Efficacy of piribedil as early combination to levodopa in patients with stable Parkinson's disease: a 6-month, randomized, placebo-controlled study.
Identifieur interne : 000320 ( Ncbi/Checkpoint ); précédent : 000319; suivant : 000321Efficacy of piribedil as early combination to levodopa in patients with stable Parkinson's disease: a 6-month, randomized, placebo-controlled study.
Auteurs : Marc Ziegler [France] ; Alexandre Castro-Caldas ; Susanna Del Signore ; Olivier RascolSource :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 2003.
English descriptors
- KwdEn :
- Adult, Aged, Antiparkinson Agents (administration & dosage), Antiparkinson Agents (adverse effects), Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Levodopa (administration & dosage), Levodopa (adverse effects), Male, Middle Aged, Parkinson Disease (diagnosis), Parkinson Disease (drug therapy), Piribedil (administration & dosage), Piribedil (adverse effects), Treatment Outcome.
- MESH :
- chemical , administration & dosage : Antiparkinson Agents, Levodopa, Piribedil.
- chemical , adverse effects : Antiparkinson Agents, Levodopa, Piribedil.
- diagnosis : Parkinson Disease.
- drug therapy : Parkinson Disease.
- Adult, Aged, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Male, Middle Aged, Treatment Outcome.
Abstract
Piribedil is a non-ergot D2/D3 agonist with a significant antagonist action on alpha2A and alpha2C 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.
DOI: 10.1002/mds.10359
PubMed: 12671949
Affiliations:
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Efficacy of piribedil as early combination to levodopa in patients with stable Parkinson's disease: a 6-month, randomized, placebo-controlled study.</title><author><name sortKey="Ziegler, Marc" sort="Ziegler, Marc" uniqKey="Ziegler M" first="Marc" last="Ziegler">Marc Ziegler</name><affiliation wicri:level="3"><nlm:affiliation>Unité James Parkinson, Hôpital L Bellan, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Unité James Parkinson, Hôpital L Bellan, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Castro Caldas, Alexandre" sort="Castro Caldas, Alexandre" uniqKey="Castro Caldas A" first="Alexandre" last="Castro-Caldas">Alexandre Castro-Caldas</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="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2003">2003</date><idno type="RBID">pubmed:12671949</idno><idno type="pmid">12671949</idno><idno type="doi">10.1002/mds.10359</idno><idno type="wicri:Area/PubMed/Corpus">001112</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001112</idno><idno type="wicri:Area/PubMed/Curation">001071</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">001071</idno><idno type="wicri:Area/PubMed/Checkpoint">001071</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">001071</idno><idno type="wicri:Area/Ncbi/Merge">000320</idno><idno type="wicri:Area/Ncbi/Curation">000320</idno><idno type="wicri:Area/Ncbi/Checkpoint">000320</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Efficacy of piribedil as early combination to levodopa in patients with stable Parkinson's disease: a 6-month, randomized, placebo-controlled study.</title><author><name sortKey="Ziegler, Marc" sort="Ziegler, Marc" uniqKey="Ziegler M" first="Marc" last="Ziegler">Marc Ziegler</name><affiliation wicri:level="3"><nlm:affiliation>Unité James Parkinson, Hôpital L Bellan, Paris, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Unité James Parkinson, Hôpital L Bellan, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Castro Caldas, Alexandre" sort="Castro Caldas, Alexandre" uniqKey="Castro Caldas A" first="Alexandre" last="Castro-Caldas">Alexandre Castro-Caldas</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="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</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="2003" type="published">2003</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Antiparkinson Agents (administration & dosage)</term><term>Antiparkinson Agents (adverse effects)</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Drug Therapy, Combination</term><term>Female</term><term>Follow-Up Studies</term><term>Humans</term><term>Levodopa (administration & dosage)</term><term>Levodopa (adverse effects)</term><term>Male</term><term>Middle Aged</term><term>Parkinson Disease (diagnosis)</term><term>Parkinson Disease (drug therapy)</term><term>Piribedil (administration & dosage)</term><term>Piribedil (adverse effects)</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antiparkinson Agents</term><term>Levodopa</term><term>Piribedil</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiparkinson Agents</term><term>Levodopa</term><term>Piribedil</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Parkinson Disease</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>Drug Administration Schedule</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>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Piribedil is a non-ergot D2/D3 agonist with a significant antagonist action on alpha2A and alpha2C 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.</div></front></TEI><affiliations><list><country><li>France</li></country><region><li>Île-de-France</li></region><settlement><li>Paris</li></settlement></list><tree><noCountry><name sortKey="Castro Caldas, Alexandre" sort="Castro Caldas, Alexandre" uniqKey="Castro Caldas A" first="Alexandre" last="Castro-Caldas">Alexandre Castro-Caldas</name><name sortKey="Del Signore, Susanna" sort="Del Signore, Susanna" uniqKey="Del Signore S" first="Susanna" last="Del Signore">Susanna Del Signore</name><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name></noCountry><country name="France"><region name="Île-de-France"><name sortKey="Ziegler, Marc" sort="Ziegler, Marc" uniqKey="Ziegler M" first="Marc" last="Ziegler">Marc Ziegler</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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