Efficacy of pramipexole in restless legs syndrome: A six‐week, multicenter, randomized, double‐blind study (effect‐RLS study)
Identifieur interne : 001246 ( Istex/Corpus ); précédent : 001245; suivant : 001247Efficacy 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 [ 0885-3185 ] ; 2007-01-15.
English descriptors
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. © 2006 Movement Disorder Society
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DOI: 10.1002/mds.21261
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ISTEX:CEC7F3437FDC1CEC349A93DA7242C8F7DC309C33Le document en format XML
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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. © 2006 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Wolfgang H. Oertel MD</name><affiliations><json:string>Philipps‐University Marburg, Marburg, Germany</json:string></affiliations></json:item><json:item><name>Karin Stiasny‐Kolster MD</name><affiliations><json:string>Philipps‐University Marburg, Marburg, Germany</json:string></affiliations></json:item><json:item><name>Bettina Bergtholdt MD</name><affiliations><json:string>Emovis GmbH, Berlin, Germany</json:string></affiliations></json:item><json:item><name>Yngve Hallström MD</name><affiliations><json:string>Neuro Center, Stockholm, Sweden</json:string></affiliations></json:item><json:item><name>Jaan Albo MD</name><affiliations><json:string>Läkarhuset Vällingby, Vällingby, Sweden</json:string></affiliations></json:item><json:item><name>Lena Leissner MD</name><affiliations><json:string>Neurologiska Kliniken, Örebro, Sweden</json:string></affiliations></json:item><json:item><name>Thomas Schindler PhD</name><affiliations><json:string>Boehringer Ingelheim Pharma GmbH & Co. KG, Germany</json:string></affiliations></json:item><json:item><name>Juergen Koester PhD</name><affiliations><json:string>Boehringer Ingelheim Pharma GmbH & Co. KG, Germany</json:string></affiliations></json:item><json:item><name>Juergen Reess MD</name><affiliations><json:string>Boehringer Ingelheim Pharma GmbH & Co. KG, Germany</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>pramipexole</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>restless legs syndrome</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>clinical trial</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>dopamine agonist</value></json:item></subject><language><json:string>eng</json:string></language><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. 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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. 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href="file:MDS.MDS21261.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="2"></count><count type="tableTotal" number="5"></count><count type="referenceTotal" number="14"></count><count type="wordTotal" number="4589"></count></countGroup><titleGroup><title type="main" xml:lang="en">Efficacy of pramipexole in restless legs syndrome: A six‐week, multicenter, randomized, double‐blind study (effect‐RLS study)</title><title type="short" xml:lang="en">Pramipexole in RLS</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes"><personName><givenNames>Wolfgang H.</givenNames><familyName>Oertel</familyName><degrees>MD</degrees></personName><contactDetails><email normalForm="oertelw@med.uni-marburg.de">oertelw@med.uni‐marburg.de</email></contactDetails></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#af1"><personName><givenNames>Karin</givenNames><familyName>Stiasny‐Kolster</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#af2"><personName><givenNames>Bettina</givenNames><familyName>Bergtholdt</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#af3"><personName><givenNames>Yngve</givenNames><familyName>Hallström</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au5" creatorRole="author" affiliationRef="#af4"><personName><givenNames>Jaan</givenNames><familyName>Albo</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au6" creatorRole="author" affiliationRef="#af5"><personName><givenNames>Lena</givenNames><familyName>Leissner</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au7" creatorRole="author" affiliationRef="#af6"><personName><givenNames>Thomas</givenNames><familyName>Schindler</familyName><degrees>PhD</degrees></personName></creator><creator xml:id="au8" creatorRole="author" affiliationRef="#af6"><personName><givenNames>Juergen</givenNames><familyName>Koester</familyName><degrees>PhD</degrees></personName></creator><creator xml:id="au9" creatorRole="author" affiliationRef="#af6"><personName><givenNames>Juergen</givenNames><familyName>Reess</familyName><degrees>MD</degrees></personName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="DE" type="organization"><unparsedAffiliation>Philipps‐University Marburg, Marburg, Germany</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="DE" type="organization"><unparsedAffiliation>Emovis GmbH, Berlin, Germany</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="SE" type="organization"><unparsedAffiliation>Neuro Center, Stockholm, Sweden</unparsedAffiliation></affiliation><affiliation xml:id="af4" countryCode="SE" type="organization"><unparsedAffiliation>Läkarhuset Vällingby, Vällingby, Sweden</unparsedAffiliation></affiliation><affiliation xml:id="af5" countryCode="SE" type="organization"><unparsedAffiliation>Neurologiska Kliniken, Örebro, Sweden</unparsedAffiliation></affiliation><affiliation