MovDisordV3, PubMed, Corpus, bibRecord, 002A59

Early piribedil monotherapy of Parkinson's disease: A planned seven-month report of the REGAIN study.

Identifieur interne : 002A59 ( PubMed/Corpus ); précédent : 002A58; suivant : 002A60

Early piribedil monotherapy of Parkinson's disease: A planned seven-month report of the REGAIN study.

Auteurs : Olivier Rascol ; Bruno Dubois ; Alexandre Castro Caldas ; Stephen Senn ; Susanna Del Signore ; Andrew Lees

Source :

Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 2006.

RBID : pubmed:17013922

English descriptors

KwdEn :
- Adult, Aged, Antiparkinson Agents (therapeutic use), Dose-Response Relationship, Drug, Double-Blind Method, Female, Follow-Up Studies, Humans, Levodopa (therapeutic use), Male, Middle Aged, Outcome Assessment (Health Care), Parkinson Disease (drug therapy), Piribedil (therapeutic use), Severity of Illness Index, Single-Blind Method, Time Factors.
MESH :
- chemical , therapeutic use : Antiparkinson Agents, Levodopa, Piribedil.
- drug therapy : Parkinson Disease.
- Adult, Aged, Dose-Response Relationship, Drug, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Middle Aged, Outcome Assessment (Health Care), Severity of Illness Index, Single-Blind Method, Time Factors.

Abstract

Piribedil is a D2 dopamine agonist, which has been shown to improve symptoms of Parkinson's disease (PD) when combined with L-dopa. The objective of this study was to compare the efficacy of piribedil monotherapy to placebo in patients with early PD over a 7-month period. Four hundred and five early PD patients were randomized (double-blind) to piribedil (150-300 mg/day) or placebo. L-dopa open-label supplementation was permitted. Unified Parkinson Disease Rating Scale part III (UPDRS III) score as the last observation on monotherapy over 7 months was the primary outcome measure. Secondary outcomes were proportion of responders (UPDRS III improvement > 30%), patients remaining on monotherapy after 7 months, UPDRS III subscores, and UPDRS II. UPDRS III improved on piribedil (-4.9 points) versus a worsening on placebo (2.6 points; estimated effect = 7.26 points; 95% CI = 5.38-9.14; P < 0.0001). The proportion of responders was significantly higher for piribedil (42%) than for placebo (14%) (OR = 4.69; 95% CI = 2.82-7.80; P < 0.001). Piribedil significantly improved several UPDRS III subscores. UPDRS II improved on piribedil by -1.2 points, while it deteriorated by 1.5 points on placebo (estimated effect = 2.71; 95% CI = 1.8-3.62; P < 0.0001). The proportion of patients remaining on monotherapy after 7 months was greater in the piribedil group (OR = 3.72; 95% CI = 2.26-6.11; P < 0.001). Safety was consistent with that reported for other dopamine agonists, gastrointestinal side effects being the most common (22% of patients in piribedil group vs. 14% on placebo). Piribedil is effective and safe as early PD therapy.

