Efficacy, safety, and tolerability of overnight switching from immediate‐ to once daily extended‐release pramipexole in early Parkinson's disease
Identifieur interne : 000849 ( Istex/Corpus ); précédent : 000848; suivant : 000850Efficacy, safety, and tolerability of overnight switching from immediate‐ to once daily extended‐release pramipexole in early Parkinson's disease
Auteurs : Olivier Rascol ; Paolo Barone ; Robert A. Hauser ; Yoshikuni Mizuno ; Werner Poewe ; Anthony H. V. Schapira ; Laurence Salin ; Mandy Sohr ; Catherine DebieuvreSource :
- Movement Disorders [ 0885-3185 ] ; 2010-10-30.
English descriptors
Abstract
The aim of this article is to test the feasibility, in early Parkinson's disease (PD), of an overnight switch from immediate‐release (IR) pramipexole to a new once‐daily extended‐release (ER) formulation. Nonfluctuating patients on pramipexole IR three‐times daily, alone or with levodopa, for early PD were randomly switched overnight to double‐blind IR three‐times daily (N = 52) or ER once‐daily (N = 104) at initially unchanged daily dosage. Successful switching (defined as no worsening >15% of baseline UPDRS II+III score and no drug‐related adverse event withdrawal) was assessed at 9 weeks, after optional dosage adjustments (primary endpoint), and at 4 weeks, before adjustment. Other secondary endpoints included adjusted mean changes from baseline in UPDRS scores and proportion of responders based on Clinical or Patient Global Impression (CGI/PGI). Absolute difference between percentage of successful switch to ER versus IR was tested for ER noninferiority, defined as a 95% confidence‐interval lower bound not exceeding −15%. At 9 weeks, 84.5% of the ER group had been successfully switched, versus 94.2% for IR. Noninferiority was not demonstrated, with a difference of −9.76% (95% CI: [−18.81%, +1.66%]). At 4 weeks, 81.6% of the ER group had been successfully switched, versus 92.3% for IR, a difference of −10.75% (95% CI: [−20.51%, +1.48%]). UPDRS changes and CGI/PGI analyses showed no differences between the groups. Both formulations were safe and well tolerated. Pramipexole ER was not equivalent to IR, but the difference was marginal. The fact that >80% of the patients successfully switched overnight at unchanged dosage shows that this practice was feasible in most patients. © 2010 Movement Disorder Society
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DOI: 10.1002/mds.23262
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ISTEX:624285B60AB87EE65180007CBA2766EED01548AFLe document en format XML
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Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2010-10-30">2010-10-30</date><biblScope unit="vol">25</biblScope><biblScope unit="issue">14</biblScope><biblScope unit="page" from="2326">2326</biblScope><biblScope unit="page" to="2332">2332</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">624285B60AB87EE65180007CBA2766EED01548AF</idno><idno type="DOI">10.1002/mds.23262</idno><idno type="ArticleID">MDS23262</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Parkinson's disease</term><term>dopamine agonist</term><term>pramipexole‐extended release</term><term>switch trial</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The aim of this article is to test the feasibility, in early Parkinson's disease (PD), of an overnight switch from immediate‐release (IR) pramipexole to a new once‐daily extended‐release (ER) formulation. Nonfluctuating patients on pramipexole IR three‐times daily, alone or with levodopa, for early PD were randomly switched overnight to double‐blind IR three‐times daily (N = 52) or ER once‐daily (N = 104) at initially unchanged daily dosage. Successful switching (defined as no worsening >15% of baseline UPDRS II+III score and no drug‐related adverse event withdrawal) was assessed at 9 weeks, after optional dosage adjustments (primary endpoint), and at 4 weeks, before adjustment. Other secondary endpoints included adjusted mean changes from baseline in UPDRS scores and proportion of responders based on Clinical or Patient Global Impression (CGI/PGI). Absolute difference between percentage of successful switch to ER versus IR was tested for ER noninferiority, defined as a 95% confidence‐interval lower bound not exceeding −15%. At 9 weeks, 84.5% of the ER group had been successfully switched, versus 94.2% for IR. Noninferiority was not demonstrated, with a difference