Efficacy of pramipexole in restless legs syndrome: a six-week, multicenter, randomized, double-blind study (effect-RLS study).
Identifieur interne : 002955 ( PubMed/Corpus ); précédent : 002954; suivant : 002956Efficacy of pramipexole in restless legs syndrome: a six-week, multicenter, randomized, double-blind study (effect-RLS study).
Auteurs : Wolfgang H. Oertel ; Karin Stiasny-Kolster ; Bettina Bergtholdt ; Yngve Hallström ; Jaan Albo ; Lena Leissner ; Thomas Schindler ; Juergen Koester ; Juergen ReessSource :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 2007.
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Aged, 80 and over, Antiparkinson Agents (therapeutic use), Benzothiazoles (therapeutic use), Demography, Double-Blind Method, Female, Humans, Male, Middle Aged, Restless Legs Syndrome (diagnosis), Restless Legs Syndrome (drug therapy), Restless Legs Syndrome (physiopathology), Severity of Illness Index, Time Factors.
- MESH :
- chemical , therapeutic use : Antiparkinson Agents, Benzothiazoles.
- diagnosis : Restless Legs Syndrome.
- drug therapy : Restless Legs Syndrome.
- physiopathology : Restless Legs Syndrome.
- Adolescent, Adult, Aged, Aged, 80 and over, Demography, Double-Blind Method, Female, Humans, Male, Middle Aged, Severity of Illness Index, Time Factors.
Abstract
We evaluated the efficacy of pramipexole versus placebo in restless legs syndrome (RLS) for 6 weeks. Overall, 345 patients were randomly assigned in a 1:2 ratio to receive either placebo (n = 115) or pramipexole (n = 230) with a starting dose of 0.125 mg/day. The dose was individually optimized according to the Patient Global Impression (PGI) assessment, up to a maximum of 0.75 mg/day. The primary endpoint consisted of two assessments: the change from baseline in the International RLS Study Group Rating Scale (IRLS) and the proportion of patients with Clinical Global Impressions-Improvement (CGI-I) assessments of "much/very much improved" (CGI-I responders) at week 6. Secondary endpoints included PGI and IRLS responder rates. Patient demographics and baseline characteristics were comparable between treatment groups. At baseline, mean IRLS scores were 24.9 (placebo) and 24.7 (pramipexole), representing severely affected patients. After 6 weeks, adjusted mean reductions (+/-SE) in IRLS score were 5.7 (+/-0.9) for placebo (median dose 0.47 mg/day) and 12.3 (+/-0.6) for pramipexole (median dose 0.35 mg/day; P < 0.0001). CGI-I responder rates were 32.5% (placebo) and 62.9% (pramipexole) (P < 0.0001). For all secondary endpoints, pramipexole showed superior results. Pramipexole was well tolerated throughout the study.
DOI: 10.1002/mds.21261
PubMed: 17133582
Links to Exploration step
pubmed:17133582Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Efficacy of pramipexole in restless legs syndrome: a six-week, multicenter, randomized, double-blind study (effect-RLS study).</title><author><name sortKey="Oertel, Wolfgang H" sort="Oertel, Wolfgang H" uniqKey="Oertel W" first="Wolfgang H" last="Oertel">Wolfgang H. Oertel</name><affiliation><nlm:affiliation>Philipps-University Marburg, Marburg, Germany. oertelw@med.uni-marburg.de</nlm:affiliation></affiliation></author><author><name sortKey="Stiasny Kolster, Karin" sort="Stiasny Kolster, Karin" uniqKey="Stiasny Kolster K" first="Karin" last="Stiasny-Kolster">Karin Stiasny-Kolster</name></author><author><name sortKey="Bergtholdt, Bettina" sort="Bergtholdt, Bettina" uniqKey="Bergtholdt B" first="Bettina" last="Bergtholdt">Bettina Bergtholdt</name></author><author><name sortKey="Hallstrom, Yngve" sort="Hallstrom, Yngve" uniqKey="Hallstrom Y" first="Yngve" last="Hallström">Yngve Hallström</name></author><author><name sortKey="Albo, Jaan" sort="Albo, Jaan" uniqKey="Albo J" first="Jaan" last="Albo">Jaan Albo</name></author><author><name sortKey="Leissner, Lena" sort="Leissner, Lena" uniqKey="Leissner L" first="Lena" last="Leissner">Lena Leissner</name></author><author><name sortKey="Schindler, Thomas" sort="Schindler, Thomas" uniqKey="Schindler T" first="Thomas" last="Schindler">Thomas Schindler</name></author><author><name sortKey="Koester, Juergen" sort="Koester, Juergen" uniqKey="Koester J" first="Juergen" last="Koester">Juergen Koester</name></author><author><name sortKey="Reess, Juergen" sort="Reess, Juergen" uniqKey="Reess J" first="Juergen" last="Reess">Juergen Reess</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2007">2007</date><idno type="doi">10.1002/mds.21261</idno><idno type="RBID">pubmed:17133582</idno><idno type="pmid">17133582</idno><idno type="wicri:Area/PubMed/Corpus">002955</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Efficacy of pramipexole in restless legs syndrome: a six-week, multicenter, randomized, double-blind study (effect-RLS study).