Early piribedil monotherapy of Parkinson's disease: A planned seven‐month report of the REGAIN study
Identifieur interne : 000144 ( France/Analysis ); précédent : 000143; suivant : 000145Early 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 ] ; 2006-12.
English descriptors
- KwdEn :
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. © 2006 Movement Disorder Society
Url:
DOI: 10.1002/mds.21122
Affiliations:
- France, Portugal, Royaume-Uni
- Angleterre, Grand Londres, Midi-Pyrénées, Écosse
- Glasgow, Londres, Paris, Toulouse
- National Hospital for Neurology and Neurosurgery, Université Toulouse III - Paul Sabatier, Université de Glasgow, Université de Toulouse
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- to stream Main, to step Exploration: 001317
- to stream France, to step Extraction: 000144
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ISTEX:4978C7624F02F4B0130A6FACC88D4C85DA47167DLe document en format XML
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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. © 2006 Movement Disorder Society</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)
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