Efficacy of piribedil as early combination to levodopa in patients with stable Parkinson's disease: A 6‐month, randomized, placebo‐controlled study
Identifieur interne : 000187 ( France/Analysis ); précédent : 000186; suivant : 000188Efficacy of piribedil as early combination to levodopa in patients with stable Parkinson's disease: A 6‐month, randomized, placebo‐controlled study
Auteurs : Marc Ziegler ; Alexandre Castro-Caldas [Portugal] ; Susanna Del Signore [France] ; Olivier Rascol [France]Source :
- Movement Disorders [ 0885-3185 ] ; 2003-04.
English descriptors
Abstract
Piribedil is a non‐ergot D2/D3 agonist with a significant antagonist action on α2A and α2C adrenergic receptor subtypes. This double‐blind placebo‐controlled study was undertaken to confirm the efficacy of 150 mg/day piribedil po in improving motor symptoms of idiopathic Parkinson's disease (PD) in nonfluctuating patients insufficiently controlled by a stable daily dose of levodopa (L‐dopa). Efficacy was assessed using the Unified Parkinson's Disease Rating Scale (UPDRS) III score as primary criterion over 4 months. A second comparison was planned at 6 months, after possible adjustment of L‐dopa. At 4 months, the rate of response, defined as a 30% decrease from baseline on UPDRS III score, was significantly greater with piribedil compared with placebo (56.4% vs. 37.7%; P = 0.040). At 6 months, the better efficacy of piribedil was maintained (61.8% of responders vs. 39.6% on placebo; P = 0.020). The difference between groups on UPDRS III change from baseline reached statistical significance only at 6 months: −10.0 points in the piribedil group vs. −6.7 points in the placebo group (P = 0.037). Secondary end‐points were not significantly different. The most frequently reported adverse events were gastrointestinal symptoms (27 of 61 patients in the piribedil group vs. 13 of 54 patients in the placebo group). In conclusion, a 6‐month oral administration of 150 mg/day piribedil in combination with L‐dopa is well tolerated, except for minor gastrointestinal symptoms at the beginning of the treatment and significantly improves motor symptoms compared with placebo in PD nonfluctuating patients. © 2003 Movement Disorder Society
Url:
DOI: 10.1002/mds.10359
Affiliations:
- France, Portugal
- Midi-Pyrénées
- Toulouse
- Université Toulouse III - Paul Sabatier, Université de Toulouse
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ISTEX:E6B31154803141D749C0259B6C5E80E33D353076Le document en format XML
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Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>New York</pubPlace><date type="published" when="2003-04">2003-04</date><biblScope unit="volume">18</biblScope><biblScope unit="issue">4</biblScope><biblScope unit="page" from="418">418</biblScope><biblScope unit="page" to="425">425</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">E6B31154803141D749C0259B6C5E80E33D353076</idno><idno type="DOI">10.1002/mds.10359</idno><idno type="ArticleID">MDS10359</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>L‐dopa</term><term>Parkinson's disease</term><term>nonfluctuating patients</term><term>piribedil</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Piribedil is a non‐ergot D2/D3 agonist with a significant antagonist action on α2A and α2C adrenergic receptor subtypes. This double‐blind placebo‐controlled study was undertaken to confirm the efficacy of 150 mg/day piribedil po in improving motor symptoms of idiopathic Parkinson's disease (PD) in nonfluctuating patients insufficiently controlled by a stable daily dose of levodopa (L‐dopa). Efficacy was assessed using the Unified Parkinson's Disease Rating Scale (UPDRS) III score as primary criterion over 4 months. A second comparison was planned at 6 months, after possible adjustment of L‐dopa. At 4 months, the rate of response, defined as a 30% decrease from baseline on UPDRS III score, was significantly greater with piribedil compared with placebo (56.4% vs. 37.7%; P = 0.040). At 6 months, the better efficacy of piribedil was maintained (61.8% of responders vs. 39.6% on placebo; P = 0.020). The difference between groups on UPDRS III change from baseline reached statistical significance only at 6 months: −10.0 points in the piribedil group vs. −6.7 points in the placebo group (P = 0.037). Secondary end‐points were not significantly different. The most frequently reported adverse events were gastrointestinal symptoms (27 of 61 patients in the piribedil group vs. 13 of 54 patients in the placebo group). In conclusion, a 6‐month oral administration of 150 mg/day piribedil in combination with L‐dopa is well tolerated, except for minor gastrointestinal symptoms at the beginning of the treatment and significantly improves motor symptoms compared with placebo in PD nonfluctuating patients. © 2003 Movement Disorder Society</div></front></TEI><affiliations><list><country><li>France</li><li>Portugal</li></country><region><li>Midi-Pyrénées</li></region><settlement><li>Toulouse</li></settlement><orgName><li>Université Toulouse III - Paul Sabatier</li><li>Université de Toulouse</li></orgName></list><tree><noCountry><name sortKey="Ziegler, Marc" sort="Ziegler, Marc" uniqKey="Ziegler M" first="Marc" last="Ziegler">Marc Ziegler</name></noCountry><country name="Portugal"><noRegion><name sortKey="Castro Aldas, Alexandre" sort="Castro Aldas, Alexandre" uniqKey="Castro Aldas A" first="Alexandre" last="Castro-Caldas">Alexandre Castro-Caldas</name></noRegion></country><country name="France"><noRegion><name sortKey="Del Signore, Susanna" sort="Del Signore, Susanna" uniqKey="Del Signore S" first="Susanna" last="Del Signore">Susanna Del Signore</name></noRegion><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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