Study of istradefylline in patients with Parkinson's disease on levodopa with motor fluctuations.
Identifieur interne : 002367 ( Ncbi/Curation ); précédent : 002366; suivant : 002368Study of istradefylline in patients with Parkinson's disease on levodopa with motor fluctuations.
Auteurs : Robert A. Hauser [États-Unis] ; Lisa M. Shulman ; Joel M. Trugman ; John W. Roberts ; Akihisa Mori ; Rocco Ballerini ; Neil M. SussmanSource :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2008.
English descriptors
- KwdEn :
- Aged, Analysis of Variance, Antiparkinson Agents (therapeutic use), Double-Blind Method, Drug-Related Side Effects and Adverse Reactions, Dyskinesia, Drug-Induced (drug therapy), Dyskinesia, Drug-Induced (etiology), Female, Humans, Levodopa (adverse effects), Male, Middle Aged, Parkinson Disease (drug therapy), Parkinson Disease (physiopathology), Purines (therapeutic use), Questionnaires, Severity of Illness Index, Time Factors.
- MESH :
- chemical , adverse effects : Levodopa.
- chemical , therapeutic use : Antiparkinson Agents, Purines.
- drug therapy : Dyskinesia, Drug-Induced, Parkinson Disease.
- etiology : Dyskinesia, Drug-Induced.
- physiopathology : Parkinson Disease.
- Aged, Analysis of Variance, Double-Blind Method, Drug-Related Side Effects and Adverse Reactions, Female, Humans, Male, Middle Aged, Questionnaires, Severity of Illness Index, Time Factors.
Abstract
The objective of this study was to evaluate the efficacy, safety, and tolerability of istradefylline 20 mg once daily versus placebo as an adjunct to levodopa in subjects with Parkinson's disease (PD) who have motor fluctuations. Istradefylline (KW-6002) is an adenosine A(2A) receptor antagonist that in primate models of PD improves motor function without causing or worsening dyskinesia. This 12-week, multicenter, double-blind, placebo-controlled, randomized, Phase 3 study of istradefylline was conducted in subjects experiencing an average daily OFF time of at least 3 hours (116 randomized to istradefylline; 115 to placebo). All were on stable levodopa regimens; 90% were also on stable regimens of other anti-Parkinson's medications. Istradefylline-treated subjects had significant placebo-corrected reductions in daily OFF time from baseline to endpoint: 4.6% (P = 0.03) and 0.7 hours (P = 0.03). For ON time with troublesome dyskinesia, the changes between istradefylline and placebo were not significant. Istradefylline was well tolerated, with 6 (5.2%) istradefylline-treated and 7 (6.1%) placebo-treated subjects withdrawing from the study because of adverse events. Dyskinesia, lightheadedness, tremor, constipation, and weight decrease were reported more often with istradefylline than placebo. We conclude that istradefylline is well tolerated and significantly reduces OFF time as an adjunct to levodopa in PD subjects with motor fluctuations.
DOI: 10.1002/mds.22095
PubMed: 18831530
Links toward previous steps (curation, corpus...)
- to stream PubMed, to step Corpus: Pour aller vers cette notice dans l'étape Curation :001F96
- to stream PubMed, to step Curation: Pour aller vers cette notice dans l'étape Curation :001F96
- to stream PubMed, to step Checkpoint: Pour aller vers cette notice dans l'étape Curation :002076
- to stream Ncbi, to step Merge: Pour aller vers cette notice dans l'étape Curation :002367
Links to Exploration step
pubmed:18831530Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Study of istradefylline in patients with Parkinson's disease on levodopa with motor fluctuations.</title><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name><affiliation wicri:level="4"><nlm:affiliation>Department of Neurology, University of South Florida, Tampa, Florida 33606, USA. rhauser@health.usf.edu</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, University of South Florida, Tampa, Florida 33606</wicri:regionArea><orgName type="university">Université de Floride du Sud</orgName><placeName><settlement type="city">Tampa</settlement><region type="state">Floride</region></placeName></affiliation></author><author><name sortKey="Shulman, Lisa M" sort="Shulman, Lisa M" uniqKey="Shulman L" first="Lisa M" last="Shulman">Lisa M. Shulman</name></author><author><name sortKey="Trugman, Joel M" sort="Trugman, Joel M" uniqKey="Trugman J" first="Joel M" last="Trugman">Joel M. Trugman</name></author><author><name sortKey="Roberts, John W" sort="Roberts, John W" uniqKey="Roberts J" first="John W" last="Roberts">John W. Roberts</name></author><author><name sortKey="Mori, Akihisa" sort="Mori, Akihisa" uniqKey="Mori A" first="Akihisa" last="Mori">Akihisa Mori</name></author><author><name sortKey="Ballerini, Rocco" sort="Ballerini, Rocco" uniqKey="Ballerini R" first="Rocco" last="Ballerini">Rocco Ballerini</name></author><author><name sortKey="Sussman, Neil M" sort="Sussman, Neil M" uniqKey="Sussman N" first="Neil M" last="Sussman">Neil M. Sussman</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2008">2008</date><idno type="doi">10.1002/mds.22095</idno><idno type="RBID">pubmed:18831530</idno><idno type="pmid">18831530</idno><idno type="wicri:Area/PubMed/Corpus">001F96</idno><idno type="wicri:Area/PubMed/Curation">001F96</idno><idno type="wicri:Area/PubMed/Checkpoint">002076</idno><idno type="wicri:Area/Ncbi/Merge">002367</idno><idno type="wicri:Area/Ncbi/Curation">002367</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Study of istradefylline in patients with Parkinson's disease on levodopa with motor fluctuations.