Ropinirole in the treatment of early Parkinson's disease: a 6-month interim report of a 5-year levodopa-controlled study. 056 Study Group.
Identifieur interne : 001491 ( PubMed/Corpus ); précédent : 001490; suivant : 001492Ropinirole in the treatment of early Parkinson's disease: a 6-month interim report of a 5-year levodopa-controlled study. 056 Study Group.
Auteurs : O. Rascol ; D J Brooks ; E R Brunt ; A D Korczyn ; W H Poewe ; F. StocchiSource :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 1998.
English descriptors
- KwdEn :
- Adult, Aged, Analysis of Variance, Antiparkinson Agents (therapeutic use), Confidence Intervals, Disease Progression, Dopamine Agonists (therapeutic use), Double-Blind Method, Female, Humans, Indoles (therapeutic use), Levodopa (therapeutic use), Longitudinal Studies, Male, Middle Aged, Odds Ratio, Parkinson Disease (drug therapy), Regression Analysis, Severity of Illness Index, Treatment Outcome.
- MESH :
- chemical , therapeutic use : Antiparkinson Agents, Dopamine Agonists, Indoles, Levodopa.
- drug therapy : Parkinson Disease.
- Adult, Aged, Analysis of Variance, Confidence Intervals, Disease Progression, Double-Blind Method, Female, Humans, Longitudinal Studies, Male, Middle Aged, Odds Ratio, Regression Analysis, Severity of Illness Index, Treatment Outcome.
Abstract
The efficacies of ropinirole and levodopa were compared after 6 months of treatment in a planned interim analysis of a 5-year, double-blind, randomized, multicenter study of patients with early Parkinson's disease requiring dopaminergic therapy. The percentage of improvement in the Unified Parkinson's Disease Rating Scale total motor examination score was significantly higher for levodopa (44%) than for ropinirole (32%). The proportion of "responders" (Unified Parkinson's Disease Rating Scale improvement of at least 30%) did not differ between groups (levodopa, 58%; ropinirole, 48%). There was no difference between the groups for improvement on the Clinical Global Impression scale in patients with Hoehn and Yahr stages I, I.5, or II, but a significantly higher proportion of patients with Hoehn and Yahr stages II.5 or III showed Clinical Global Impression score improvement with levodopa. Emergent adverse events occurred in 84% of patients in both treatment groups, the principal symptom in each group being nausea. The incidence of serious adverse events was low (8% for ropinirole, 9% for levodopa). The results suggest that ropinirole and levodopa are equally effective in less severe Parkinson's disease; in more advanced Parkinson's disease, levodopa is superior.
DOI: 10.1002/mds.870130111
PubMed: 9452324
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Rascol</name><affiliation><nlm:affiliation>Department of Clinical Pharmacology and Clinical Investigation Centre, Faculty of Medicine, INSERM U455, University Hospital, Toulouse, France.</nlm:affiliation></affiliation></author><author><name sortKey="Brooks, D J" sort="Brooks, D J" uniqKey="Brooks D" first="D J" last="Brooks">D J Brooks</name></author><author><name sortKey="Brunt, E R" sort="Brunt, E R" uniqKey="Brunt E" first="E R" last="Brunt">E R Brunt</name></author><author><name sortKey="Korczyn, A D" sort="Korczyn, A D" uniqKey="Korczyn A" first="A D" last="Korczyn">A D Korczyn</name></author><author><name sortKey="Poewe, W H" sort="Poewe, W H" uniqKey="Poewe W" first="W H" last="Poewe">W H Poewe</name></author><author><name sortKey="Stocchi, F" sort="Stocchi, F" uniqKey="Stocchi F" first="F" last="Stocchi">F. Stocchi</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="1998">1998</date><idno type="RBID">pubmed:9452324</idno><idno type="pmid">9452324</idno><idno type="doi">10.1002/mds.870130111</idno><idno type="wicri:Area/PubMed/Corpus">001491</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001491</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Ropinirole in the treatment of early Parkinson's disease: a 6-month interim report of a 5-year levodopa-controlled study. 056 Study Group.</title><author><name sortKey="Rascol, O" sort="Rascol, O" uniqKey="Rascol O" first="O" last="Rascol">O. Rascol</name><affiliation><nlm:affiliation>Department of Clinical Pharmacology and Clinical Investigation Centre, Faculty of Medicine, INSERM U455, University Hospital, Toulouse, France.</nlm:affiliation></affiliation></author><author><name sortKey="Brooks, D J" sort="Brooks, D J" uniqKey="Brooks D" first="D J" last="Brooks">D J Brooks</name></author><author><name sortKey="Brunt, E R" sort="Brunt, E R" uniqKey="Brunt E" first="E R" last="Brunt">E R Brunt</name></author><author><name sortKey="Korczyn, A D" sort="Korczyn, A D" uniqKey="Korczyn A" first="A D" last="Korczyn">A D Korczyn</name></author><author><name sortKey="Poewe, W H" sort="Poewe, W H" uniqKey="Poewe W" first="W H" last="Poewe">W H Poewe</name></author><author><name sortKey="Stocchi, F" sort="Stocchi, F" uniqKey="Stocchi F" first="F" last="Stocchi">F. Stocchi</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="ISSN">0885-3185</idno><imprint><date when="1998" type="published">1998</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Analysis of Variance</term><term>Antiparkinson Agents (therapeutic use)</term><term>Confidence Intervals</term><term>Disease Progression</term><term>Dopamine Agonists (therapeutic use)</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Indoles (therapeutic use)</term><term>Levodopa (therapeutic use)</term><term>Longitudinal