The Parkinson–Control study: A 1‐year randomized, double‐blind trial comparing piribedil (150 mg/day) with bromocriptine (25 mg/day) in early combination with levodopa in Parkinson's disease
Identifieur interne : 004463 ( Main/Merge ); précédent : 004462; suivant : 004464The Parkinson–Control study: A 1‐year randomized, double‐blind trial comparing piribedil (150 mg/day) with bromocriptine (25 mg/day) in early combination with levodopa in Parkinson's disease
Auteurs : Alexandre Castro-Caldas [Portugal] ; Paul Delwaide [Belgique] ; Wolfgang Jost [Allemagne] ; Marcelo Merello [Argentine] ; Adrian Williams [Royaume-Uni] ; Paolo Lamberti [Italie] ; Miguel Aguilar [Espagne] ; Susanna Del Signore [France] ; Pierre Cesaro [France]Source :
- Movement Disorders [ 0885-3185 ] ; 2006-04.
English descriptors
- KwdEn :
- Adult, Aged, Antiparkinson Agents (therapeutic use), Bromocriptine (therapeutic use), Case-Control Studies, Double-Blind Method, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Male, Middle Aged, Parkinson Disease (drug therapy), Parkinson's disease, Piribedil (therapeutic use), Severity of Illness Index, Time Factors, Treatment Outcome, bromocriptine, dopamine agonists, levodopa, piribedil.
- MESH :
- chemical , therapeutic use : Antiparkinson Agents, Bromocriptine, Piribedil.
- drug therapy : Parkinson Disease.
- Adult, Aged, Case-Control Studies, Double-Blind Method, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Male, Middle Aged, Severity of Illness Index, Time Factors, Treatment Outcome.
Abstract
Dopamine agonists have been recommended as early treatment for Parkinson's disease (PD), alone or combined with levodopa. Piribedil is a non‐ergot selective D2/D3 agonist with α2 antagonist properties shown to be effective in the treatment of PD. This 12‐month international, randomized, double‐blind trial aimed to assess the efficacy of piribedil 150 mg versus bromocriptine 25 mg, in early combination with levodopa in Stage I to III PD patients. Motor efficacy was assessed using the Unified Parkinson's Disease Rating Scale (UPDRS III, Items 18–31) as improvement from baseline. Response rate was defined as a 30% improvement. Among the 425 randomly assigned patients, 178 were also included in a substudy on cognitive follow‐up evaluated by a dysexecutive syndrome oriented battery. A relevant improvement in UPDRS III over the 12‐month study duration was observed both in the piribedil and bromocriptine groups (−7.9 ± 9.7 points from baseline versus −8.0 ± 9.5; not significant [n.s.]) with a response rate of 58.4% and 55.3% (n.s.), respectively. Piribedil and bromocriptine resulted in similar improvement on all UPDRS III subscores. Piribedil patients required less levodopa dose increase than those on bromocriptine. Cognitive performance remained generally unchanged in both groups, with a significant effect of piribedil limited to the Wisconsin Card Sorting Test. An overall good tolerability of piribedil was observed. Early combination of piribedil 150 mg with levodopa resulted in significant long‐term improvement of all motor symptoms in PD patients insufficiently controlled by levodopa alone. Taking into account both efficacy and acceptability in the long‐term, piribedil proved in this bromocriptine controlled study to be an effective and safe treatment for PD. © 2005 Movement Disorder Society
Url:
DOI: 10.1002/mds.20750
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ISTEX:1D2A61A7276EAF947FA7688AEC063C396BB88CB1Le document en format XML
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<front><div type="abstract" xml:lang="en">Dopamine agonists have been recommended as early treatment for Parkinson's disease (PD), alone or combined with levodopa. Piribedil is a non‐ergot selective D2/D3 agonist with α2 antagonist properties shown to be effective in the treatment of PD. This 12‐month international, randomized, double‐blind trial aimed to assess the efficacy of piribedil 150 mg versus bromocriptine 25 mg, in early combination with levodopa in Stage I to III PD patients. Motor efficacy was assessed using the Unified Parkinson's Disease Rating Scale (UPDRS III, Items 18–31) as improvement from baseline. Response rate was defined as a 30% improvement. Among the 425 randomly assigned patients, 178 were also included in a substudy on cognitive follow‐up evaluated by a dysexecutive syndrome oriented battery. A relevant improvement in UPDRS III over the 12‐month study duration was observed both in the piribedil and bromocriptine groups (−7.9 ± 9.7 points from baseline versus −8.0 ± 9.5; not significant [n.s.]) with a response rate of 58.4% and 55.3% (n.s.), respectively. Piribedil and bromocriptine resulted in similar improvement on all UPDRS III subscores. Piribedil patients required less levodopa dose increase than those on bromocriptine. Cognitive performance remained generally unchanged in both groups, with a significant effect of piribedil limited to the Wisconsin Card Sorting Test. An overall good tolerability of piribedil was observed. Early combination of piribedil 150 mg with levodopa resulted in significant long‐term improvement of all motor symptoms in PD patients insufficiently controlled by levodopa alone. Taking into account both efficacy and acceptability in the long‐term, piribedil proved in this bromocriptine controlled study to be an effective and safe treatment for PD. © 2005 Movement Disorder Society</div>
