levodopa/dopa decarboxylase inhibitor (≥ 3 daily doses) in patients with idiopathic Parkinson's disease and end-of-dose motor fluctuations. The 8-week study included 489 patients under conditions of typical daily medical practice. Patients were treated with a 200-mg fixed dose of entacapone administered with each scheduled dose of levodopa to a maximum of 10 doses per day. Other antiparkinsonian medication should have been stable for at least 1 month. The primary efficacy criteria were: (1) Part II (activities of daily living, ADL) of the Unified Parkinson's Disease Rating Scale (UPDRS), (2) the reduction of 'off' time during the daily waking period as assessed by the percentage of patients improving by at least one category at Item 39 of Part IV of the UPDRS. Secondary outcome measures included: (1) the investigator's global assessment of change, (2) quality of life (QoL) was assessed using the Parkinson's Disease Questionnaire (PDQ-39). Adverse events, vital signs and liver enzymes were monitored at weeks 2 and 8. The baseline mean score for ADL was 10.5 (±7.04), which decreased to 8.5 (±6.37) at the end of the study (p<0.0001). Compared to baseline, 40.8% of patients experienced a reduction in 'off' time during the waking period; this improvement was highly significant (p< 0.0001). A reduction in the daily dose of levodopa was observed in 35.8% of patients (mean decrease 209 ± 149 mg). QoL was improved by a mean of 10% in all categories of the PDQ-39 (p<0.001), except social support and cognition. This improvement was statistically significant (p < 0.001). The dyskinesia score (UPDRS Item 32) was decreased significantly from 2.3 to 2.1 from baseline to end of study (p < 0.001), although 52.7% of patients reported levodopa-induced dyskinesia as an adverse event. There was no case of increased liver enzymes. The study results confirm that the excellent risk/benefit ratio seen in phase III controlled studies can be seen in daily neurological practice. Moreover, the study suggests that the benefits of entacapone are associated with a significant improvement in QoL.
Links toward previous steps (curation, corpus...)
- to stream PascalFrancis, to step Corpus: Pour aller vers cette notice dans l'étape Curation :001253
- to stream PascalFrancis, to step Curation: Pour aller vers cette notice dans l'étape Curation :000185
- to stream PascalFrancis, to step Checkpoint: Pour aller vers cette notice dans l'étape Curation :001070
- to stream Main, to step Merge: Pour aller vers cette notice dans l'étape Curation :003E26
- to stream PubMed, to step Corpus: Pour aller vers cette notice dans l'étape Curation :001270
- to stream PubMed, to step Curation: Pour aller vers cette notice dans l'étape Curation :001229
- to stream PubMed, to step Checkpoint: Pour aller vers cette notice dans l'étape Curation :001229
- to stream Ncbi, to step Merge: Pour aller vers cette notice dans l'étape Curation :000174
- to stream Ncbi, to step Curation: Pour aller vers cette notice dans l'étape Curation :000174
- to stream Ncbi, to step Checkpoint: Pour aller vers cette notice dans l'étape Curation :000174
- to stream Main, to step Merge: Pour aller vers cette notice dans l'étape Curation :003B48
Links to Exploration step
Pascal:01-0148483Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Efficacy and tolerability of entacapone as adjunctive therapy to levodopa in patients with Parkinson's Disease and end-of-dose deterioration in daily medical practice : An open, multicenter study</title>
<author><name sortKey="Durif, F" sort="Durif, F" uniqKey="Durif F" first="F." last="Durif">F. Durif</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Neurology, University Hospital of Clermont-Ferrand</s1>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>France</country>
<wicri:noRegion>University Hospital of Clermont-Ferrand</wicri:noRegion>
<wicri:noRegion>Department of Neurology, University Hospital of Clermont-Ferrand</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Devaux, I" sort="Devaux, I" uniqKey="Devaux I" first="I." last="Devaux">I. Devaux</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Neurology, University Hospital of Clermont-Ferrand</s1>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>France</country>
<wicri:noRegion>University Hospital of Clermont-Ferrand</wicri:noRegion>
<wicri:noRegion>Department of Neurology, University Hospital of Clermont-Ferrand</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Pere, J J" sort="Pere, J J" uniqKey="Pere J" first="J.-J." last="Pere">J.-J. Pere</name>
<affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Novartis Pharma SA</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Delumeau, J C" sort="Delumeau, J C" uniqKey="Delumeau J" first="J.-C." last="Delumeau">J.-C. Delumeau</name>
<affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Novartis Pharma AG</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>Suisse</country>
<wicri:noRegion>Novartis Pharma AG</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Bourdeix, I" sort="Bourdeix, I" uniqKey="Bourdeix I" first="I." last="Bourdeix">I. Bourdeix</name>
<affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Novartis Pharma SA</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">INIST</idno>
<idno type="inist">01-0148483</idno>
<date when="2001">2001</date>
<idno type="stanalyst">PASCAL 01-0148483 INIST</idno>
<idno type="RBID">Pascal:01-0148483</idno>
<idno type="wicri:Area/PascalFrancis/Corpus">001253</idno>
<idno type="wicri:Area/PascalFrancis/Curation">000185</idno>
<idno type="wicri:Area/PascalFrancis/Checkpoint">001070</idno>
<idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">001070</idno>
<idno type="wicri:doubleKey">0014-3022:2001:Durif F:efficacy:and:tolerability</idno>
<idno type="wicri:Area/Main/Merge">003E26</idno>
<idno type="wicri:source">PubMed</idno>
<idno type="RBID">pubmed:11244274</idno>
<idno type="wicri:Area/PubMed/Corpus">001270</idno>
<idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001270</idno>
<idno type="wicri:Area/PubMed/Curation">001229</idno>
<idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">001229</idno>
<idno type="wicri:Area/PubMed/Checkpoint">001229</idno>
<idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">001229</idno>
<idno type="wicri:Area/Ncbi/Merge">000174</idno>
<idno type="wicri:Area/Ncbi/Curation">000174</idno>
<idno type="wicri:Area/Ncbi/Checkpoint">000174</idno>
<idno type="wicri:doubleKey">0014-3022:2001:Durif F:efficacy:and:tolerability</idno>
<idno type="wicri:Area/Main/Merge">003B48</idno>
<idno type="wicri:Area/Main/Curation">003833</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Efficacy and tolerability of entacapone as adjunctive therapy to levodopa in patients with Parkinson's Disease and end-of-dose deterioration in daily medical practice : An open, multicenter study</title>
<author><name sortKey="Durif, F" sort="Durif, F" uniqKey="Durif F" first="F." last="Durif">F. Durif</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Neurology, University Hospital of Clermont-Ferrand</s1>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>France</country>
<wicri:noRegion>University Hospital of Clermont-Ferrand</wicri:noRegion>
<wicri:noRegion>Department of Neurology, University Hospital of Clermont-Ferrand</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Devaux, I" sort="Devaux, I" uniqKey="Devaux I" first="I." last="Devaux">I. Devaux</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Neurology, University Hospital of Clermont-Ferrand</s1>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>France</country>
<wicri:noRegion>University Hospital of Clermont-Ferrand</wicri:noRegion>
<wicri:noRegion>Department of Neurology, University Hospital of Clermont-Ferrand</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Pere, J J" sort="Pere, J J" uniqKey="Pere J" first="J.-J." last="Pere">J.-J. Pere</name>
<affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Novartis Pharma SA</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Delumeau, J C" sort="Delumeau, J C" uniqKey="Delumeau J" first="J.-C." last="Delumeau">J.-C. Delumeau</name>
<affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Novartis Pharma AG</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>Suisse</country>
<wicri:noRegion>Novartis Pharma AG</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Bourdeix, I" sort="Bourdeix, I" uniqKey="Bourdeix I" first="I." last="Bourdeix">I. Bourdeix</name>
<affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Novartis Pharma SA</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">European neurology</title>
<title level="j" type="abbreviated">Eur. neurol.</title>
<idno type="ISSN">0014-3022</idno>
<imprint><date when="2001">2001</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">European neurology</title>
<title level="j" type="abbreviated">Eur. neurol.</title>
<idno type="ISSN">0014-3022</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 (administration & dosage)</term>
<term>Antiparkinson Agents (adverse effects)</term>
<term>Antiparkinson agent</term>
<term>Catechol O-Methyltransferase Inhibitors</term>
<term>Catechols (administration & dosage)</term>
<term>Catechols (adverse effects)</term>
<term>Chemotherapy</term>
<term>Dose-Response Relationship, Drug</term>
<term>Drug Administration Schedule</term>
<term>Drug Therapy, Combination</term>
<term>Entacapone</term>
<term>Female</term>
<term>Human</term>
<term>Humans</term>
<term>Levodopa</term>
<term>Levodopa (administration & dosage)</term>
<term>Levodopa (adverse effects)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Neurologic Examination</term>
<term>Nitriles</term>