xml:id="af6" countryCode="DE" type="organization"><unparsedAffiliation>Boehringer Ingelheim Pharma GmbH & Co. KG, Germany</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">pramipexole</keyword><keyword xml:id="kwd2">restless legs syndrome</keyword><keyword xml:id="kwd3">clinical trial</keyword><keyword xml:id="kwd4">dopamine agonist</keyword></keywordGroup><fundingInfo><fundingAgency>Boehringer Ingelheim International</fundingAgency></fundingInfo><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>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; <i>P</i> < 0.0001). CGI‐I responder rates were 32.5% (placebo) and 62.9% (pramipexole) (<i>P</i> < 0.0001). For all secondary endpoints, pramipexole showed superior results. Pramipexole was well tolerated throughout the study. © 2006 Movement Disorder Society</p></abstract></abstractGroup></contentMeta></header></component></istex:document></istex:metadataXml><!--Version 0.6 générée le 3-12-2015--><mods version="3.6"><titleInfo lang="en"><title>Efficacy of pramipexole in restless legs syndrome: A six‐week, multicenter, randomized, double‐blind study (effect‐RLS study)</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Pramipexole in RLS</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Efficacy of pramipexole in restless legs syndrome: A six‐week, multicenter, randomized, double‐blind study (effect‐RLS study)</title></titleInfo><name type="personal"><namePart type="given">Wolfgang H.</namePart><namePart type="family">Oertel</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Philipps‐University Marburg, Marburg, Germany</affiliation><description>Correspondence: Department of Neurology, Philipps‐University Marburg, Rudolf‐Bultmann‐Strasse 8, D‐35039 Marburg, Germany</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Karin</namePart><namePart type="family">Stiasny‐Kolster</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Philipps‐University Marburg, Marburg, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Bettina</namePart><namePart type="family">Bergtholdt</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Emovis GmbH, Berlin, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Yngve</namePart><namePart type="family">Hallström</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Neuro Center, Stockholm, Sweden</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Jaan</namePart><namePart type="family">Albo</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Läkarhuset Vällingby, Vällingby, Sweden</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Lena</namePart><namePart type="family">Leissner</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Neurologiska Kliniken, Örebro, Sweden</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Thomas</namePart><namePart type="family">Schindler</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>Boehringer Ingelheim Pharma GmbH & Co. KG, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Juergen</namePart><namePart type="family">Koester</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>Boehringer Ingelheim Pharma GmbH & Co. KG, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Juergen</namePart><namePart type="family">Reess</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Boehringer Ingelheim Pharma GmbH & Co. KG, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre authority="originalCategForm">article</genre><originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Hoboken</placeTerm></place><dateIssued encoding="w3cdtf">2007-01-15</dateIssued><dateCaptured encoding="w3cdtf">2006-04-05</dateCaptured><dateValid encoding="w3cdtf">2006-08-21</dateValid><copyrightDate encoding="w3cdtf">2007</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType><extent unit="figures">2</extent><extent unit="tables">5</extent><extent unit="references">14</extent><extent unit="words">4589</extent></physicalDescription><abstract 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. © 2006 Movement Disorder Society</abstract><note type="funding">Boehringer Ingelheim International</note><subject lang="en"><genre>Keywords</genre><topic>pramipexole</topic><topic>restless legs syndrome</topic><topic>clinical trial</topic><topic>dopamine agonist</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title><subTitle>Official Journal of the Movement Disorder Society</subTitle></titleInfo><titleInfo type="abbreviated"><title>Mov. Disord.</title></titleInfo><subject><genre>article category</genre><topic>Research Article</topic></subject><identifier type="ISSN">0885-3185</identifier><identifier type="eISSN">1531-8257</identifier><identifier type="DOI">10.1002/(ISSN)1531-8257</identifier><identifier type="PublisherID">MDS</identifier><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>22</number></detail><detail type="issue"><caption>no.</caption><number>2</number></detail><extent unit="pages"><start>213</start><end>219</end><total>7</total></extent></part></relatedItem><identifier type="istex">CEC7F3437FDC1CEC349A93DA7242C8F7DC309C33</identifier><identifier type="DOI">10.1002/mds.21261</identifier><identifier type="ArticleID">MDS21261</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2006 Movement Disorder Society</accessCondition><recordInfo><recordOrigin>Wiley Subscription Services, Inc., A Wiley Company</recordOrigin><recordContentSource>WILEY</recordContentSource></recordInfo></mods></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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