of −9.76% (95% CI: [−18.81%, +1.66%]). At 4 weeks, 81.6% of the ER group had been successfully switched, versus 92.3% for IR, a difference of −10.75% (95% CI: [−20.51%, +1.48%]). UPDRS changes and CGI/PGI analyses showed no differences between the groups. Both formulations were safe and well tolerated. Pramipexole ER was not equivalent to IR, but the difference was marginal. The fact that >80% of the patients successfully switched overnight at unchanged dosage shows that this practice was feasible in most patients. © 2010 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Olivier Rascol MD, PhD</name><affiliations><json:string>Departments of Clinical Pharmacology and Neurosciences, Toulouse University Hospital, INSERM CIC9302‐UMR825 Toulouse, France</json:string></affiliations></json:item><json:item><name>Paolo Barone MD</name><affiliations><json:string>Department of Neurological Sciences, University of Naples, Naples, Italy</json:string></affiliations></json:item><json:item><name>Robert A. Hauser MD</name><affiliations><json:string>Department of Neurology, University of South Florida, Tampa, Florida, USA</json:string></affiliations></json:item><json:item><name>Yoshikuni Mizuno MD</name><affiliations><json:string>Department of Neurology, Juntendo University School of Medicine, Bunkyo‐ku, Tokyo, Japan</json:string></affiliations></json:item><json:item><name>Werner Poewe MD</name><affiliations><json:string>Department of Neurology, Innsbruck Medical University, Innsbruck, Austria</json:string></affiliations></json:item><json:item><name>Anthony H.V. Schapira MD, DSc, FRCP, FmedSci</name><affiliations><json:string>University Department of Clinical Neurosciences, Institute of Neurology, University College London, London, United Kingdom</json:string></affiliations></json:item><json:item><name>Laurence Salin MD</name><affiliations><json:string>Clinical Research Department, Boehringer Ingelheim France S.A.S., Reims, France</json:string></affiliations></json:item><json:item><name>Mandy Sohr PhD</name><affiliations><json:string>Medical Division, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany</json:string></affiliations></json:item><json:item><name>Catherine Debieuvre PharmD, PhD</name><affiliations><json:string>Clinical Research Department, Boehringer Ingelheim France S.A.S., Reims, France</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>pramipexole‐extended release</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Parkinson's disease</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>dopamine agonist</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>switch trial</value></json:item></subject><language><json:string>eng</json:string></language><abstract>The aim of this article is to test the feasibility, in early Parkinson's disease (PD), of an overnight switch from immediate‐release (IR) pramipexole to a new once‐daily extended‐release (ER) formulation. Nonfluctuating patients on pramipexole IR three‐times daily, alone or with levodopa, for early PD were randomly switched overnight to double‐blind IR three‐times daily (N = 52) or ER once‐daily (N = 104) at initially unchanged daily dosage. Successful switching (defined as no worsening >15% of baseline UPDRS II+III score and no drug‐related adverse event withdrawal) was assessed at 9 weeks, after optional dosage adjustments (primary endpoint), and at 4 weeks, before adjustment. Other secondary endpoints included adjusted mean changes from baseline in UPDRS scores and proportion of responders based on Clinical or Patient Global Impression (CGI/PGI). Absolute difference between percentage of successful switch to ER versus IR was tested for ER noninferiority, defined as a 95% confidence‐interval lower bound not exceeding −15%. At 9 weeks, 84.5% of the ER group had been successfully switched, versus 94.2% for IR. Noninferiority was not demonstrated, with a difference of −9.76% (95% CI: [−18.81%, +1.66%]). At 4 weeks, 81.6% of the ER group had been successfully switched, versus 92.3% for IR, a difference of −10.75% (95% CI: [−20.51%, +1.48%]). UPDRS changes and CGI/PGI analyses showed no differences between the groups. Both formulations were safe and well tolerated. Pramipexole ER was not equivalent to IR, but the difference was marginal. The fact that >80% of the patients successfully switched overnight at unchanged dosage shows that this practice was feasible in most patients. © 2010 Movement Disorder