<term>Parkinson Disease (drug therapy)</term>
<term>Parkinson disease</term>
<term>Prospective Studies</term>
<term>Quality of life</term>
<term>Tolerance</term>
<term>Treatment Outcome</term>
<term>Treatment efficiency</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antiparkinson Agents</term>
<term>Catechols</term>
<term>Levodopa</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiparkinson Agents</term>
<term>Catechols</term>
<term>Levodopa</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Catechol O-Methyltransferase Inhibitors</term>
<term>Dose-Response Relationship, Drug</term>
<term>Drug Administration Schedule</term>
<term>Drug Therapy, Combination</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Neurologic Examination</term>
<term>Nitriles</term>
<term>Prospective Studies</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Parkinson maladie</term>
<term>Lévodopa</term>
<term>Antiparkinsonien</term>
<term>Entacapone</term>
<term>Chimiothérapie</term>
<term>Efficacité traitement</term>
<term>Tolérance</term>
<term>Homme</term>
<term>Qualité vie</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Entacapone is a potent, reversible and orally active inhibitor of catechol-O-methyltransferase. This open multicenter study evaluated the efficacy, safety and tolerability of entacapone as adjunct therapy to levodopa/dopa decarboxylase inhibitor (≥ 3 daily doses) in patients with idiopathic Parkinson's disease and end-of-dose motor fluctuations. The 8-week study included 489 patients under conditions of typical daily medical practice. Patients were treated with a 200-mg fixed dose of entacapone administered with each scheduled dose of levodopa to a maximum of 10 doses per day. Other antiparkinsonian medication should have been stable for at least 1 month. The primary efficacy criteria were: (1) Part II (activities of daily living, ADL) of the Unified Parkinson's Disease Rating Scale (UPDRS), (2) the reduction of 'off' time during the daily waking period as assessed by the percentage of patients improving by at least one category at Item 39 of Part IV of the UPDRS. Secondary outcome measures included: (1) the investigator's global assessment of change, (2) quality of life (QoL) was assessed using the Parkinson's Disease Questionnaire (PDQ-39). Adverse events, vital signs and liver enzymes were monitored at weeks 2 and 8. The baseline mean score for ADL was 10.5 (±7.04), which decreased to 8.5 (±6.37) at the end of the study (p<0.0001). Compared to baseline, 40.8% of patients experienced a reduction in 'off' time during the waking period; this improvement was highly significant (p< 0.0001). A reduction in the daily dose of levodopa was observed in 35.8% of patients (mean decrease 209 ± 149 mg). QoL was improved by a mean of 10% in all categories of the PDQ-39 (p<0.001), except social support and cognition. This improvement was statistically significant (p < 0.001). The dyskinesia score (UPDRS Item 32) was decreased significantly from 2.3 to 2.1 from baseline to end of study (p < 0.001), although 52.7% of patients reported levodopa-induced dyskinesia as an adverse event. There was no case of increased liver enzymes. The study results confirm that the excellent risk/benefit ratio seen in phase III controlled studies can be seen in daily neurological practice. Moreover, the study suggests that the benefits of entacapone are associated with a significant improvement in QoL.</div>
</front>
</TEI>
<double idat="0014-3022:2001:Durif F:efficacy:and:tolerability"><INIST><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Efficacy and tolerability of entacapone as adjunctive therapy to levodopa in patients with Parkinson's Disease and end-of-dose deterioration in daily medical practice : An open, multicenter study</title>
<author><name sortKey="Durif, F" sort="Durif, F" uniqKey="Durif F" first="F." last="Durif">F. Durif</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Neurology, University Hospital of Clermont-Ferrand</s1>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>France</country>
<wicri:noRegion>University Hospital of Clermont-Ferrand</wicri:noRegion>
<wicri:noRegion>Department of Neurology, University Hospital of Clermont-Ferrand</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Devaux, I" sort="Devaux, I" uniqKey="Devaux I" first="I." last="Devaux">I. Devaux</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Neurology, University Hospital of Clermont-Ferrand</s1>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>France</country>
<wicri:noRegion>University Hospital of Clermont-Ferrand</wicri:noRegion>
<wicri:noRegion>Department of Neurology, University Hospital of Clermont-Ferrand</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Pere, J J" sort="Pere, J J" uniqKey="Pere J" first="J.-J." last="Pere">J.-J. Pere</name>
<affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Novartis Pharma SA</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Delumeau, J C" sort="Delumeau, J C" uniqKey="Delumeau J" first="J.-C." last="Delumeau">J.-C. Delumeau</name>
<affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Novartis Pharma AG</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>Suisse</country>
<wicri:noRegion>Novartis Pharma AG</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Bourdeix, I" sort="Bourdeix, I" uniqKey="Bourdeix I" first="I." last="Bourdeix">I. Bourdeix</name>
<affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Novartis Pharma SA</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">INIST</idno>
<idno type="inist">01-0148483</idno>
<date when="2001">2001</date>
<idno type="stanalyst">PASCAL 01-0148483 INIST</idno>
<idno type="RBID">Pascal:01-0148483</idno>
<idno type="wicri:Area/PascalFrancis/Corpus">001253</idno>
<idno type="wicri:Area/PascalFrancis/Curation">000185</idno>
<idno type="wicri:Area/PascalFrancis/Checkpoint">001070</idno>
<idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">001070</idno>
<idno type="wicri:doubleKey">0014-3022:2001:Durif F:efficacy:and:tolerability</idno>
<idno type="wicri:Area/Main/Merge">003E26</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Efficacy and tolerability of entacapone as adjunctive therapy to levodopa in patients with Parkinson's Disease and end-of-dose deterioration in daily medical practice : An open, multicenter study</title>
<author><name sortKey="Durif, F" sort="Durif, F" uniqKey="Durif F" first="F." last="Durif">F. Durif</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Neurology, University Hospital of Clermont-Ferrand</s1>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>France</country>
<wicri:noRegion>University Hospital of Clermont-Ferrand</wicri:noRegion>
<wicri:noRegion>Department of Neurology, University Hospital of Clermont-Ferrand</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Devaux, I" sort="Devaux, I" uniqKey="Devaux I" first="I." last="Devaux">I. Devaux</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Neurology, University Hospital of Clermont-Ferrand</s1>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>France</country>
<wicri:noRegion>University Hospital of Clermont-Ferrand</wicri:noRegion>
<wicri:noRegion>Department of Neurology, University Hospital of Clermont-Ferrand</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Pere, J J" sort="Pere, J J" uniqKey="Pere J" first="J.-J." last="Pere">J.-J. Pere</name>
<affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Novartis Pharma SA</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Delumeau, J C" sort="Delumeau, J C" uniqKey="Delumeau J" first="J.-C." last="Delumeau">J.-C. Delumeau</name>
<affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Novartis Pharma AG</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>Suisse</country>
<wicri:noRegion>Novartis Pharma AG</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Bourdeix, I" sort="Bourdeix, I" uniqKey="Bourdeix I" first="I." last="Bourdeix">I. Bourdeix</name>
<affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Novartis Pharma SA</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">European neurology</title>
<title level="j" type="abbreviated">Eur. neurol.</title>
<idno type="ISSN">0014-3022</idno>
<imprint><date when="2001">2001</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">European neurology</title>
<title level="j" type="abbreviated">Eur. neurol.</title>
<idno type="ISSN">0014-3022</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiparkinson agent</term>
<term>Chemotherapy</term>
<term>Entacapone</term>
<term>Human</term>
<term>Levodopa</term>
<term>Parkinson disease</term>
<term>Quality of life</term>
<term>Tolerance</term>
<term>Treatment efficiency</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Parkinson maladie</term>
<term>Lévodopa</term>
<term>Antiparkinsonien</term>
<term>Entacapone</term>
<term>Chimiothérapie</term>
<term>Efficacité traitement</term>
<term>Tolérance</term>
<term>Homme</term>
<term>Qualité vie</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Entacapone is a potent, reversible and orally active inhibitor of catechol-O-methyltransferase. This open multicenter study evaluated the efficacy, safety and tolerability of entacapone as adjunct therapy to levodopa/dopa decarboxylase inhibitor (≥ 3 daily doses) in patients with idiopathic Parkinson's disease and end-of-dose motor fluctuations. The 8-week study included 489 patients under conditions of typical daily medical practice. Patients were treated with a 200-mg fixed dose of entacapone administered with each scheduled dose of levodopa to a maximum of 10 doses per day. Other antiparkinsonian medication should have been stable for at least 1 month. The primary