DOI: 10.1002/mds.21122
PubMed: 17013922

Links to Exploration step

pubmed:17013922

Le document en format XML

<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Early piribedil monotherapy of Parkinson's disease: A planned seven-month report of the REGAIN study.</title>
<author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name>
<affiliation><nlm:affiliation>INSERM U455, Clinical Investigation Center and Departments of Clinical Pharmacology and Neurosciences, Faculté de Médecine, Toulouse, France. rascol@cict.fr</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Dubois, Bruno" sort="Dubois, Bruno" uniqKey="Dubois B" first="Bruno" last="Dubois">Bruno Dubois</name>
</author>
<author><name sortKey="Caldas, Alexandre Castro" sort="Caldas, Alexandre Castro" uniqKey="Caldas A" first="Alexandre Castro" last="Caldas">Alexandre Castro Caldas</name>
</author>
<author><name sortKey="Senn, Stephen" sort="Senn, Stephen" uniqKey="Senn S" first="Stephen" last="Senn">Stephen Senn</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="Lees, Andrew" sort="Lees, Andrew" uniqKey="Lees A" first="Andrew" last="Lees">Andrew Lees</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Early piribedil monotherapy of Parkinson's disease: A planned seven-month report of the REGAIN study.</title>
<author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name>
<affiliation><nlm:affiliation>INSERM U455, Clinical Investigation Center and Departments of Clinical Pharmacology and Neurosciences, Faculté de Médecine, Toulouse, France. rascol@cict.fr</nlm:affiliation>
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<author><name sortKey="Dubois, Bruno" sort="Dubois, Bruno" uniqKey="Dubois B" first="Bruno" last="Dubois">Bruno Dubois</name>
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<author><name sortKey="Caldas, Alexandre Castro" sort="Caldas, Alexandre Castro" uniqKey="Caldas A" first="Alexandre Castro" last="Caldas">Alexandre Castro Caldas</name>
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<author><name sortKey="Senn, Stephen" sort="Senn, Stephen" uniqKey="Senn S" first="Stephen" last="Senn">Stephen Senn</name>
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<author><name sortKey="Del Signore, Susanna" sort="Del Signore, Susanna" uniqKey="Del Signore S" first="Susanna" last="Del Signore">Susanna Del Signore</name>
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<author><name sortKey="Lees, Andrew" sort="Lees, Andrew" uniqKey="Lees A" first="Andrew" last="Lees">Andrew Lees</name>
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<series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title>
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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>Dose-Response Relationship, Drug</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Levodopa (therapeutic use)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Outcome Assessment (Health Care)</term>
<term>Parkinson Disease (drug therapy)</term>
<term>Piribedil (therapeutic use)</term>
<term>Severity of Illness Index</term>
<term>Single-Blind Method</term>
<term>Time Factors</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</term>
<term>Levodopa</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>Dose-Response Relationship, Drug</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Outcome Assessment (Health Care)</term>
<term>Severity of Illness Index</term>
<term>Single-Blind Method</term>
<term>Time Factors</term>
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<front><div type="abstract" xml:lang="en">Piribedil is a D2 dopamine agonist, which has been shown to improve symptoms of Parkinson's disease (PD) when combined with L-dopa. The objective of this study was to compare the efficacy of piribedil monotherapy to placebo in patients with early PD over a 7-month period. Four hundred and five early PD patients were randomized (double-blind) to piribedil (150-300 mg/day) or placebo. L-dopa open-label supplementation was permitted. Unified Parkinson Disease Rating Scale part III (UPDRS III) score as the last observation on monotherapy over 7 months was the primary outcome measure. Secondary outcomes were proportion of responders (UPDRS III improvement > 30%), patients remaining on monotherapy after 7 months, UPDRS III subscores, and UPDRS II. UPDRS III improved on piribedil (-4.9 points) versus a worsening on placebo (2.6 points; estimated effect = 7.26 points; 95% CI = 5.38-9.14; P < 0.0001). The proportion of responders was significantly higher for piribedil (42%) than for placebo (14%) (OR = 4.69; 95% CI = 2.82-7.80; P < 0.001). Piribedil significantly improved several UPDRS III subscores. UPDRS II improved on piribedil by -1.2 points, while it deteriorated by 1.5 points on placebo (estimated effect = 2.71; 95% CI = 1.8-3.62; P < 0.0001). The proportion of patients remaining on monotherapy after 7 months was greater in the piribedil group (OR = 3.72; 95% CI = 2.26-6.11; P < 0.001). Safety was consistent with that reported for other dopamine agonists, gastrointestinal side effects being the most common (22% of patients in piribedil group vs. 14% on placebo). Piribedil is effective and safe as early PD therapy.</div>
</front>
</TEI>
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<DateCreated><Year>2006</Year>
<Month>12</Month>
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<Title>Movement disorders : official journal of the Movement Disorder Society</Title>
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<ArticleTitle>Early piribedil monotherapy of Parkinson's disease: A planned seven-month report of the REGAIN study.</ArticleTitle>
<Pagination><MedlinePgn>2110-5</MedlinePgn>
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<Abstract><AbstractText>Piribedil is a D2 dopamine agonist, which has been shown to improve symptoms of Parkinson's disease (PD) when combined with L-dopa. The objective of this study was to compare the efficacy of piribedil monotherapy to placebo in patients with early PD over a 7-month period. Four hundred and five early PD patients were randomized (double-blind) to piribedil (150-300 mg/day) or placebo. L-dopa open-label supplementation was permitted. Unified Parkinson Disease Rating Scale part III (UPDRS III) score as the last observation on monotherapy over 7 months was the primary outcome measure. Secondary outcomes were proportion of responders (UPDRS III improvement > 30%), patients remaining on monotherapy after 7 months, UPDRS III subscores, and UPDRS II. UPDRS III improved on piribedil (-4.9 points) versus a worsening on placebo (2.6 points; estimated effect = 7.26 points; 95% CI = 5.38-9.14; P < 0.0001). The proportion of responders was significantly higher for piribedil (42%) than for placebo (14%) (OR = 4.69; 95% CI = 2.82-7.80; P < 0.001). Piribedil significantly improved several UPDRS III subscores. UPDRS II improved on piribedil by -1.2 points, while it deteriorated by 1.5 points on placebo (estimated effect = 2.71; 95% CI = 1.8-3.62; P < 0.0001). The proportion of patients remaining on monotherapy after 7 months was greater in the piribedil group (OR = 3.72; 95% CI = 2.26-6.11; P < 0.001). Safety was consistent with that reported for other dopamine agonists, gastrointestinal side effects being the most common (22% of patients in piribedil group vs. 14% on placebo). Piribedil is effective and safe as early PD therapy.</AbstractText>
<CopyrightInformation>Copyright 2006 Movement Disorder Society.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Rascol</LastName>
<ForeName>Olivier</ForeName>
<Initials>O</Initials>
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<Author ValidYN="Y"><LastName>Caldas</LastName>
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<MeshHeading><DescriptorName MajorTopicYN="N" UI="D012720">Severity of Illness Index</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N" UI="D016037">Single-Blind Method</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N" UI="D013997">Time Factors</DescriptorName>
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	Movement Disorders (revue)
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Movement Disorders (revue)

Early piribedil monotherapy of Parkinson's disease: A planned seven-month report of the REGAIN study.

Early piribedil monotherapy of Parkinson's disease: A planned seven-month report of the REGAIN study.

Source :

English descriptors

Abstract

Links to Exploration step

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri

Pour générer des pages wiki