Society</abstract><qualityIndicators><score>7.198</score><pdfVersion>1.3</pdfVersion><pdfPageSize>612 x 810 pts</pdfPageSize><refBibsNative>true</refBibsNative><abstractCharCount>1736</abstractCharCount><pdfWordCount>4198</pdfWordCount><pdfCharCount>28047</pdfCharCount><pdfPageCount>7</pdfPageCount><abstractWordCount>262</abstractWordCount></qualityIndicators><title>Efficacy, safety, and tolerability of overnight switching from immediate‐ to once daily extended‐release pramipexole in early Parkinson's disease</title><corporate><json:item><name></name></json:item></corporate><genre><json:string>Serial article</json:string></genre><host><volume>25</volume><pages><total>7</total><last>2332</last><first>2326</first></pages><issn><json:string>0885-3185</json:string></issn><issue>14</issue><subject><json:item><value>Research Article</value></json:item></subject><genre></genre><language><json:string>unknown</json:string></language><title>Movement Disorders</title><doi><json:string>10.1002/(ISSN)1531-8257</json:string></doi></host><publicationDate>2010</publicationDate><copyrightDate>2010</copyrightDate><doi><json:string>10.1002/mds.23262</json:string></doi><id>624285B60AB87EE65180007CBA2766EED01548AF</id><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/624285B60AB87EE65180007CBA2766EED01548AF/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/624285B60AB87EE65180007CBA2766EED01548AF/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/624285B60AB87EE65180007CBA2766EED01548AF/fulltext/tei"><teiHeader type="text"><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Efficacy, safety, and tolerability of overnight switching from immediate‐ to once daily extended‐release pramipexole in early Parkinson's disease</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><availability><p>Wiley Subscription Services, Inc., A Wiley Company</p></availability><date>2010</date></publicationStmt><notesStmt><note type="content">*Potential Conflict of Interest: Drs. Olivier Rascol, Paolo Barone, Robert Hauser, Yoshikuni Mizuno, Werner Poewe, Anthony Schapira have received financial support to disclose for this study; Drs. Laurence Salin, Mandy Sohr, Catherine Debieuvre are employees of Boehringer Ingelheim.</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Efficacy, safety, and tolerability of overnight switching from immediate‐ to once daily extended‐release pramipexole in early Parkinson's disease</title><author><orgName>for the Pramipexole Switch Study Group</orgName></author><author><persName><forename type="first">Olivier</forename><surname>Rascol</surname><roleName type="degree">MD, PhD</roleName></persName><note type="correspondence"><p>Correspondence: Departments of Clinical Pharmacology and Neurosciences, Faculty of Medicine, 37 Allées Jules Guesde, 31000 Toulouse, France</p></note><affiliation>Departments of Clinical Pharmacology and Neurosciences, Toulouse University Hospital, INSERM CIC9302‐UMR825 Toulouse, France</affiliation></author><author><persName><forename type="first">Paolo</forename><surname>Barone</surname><roleName type="degree">MD</roleName></persName><affiliation>Department of Neurological Sciences, University of Naples, Naples, Italy</affiliation></author><author><persName><forename type="first">Robert A.</forename><surname>Hauser</surname><roleName type="degree">MD</roleName></persName><affiliation>Department of Neurology, University of South Florida, Tampa, Florida, USA</affiliation></author><author><persName><forename type="first">Yoshikuni</forename><surname>Mizuno</surname><roleName type="degree">MD</roleName></persName><affiliation>Department of Neurology, Juntendo University School of Medicine, Bunkyo‐ku, Tokyo, Japan</affiliation></author><author><persName><forename type="first">Werner</forename><surname>Poewe</surname><roleName type="degree">MD</roleName></persName><affiliation>Department of Neurology, Innsbruck Medical University, Innsbruck, Austria</affiliation></author><author><persName><forename type="first">Anthony H.V.