Systematic evaluation of augmentation during treatment with ropinirole in restless legs syndrome (Willis-Ekbom disease): results from a prospective, multicenter study over 66 weeks.
Identifieur interne : 000E61 ( PubMed/Corpus ); précédent : 000E60; suivant : 000E62Systematic evaluation of augmentation during treatment with ropinirole in restless legs syndrome (Willis-Ekbom disease): results from a prospective, multicenter study over 66 weeks.
Auteurs : Diego García-Borreguero ; Birgit Högl ; Luigi Ferini-Strambi ; John Winkelman ; Christina Hill-Zabala ; Afsaneh Asgharian ; Richard AllenSource :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2012.
English descriptors
- KwdEn :
- Adult, Aged, Antiparkinson Agents (therapeutic use), Double-Blind Method, Female, Follow-Up Studies, Humans, Indoles (therapeutic use), Kaplan-Meier Estimate, Male, Middle Aged, Prospective Studies, Restless Legs Syndrome (drug therapy), Restless Legs Syndrome (mortality), Severity of Illness Index, Time Factors, Treatment Outcome.
- MESH :
- chemical , therapeutic use : Antiparkinson Agents, Indoles.
- drug therapy : Restless Legs Syndrome.
- mortality : Restless Legs Syndrome.
- Adult, Aged, Double-Blind Method, Female, Follow-Up Studies, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Prospective Studies, Severity of Illness Index, Time Factors, Treatment Outcome.
Abstract
The purpose of this study was to evaluate the incidence of augmentation over 66 weeks of treatment with ropinirole in patients with primary restless legs syndrome (RLS). Augmentation is the main complication of long-term dopaminergic treatment of RLS. Despite widespread use of ropinirole in RLS, no studies have prospectively and systematically assessed the incidence of augmentation with its use. The study consisted of 26 weeks of double-blind flexible-dose treatment with ropinirole or placebo, followed by 40 weeks of open-label ropinirole treatment.. Patients had no previous history of augmentation. Potential cases of augmentation were identified with the Structured Interview for the Diagnosis of Augmentation and the Augmentation Severity Rating Scale and through reporting of adverse events. Cases were blindly evaluated by an expert panel using the NIH diagnostic criteria for augmentation. Four hundred and four patients participated in the double-blind study and 269 in the open-label phase, with a discontinuation rate of 42%. IRLS baseline scores improved at the end of the double-blind (DB) phase (mean ± SE) by -15.9 ± 0.76 for ropinirole, by -13.4 ± 0.77 for placebo (P < .05) and by -20.4 ± 0.55 during the open-label phase. The incidence rates of augmentation were 3.5% for ropinirole and <1% for placebo during the DB phase and 3% during the open-label phase. Clinically significant augmentation occurred in 3%, <1%, and 2%, respectively. Discontinuation of treatment occurred in 50% of all patients (7 of 14) with augmentation. The incidence of augmentation was 3.1% higher with ropinirole than with placebo. New patients with first episodes of augmentation continued to cumulate at a stable rate over the duration of this study.
