Tolcapone improves motor function in parkinsonian patients with the "wearing-off" phenomenon: a double-blind, placebo-controlled, multicenter trial.
Identifieur interne : 001673 ( PubMed/Checkpoint ); précédent : 001672; suivant : 001674Tolcapone improves motor function in parkinsonian patients with the "wearing-off" phenomenon: a double-blind, placebo-controlled, multicenter trial.
Auteurs : A H Rajput [Canada] ; W. Martin ; M H Saint-Hilaire ; E. Dorflinger ; S. PedderSource :
- Neurology [ 0028-3878 ] ; 1998.
Descripteurs français
- Wicri :
- geographic : Canada, États-Unis.
English descriptors
- KwdEn :
- Aged, Antiparkinson Agents (adverse effects), Antiparkinson Agents (pharmacology), Benzophenones (adverse effects), Benzophenones (pharmacology), Canada, Catechol O-Methyltransferase Inhibitors, Dopamine Agents (pharmacokinetics), Double-Blind Method, Enzyme Inhibitors (adverse effects), Enzyme Inhibitors (pharmacology), Female, Humans, Levodopa (pharmacokinetics), Male, Middle Aged, Nitrophenols, Parkinson Disease (drug therapy), Parkinson Disease (enzymology), Parkinson Disease (physiopathology), Psychomotor Performance (drug effects), United States.
- MESH :
- chemical , adverse effects : Antiparkinson Agents, Benzophenones, Enzyme Inhibitors.
- chemical , pharmacokinetics : Dopamine Agents, Levodopa.
- chemical , pharmacology : Antiparkinson Agents, Benzophenones, Enzyme Inhibitors.
- geographic : Canada, Catechol O-Methyltransferase Inhibitors, Nitrophenols, United States.
- drug effects : Psychomotor Performance.
- drug therapy : Parkinson Disease.
- enzymology : Parkinson Disease.
- physiopathology : Parkinson Disease.
- Aged, Double-Blind Method, Female, Humans, Male, Middle Aged.
Abstract
We studied the new catechol-O-methyltransferase inhibitor tolcapone, 100 and 200 mg, three times daily (tid) in a randomized, double-blind, parallel-group trial involving 202 parkinsonian patients who were experiencing the "wearing-off" phenomenon on levodopa therapy. After 3 months, patients receiving tolcapone had a significant decrease in mean daily levodopa dose requirement compared with placebo-treated patients (p < 0.01). In patients treated with tolcapone 200 mg tid, daily "off" time, measured using patient diaries, was reduced from baseline by 3.25 hours; this reduction was significantly different from that seen in the placebo group (p < 0.01). Moreover, the number of daily levodopa intakes was reduced significantly in each tolcapone group compared with placebo (p < 0.01). We found significant improvements in motor function and overall efficacy in the tolcapone groups (p < 0.01). The most frequent adverse events were associated with levodopa treatment. Dyskinesia developed or worsened in 18% of patients receiving placebo, in 51% receiving tolcapone 100 mg tid, and in 64% receiving 200 mg tid, with most cases occurring within the first 30 days of the study. Diarrhea was the most frequent nondopaminergic event, occurring in 14% on placebo, 13% on tolcapone 100 mg tid, and 19% on 200 mg tid. Overall 18% of patients withdrew because of adverse events: 15% on placebo, 17% on tolcapone 100 mg tid, and 22% on 200 mg tid. We conclude that tolcapone as an adjunct offers promise for the relief of the "wearing-off " phenomenon in levodopa-treated parkinsonian patients.
PubMed: 9591523
Affiliations:
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Tolcapone improves motor function in parkinsonian patients with the "wearing-off" phenomenon: a double-blind, placebo-controlled, multicenter trial.</title><author><name sortKey="Rajput, A H" sort="Rajput, A H" uniqKey="Rajput A" first="A H" last="Rajput">A H Rajput</name><affiliation wicri:level="1"><nlm:affiliation>Division of Neurology, Royal University Hospital, Saskatoon, Saskatchewan, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Division of Neurology, Royal University Hospital, Saskatoon, Saskatchewan</wicri:regionArea><wicri:noRegion>Saskatchewan</wicri:noRegion></affiliation></author><author><name sortKey="Martin, W" sort="Martin, W" uniqKey="Martin W" first="W" last="Martin">W. Martin</name></author><author><name sortKey="Saint Hilaire, M H" sort="Saint Hilaire, M H" uniqKey="Saint Hilaire M" first="M H" last="Saint-Hilaire">M H Saint-Hilaire</name></author><author><name sortKey="Dorflinger, E" sort="Dorflinger, E" uniqKey="Dorflinger E" first="E" last="Dorflinger">E. Dorflinger</name></author><author><name sortKey="Pedder, S" sort="Pedder, S" uniqKey="Pedder S" first="S" last="Pedder">S. Pedder</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="1998">1998</date><idno type="RBID">pubmed:9591523</idno><idno type="pmid">9591523</idno><idno type="wicri:Area/PubMed/Corpus">001772</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001772</idno><idno type="wicri:Area/PubMed/Curation">001772</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">001772</idno><idno type="wicri:Area/PubMed/Checkpoint">001772</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">001772</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Tolcapone improves motor function in parkinsonian patients with the "wearing-off" phenomenon: a double-blind, placebo-controlled, multicenter trial.