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<front><div type="abstract" xml:lang="en">Dopamine agonists have been recommended as early treatment for Parkinson's disease (PD), alone or combined with levodopa. Piribedil is a non‐ergot selective D2/D3 agonist with α2 antagonist properties shown to be effective in the treatment of PD. This 12‐month international, randomized, double‐blind trial aimed to assess the efficacy of piribedil 150 mg versus bromocriptine 25 mg, in early combination with levodopa in Stage I to III PD patients. Motor efficacy was assessed using the Unified Parkinson's Disease Rating Scale (UPDRS III, Items 18–31) as improvement from baseline. Response rate was defined as a 30% improvement. Among the 425 randomly assigned patients, 178 were also included in a substudy on cognitive follow‐up evaluated by a dysexecutive syndrome oriented battery. A relevant improvement in UPDRS III over the 12‐month study duration was observed both in the piribedil and bromocriptine groups (−7.9 ± 9.7 points from baseline versus −8.0 ± 9.5; not significant [n.s.]) with a response rate of 58.4% and 55.3% (n.s.), respectively. Piribedil and bromocriptine resulted in similar improvement on all UPDRS III subscores. Piribedil patients required less levodopa dose increase than those on bromocriptine. Cognitive performance remained generally unchanged in both groups, with a significant effect of piribedil limited to the Wisconsin Card Sorting Test. An overall good tolerability of piribedil was observed. Early combination of piribedil 150 mg with levodopa resulted in significant long‐term improvement of all motor symptoms in PD patients insufficiently controlled by levodopa alone. Taking into account both efficacy and acceptability in the long‐term, piribedil proved in this bromocriptine controlled study to be an effective and safe treatment for PD. © 2005 Movement Disorder Society</div>
</front>
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<PubMed><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">The Parkinson-Control study: a 1-year randomized, double-blind trial comparing piribedil (150 mg/day) with bromocriptine (25 mg/day) in early combination with levodopa in Parkinson's disease.</title>
<author><name sortKey="Castro Caldas, Alexandre" sort="Castro Caldas, Alexandre" uniqKey="Castro Caldas A" first="Alexandre" last="Castro-Caldas">Alexandre Castro-Caldas</name>
<affiliation wicri:level="1"><nlm:affiliation>Instituto de Ciências da Saúde, Universidade Católica Portuguesa, Lisboa, Portugal.</nlm:affiliation>
<country xml:lang="fr">Portugal</country>
<wicri:regionArea>Instituto de Ciências da Saúde, Universidade Católica Portuguesa, Lisboa</wicri:regionArea>
<wicri:noRegion>Lisboa</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Delwaide, Paul" sort="Delwaide, Paul" uniqKey="Delwaide P" first="Paul" last="Delwaide">Paul Delwaide</name>
</author>
<author><name sortKey="Jost, Wolfgang" sort="Jost, Wolfgang" uniqKey="Jost W" first="Wolfgang" last="Jost">Wolfgang Jost</name>
</author>
<author><name sortKey="Merello, Marcelo" sort="Merello, Marcelo" uniqKey="Merello M" first="Marcelo" last="Merello">Marcelo Merello</name>
</author>
<author><name sortKey="Williams, Adrian" sort="Williams, Adrian" uniqKey="Williams A" first="Adrian" last="Williams">Adrian Williams</name>
</author>
<author><name sortKey="Lamberti, Paolo" sort="Lamberti, Paolo" uniqKey="Lamberti P" first="Paolo" last="Lamberti">Paolo Lamberti</name>
</author>
<author><name sortKey="Aguilar, Miguel" sort="Aguilar, Miguel" uniqKey="Aguilar M" first="Miguel" last="Aguilar">Miguel Aguilar</name>
</author>
<author><name sortKey="Del Signore, Susanna" sort="Del Signore, Susanna" uniqKey="Del Signore S" first="Susanna" last="Del Signore">Susanna Del Signore</name>
</author>
<author><name sortKey="Cesaro, Pierre" sort="Cesaro, Pierre" uniqKey="Cesaro P" first="Pierre" last="Cesaro">Pierre Cesaro</name>
</author>
</titleStmt>
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<date when="2006">2006</date>
<idno type="doi">10.1002/mds.20750</idno>
<idno type="RBID">pubmed:16267842</idno>
<idno type="pmid">16267842</idno>