DOI: 10.1002/mds.24889
PubMed: 22328464
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Systematic evaluation of augmentation during treatment with ropinirole in restless legs syndrome (Willis-Ekbom disease): results from a prospective, multicenter study over 66 weeks.</title><author><name sortKey="Garcia Borreguero, Diego" sort="Garcia Borreguero, Diego" uniqKey="Garcia Borreguero D" first="Diego" last="García-Borreguero">Diego García-Borreguero</name><affiliation><nlm:affiliation>Sleep Research Institute, Madrid, Spain. dgb@iis.es</nlm:affiliation></affiliation></author><author><name sortKey="Hogl, Birgit" sort="Hogl, Birgit" uniqKey="Hogl B" first="Birgit" last="Högl">Birgit Högl</name></author><author><name sortKey="Ferini Strambi, Luigi" sort="Ferini Strambi, Luigi" uniqKey="Ferini Strambi L" first="Luigi" last="Ferini-Strambi">Luigi Ferini-Strambi</name></author><author><name sortKey="Winkelman, John" sort="Winkelman, John" uniqKey="Winkelman J" first="John" last="Winkelman">John Winkelman</name></author><author><name sortKey="Hill Zabala, Christina" sort="Hill Zabala, Christina" uniqKey="Hill Zabala C" first="Christina" last="Hill-Zabala">Christina Hill-Zabala</name></author><author><name sortKey="Asgharian, Afsaneh" sort="Asgharian, Afsaneh" uniqKey="Asgharian A" first="Afsaneh" last="Asgharian">Afsaneh Asgharian</name></author><author><name sortKey="Allen, Richard" sort="Allen, Richard" uniqKey="Allen R" first="Richard" last="Allen">Richard Allen</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2012">2012</date><idno type="doi">10.1002/mds.24889</idno><idno type="RBID">pubmed:22328464</idno><idno type="pmid">22328464</idno><idno type="wicri:Area/PubMed/Corpus">000E61</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Systematic evaluation of augmentation during treatment with ropinirole in restless legs syndrome (Willis-Ekbom disease): results from a prospective, multicenter study over 66 weeks.</title><author><name sortKey="Garcia Borreguero, Diego" sort="Garcia Borreguero, Diego" uniqKey="Garcia Borreguero D" first="Diego" last="García-Borreguero">Diego García-Borreguero</name><affiliation><nlm:affiliation>Sleep Research Institute, Madrid, Spain. dgb@iis.es</nlm:affiliation></affiliation></author><author><name sortKey="Hogl, Birgit" sort="Hogl, Birgit" uniqKey="Hogl B" first="Birgit" last="Högl">Birgit Högl</name></author><author><name sortKey="Ferini Strambi, Luigi" sort="Ferini Strambi, Luigi" uniqKey="Ferini Strambi L" first="Luigi" last="Ferini-Strambi">Luigi Ferini-Strambi</name></author><author><name sortKey="Winkelman, John" sort="Winkelman, John" uniqKey="Winkelman J" first="John" last="Winkelman">John Winkelman</name></author><author><name sortKey="Hill Zabala, Christina" sort="Hill Zabala, Christina" uniqKey="Hill Zabala C" first="Christina" last="Hill-Zabala">Christina Hill-Zabala</name></author><author><name sortKey="Asgharian, Afsaneh" sort="Asgharian, Afsaneh" uniqKey="Asgharian A" first="Afsaneh" last="Asgharian">Afsaneh Asgharian</name></author><author><name sortKey="Allen, Richard" sort="Allen, Richard" uniqKey="Allen R" first="Richard" last="Allen">Richard Allen</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="2012" type="published">2012</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Antiparkinson Agents (therapeutic use)</term><term>Double-Blind Method</term><term>Female</term><term>Follow-Up Studies</term><term>Humans</term><term>Indoles (therapeutic use)</term><term>Kaplan-Meier Estimate</term><term>Male</term><term>Middle Aged</term><term>Prospective Studies</term><term>Restless Legs Syndrome (drug therapy)</term><term>Restless Legs Syndrome (mortality)</term><term>Severity of Illness Index</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</term><term>Indoles</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Restless Legs Syndrome</term></keywords><keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Restless Legs Syndrome</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Double-Blind Method</term><term>Female</term><term>Follow-Up Studies</term><term>Humans</term><term>Kaplan-Meier Estimate</term><term>Male</term><term>Middle Aged</term><term>Prospective Studies</term><term>Severity of Illness Index</term><term>Time Factors</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The purpose of this study was to evaluate the incidence of augmentation over 66 weeks of treatment with ropinirole in patients with primary restless legs syndrome (RLS). Augmentation is the main complication of long-term dopaminergic treatment of RLS. Despite widespread use of ropinirole in RLS, no studies have prospectively and systematically assessed the incidence of augmentation with its use. The study consisted of 26 weeks of double-blind flexible-dose treatment with ropinirole or