</forename><surname>Schapira</surname><roleName type="degree">MD, DSc, FRCP, FmedSci</roleName></persName><affiliation>University Department of Clinical Neurosciences, Institute of Neurology, University College London, London, United Kingdom</affiliation></author><author><persName><forename type="first">Laurence</forename><surname>Salin</surname><roleName type="degree">MD</roleName></persName><affiliation>Clinical Research Department, Boehringer Ingelheim France S.A.S., Reims, France</affiliation></author><author><persName><forename type="first">Mandy</forename><surname>Sohr</surname><roleName type="degree">PhD</roleName></persName><affiliation>Medical Division, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany</affiliation></author><author><persName><forename type="first">Catherine</forename><surname>Debieuvre</surname><roleName type="degree">PharmD, PhD</roleName></persName><affiliation>Clinical Research Department, Boehringer Ingelheim France S.A.S., Reims, France</affiliation></author></analytic><monogr><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="pISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><idno type="DOI">10.1002/(ISSN)1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2010-10-30"></date><biblScope unit="vol">25</biblScope><biblScope unit="issue">14</biblScope><biblScope unit="page" from="2326">2326</biblScope><biblScope unit="page" to="2332">2332</biblScope></imprint></monogr><idno type="istex">624285B60AB87EE65180007CBA2766EED01548AF</idno><idno type="DOI">10.1002/mds.23262</idno><idno type="ArticleID">MDS23262</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2010</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>The aim of this article is to test the feasibility, in early Parkinson's disease (PD), of an overnight switch from immediate‐release (IR) pramipexole to a new once‐daily extended‐release (ER) formulation. Nonfluctuating patients on pramipexole IR three‐times daily, alone or with levodopa, for early PD were randomly switched overnight to double‐blind IR three‐times daily (N = 52) or ER once‐daily (N = 104) at initially unchanged daily dosage. Successful switching (defined as no worsening >15% of baseline UPDRS II+III score and no drug‐related adverse event withdrawal) was assessed at 9 weeks, after optional dosage adjustments (primary endpoint), and at 4 weeks, before adjustment. Other secondary endpoints included adjusted mean changes from baseline in UPDRS scores and proportion of responders based on Clinical or Patient Global Impression (CGI/PGI). Absolute difference between percentage of successful switch to ER versus IR was tested for ER noninferiority, defined as a 95% confidence‐interval lower bound not exceeding −15%. At 9 weeks, 84.5% of the ER group had been successfully switched, versus 94.2% for IR. Noninferiority was not demonstrated, with a difference of −9.76% (95% CI: [−18.81%, +1.66%]). At 4 weeks, 81.6% of the ER group had been successfully switched, versus 92.3% for IR, a difference of −10.75% (95% CI: [−20.51%, +1.48%]). UPDRS changes and CGI/PGI analyses showed no differences between the groups. Both formulations were safe and well tolerated. Pramipexole ER was not equivalent to IR, but the difference was marginal. 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Disord.</title></titleGroup></publicationMeta><publicationMeta level="part" position="140"><doi origin="wiley" registered="yes">10.1002/mds.v25:14</doi><numberingGroup><numbering type="journalVolume" number="25">25</numbering><numbering type="journalIssue">14</numbering></numberingGroup><coverDate startDate="2010-10-30">30 October 2010</coverDate></publicationMeta><publicationMeta level="unit" type="article" position="100" status="forIssue"><doi origin="wiley" registered="yes">10.1002/mds.23262</doi><idGroup><id type="unit" value="MDS23262"></id></idGroup><countGroup><count type="pageTotal" number="7"></count></countGroup><titleGroup><title type="articleCategory">Research Article</title><title type="tocHeading1">Research Articles</title></titleGroup><copyright ownership="thirdParty">Copyright © 2010 Movement Disorder Society</copyright><eventGroup><event type="manuscriptReceived" date="2009-12-22"></event><event type="manuscriptRevised" date="2010-03-29"></event><event type="manuscriptAccepted" date="2010-04-26"></event><event type="firstOnline" date="2010-07-28"></event><event type="publishedOnlineAcceptedOrEarlyUnpaginated" date="2010-07-28"></event><event type="xmlConverted" agent="Converter:JWSART34_TO_WML3G version:2.5.2 mode:FullText source:FullText result:FullText" date="2011-07-06"></event><event type="publishedOnlineFinalForm" date="2010-10-25"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:3.8.8" date="2014-02-02"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.1.7 mode:FullText,remove_FC" date="2014-10-31"></event></eventGroup><numberingGroup><numbering type="pageFirst">2326</numbering><numbering type="pageLast">2332</numbering></numberingGroup><correspondenceTo>Departments of Clinical Pharmacology and Neurosciences, Faculty of Medicine, 37 Allées Jules Guesde, 31000 Toulouse, France</correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:MDS.MDS23262.