Early piribedil monotherapy of Parkinson's disease : A planned seven-month report of the REGAIN study
Identifieur interne : 004C26 ( Main/Merge ); précédent : 004C25; suivant : 004C27Early piribedil monotherapy of Parkinson's disease : A planned seven-month report of the REGAIN study
Auteurs : Olivier Rascol [France] ; Bruno Dubois [France] ; Alexandre Castro Caldas [Portugal] ; Stephen Senn [Royaume-Uni] ; Susanna Del Signore [France] ; Andrew Lees (neurologue) [Royaume-Uni]Source :
- Movement disorders [ 0885-3185 ] ; 2006.
Descripteurs français
- Pascal (Inist)
English descriptors
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.
Links toward previous steps (curation, corpus...)
- to stream PascalFrancis, to step Corpus: 001877
- to stream PascalFrancis, to step Curation: 001444
- to stream PascalFrancis, to step Checkpoint: 001B31
Links to Exploration step
Pascal:07-0090862Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">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 wicri:level="1"><inist:fA14 i1="01"><s1>INSERM U455, Clinical Investigation Center and Departments of Clinical Pharmacology and Neurosciences, Faculté de Médecine</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>1 aut.</sZ></inist:fA14><country>France</country><placeName><settlement type="city">Toulouse</settlement></placeName><placeName><settlement type="city">Toulouse</settlement><region type="region" nuts="2">Midi-Pyrénées</region></placeName><orgName type="university" n="3">Université Toulouse III - Paul Sabatier</orgName><orgName type="institution" wicri:auto="newGroup">Université de Toulouse</orgName></affiliation></author><author><name sortKey="Dubois, Bruno" sort="Dubois, Bruno" uniqKey="Dubois B" first="Bruno" last="Dubois">Bruno Dubois</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>INSERM U610/Gmupe Hospitalier Pitié-Salpêtrière</s1><s2>Paris</s2><s3>FRA</s3><sZ>2 aut.</sZ></inist:fA14><country>France</country><placeName><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Caldas, Alexandre Castro" sort="Caldas, Alexandre Castro" uniqKey="Caldas A" first="Alexandre Castro" last="Caldas">Alexandre Castro Caldas</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Instituto de Ciënsas da Saùde</s1><s2>Lisbon</s2><s3>PRT</s3><sZ>3 aut.</sZ></inist:fA14><country>Portugal</country><wicri:noRegion>Instituto de Ciënsas da Saùde</wicri:noRegion></affiliation></author><author><name sortKey="Senn, Stephen" sort="Senn, Stephen" uniqKey="Senn S" first="Stephen" last="Senn">Stephen Senn</name><affiliation wicri:level="4"><inist:fA14 i1="04"><s1>Department of Statistics, University of Glasgow</s1><s2>Glasgow</s2><s3>GBR</s3><sZ>4 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Glasgow</settlement><region type="country">Écosse</region></placeName><orgName type="university">Université de Glasgow</orgName></affiliation></author><author><name sortKey="Del Signore, Susanna" sort="Del Signore, Susanna" uniqKey="Del Signore S" first="Susanna" last="Del Signore">Susanna Del Signore</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Institut de Recherches Internationales Servier</s1><s2>Courbevoie</s2><s3>FRA</s3><sZ>5 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Courbevoie</wicri:noRegion><wicri:noRegion>Institut de Recherches Internationales Servier</wicri:noRegion><wicri:noRegion>Institut de Recherches Internationales Servier</wicri:noRegion></affiliation></author><author><name sortKey="Lees, Andrew" sort="Lees, Andrew" uniqKey="Lees A" first="Andrew" last="Lees">Andrew Lees (neurologue)</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Royal Free and University College Medical School, University College London/Reta Lila, Weston Institute of Neurological Studies</s1><s2>London</s2><s3>GBR</s3><sZ>6 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName><orgName>National Hospital for Neurology and Neurosurgery</orgName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">07-0090862</idno><date when="2006">2006</date><idno type="stanalyst">PASCAL 07-0090862 INIST</idno><idno type="RBID">Pascal:07-0090862</idno><idno type="wicri:Area/PascalFrancis/Corpus">001877</idno><idno type="wicri:Area/PascalFrancis/Curation">001444</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">001B31</idno><idno type="wicri:doubleKey">0885-3185:2006:Rascol O:early:piribedil:monotherapy</idno><idno type="wicri:Area/Main/Merge">004C26</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">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 wicri:level="1"><inist:fA14 i1="01"><s1>INSERM U455, Clinical Investigation Center and Departments of Clinical Pharmacology and Neurosciences, Faculté de Médecine</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>1 aut.