</title><author><name sortKey="Rajput, A H" sort="Rajput, A H" uniqKey="Rajput A" first="A H" last="Rajput">A H Rajput</name><affiliation wicri:level="1"><nlm:affiliation>Division of Neurology, Royal University Hospital, Saskatoon, Saskatchewan, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>Division of Neurology, Royal University Hospital, Saskatoon, Saskatchewan</wicri:regionArea><wicri:noRegion>Saskatchewan</wicri:noRegion></affiliation></author><author><name sortKey="Martin, W" sort="Martin, W" uniqKey="Martin W" first="W" last="Martin">W. Martin</name></author><author><name sortKey="Saint Hilaire, M H" sort="Saint Hilaire, M H" uniqKey="Saint Hilaire M" first="M H" last="Saint-Hilaire">M H Saint-Hilaire</name></author><author><name sortKey="Dorflinger, E" sort="Dorflinger, E" uniqKey="Dorflinger E" first="E" last="Dorflinger">E. Dorflinger</name></author><author><name sortKey="Pedder, S" sort="Pedder, S" uniqKey="Pedder S" first="S" last="Pedder">S. Pedder</name></author></analytic><series><title level="j">Neurology</title><idno type="ISSN">0028-3878</idno><imprint><date when="1998" type="published">1998</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Antiparkinson Agents (adverse effects)</term><term>Antiparkinson Agents (pharmacology)</term><term>Benzophenones (adverse effects)</term><term>Benzophenones (pharmacology)</term><term>Canada</term><term>Catechol O-Methyltransferase Inhibitors</term><term>Dopamine Agents (pharmacokinetics)</term><term>Double-Blind Method</term><term>Enzyme Inhibitors (adverse effects)</term><term>Enzyme Inhibitors (pharmacology)</term><term>Female</term><term>Humans</term><term>Levodopa (pharmacokinetics)</term><term>Male</term><term>Middle Aged</term><term>Nitrophenols</term><term>Parkinson Disease (drug therapy)</term><term>Parkinson Disease (enzymology)</term><term>Parkinson Disease (physiopathology)</term><term>Psychomotor Performance (drug effects)</term><term>United States</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiparkinson Agents</term><term>Benzophenones</term><term>Enzyme Inhibitors</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacokinetics" xml:lang="en"><term>Dopamine Agents</term><term>Levodopa</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacology" xml:lang="en"><term>Antiparkinson Agents</term><term>Benzophenones</term><term>Enzyme Inhibitors</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Canada</term><term>Catechol O-Methyltransferase Inhibitors</term><term>Nitrophenols</term><term>United States</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Psychomotor Performance</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="enzymology" xml:lang="en"><term>Parkinson Disease</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>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Canada</term><term>États-Unis</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">We studied the new catechol-O-methyltransferase inhibitor tolcapone, 100 and 200 mg, three times daily (tid) in a randomized, double-blind, parallel-group trial involving 202 parkinsonian patients who were experiencing the "wearing-off" phenomenon on levodopa therapy. After 3 months, patients receiving tolcapone had a significant decrease in mean daily levodopa dose requirement compared with placebo-treated patients (p < 0.01). In patients treated with tolcapone 200 mg tid, daily "off" time, measured using patient diaries, was reduced from baseline by 3.25 hours; this reduction was significantly different from that seen in the placebo group (p < 0.01). Moreover, the number of daily levodopa intakes was reduced significantly in each tolcapone group compared with placebo (p < 0.01). We found significant improvements in motor function and overall efficacy in the tolcapone groups (p < 0.01). The most frequent adverse events were associated with levodopa treatment. Dyskinesia developed or worsened in 18% of patients receiving placebo, in 51% receiving tolcapone 100 mg tid, and in 64% receiving 200 mg tid, with most cases occurring within the first 30 days of the study. Diarrhea was the most frequent nondopaminergic event, occurring in 14% on placebo, 13% on tolcapone 100 mg tid, and 19% on 200 mg tid. Overall 18% of patients withdrew because of adverse events: 15% on placebo, 17% on tolcapone 100 mg tid, and 22% on 200 mg tid. We conclude that tolcapone as an adjunct offers promise for the relief of the "wearing-off " phenomenon in levodopa-treated parkinsonian patients.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">9591523</PMID><DateCreated><Year>1998</Year><Month>06</Month><Day>09</Day></DateCreated><DateCompleted><Year>1998</Year><Month>06</Month><Day>09</Day></DateCompleted><DateRevised><Year>2014</Year><Month>11</Month><Day>20</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0028-3878</ISSN><JournalIssue CitedMedium="Print"><Volume>50</Volume><Issue>5 Suppl 5</Issue><PubDate><Year>1998</Year><Month>May</Month></PubDate></JournalIssue><Title>Neurology</Title><ISOAbbreviation>Neurology</ISOAbbreviation></Journal><ArticleTitle>Tolcapone improves motor function in parkinsonian patients with the "wearing-off" phenomenon: a double-blind, placebo-controlled, multicenter trial.