Antiparkinsonian drug-induced sleepiness: a double-blind placebo-controlled study of L-dopa, bromocriptine and pramipexole in healthy subjects.
Identifieur interne : 000B46 ( PubMed/Checkpoint ); précédent : 000B45; suivant : 000B47Antiparkinsonian drug-induced sleepiness: a double-blind placebo-controlled study of L-dopa, bromocriptine and pramipexole in healthy subjects.
Auteurs : Joëlle Micallef [France] ; Marc Rey ; Alexandre Eusebio ; Christine Audebert ; Frank Rouby ; Elisabeth Jouve ; Sophie Tardieu ; Oliver BlinSource :
- British journal of clinical pharmacology [ 1365-2125 ] ; 2009.
English descriptors
- KwdEn :
- Adolescent, Adult, Antiparkinson Agents (adverse effects), Benzothiazoles (adverse effects), Bromocriptine (adverse effects), Cross-Over Studies, Double-Blind Method, Humans, Levodopa (adverse effects), Male, Middle Aged, Parkinson Disease (drug therapy), Polysomnography, Sleep Wake Disorders (chemically induced), Treatment Outcome, Young Adult.
- MESH :
- chemical , adverse effects : Antiparkinson Agents, Benzothiazoles, Bromocriptine, Levodopa.
- chemically induced : Sleep Wake Disorders.
- drug therapy : Parkinson Disease.
- Adolescent, Adult, Cross-Over Studies, Double-Blind Method, Humans, Male, Middle Aged, Polysomnography, Treatment Outcome, Young Adult.
Abstract
To assess the sleepiness induced by pramipexole, a D2/D3-dopamine receptor agonist commonly used in Parkinson's disease and restless legs syndrome, without the problem of the confounding factors related to the disease.
DOI: 10.1111/j.1365-2125.2008.03310.x
PubMed: 19220275
Affiliations:
Links toward previous steps (curation, corpus...)
Links to Exploration step
pubmed:19220275Le document en format XML
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type="city">Marseille</settlement></placeName></affiliation></author><author><name sortKey="Rey, Marc" sort="Rey, Marc" uniqKey="Rey M" first="Marc" last="Rey">Marc Rey</name></author><author><name sortKey="Eusebio, Alexandre" sort="Eusebio, Alexandre" uniqKey="Eusebio A" first="Alexandre" last="Eusebio">Alexandre Eusebio</name></author><author><name sortKey="Audebert, Christine" sort="Audebert, Christine" uniqKey="Audebert C" first="Christine" last="Audebert">Christine Audebert</name></author><author><name sortKey="Rouby, Frank" sort="Rouby, Frank" uniqKey="Rouby F" first="Frank" last="Rouby">Frank Rouby</name></author><author><name sortKey="Jouve, Elisabeth" sort="Jouve, Elisabeth" uniqKey="Jouve E" first="Elisabeth" last="Jouve">Elisabeth Jouve</name></author><author><name sortKey="Tardieu, Sophie" sort="Tardieu, Sophie" uniqKey="Tardieu S" first="Sophie" last="Tardieu">Sophie Tardieu</name></author><author><name sortKey="Blin, Oliver" sort="Blin, Oliver" uniqKey="Blin O" first="Oliver" last="Blin">Oliver Blin</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2009">2009</date><idno type="RBID">pubmed:19220275</idno><idno type="pmid">19220275</idno><idno type="doi">10.1111/j.1365-2125.2008.03310.x</idno><idno type="wicri:Area/PubMed/Corpus">000C09</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000C09</idno><idno type="wicri:Area/PubMed/Curation">000B69</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000B69</idno><idno type="wicri:Area/PubMed/Checkpoint">000B69</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">000B69</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Antiparkinsonian drug-induced sleepiness: a double-blind placebo-controlled study of L-dopa, bromocriptine and pramipexole in healthy subjects.</title><author><name sortKey="Micallef, Joelle" sort="Micallef, Joelle" uniqKey="Micallef J" first="Joëlle" last="Micallef">Joëlle Micallef</name><affiliation wicri:level="3"><nlm:affiliation>Clinical Investigation Centre (CIC-UPCET) and Department of Clinical Pharmacology, UMR-CNRS 6193 Institute of Cognitive Neurosciences, CHU Timone, Marseille, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Clinical Investigation Centre (CIC-UPCET) and Department of Clinical Pharmacology, UMR-CNRS 6193 Institute of Cognitive Neurosciences, CHU Timone, Marseille</wicri:regionArea><placeName><region type="region">Provence-Alpes-Côte d'Azur</region><region type="old region">Provence-Alpes-Côte d'Azur</region><settlement type="city">Marseille</settlement></placeName></affiliation></author><author><name sortKey="Rey, Marc" sort="Rey, Marc" uniqKey="Rey M" first="Marc" last="Rey">Marc Rey</name></author><author><name sortKey="Eusebio, Alexandre" sort="Eusebio, Alexandre" uniqKey="Eusebio A" first="Alexandre" last="Eusebio">Alexandre Eusebio</name></author><author><name