Studies</term><term>Male</term><term>Middle Aged</term><term>Odds Ratio</term><term>Parkinson Disease (drug therapy)</term><term>Regression Analysis</term><term>Severity of Illness Index</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</term><term>Dopamine Agonists</term><term>Indoles</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>Analysis of Variance</term><term>Confidence Intervals</term><term>Disease Progression</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Longitudinal Studies</term><term>Male</term><term>Middle Aged</term><term>Odds Ratio</term><term>Regression Analysis</term><term>Severity of Illness Index</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The efficacies of ropinirole and levodopa were compared after 6 months of treatment in a planned interim analysis of a 5-year, double-blind, randomized, multicenter study of patients with early Parkinson's disease requiring dopaminergic therapy. The percentage of improvement in the Unified Parkinson's Disease Rating Scale total motor examination score was significantly higher for levodopa (44%) than for ropinirole (32%). The proportion of "responders" (Unified Parkinson's Disease Rating Scale improvement of at least 30%) did not differ between groups (levodopa, 58%; ropinirole, 48%). There was no difference between the groups for improvement on the Clinical Global Impression scale in patients with Hoehn and Yahr stages I, I.5, or II, but a significantly higher proportion of patients with Hoehn and Yahr stages II.5 or III showed Clinical Global Impression score improvement with levodopa. Emergent adverse events occurred in 84% of patients in both treatment groups, the principal symptom in each group being nausea. The incidence of serious adverse events was low (8% for ropinirole, 9% for levodopa). The results suggest that ropinirole and levodopa are equally effective in less severe Parkinson's disease; in more advanced Parkinson's disease, levodopa is superior.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">9452324</PMID><DateCreated><Year>1998</Year><Month>03</Month><Day>26</Day></DateCreated><DateCompleted><Year>1998</Year><Month>03</Month><Day>26</Day></DateCompleted><DateRevised><Year>2013</Year><Month>11</Month><Day>21</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0885-3185</ISSN><JournalIssue CitedMedium="Print"><Volume>13</Volume><Issue>1</Issue><PubDate><Year>1998</Year><Month>Jan</Month></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>Ropinirole in the treatment of early Parkinson's disease: a 6-month interim report of a 5-year levodopa-controlled study. 056 Study Group.</ArticleTitle><Pagination><MedlinePgn>39-45</MedlinePgn></Pagination><Abstract><AbstractText>The efficacies of ropinirole and levodopa were compared after 6 months of treatment in a planned interim analysis of a 5-year, double-blind, randomized, multicenter study of patients with early Parkinson's disease requiring dopaminergic therapy. The percentage of improvement in the Unified Parkinson's Disease Rating Scale total motor examination score was significantly higher for levodopa (44%) than for ropinirole (32%). The proportion of "responders" (Unified Parkinson's Disease Rating Scale improvement of at least 30%) did not differ between groups (levodopa, 58%; ropinirole, 48%). There was no difference between the groups for improvement on the Clinical Global Impression scale in patients with Hoehn and Yahr stages I, I.5, or II, but a significantly higher proportion of patients with Hoehn and Yahr stages II.5 or III showed Clinical Global Impression score improvement with levodopa. Emergent adverse events occurred in 84% of patients in both treatment groups, the principal symptom in each group being nausea. The incidence of serious adverse events was low (8% for ropinirole, 9% for levodopa). 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ValidYN="Y"><LastName>Stocchi</LastName><ForeName>F</ForeName><Initials>F</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016430">Clinical Trial</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Mov Disord</MedlineTA><NlmUniqueID>8610688</NlmUniqueID><ISSNLinking>0885-3185</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000978">Antiparkinson Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D018491">Dopamine Agonists</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007211">Indoles</NameOfSubstance></Chemical><Chemical><RegistryNumber>030PYR8953</RegistryNumber><NameOfSubstance UI="C046649">ropinirole</NameOfSubstance></Chemical><Chemical><RegistryNumber>46627O600J</RegistryNumber><NameOfSubstance UI="D007980">Levodopa</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000704" MajorTopicYN="N">Analysis of Variance</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000978" MajorTopicYN="N">Antiparkinson Agents</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016001" MajorTopicYN="N">Confidence Intervals</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D018450" MajorTopicYN="N">Disease Progression</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D018491" MajorTopicYN="N">Dopamine Agonists</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007211" MajorTopicYN="N">Indoles</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D007980" MajorTopicYN="N">Levodopa</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008137" MajorTopicYN="N">Longitudinal 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