</title><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A" last="Hauser">Robert A. Hauser</name><affiliation wicri:level="4"><nlm:affiliation>Department of Neurology, University of South Florida, Tampa, Florida 33606, USA. rhauser@health.usf.edu</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, University of South Florida, Tampa, Florida 33606</wicri:regionArea><orgName type="university">Université de Floride du Sud</orgName><placeName><settlement type="city">Tampa</settlement><region type="state">Floride</region></placeName></affiliation></author><author><name sortKey="Shulman, Lisa M" sort="Shulman, Lisa M" uniqKey="Shulman L" first="Lisa M" last="Shulman">Lisa M. Shulman</name></author><author><name sortKey="Trugman, Joel M" sort="Trugman, Joel M" uniqKey="Trugman J" first="Joel M" last="Trugman">Joel M. Trugman</name></author><author><name sortKey="Roberts, John W" sort="Roberts, John W" uniqKey="Roberts J" first="John W" last="Roberts">John W. Roberts</name></author><author><name sortKey="Mori, Akihisa" sort="Mori, Akihisa" uniqKey="Mori A" first="Akihisa" last="Mori">Akihisa Mori</name></author><author><name sortKey="Ballerini, Rocco" sort="Ballerini, Rocco" uniqKey="Ballerini R" first="Rocco" last="Ballerini">Rocco Ballerini</name></author><author><name sortKey="Sussman, Neil M" sort="Sussman, Neil M" uniqKey="Sussman N" first="Neil M" last="Sussman">Neil M. Sussman</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="eISSN">1531-8257</idno><imprint><date when="2008" type="published">2008</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Analysis of Variance</term><term>Antiparkinson Agents (therapeutic use)</term><term>Double-Blind Method</term><term>Drug-Related Side Effects and Adverse Reactions</term><term>Dyskinesia, Drug-Induced (drug therapy)</term><term>Dyskinesia, Drug-Induced (etiology)</term><term>Female</term><term>Humans</term><term>Levodopa (adverse effects)</term><term>Male</term><term>Middle Aged</term><term>Parkinson Disease (drug therapy)</term><term>Parkinson Disease (physiopathology)</term><term>Purines (therapeutic use)</term><term>Questionnaires</term><term>Severity of Illness Index</term><term>Time Factors</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Levodopa</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</term><term>Purines</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Dyskinesia, Drug-Induced</term><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Dyskinesia, Drug-Induced</term></keywords><keywords scheme="MESH" qualifier="physiopathology" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Analysis of Variance</term><term>Double-Blind Method</term><term>Drug-Related Side Effects and Adverse Reactions</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Questionnaires</term><term>Severity of Illness Index</term><term>Time Factors</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The objective of this study was to evaluate the efficacy, safety, and tolerability of istradefylline 20 mg once daily versus placebo as an adjunct to levodopa in subjects with Parkinson's disease (PD) who have motor fluctuations. Istradefylline (KW-6002) is an adenosine A(2A) receptor antagonist that in primate models of PD improves motor function without causing or worsening dyskinesia. This 12-week, multicenter, double-blind, placebo-controlled, randomized, Phase 3 study of istradefylline was conducted in subjects experiencing an average daily OFF time of at least 3 hours (116 randomized to istradefylline; 115 to placebo). All were on stable levodopa regimens; 90% were also on stable regimens of other anti-Parkinson's medications. Istradefylline-treated subjects had significant placebo-corrected reductions in daily OFF time from baseline to endpoint: 4.6% (P = 0.03) and 0.7 hours (P = 0.03). For ON time with troublesome dyskinesia, the changes between istradefylline and placebo were not significant. Istradefylline was well tolerated, with 6 (5.2%) istradefylline-treated and 7 (6.1%) placebo-treated subjects withdrawing from the study because of adverse events. Dyskinesia, lightheadedness, tremor, constipation, and weight decrease were reported more often with istradefylline than placebo. We conclude that istradefylline is well tolerated and significantly reduces OFF time as an adjunct to levodopa in PD subjects with motor fluctuations.</div></front></TEI></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Santé/explor/MovDisordV3/Data/Ncbi/Curation
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 002367 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Ncbi/Curation/biblio.hfd -nk 002367 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Santé
|area= MovDisordV3
|flux= Ncbi
|étape= Curation
|type= RBID
|clé= pubmed:18831530
|texte= Study of istradefylline in patients with Parkinson's disease on levodopa with motor fluctuations.
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Ncbi/Curation/RBID.i -Sk "pubmed:18831530" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Ncbi/Curation/biblio.hfd \
| NlmPubMed2Wicri -a MovDisordV3
| This area was generated with Dilib version V0.6.23. |  |