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="3"></count><count type="tableTotal" number="4"></count><count type="referenceTotal" number="25"></count><count type="wordTotal" number="5711"></count></countGroup><titleGroup><title type="main" xml:lang="en">Efficacy, safety, and tolerability of overnight switching from immediate‐ to once daily extended‐release pramipexole in early Parkinson's disease<link href="#fn3"></link></title><title type="short" xml:lang="en">Pramipexole Extended‐Release Overnight Switch</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes"><personName><givenNames>Olivier</givenNames><familyName>Rascol</familyName><degrees>MD, PhD</degrees></personName><contactDetails><email>rascol@cict.fr</email></contactDetails></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#af2"><personName><givenNames>Paolo</givenNames><familyName>Barone</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#af3"><personName><givenNames>Robert A.</givenNames><familyName>Hauser</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#af4"><personName><givenNames>Yoshikuni</givenNames><familyName>Mizuno</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au5" creatorRole="author" affiliationRef="#af5"><personName><givenNames>Werner</givenNames><familyName>Poewe</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au6" creatorRole="author" affiliationRef="#af6"><personName><givenNames>Anthony H.V.</givenNames><familyName>Schapira</familyName><degrees>MD, DSc, FRCP, FmedSci</degrees></personName></creator><creator xml:id="au7" creatorRole="author" affiliationRef="#af7"><personName><givenNames>Laurence</givenNames><familyName>Salin</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au8" creatorRole="author" affiliationRef="#af8"><personName><givenNames>Mandy</givenNames><familyName>Sohr</familyName><degrees>PhD</degrees></personName></creator><creator xml:id="au9" creatorRole="author" affiliationRef="#af7"><personName><givenNames>Catherine</givenNames><familyName>Debieuvre</familyName><degrees>PharmD, PhD</degrees></personName></creator><creator xml:id="au10" creatorRole="author"><groupName>for the Pramipexole Switch Study Group</groupName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="FR" type="organization"><unparsedAffiliation>Departments of Clinical Pharmacology and Neurosciences, Toulouse University Hospital, INSERM CIC9302‐UMR825 Toulouse, France</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="IT" type="organization"><unparsedAffiliation>Department of Neurological Sciences, University of Naples, Naples, Italy</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, University of South Florida, Tampa, Florida, USA</unparsedAffiliation></affiliation><affiliation xml:id="af4" countryCode="JP" type="organization"><unparsedAffiliation>Department of Neurology, Juntendo University School of Medicine, Bunkyo‐ku, Tokyo, Japan</unparsedAffiliation></affiliation><affiliation xml:id="af5" countryCode="AT" type="organization"><unparsedAffiliation>Department of Neurology, Innsbruck Medical University, Innsbruck, Austria</unparsedAffiliation></affiliation><affiliation xml:id="af6" countryCode="GB" type="organization"><unparsedAffiliation>University Department of Clinical Neurosciences, Institute of Neurology, University College London, London, United Kingdom</unparsedAffiliation></affiliation><affiliation xml:id="af7" countryCode="FR" type="organization"><unparsedAffiliation>Clinical Research Department, Boehringer Ingelheim France S.A.S., Reims, France</unparsedAffiliation></affiliation><affiliation xml:id="af8" countryCode="DE" type="organization"><unparsedAffiliation>Medical Division, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">pramipexole‐extended release</keyword><keyword xml:id="kwd2">Parkinson's disease</keyword><keyword xml:id="kwd3">dopamine agonist</keyword><keyword xml:id="kwd4">switch trial</keyword></keywordGroup><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>The aim of this article is to test the feasibility, in early Parkinson's disease (PD), of an overnight switch from immediate‐release (IR) pramipexole to a new once‐daily extended‐release (ER) formulation. Nonfluctuating patients on pramipexole IR three‐times daily, alone or with levodopa, for early PD were randomly switched overnight to double‐blind IR three‐times daily (N = 52) or ER once‐daily (N = 104) at initially unchanged daily dosage. Successful switching (defined as no worsening >15% of baseline UPDRS II+III score and no drug‐related adverse event withdrawal) was assessed at 9 weeks, after optional dosage adjustments (primary endpoint), and at 4 weeks, before adjustment. Other secondary endpoints included adjusted mean changes from baseline in UPDRS scores and proportion of responders based on Clinical or Patient Global Impression (CGI/PGI). Absolute difference between percentage of successful switch to ER versus IR was tested for ER noninferiority, defined as a 95% confidence‐interval lower bound not exceeding −15%. At 9 weeks, 84.5% of the ER group had been successfully switched, versus 94.2% for IR. Noninferiority was not demonstrated, with a difference of −9.76% (95% CI: [−18.81%, +1.66%]). At 4 weeks, 81.6% of the ER group had been successfully switched, versus 92.3% for IR, a difference of −10.75% (95% CI: [−20.51%, +1.48%]). UPDRS changes and CGI/PGI analyses showed no differences between the groups. Both formulations were safe and well tolerated. Pramipexole ER was not equivalent to IR, but the difference was marginal. The fact that >80% of the patients successfully switched overnight at unchanged dosage shows that this practice was feasible in most patients. © 2010 Movement Disorder Society</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn3"><p>Potential Conflict of Interest: Drs. Olivier Rascol, Paolo Barone, Robert Hauser, Yoshikuni Mizuno, Werner Poewe, Anthony Schapira have received financial support to disclose for this study; Drs. Laurence Salin, Mandy Sohr, Catherine Debieuvre are employees of Boehringer Ingelheim.</p></note></noteGroup></header></component></istex:document></istex:metadataXml><!--Version 0.6 générée le 3-12-2015--><mods version="3.6"><titleInfo lang="en"><title>Efficacy, safety, and tolerability of overnight switching from immediate‐ to once daily extended‐release pramipexole in early Parkinson's disease</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Pramipexole Extended‐Release Overnight Switch</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Efficacy, safety, and tolerability of overnight switching from immediate‐ to once daily extended‐release pramipexole in early Parkinson's disease</title></titleInfo><name type="personal"><namePart type="given">Olivier</namePart><namePart type="family">Rascol</namePart><namePart type="termsOfAddress">MD, PhD</namePart><affiliation>Departments of Clinical Pharmacology and Neurosciences, Toulouse University Hospital, INSERM CIC9302‐UMR825 Toulouse, France</affiliation><description>Correspondence: Departments of Clinical Pharmacology and Neurosciences, Faculty of Medicine, 37 Allées Jules Guesde, 31000 Toulouse, France</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Paolo</namePart><namePart type="family">Barone</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurological Sciences, University of Naples, Naples, Italy</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Robert A.</namePart><namePart type="family">Hauser</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, University of South Florida, Tampa, Florida, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Yoshikuni</namePart><namePart type="family">Mizuno</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Juntendo University School of Medicine, Bunkyo‐ku, Tokyo, Japan</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Werner</namePart><namePart type="family">Poewe</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Innsbruck Medical University, Innsbruck, Austria</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Anthony H.V.