sortKey="Audebert, Christine" sort="Audebert, Christine" uniqKey="Audebert C" first="Christine" last="Audebert">Christine Audebert</name></author><author><name sortKey="Rouby, Frank" sort="Rouby, Frank" uniqKey="Rouby F" first="Frank" last="Rouby">Frank Rouby</name></author><author><name sortKey="Jouve, Elisabeth" sort="Jouve, Elisabeth" uniqKey="Jouve E" first="Elisabeth" last="Jouve">Elisabeth Jouve</name></author><author><name sortKey="Tardieu, Sophie" sort="Tardieu, Sophie" uniqKey="Tardieu S" first="Sophie" last="Tardieu">Sophie Tardieu</name></author><author><name sortKey="Blin, Oliver" sort="Blin, Oliver" uniqKey="Blin O" first="Oliver" last="Blin">Oliver Blin</name></author></analytic><series><title level="j">British journal of clinical pharmacology</title><idno type="eISSN">1365-2125</idno><imprint><date when="2009" type="published">2009</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Antiparkinson Agents (adverse effects)</term><term>Benzothiazoles (adverse effects)</term><term>Bromocriptine (adverse effects)</term><term>Cross-Over Studies</term><term>Double-Blind Method</term><term>Humans</term><term>Levodopa (adverse effects)</term><term>Male</term><term>Middle Aged</term><term>Parkinson Disease (drug therapy)</term><term>Polysomnography</term><term>Sleep Wake Disorders (chemically induced)</term><term>Treatment Outcome</term><term>Young Adult</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiparkinson Agents</term><term>Benzothiazoles</term><term>Bromocriptine</term><term>Levodopa</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Sleep Wake Disorders</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Cross-Over Studies</term><term>Double-Blind Method</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Polysomnography</term><term>Treatment Outcome</term><term>Young Adult</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">To assess the sleepiness induced by pramipexole, a D2/D3-dopamine receptor agonist commonly used in Parkinson's disease and restless legs syndrome, without the problem of the confounding factors related to the disease.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">19220275</PMID><DateCreated><Year>2009</Year><Month>06</Month><Day>15</Day></DateCreated><DateCompleted><Year>2009</Year><Month>12</Month><Day>14</Day></DateCompleted><DateRevised><Year>2015</Year><Month>11</Month><Day>19</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1365-2125</ISSN><JournalIssue CitedMedium="Internet"><Volume>67</Volume><Issue>3</Issue><PubDate><Year>2009</Year><Month>Mar</Month></PubDate></JournalIssue><Title>British journal of clinical pharmacology</Title><ISOAbbreviation>Br J Clin Pharmacol</ISOAbbreviation></Journal><ArticleTitle>Antiparkinsonian drug-induced sleepiness: a double-blind placebo-controlled study of L-dopa, bromocriptine and pramipexole in healthy subjects.</ArticleTitle><Pagination><MedlinePgn>333-40</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1111/j.1365-2125.2008.03310.x</ELocationID><Abstract><AbstractText Label="AIMS" NlmCategory="OBJECTIVE">To assess the sleepiness induced by pramipexole, a D2/D3-dopamine receptor agonist commonly used in Parkinson's disease and restless legs syndrome, without the problem of the confounding factors related to the disease.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Placebo, bromocriptine (2.5 mg), L-dopa (100 mg) and pramipexole (0.5 mg) were administered in a single oral dose on four separate days, with at least a 2-week wash-out period in a randomized cross-over design. Induced somnolence was assessed using Multiple Sleep Latency Test (MSLT) and subjective scaling of vigilance. Twelve male subjects (26.3 +/- 5.5 years old) without anxiety, mood, sleep or sedation disorders were enrolled.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Pramipexole significantly reduced mean sleep latency compared with placebo 3 h 30 min [-6.1 min (-9.8, -2.4), P = 0.002] and 5 h 30 min [-5.6 min (-7.7, -3.5), P = 0.003] after administration. In addition, the total duration of sleep during the tests was higher with pramipexole than with placebo [+6.0 min (2.3, 9.7), P < 0.001]. These differences were not observed with L-dopa and bromocriptine in comparison with placebo. The induced sleepiness was not associated with an increase in subjective somnolence scaling, indicating that this adverse event may occur without prior warning.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">These results show that a single oral dose of pramipexole induces sleepiness as assessed by MSLT in healthy young subjects, independent of disease-related sleep dysfunction.