efficacy criteria were: (1) Part II (activities of daily living, ADL) of the Unified Parkinson's Disease Rating Scale (UPDRS), (2) the reduction of 'off' time during the daily waking period as assessed by the percentage of patients improving by at least one category at Item 39 of Part IV of the UPDRS. Secondary outcome measures included: (1) the investigator's global assessment of change, (2) quality of life (QoL) was assessed using the Parkinson's Disease Questionnaire (PDQ-39). Adverse events, vital signs and liver enzymes were monitored at weeks 2 and 8. The baseline mean score for ADL was 10.5 (±7.04), which decreased to 8.5 (±6.37) at the end of the study (p<0.0001). Compared to baseline, 40.8% of patients experienced a reduction in 'off' time during the waking period; this improvement was highly significant (p< 0.0001). A reduction in the daily dose of levodopa was observed in 35.8% of patients (mean decrease 209 ± 149 mg). QoL was improved by a mean of 10% in all categories of the PDQ-39 (p<0.001), except social support and cognition. This improvement was statistically significant (p < 0.001). The dyskinesia score (UPDRS Item 32) was decreased significantly from 2.3 to 2.1 from baseline to end of study (p < 0.001), although 52.7% of patients reported levodopa-induced dyskinesia as an adverse event. There was no case of increased liver enzymes. The study results confirm that the excellent risk/benefit ratio seen in phase III controlled studies can be seen in daily neurological practice. Moreover, the study suggests that the benefits of entacapone are associated with a significant improvement in QoL.</div>
</front>
</TEI>
</INIST>
<PubMed><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Efficacy and tolerability of entacapone as adjunctive therapy to levodopa in patients with Parkinson's disease and end-of-dose deterioration in daily medical practice: an open, multicenter study.</title>
<author><name sortKey="Durif, F" sort="Durif, F" uniqKey="Durif F" first="F" last="Durif">F. Durif</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Neurology, University Hospital of Clermont-Ferrand, France. fdurif@chu-clermontferrand.fr</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Neurology, University Hospital of Clermont-Ferrand</wicri:regionArea>
<wicri:noRegion>University Hospital of Clermont-Ferrand</wicri:noRegion>
<wicri:noRegion>University Hospital of Clermont-Ferrand</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Devaux, I" sort="Devaux, I" uniqKey="Devaux I" first="I" last="Devaux">I. Devaux</name>
</author>
<author><name sortKey="Pere, J J" sort="Pere, J J" uniqKey="Pere J" first="J J" last="Pere">J J Pere</name>
</author>
<author><name sortKey="Delumeau, J C" sort="Delumeau, J C" uniqKey="Delumeau J" first="J C" last="Delumeau">J C Delumeau</name>
</author>
<author><name sortKey="Bourdeix, I" sort="Bourdeix, I" uniqKey="Bourdeix I" first="I" last="Bourdeix">I. Bourdeix</name>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">PubMed</idno>
<date when="2001">2001</date>
<idno type="RBID">pubmed:11244274</idno>
<idno type="pmid">11244274</idno>
<idno type="doi">52104</idno>
<idno type="wicri:Area/PubMed/Corpus">001270</idno>
<idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001270</idno>
<idno type="wicri:Area/PubMed/Curation">001229</idno>
<idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">001229</idno>
<idno type="wicri:Area/PubMed/Checkpoint">001229</idno>
<idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">001229</idno>
<idno type="wicri:Area/Ncbi/Merge">000174</idno>
<idno type="wicri:Area/Ncbi/Curation">000174</idno>
<idno type="wicri:Area/Ncbi/Checkpoint">000174</idno>
<idno type="wicri:doubleKey">0014-3022:2001:Durif F:efficacy:and:tolerability</idno>
<idno type="wicri:Area/Main/Merge">003B48</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en">Efficacy and tolerability of entacapone as adjunctive therapy to levodopa in patients with Parkinson's disease and end-of-dose deterioration in daily medical practice: an open, multicenter study.</title>
<author><name sortKey="Durif, F" sort="Durif, F" uniqKey="Durif F" first="F" last="Durif">F. Durif</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Neurology, University Hospital of Clermont-Ferrand, France. fdurif@chu-clermontferrand.fr</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Department of Neurology, University Hospital of Clermont-Ferrand</wicri:regionArea>
<wicri:noRegion>University Hospital of Clermont-Ferrand</wicri:noRegion>
<wicri:noRegion>University Hospital of Clermont-Ferrand</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Devaux, I" sort="Devaux, I" uniqKey="Devaux I" first="I" last="Devaux">I. Devaux</name>
</author>
<author><name sortKey="Pere, J J" sort="Pere, J J" uniqKey="Pere J" first="J J" last="Pere">J J Pere</name>
</author>