</sZ></inist:fA14><country>France</country><placeName><settlement type="city">Toulouse</settlement></placeName><placeName><settlement type="city">Toulouse</settlement><region type="region" nuts="2">Midi-Pyrénées</region></placeName><orgName type="university" n="3">Université Toulouse III - Paul Sabatier</orgName><orgName type="institution" wicri:auto="newGroup">Université de Toulouse</orgName></affiliation></author><author><name sortKey="Dubois, Bruno" sort="Dubois, Bruno" uniqKey="Dubois B" first="Bruno" last="Dubois">Bruno Dubois</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>INSERM U610/Gmupe Hospitalier Pitié-Salpêtrière</s1><s2>Paris</s2><s3>FRA</s3><sZ>2 aut.</sZ></inist:fA14><country>France</country><placeName><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Caldas, Alexandre Castro" sort="Caldas, Alexandre Castro" uniqKey="Caldas A" first="Alexandre Castro" last="Caldas">Alexandre Castro Caldas</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Instituto de Ciënsas da Saùde</s1><s2>Lisbon</s2><s3>PRT</s3><sZ>3 aut.</sZ></inist:fA14><country>Portugal</country><wicri:noRegion>Instituto de Ciënsas da Saùde</wicri:noRegion></affiliation></author><author><name sortKey="Senn, Stephen" sort="Senn, Stephen" uniqKey="Senn S" first="Stephen" last="Senn">Stephen Senn</name><affiliation wicri:level="4"><inist:fA14 i1="04"><s1>Department of Statistics, University of Glasgow</s1><s2>Glasgow</s2><s3>GBR</s3><sZ>4 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Glasgow</settlement><region type="country">Écosse</region></placeName><orgName type="university">Université de Glasgow</orgName></affiliation></author><author><name sortKey="Del Signore, Susanna" sort="Del Signore, Susanna" uniqKey="Del Signore S" first="Susanna" last="Del Signore">Susanna Del Signore</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Institut de Recherches Internationales Servier</s1><s2>Courbevoie</s2><s3>FRA</s3><sZ>5 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Courbevoie</wicri:noRegion><wicri:noRegion>Institut de Recherches Internationales Servier</wicri:noRegion><wicri:noRegion>Institut de Recherches Internationales Servier</wicri:noRegion></affiliation></author><author><name sortKey="Lees, Andrew" sort="Lees, Andrew" uniqKey="Lees A" first="Andrew" last="Lees">Andrew Lees (neurologue)</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Royal Free and University College Medical School, University College London/Reta Lila, Weston Institute of Neurological Studies</s1><s2>London</s2><s3>GBR</s3><sZ>6 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName><orgName>National Hospital for Neurology and Neurosurgery</orgName></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="2006">2006</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>Levodopa</term><term>Nervous system diseases</term><term>Parkinson disease</term><term>Piribedil</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Système nerveux pathologie</term><term>Parkinson maladie</term><term>Piribédil</term><term>Lévodopa</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Piribedil is a D<sub>2</sub> 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><affiliations><list><country><li>France</li><li>Portugal</li><li>Royaume-Uni</li></country><region><li>Angleterre</li><li>Grand Londres</li><li>Midi-Pyrénées</li><li>Écosse</li></region><settlement><li>Glasgow</li><li>Londres</li><li>Paris</li><li>Toulouse</li></settlement><orgName><li>National Hospital for Neurology and Neurosurgery</li><li>Université Toulouse III - Paul Sabatier</li><li>Université de Glasgow</li><li>Université de Toulouse</li></orgName></list><tree><country name="France"><noRegion><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name></noRegion><name sortKey="Del Signore, Susanna" sort="Del Signore, Susanna" uniqKey="Del Signore S" first="Susanna" last="Del Signore">Susanna Del Signore</name><name sortKey="Dubois, Bruno" sort="Dubois, Bruno" uniqKey="Dubois B" first="Bruno" last="Dubois">Bruno Dubois</name></country><country name="Portugal"><noRegion><name sortKey="Caldas, Alexandre Castro" sort="Caldas, Alexandre Castro" uniqKey="Caldas A" first="Alexandre Castro" last="Caldas">Alexandre Castro Caldas</name></noRegion></country><country name="Royaume-Uni"><region name="Écosse"><name sortKey="Senn, Stephen" sort="Senn, Stephen" uniqKey="Senn S" first="Stephen" last="Senn">Stephen Senn</name></region><name sortKey="Lees, Andrew" sort="Lees, Andrew" uniqKey="Lees A" first="Andrew" last="Lees">Andrew Lees (neurologue)</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Santé/explor/MovDisordV3/Data/Main/Merge
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 004C26 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Merge/biblio.hfd -nk 004C26 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Santé
|area= MovDisordV3
|flux= Main
|étape= Merge
|type= RBID
|clé= Pascal:07-0090862
|texte= Early piribedil monotherapy of Parkinson's disease : A planned seven-month report of the REGAIN study
}}
| This area was generated with Dilib version V0.6.23. |  |