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Micallef</LastName><ForeName>Joëlle</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Clinical Investigation Centre (CIC-UPCET) and Department of Clinical Pharmacology, UMR-CNRS 6193 Institute of Cognitive Neurosciences, CHU Timone, Marseille, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rey</LastName><ForeName>Marc</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Eusebio</LastName><ForeName>Alexandre</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Audebert</LastName><ForeName>Christine</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Rouby</LastName><ForeName>Frank</ForeName><Initials>F</Initials></Author><Author ValidYN="Y"><LastName>Jouve</LastName><ForeName>Elisabeth</ForeName><Initials>E</Initials></Author><Author ValidYN="Y"><LastName>Tardieu</LastName><ForeName>Sophie</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Blin</LastName><ForeName>Oliver</ForeName><Initials>O</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2008</Year><Month>09</Month><Day>19</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Br J Clin Pharmacol</MedlineTA><NlmUniqueID>7503323</NlmUniqueID><ISSNLinking>0306-5251</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000978">Antiparkinson Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D052160">Benzothiazoles</NameOfSubstance></Chemical><Chemical><RegistryNumber>3A64E3G5ZO</RegistryNumber><NameOfSubstance UI="D001971">Bromocriptine</NameOfSubstance></Chemical><Chemical><RegistryNumber>46627O600J</RegistryNumber><NameOfSubstance UI="D007980">Levodopa</NameOfSubstance></Chemical><Chemical><RegistryNumber>83619PEU5T</RegistryNumber><NameOfSubstance UI="C061333">pramipexole</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections 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UI="D000978" MajorTopicYN="N">Antiparkinson Agents</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D052160" MajorTopicYN="N">Benzothiazoles</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D001971" MajorTopicYN="N">Bromocriptine</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D018592" MajorTopicYN="N">Cross-Over Studies</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007980" MajorTopicYN="N">Levodopa</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D010300" MajorTopicYN="N">Parkinson Disease</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D017286" MajorTopicYN="N">Polysomnography</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012893" MajorTopicYN="N">Sleep Wake Disorders</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="Y">chemically induced</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList><OtherID Source="NLM">PMC2675044</OtherID></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2009</Year><Month>2</Month><Day>18</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2009</Year><Month>2</Month><Day>18</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2009</Year><Month>12</Month><Day>16</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">19220275</ArticleId><ArticleId IdType="pii">BCP3310</ArticleId><ArticleId IdType="doi">10.1111/j.1365-2125.2008.03310.x</ArticleId><ArticleId IdType="pmc">PMC2675044</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>France</li></country><region><li>Provence-Alpes-Côte d'Azur</li></region><settlement><li>Marseille</li></settlement></list><tree><noCountry><name sortKey="Audebert, Christine" sort="Audebert, Christine" uniqKey="Audebert C" first="Christine" last="Audebert">Christine Audebert</name><name sortKey="Blin, Oliver" sort="Blin, Oliver" uniqKey="Blin O" first="Oliver" last="Blin">Oliver Blin</name><name sortKey="Eusebio, Alexandre" sort="Eusebio, Alexandre" uniqKey="Eusebio A" first="Alexandre" last="Eusebio">Alexandre Eusebio</name><name sortKey="Jouve, Elisabeth" sort="Jouve, Elisabeth" uniqKey="Jouve E" first="Elisabeth" last="Jouve">Elisabeth Jouve</name><name sortKey="Rey, Marc" sort="Rey, Marc" uniqKey="Rey M" first="Marc" last="Rey">Marc Rey</name><name sortKey="Rouby, Frank" sort="Rouby, Frank" uniqKey="Rouby F" first="Frank" last="Rouby">Frank Rouby</name><name sortKey="Tardieu, Sophie" sort="Tardieu, Sophie" uniqKey="Tardieu S" first="Sophie" last="Tardieu">Sophie Tardieu</name></noCountry><country name="France"><region name="Provence-Alpes-Côte d'Azur"><name sortKey="Micallef, Joelle" sort="Micallef, Joelle" uniqKey="Micallef J" first="Joëlle" last="Micallef">Joëlle 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