Cabergoline compared to levodopa in the treatment of patients with severe restless legs syndrome: results from a multi-center, randomized, active controlled trial.
Identifieur interne : 002849 ( PubMed/Curation ); précédent : 002848; suivant : 002850Cabergoline compared to levodopa in the treatment of patients with severe restless legs syndrome: results from a multi-center, randomized, active controlled trial.
Auteurs : Claudia Trenkwalder [Allemagne] ; Heike Benes ; Ludger Grote ; Svenja Happe ; Birgit Högl ; Johannes Mathis ; Gerda M. Saletu-Zyhlarz ; Ralf KohnenSource :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 2007.
English descriptors
- KwdEn :
- Adult, Aged, Antiparkinson Agents (adverse effects), Antiparkinson Agents (therapeutic use), Dopamine Agonists (adverse effects), Dopamine Agonists (therapeutic use), Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Ergolines (adverse effects), Ergolines (therapeutic use), Europe, Female, Humans, Levodopa (adverse effects), Levodopa (therapeutic use), Male, Middle Aged, Neurologic Examination (drug effects), Restless Legs Syndrome (drug therapy).
- MESH :
- chemical , adverse effects : Antiparkinson Agents, Dopamine Agonists, Ergolines, Levodopa.
- chemical , therapeutic use : Antiparkinson Agents, Dopamine Agonists, Ergolines, Levodopa.
- geographic : Europe.
- drug effects : Neurologic Examination.
- drug therapy : Restless Legs Syndrome.
- Adult, Aged, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Middle Aged.
Abstract
We report the first large-scale double-blind, randomly assigned study to compare two active dopaminergic therapies for Restless Legs Syndrome (RLS), the dopamine agonist cabergoline (CAB) and levodopa/benserazide (levodopa). Patients with idiopathic RLS were treated with fixed daily doses of 2 or 3 mg CAB or 200 or 300 mg levodopa for 30 weeks. Efficacy was assessed by changes in the IRLS (International RLS Severity Scale) and by time to discontinuation of treatment due to loss of efficacy or augmentation. 361 of 418 screened patients (age 58 +/- 12 years, 71% females) were randomly assigned and treated (CAB: n = 178; levodopa: n = 183) in 51 centers of four European countries. Baseline IRLS total score was 25.7 +/- 6.8. The baseline-adjusted mean change from baseline to week 6 in IRLS sum score was d = -16.1 in the CAB group and d = -9.5 in the levodopa group (d = -6.6, P < 0.0001). More patients in the levodopa group (24.0%) than in the CAB group (11.9%, P = 0.0029, log-rank test) discontinued because of loss of efficacy (14.2% vs. 7.9%, P = 0.0290) or augmentation (9.8% vs. 4.0%, P = 0.0412). Adverse events (AEs) occurred in 83.1% of the CAB group and in 77.6% of the levodopa group. In both groups, most frequent AEs were gastrointestinal symptoms (CAB: 55.6%, levodopa: 30.6%, P < 0.0001). This first large-scale active controlled study in RLS showed superior efficacy of cabergoline versus levodopa after a 30-week long-term therapy. Tolerability was found more favorable with levodopa than with cabergoline.
DOI: 10.1002/mds.21401
PubMed: 17274039
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Saletu-Zyhlarz</name></author><author><name sortKey="Kohnen, Ralf" sort="Kohnen, Ralf" uniqKey="Kohnen R" first="Ralf" last="Kohnen">Ralf Kohnen</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2007">2007</date><idno type="doi">10.1002/mds.21401</idno><idno type="RBID">pubmed:17274039</idno><idno type="pmid">17274039</idno><idno type="wicri:Area/PubMed/Corpus">002849</idno><idno type="wicri:Area/PubMed/Curation">002849</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Cabergoline compared to levodopa in the treatment of patients with severe restless legs syndrome: results from a multi-center, randomized, active controlled trial.</title><author><name sortKey="Trenkwalder, Claudia" sort="Trenkwalder, Claudia" uniqKey="Trenkwalder C" first="Claudia" last="Trenkwalder">Claudia Trenkwalder</name><affiliation wicri:level="1"><nlm:affiliation>Paracelsus-Elena Hospital, University of Göttingen, Kassel, Germany. ctrenkwalder@gmx.de</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Paracelsus-Elena Hospital, University of Göttingen, Kassel</wicri:regionArea></affiliation></author><author><name sortKey="Benes, Heike" sort="Benes, Heike" uniqKey="Benes H" first="Heike" last="Benes">Heike Benes</name></author><author><name sortKey="Grote, Ludger" sort="Grote, Ludger" uniqKey="Grote L" first="Ludger" last="Grote">Ludger Grote</name></author><author><name sortKey="Happe, Svenja" sort="Happe, Svenja" uniqKey="Happe S" first="Svenja" last="Happe">Svenja Happe</name></author><author><name sortKey="Hogl, Birgit" sort="Hogl, Birgit" uniqKey="Hogl B" first="Birgit" last="Högl">Birgit Högl</name></author><author><name sortKey="Mathis, Johannes" sort="Mathis, Johannes" uniqKey="Mathis J" first="Johannes" last="Mathis">Johannes Mathis</name></author><author><name sortKey="Saletu Zyhlarz, Gerda M" sort="Saletu Zyhlarz, Gerda M" uniqKey="Saletu Zyhlarz G" first="Gerda M" last="Saletu-Zyhlarz">Gerda M. Saletu-Zyhlarz</name></author><author><name sortKey="Kohnen, Ralf" sort="Kohnen, Ralf" uniqKey="Kohnen R" first="Ralf" last="Kohnen">Ralf Kohnen</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="2007" type="published">2007</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Antiparkinson Agents (adverse effects)</term><term>Antiparkinson Agents (therapeutic use)</term><term>Dopamine Agonists (adverse effects)</term><term>Dopamine Agonists (therapeutic use)</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Ergolines (adverse effects)</term><term>Ergolines (therapeutic use)</term><term>Europe</term><term>Female</term><term>Humans</term><term>Levodopa (adverse effects)</term><term>Levodopa (therapeutic use)</term><term>Male</term><term>Middle Aged</term><term>Neurologic Examination (drug effects)</term><term>Restless Legs Syndrome (drug therapy)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiparkinson Agents</term><term>Dopamine Agonists</term><term>Ergolines</term><term>Levodopa</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</term><term>Dopamine Agonists</term><term>Ergolines</term><term>Levodopa</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Europe</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Neurologic Examination</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Restless Legs Syndrome</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>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">We report the first large-scale double-blind, randomly assigned study to compare two active dopaminergic therapies for Restless Legs Syndrome (RLS), the dopamine agonist cabergoline (CAB) and levodopa/benserazide (levodopa). Patients with idiopathic RLS were treated with fixed daily doses of 2 or 3 mg CAB or 200 or 300 mg levodopa for 30 weeks. Efficacy was assessed by changes in the IRLS (International RLS Severity Scale) and by time to discontinuation of treatment due to loss of efficacy or augmentation. 