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<idno type="wicri:doubleKey">0885-3185:2006:Castro Caldas A:the:parkinson:control</idno>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">The Parkinson-Control study: a 1-year randomized, double-blind trial comparing piribedil (150 mg/day) with bromocriptine (25 mg/day) in early combination with levodopa in Parkinson's disease.</title>
<author><name sortKey="Castro Caldas, Alexandre" sort="Castro Caldas, Alexandre" uniqKey="Castro Caldas A" first="Alexandre" last="Castro-Caldas">Alexandre Castro-Caldas</name>
<affiliation wicri:level="1"><nlm:affiliation>Instituto de Ciências da Saúde, Universidade Católica Portuguesa, Lisboa, Portugal.</nlm:affiliation>
<country xml:lang="fr">Portugal</country>
<wicri:regionArea>Instituto de Ciências da Saúde, Universidade Católica Portuguesa, Lisboa</wicri:regionArea>
<wicri:noRegion>Lisboa</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Delwaide, Paul" sort="Delwaide, Paul" uniqKey="Delwaide P" first="Paul" last="Delwaide">Paul Delwaide</name>
</author>
<author><name sortKey="Jost, Wolfgang" sort="Jost, Wolfgang" uniqKey="Jost W" first="Wolfgang" last="Jost">Wolfgang Jost</name>
</author>
<author><name sortKey="Merello, Marcelo" sort="Merello, Marcelo" uniqKey="Merello M" first="Marcelo" last="Merello">Marcelo Merello</name>
</author>
<author><name sortKey="Williams, Adrian" sort="Williams, Adrian" uniqKey="Williams A" first="Adrian" last="Williams">Adrian Williams</name>
</author>
<author><name sortKey="Lamberti, Paolo" sort="Lamberti, Paolo" uniqKey="Lamberti P" first="Paolo" last="Lamberti">Paolo Lamberti</name>
</author>
<author><name sortKey="Aguilar, Miguel" sort="Aguilar, Miguel" uniqKey="Aguilar M" first="Miguel" last="Aguilar">Miguel Aguilar</name>
</author>
<author><name sortKey="Del Signore, Susanna" sort="Del Signore, Susanna" uniqKey="Del Signore S" first="Susanna" last="Del Signore">Susanna Del Signore</name>
</author>
<author><name sortKey="Cesaro, Pierre" sort="Cesaro, Pierre" uniqKey="Cesaro P" first="Pierre" last="Cesaro">Pierre Cesaro</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="2006" type="published">2006</date>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Antiparkinson Agents (therapeutic use)</term>
<term>Bromocriptine (therapeutic use)</term>
<term>Case-Control Studies</term>
<term>Double-Blind Method</term>
<term>Drug Therapy, Combination</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Parkinson Disease (drug therapy)</term>
<term>Piribedil (therapeutic use)</term>
<term>Severity of Illness Index</term>
<term>Time Factors</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</term>
<term>Bromocriptine</term>
<term>Piribedil</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>Case-Control Studies</term>
<term>Double-Blind Method</term>
<term>Drug Therapy, Combination</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Severity of Illness Index</term>
<term>Time Factors</term>
<term>Treatment Outcome</term>
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<front><div type="abstract" xml:lang="en">Dopamine agonists have been recommended as early treatment for Parkinson's disease (PD), alone or combined with levodopa. Piribedil is a non-ergot selective D(2)/D(3) agonist with alpha(2) antagonist properties shown to be effective in the treatment of PD. This 12-month international, randomized, double-blind trial aimed to assess the efficacy of piribedil 150 mg versus bromocriptine 25 mg, in early combination with levodopa in Stage I to III PD patients. Motor efficacy was assessed using the Unified Parkinson's Disease Rating Scale (UPDRS III, Items 18-31) as improvement from baseline. Response rate was defined as a 30% improvement. Among the 425 randomly assigned patients, 178 were also included in a substudy on cognitive follow-up evaluated by a dysexecutive syndrome oriented battery. A relevant improvement in UPDRS III over the 12-month study duration was observed both in the piribedil and bromocriptine groups (-7.9 +/- 9.7 points from baseline versus -8.0 +/- 9.5; not significant [n.s.]) with a response rate of 58.4% and 55.3% (n.s.), respectively. Piribedil and bromocriptine resulted in similar improvement on all UPDRS III subscores. Piribedil patients required less levodopa dose increase than those on bromocriptine. Cognitive performance remained generally unchanged in both groups, with a significant effect of piribedil limited to the Wisconsin Card Sorting Test. An overall good tolerability of piribedil was observed. Early combination of piribedil 150 mg with levodopa resulted in significant long-term improvement of all motor symptoms in PD patients insufficiently controlled by levodopa alone. Taking into account both efficacy and acceptability in the long-term, piribedil proved in this bromocriptine controlled study to be an effective and safe treatment for PD.</div>
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