</title><author><name sortKey="Oertel, Wolfgang H" sort="Oertel, Wolfgang H" uniqKey="Oertel W" first="Wolfgang H" last="Oertel">Wolfgang H. Oertel</name><affiliation><nlm:affiliation>Philipps-University Marburg, Marburg, Germany. oertelw@med.uni-marburg.de</nlm:affiliation></affiliation></author><author><name sortKey="Stiasny Kolster, Karin" sort="Stiasny Kolster, Karin" uniqKey="Stiasny Kolster K" first="Karin" last="Stiasny-Kolster">Karin Stiasny-Kolster</name></author><author><name sortKey="Bergtholdt, Bettina" sort="Bergtholdt, Bettina" uniqKey="Bergtholdt B" first="Bettina" last="Bergtholdt">Bettina Bergtholdt</name></author><author><name sortKey="Hallstrom, Yngve" sort="Hallstrom, Yngve" uniqKey="Hallstrom Y" first="Yngve" last="Hallström">Yngve Hallström</name></author><author><name sortKey="Albo, Jaan" sort="Albo, Jaan" uniqKey="Albo J" first="Jaan" last="Albo">Jaan Albo</name></author><author><name sortKey="Leissner, Lena" sort="Leissner, Lena" uniqKey="Leissner L" first="Lena" last="Leissner">Lena Leissner</name></author><author><name sortKey="Schindler, Thomas" sort="Schindler, Thomas" uniqKey="Schindler T" first="Thomas" last="Schindler">Thomas Schindler</name></author><author><name sortKey="Koester, Juergen" sort="Koester, Juergen" uniqKey="Koester J" first="Juergen" last="Koester">Juergen Koester</name></author><author><name sortKey="Reess, Juergen" sort="Reess, Juergen" uniqKey="Reess J" first="Juergen" last="Reess">Juergen Reess</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>Adolescent</term><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Antiparkinson Agents (therapeutic use)</term><term>Benzothiazoles (therapeutic use)</term><term>Demography</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Restless Legs Syndrome (diagnosis)</term><term>Restless Legs Syndrome (drug therapy)</term><term>Restless Legs Syndrome (physiopathology)</term><term>Severity of Illness Index</term><term>Time Factors</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</term><term>Benzothiazoles</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Restless Legs Syndrome</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Restless Legs Syndrome</term></keywords><keywords scheme="MESH" qualifier="physiopathology" xml:lang="en"><term>Restless Legs Syndrome</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Demography</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Severity of Illness Index</term><term>Time Factors</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">We evaluated the efficacy of pramipexole versus placebo in restless legs syndrome (RLS) for 6 weeks. Overall, 345 patients were randomly assigned in a 1:2 ratio to receive either placebo (n = 115) or pramipexole (n = 230) with a starting dose of 0.125 mg/day. The dose was individually optimized according to the Patient Global Impression (PGI) assessment, up to a maximum of 0.75 mg/day. The primary endpoint consisted of two assessments: the change from baseline in the International RLS Study Group Rating Scale (IRLS) and the proportion of patients with Clinical Global Impressions-Improvement (CGI-I) assessments of "much/very much improved" (CGI-I responders) at week 6. Secondary endpoints included PGI and IRLS responder rates. Patient demographics and baseline characteristics were comparable between treatment groups. At baseline, mean IRLS scores were 24.9 (placebo) and 24.7 (pramipexole), representing severely affected patients. After 6 weeks, adjusted mean reductions (+/-SE) in IRLS score were 5.7 (+/-0.9) for placebo (median dose 0.47 mg/day) and 12.3 (+/-0.6) for pramipexole (median dose 0.35 mg/day; P < 0.0001). CGI-I responder rates were 32.5% (placebo) and 62.9% (pramipexole) (P < 0.0001). For all secondary endpoints, pramipexole showed superior results. Pramipexole was well tolerated throughout the study.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">17133582</PMID><DateCreated><Year>2007</Year><Month>02</Month><Day>05</Day></DateCreated><DateCompleted><Year>2007</Year><Month>03</Month><Day>23</Day></DateCompleted><DateRevised><Year>2012</Year><Month>11</Month><Day>15</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0885-3185</ISSN><JournalIssue CitedMedium="Print"><Volume>22</Volume><Issue>2</Issue><PubDate><Year>2007</Year><Month>Jan</Month><Day>15</Day></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>Efficacy of pramipexole in restless legs syndrome: a six-week, multicenter, randomized, double-blind study (effect-RLS study).