361 of 418 screened patients (age 58 +/- 12 years, 71% females) were randomly assigned and treated (CAB: n = 178; levodopa: n = 183) in 51 centers of four European countries. Baseline IRLS total score was 25.7 +/- 6.8. The baseline-adjusted mean change from baseline to week 6 in IRLS sum score was d = -16.1 in the CAB group and d = -9.5 in the levodopa group (d = -6.6, P < 0.0001). More patients in the levodopa group (24.0%) than in the CAB group (11.9%, P = 0.0029, log-rank test) discontinued because of loss of efficacy (14.2% vs. 7.9%, P = 0.0290) or augmentation (9.8% vs. 4.0%, P = 0.0412). Adverse events (AEs) occurred in 83.1% of the CAB group and in 77.6% of the levodopa group. In both groups, most frequent AEs were gastrointestinal symptoms (CAB: 55.6%, levodopa: 30.6%, P < 0.0001). This first large-scale active controlled study in RLS showed superior efficacy of cabergoline versus levodopa after a 30-week long-term therapy. Tolerability was found more favorable with levodopa than with cabergoline.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">17274039</PMID><DateCreated><Year>2007</Year><Month>05</Month><Day>01</Day></DateCreated><DateCompleted><Year>2007</Year><Month>07</Month><Day>23</Day></DateCompleted><DateRevised><Year>2013</Year><Month>11</Month><Day>21</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0885-3185</ISSN><JournalIssue CitedMedium="Print"><Volume>22</Volume><Issue>5</Issue><PubDate><Year>2007</Year><Month>Apr</Month><Day>15</Day></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. 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Baseline IRLS total score was 25.7 +/- 6.8. The baseline-adjusted mean change from baseline to week 6 in IRLS sum score was d = -16.1 in the CAB group and d = -9.5 in the levodopa group (d = -6.6, P < 0.0001). More patients in the levodopa group (24.0%) than in the CAB group (11.9%, P = 0.0029, log-rank test) discontinued because of loss of efficacy (14.2% vs. 7.9%, P = 0.0290) or augmentation (9.8% vs. 4.0%, P = 0.0412). Adverse events (AEs) occurred in 83.1% of the CAB group and in 77.6% of the levodopa group. In both groups, most frequent AEs were gastrointestinal symptoms (CAB: 55.6%, levodopa: 30.6%, P < 0.0001). This first large-scale active controlled study in RLS showed superior efficacy of cabergoline versus levodopa after a 30-week long-term therapy. Tolerability was found more favorable with levodopa than with cabergoline.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Trenkwalder</LastName><ForeName>Claudia</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Paracelsus-Elena Hospital, University of Göttingen, Kassel, Germany. ctrenkwalder@gmx.de</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Benes</LastName><ForeName>Heike</ForeName><Initials>H</Initials></Author><Author ValidYN="Y"><LastName>Grote</LastName><ForeName>Ludger</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><LastName>Happe</LastName><ForeName>Svenja</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Högl</LastName><ForeName>Birgit</ForeName><Initials>B</Initials></Author><Author ValidYN="Y"><LastName>Mathis</LastName><ForeName>Johannes</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Saletu-Zyhlarz</LastName><ForeName>Gerda M</ForeName><Initials>GM</Initials></Author><Author ValidYN="Y"><LastName>Kohnen</LastName><ForeName>Ralf</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><CollectiveName>CALDIR Study Group</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D003160">Comparative Study</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>Mov Disord</MedlineTA><NlmUniqueID>8610688</NlmUniqueID><ISSNLinking>0885-3185</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000978">Antiparkinson 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use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D018491">Dopamine Agonists</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000009">adverse effects</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004305">Dose-Response Relationship, Drug</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004311">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004334">Drug Administration Schedule</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004873">Ergolines</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000009">adverse effects</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" Type="Geographic" UI="D005060">Europe</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005260">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D007980">Levodopa</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000009">adverse effects</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008297">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008875">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D009460">Neurologic Examination</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000187">drug effects</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D012148">Restless Legs Syndrome</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000188">drug therapy</QualifierName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2007</Year><Month>2</Month><Day>3</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2007</Year><Month>7</Month><Day>24</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2007</Year><Month>2</Month><Day>3</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="doi">10.1002/mds.21401</ArticleId><ArticleId IdType="pubmed">17274039</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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