</ArticleTitle><Pagination><MedlinePgn>S54-9</MedlinePgn></Pagination><Abstract><AbstractText>We studied the new catechol-O-methyltransferase inhibitor tolcapone, 100 and 200 mg, three times daily (tid) in a randomized, double-blind, parallel-group trial involving 202 parkinsonian patients who were experiencing the "wearing-off" phenomenon on levodopa therapy. After 3 months, patients receiving tolcapone had a significant decrease in mean daily levodopa dose requirement compared with placebo-treated patients (p < 0.01). In patients treated with tolcapone 200 mg tid, daily "off" time, measured using patient diaries, was reduced from baseline by 3.25 hours; this reduction was significantly different from that seen in the placebo group (p < 0.01). Moreover, the number of daily levodopa intakes was reduced significantly in each tolcapone group compared with placebo (p < 0.01). We found significant improvements in motor function and overall efficacy in the tolcapone groups (p < 0.01). The most frequent adverse events were associated with levodopa treatment. Dyskinesia developed or worsened in 18% of patients receiving placebo, in 51% receiving tolcapone 100 mg tid, and in 64% receiving 200 mg tid, with most cases occurring within the first 30 days of the study. Diarrhea was the most frequent nondopaminergic event, occurring in 14% on placebo, 13% on tolcapone 100 mg tid, and 19% on 200 mg tid. Overall 18% of patients withdrew because of adverse events: 15% on placebo, 17% on tolcapone 100 mg tid, and 22% on 200 mg tid. We conclude that tolcapone as an adjunct offers promise for the relief of the "wearing-off " phenomenon in levodopa-treated parkinsonian patients.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Rajput</LastName><ForeName>A H</ForeName><Initials>AH</Initials><AffiliationInfo><Affiliation>Division of Neurology, Royal University Hospital, Saskatoon, Saskatchewan, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Martin</LastName><ForeName>W</ForeName><Initials>W</Initials></Author><Author ValidYN="Y"><LastName>Saint-Hilaire</LastName><ForeName>M H</ForeName><Initials>MH</Initials></Author><Author ValidYN="Y"><LastName>Dorflinger</LastName><ForeName>E</ForeName><Initials>E</Initials></Author><Author ValidYN="Y"><LastName>Pedder</LastName><ForeName>S</ForeName><Initials>S</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016430">Clinical Trial</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Neurology</MedlineTA><NlmUniqueID>0401060</NlmUniqueID><ISSNLinking>0028-3878</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000978">Antiparkinson Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D001577">Benzophenones</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D065098">Catechol O-Methyltransferase Inhibitors</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D015259">Dopamine Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D004791">Enzyme Inhibitors</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D009596">Nitrophenols</NameOfSubstance></Chemical><Chemical><RegistryNumber>46627O600J</RegistryNumber><NameOfSubstance UI="D007980">Levodopa</NameOfSubstance></Chemical><Chemical><RegistryNumber>CIF6334OLY</RegistryNumber><NameOfSubstance UI="C066340">tolcapone</NameOfSubstance></Chemical></ChemicalList><CitationSubset>AIM</CitationSubset><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000978" MajorTopicYN="N">Antiparkinson Agents</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000494" MajorTopicYN="Y">pharmacology</QualifierName></MeshHeading><MeshHeading><DescriptorName 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MajorTopicYN="Y">pharmacology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007980" MajorTopicYN="N">Levodopa</DescriptorName><QualifierName UI="Q000493" MajorTopicYN="Y">pharmacokinetics</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009596" MajorTopicYN="N">Nitrophenols</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D010300" MajorTopicYN="N">Parkinson Disease</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000201" MajorTopicYN="N">enzymology</QualifierName><QualifierName UI="Q000503" MajorTopicYN="Y">physiopathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011597" MajorTopicYN="N">Psychomotor Performance</DescriptorName><QualifierName UI="Q000187" MajorTopicYN="Y">drug effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D014481" MajorTopicYN="N" Type="Geographic">United States</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>1998</Year><Month>5</Month><Day>20</Day></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>1998</Year><Month>5</Month><Day>20</Day><Hour>0</Hour><Minute>1</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>1998</Year><Month>5</Month><Day>20</Day><Hour>0</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">9591523</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Canada</li></country></list><tree><noCountry><name sortKey="Dorflinger, E" sort="Dorflinger, E" uniqKey="Dorflinger E" first="E" last="Dorflinger">E. Dorflinger</name><name sortKey="Martin, W" sort="Martin, W" uniqKey="Martin W" first="W" last="Martin">W. Martin</name><name sortKey="Pedder, S" sort="Pedder, S" uniqKey="Pedder S" first="S" last="Pedder">S. Pedder</name><name sortKey="Saint Hilaire, M H" sort="Saint Hilaire, M H" uniqKey="Saint Hilaire M" first="M H" last="Saint-Hilaire">M H Saint-Hilaire</name></noCountry><country name="Canada"><noRegion><name sortKey="Rajput, A H" sort="Rajput, A H" uniqKey="Rajput A" first="A H" last="Rajput">A H Rajput</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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