placebo, followed by 40 weeks of open-label ropinirole treatment.. Patients had no previous history of augmentation. Potential cases of augmentation were identified with the Structured Interview for the Diagnosis of Augmentation and the Augmentation Severity Rating Scale and through reporting of adverse events. Cases were blindly evaluated by an expert panel using the NIH diagnostic criteria for augmentation. Four hundred and four patients participated in the double-blind study and 269 in the open-label phase, with a discontinuation rate of 42%. IRLS baseline scores improved at the end of the double-blind (DB) phase (mean ± SE) by -15.9 ± 0.76 for ropinirole, by -13.4 ± 0.77 for placebo (P < .05) and by -20.4 ± 0.55 during the open-label phase. The incidence rates of augmentation were 3.5% for ropinirole and <1% for placebo during the DB phase and 3% during the open-label phase. Clinically significant augmentation occurred in 3%, <1%, and 2%, respectively. Discontinuation of treatment occurred in 50% of all patients (7 of 14) with augmentation. The incidence of augmentation was 3.1% higher with ropinirole than with placebo. New patients with first episodes of augmentation continued to cumulate at a stable rate over the duration of this study.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">22328464</PMID><DateCreated><Year>2012</Year><Month>02</Month><Day>13</Day></DateCreated><DateCompleted><Year>2012</Year><Month>06</Month><Day>14</Day></DateCompleted><DateRevised><Year>2012</Year><Month>11</Month><Day>15</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1531-8257</ISSN><JournalIssue CitedMedium="Internet"><Volume>27</Volume><Issue>2</Issue><PubDate><Year>2012</Year><Month>Feb</Month></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>Systematic evaluation of augmentation during treatment with ropinirole in restless legs syndrome (Willis-Ekbom disease): results from a prospective, multicenter study over 66 weeks.</ArticleTitle><Pagination><MedlinePgn>277-83</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/mds.24889</ELocationID><Abstract><AbstractText>The purpose of this study was to evaluate the incidence of augmentation over 66 weeks of treatment with ropinirole in patients with primary restless legs syndrome (RLS). Augmentation is the main complication of long-term dopaminergic treatment of RLS. Despite widespread use of ropinirole in RLS, no studies have prospectively and systematically assessed the incidence of augmentation with its use. The study consisted of 26 weeks of double-blind flexible-dose treatment with ropinirole or placebo, followed by 40 weeks of open-label ropinirole treatment.. Patients had no previous history of augmentation. Potential cases of augmentation were identified with the Structured Interview for the Diagnosis of Augmentation and the Augmentation Severity Rating Scale and through reporting of adverse events. Cases were blindly evaluated by an expert panel using the NIH diagnostic criteria for augmentation. Four hundred and four patients participated in the double-blind study and 269 in the open-label phase, with a discontinuation rate of 42%. IRLS baseline scores improved at the end of the double-blind (DB) phase (mean ± SE) by -15.9 ± 0.76 for ropinirole, by -13.4 ± 0.77 for placebo (P < .05) and by -20.4 ± 0.55 during the open-label phase. The incidence rates of augmentation were 3.5% for ropinirole and <1% for placebo during the DB phase and 3% during the open-label phase. Clinically significant augmentation occurred in 3%, <1%, and 2%, respectively. Discontinuation of treatment occurred in 50% of all patients (7 of 14) with augmentation. The incidence of augmentation was 3.1% higher with ropinirole than with placebo. 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ValidYN="Y"><LastName>Asgharian</LastName><ForeName>Afsaneh</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Allen</LastName><ForeName>Richard</ForeName><Initials>R</Initials></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT00329602</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><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><ArticleDate DateType="Electronic"><Year>2012</Year><Month>01</Month><Day>04</Day></ArticleDate></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 Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D007211">Indoles</NameOfSubstance></Chemical><Chemical><RegistryNumber>030PYR8953</RegistryNumber><NameOfSubstance UI="C046649">ropinirole</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000328">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000368">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000978">Antiparkinson Agents</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004311">Double-Blind 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