<author><name sortKey="Delumeau, J C" sort="Delumeau, J C" uniqKey="Delumeau J" first="J C" last="Delumeau">J C Delumeau</name>
</author>
<author><name sortKey="Bourdeix, I" sort="Bourdeix, I" uniqKey="Bourdeix I" first="I" last="Bourdeix">I. Bourdeix</name>
</author>
</analytic>
<series><title level="j">European neurology</title>
<idno type="ISSN">0014-3022</idno>
<imprint><date when="2001" type="published">2001</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 (administration & dosage)</term>
<term>Antiparkinson Agents (adverse effects)</term>
<term>Catechol O-Methyltransferase Inhibitors</term>
<term>Catechols (administration & dosage)</term>
<term>Catechols (adverse effects)</term>
<term>Dose-Response Relationship, Drug</term>
<term>Drug Administration Schedule</term>
<term>Drug Therapy, Combination</term>
<term>Female</term>
<term>Humans</term>
<term>Levodopa (administration & dosage)</term>
<term>Levodopa (adverse effects)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Neurologic Examination</term>
<term>Nitriles</term>
<term>Parkinson Disease (drug therapy)</term>
<term>Prospective Studies</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antiparkinson Agents</term>
<term>Catechols</term>
<term>Levodopa</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiparkinson Agents</term>
<term>Catechols</term>
<term>Levodopa</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Catechol O-Methyltransferase Inhibitors</term>
<term>Dose-Response Relationship, Drug</term>
<term>Drug Administration Schedule</term>
<term>Drug Therapy, Combination</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Neurologic Examination</term>
<term>Nitriles</term>
<term>Prospective Studies</term>
<term>Treatment Outcome</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Entacapone is a potent, reversible and orally active inhibitor of catechol-O-methyltransferase. This open multicenter study evaluated the efficacy, safety and tolerability of entacapone as adjunct therapy to levodopa/dopa decarboxylase inhibitor (> or = 3 daily doses) in patients with idiopathic Parkinson's disease and end-of-dose motor fluctuations. The 8-week study included 489 patients under conditions of typical daily medical practice. Patients were treated with a 200-mg fixed dose of entacapone administered with each scheduled dose of levodopa to a maximum of 10 doses per day. Other antiparkinsonian medication should have been stable for at least 1 month. The primary efficacy criteria were: (1) Part II (activities of daily living, ADL) of the Unified Parkinson's Disease Rating Scale (UPDRS), (2) the reduction of 'off' time during the daily waking period as assessed by the percentage of patients improving by at least one category at Item 39 of Part IV of the UPDRS. Secondary outcome measures included: (1) the investigator's global assessment of change, (2) quality of life (QoL) was assessed using the Parkinson's Disease Questionnaire (PDQ-39). Adverse events, vital signs and liver enzymes were monitored at weeks 2 and 8. The baseline mean score for ADL was 10.5 (+/-7.04), which decreased to 8.5 (+/-6.37) at the end of the study (p < 0.0001). Compared to baseline, 40.8% of patients experienced a reduction in 'off' time during the waking period; this improvement was highly significant (p < 0.0001). A reduction in the daily dose of levodopa was observed in 35.8% of patients (mean decrease 209 +/- 149 mg). QoL was improved by a mean of 10% in all categories of the PDQ-39 (p < 0.001), except social support and cognition. This improvement was statistically significant (p < 0.001). The dyskinesia score (UPDRS Item 32) was decreased significantly from 2.3 to 2.1 from baseline to end of study (p < 0.001), although 52.7% of patients reported levodopa-induced dyskinesia as an adverse event. There was no case of increased liver enzymes. The study results confirm that the excellent risk/benefit ratio seen in phase III controlled studies can be seen in daily neurological practice. Moreover, the study suggests that the benefits of entacapone are associated with a significant improvement in QoL.</div>
</front>
</TEI>
</PubMed>
</double>
</record>
Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Sante/explor/ParkinsonFranceV1/Data/Main/Curation
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 003833 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Curation/biblio.hfd -nk 003833 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien |wiki= Wicri/Sante |area= ParkinsonFranceV1 |flux= Main |étape= Curation |type= RBID |clé= Pascal:01-0148483 |texte= Efficacy and tolerability of entacapone as adjunctive therapy to levodopa in patients with Parkinson's Disease and end-of-dose deterioration in daily medical practice : An open, multicenter study }}
![]() | This area was generated with Dilib version V0.6.29. | ![]() |