</ArticleTitle><Pagination><MedlinePgn>213-9</MedlinePgn></Pagination><Abstract><AbstractText>We evaluated the efficacy of pramipexole versus placebo in restless legs syndrome (RLS) for 6 weeks. Overall, 345 patients were randomly assigned in a 1:2 ratio to receive either placebo (n = 115) or pramipexole (n = 230) with a starting dose of 0.125 mg/day. The dose was individually optimized according to the Patient Global Impression (PGI) assessment, up to a maximum of 0.75 mg/day. The primary endpoint consisted of two assessments: the change from baseline in the International RLS Study Group Rating Scale (IRLS) and the proportion of patients with Clinical Global Impressions-Improvement (CGI-I) assessments of "much/very much improved" (CGI-I responders) at week 6. Secondary endpoints included PGI and IRLS responder rates. Patient demographics and baseline characteristics were comparable between treatment groups. At baseline, mean IRLS scores were 24.9 (placebo) and 24.7 (pramipexole), representing severely affected patients. After 6 weeks, adjusted mean reductions (+/-SE) in IRLS score were 5.7 (+/-0.9) for placebo (median dose 0.47 mg/day) and 12.3 (+/-0.6) for pramipexole (median dose 0.35 mg/day; P < 0.0001). CGI-I responder rates were 32.5% (placebo) and 62.9% (pramipexole) (P < 0.0001). For all secondary endpoints, pramipexole showed superior results. Pramipexole was well tolerated throughout the study.</AbstractText><CopyrightInformation>(c) 2006 Movement Disorder Society.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Oertel</LastName><ForeName>Wolfgang H</ForeName><Initials>WH</Initials><AffiliationInfo><Affiliation>Philipps-University Marburg, Marburg, Germany. oertelw@med.uni-marburg.de</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stiasny-Kolster</LastName><ForeName>Karin</ForeName><Initials>K</Initials></Author><Author ValidYN="Y"><LastName>Bergtholdt</LastName><ForeName>Bettina</ForeName><Initials>B</Initials></Author><Author ValidYN="Y"><LastName>Hallström</LastName><ForeName>Yngve</ForeName><Initials>Y</Initials></Author><Author ValidYN="Y"><LastName>Albo</LastName><ForeName>Jaan</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Leissner</LastName><ForeName>Lena</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><LastName>Schindler</LastName><ForeName>Thomas</ForeName><Initials>T</Initials></Author><Author ValidYN="Y"><LastName>Koester</LastName><ForeName>Juergen</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Reess</LastName><ForeName>Juergen</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><CollectiveName>Pramipexole RLS Study Group</CollectiveName></Author></AuthorList><Language>eng</Language><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></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="D052160">Benzothiazoles</NameOfSubstance></Chemical><Chemical><RegistryNumber>83619PEU5T</RegistryNumber><NameOfSubstance UI="C061333">pramipexole</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000293">Adolescent</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000328">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000368">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000369">Aged, 80 and over</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="D052160">Benzothiazoles</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D003710">Demography</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004311">Double-Blind Method</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="D008297">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008875">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D012148">Restless Legs Syndrome</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000175">diagnosis</QualifierName><QualifierName MajorTopicYN="Y" UI="Q000188">drug therapy</QualifierName><QualifierName MajorTopicYN="N" UI="Q000503">physiopathology</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D012720">Severity of Illness Index</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D013997">Time Factors</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2006</Year><Month>11</Month><Day>30</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2007</Year><Month>3</Month><Day>24</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2006</Year><Month>11</Month><Day>30</Day><Hour>9</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="doi">10.1002/mds.21261</ArticleId><ArticleId IdType="pubmed">17133582</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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