</namePart><namePart type="family">Schapira</namePart><namePart type="termsOfAddress">MD, DSc, FRCP, FmedSci</namePart><affiliation>University Department of Clinical Neurosciences, Institute of Neurology, University College London, London, United Kingdom</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Laurence</namePart><namePart type="family">Salin</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Clinical Research Department, Boehringer Ingelheim France S.A.S., Reims, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Mandy</namePart><namePart type="family">Sohr</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>Medical Division, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Catherine</namePart><namePart type="family">Debieuvre</namePart><namePart type="termsOfAddress">PharmD, PhD</namePart><affiliation>Clinical Research Department, Boehringer Ingelheim France S.A.S., Reims, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="corporate"><namePart>for the Pramipexole Switch Study Group</namePart><description>Departments of Clinical Pharmacology and Neurosciences, Toulouse University Hospital, INSERM CIC9302‐UMR825 Toulouse, FranceDepartment of Neurological Sciences, University of Naples, Naples, ItalyDepartment of Neurology, University of South Florida, Tampa, Florida, USADepartment of Neurology, Juntendo University School of Medicine, Bunkyo‐ku, Tokyo, JapanDepartment of Neurology, Innsbruck Medical University, Innsbruck, AustriaUniversity Department of Clinical Neurosciences, Institute of Neurology, University College London, London, United KingdomClinical Research Department, Boehringer Ingelheim France S.A.S., Reims, FranceMedical Division, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany</description></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">2010-10-30</dateIssued><dateCaptured encoding="w3cdtf">2009-12-22</dateCaptured><dateValid encoding="w3cdtf">2010-04-26</dateValid><copyrightDate encoding="w3cdtf">2010</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">3</extent><extent unit="tables">4</extent><extent unit="references">25</extent><extent unit="words">5711</extent></physicalDescription><abstract lang="en">The aim of this article is to test the feasibility, in early Parkinson's disease (PD), of an overnight switch from immediate‐release (IR) pramipexole to a new once‐daily extended‐release (ER) formulation. Nonfluctuating patients on pramipexole IR three‐times daily, alone or with levodopa, for early PD were randomly switched overnight to double‐blind IR three‐times daily (N = 52) or ER once‐daily (N = 104) at initially unchanged daily dosage. Successful switching (defined as no worsening >15% of baseline UPDRS II+III score and no drug‐related adverse event withdrawal) was assessed at 9 weeks, after optional dosage adjustments (primary endpoint), and at 4 weeks, before adjustment. Other secondary endpoints included adjusted mean changes from baseline in UPDRS scores and proportion of responders based on Clinical or Patient Global Impression (CGI/PGI). Absolute difference between percentage of successful switch to ER versus IR was tested for ER noninferiority, defined as a 95% confidence‐interval lower bound not exceeding −15%. At 9 weeks, 84.5% of the ER group had been successfully switched, versus 94.2% for IR. Noninferiority was not demonstrated, with a difference of −9.76% (95% CI: [−18.81%, +1.66%]). At 4 weeks, 81.6% of the ER group had been successfully switched, versus 92.3% for IR, a difference of −10.75% (95% CI: [−20.51%, +1.48%]). UPDRS changes and CGI/PGI analyses showed no differences between the groups. Both formulations were safe and well tolerated. Pramipexole ER was not equivalent to IR, but the difference was marginal. The fact that >80% of the patients successfully switched overnight at unchanged dosage shows that this practice was feasible in most patients. © 2010 Movement Disorder Society</abstract><note type="content">*Potential Conflict of Interest: Drs. Olivier Rascol, Paolo Barone, Robert Hauser, Yoshikuni Mizuno, Werner Poewe, Anthony Schapira have received financial support to disclose for this study; Drs. Laurence Salin, Mandy Sohr, Catherine Debieuvre are employees of Boehringer Ingelheim.</note><subject lang="en"><genre>Keywords</genre><topic>pramipexole‐extended release</topic><topic>Parkinson's disease</topic><topic>dopamine agonist</topic><topic>switch trial</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title></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>2010</date><detail type="volume"><caption>vol.</caption><number>25</number></detail><detail type="issue"><caption>no.</caption><number>14</number></detail><extent unit="pages"><start>2326</start><end>2332</end><total>7</total></extent></part></relatedItem><identifier type="istex">624285B60AB87EE65180007CBA2766EED01548AF</identifier><identifier type="DOI">10.1002/mds.23262</identifier><identifier type="ArticleID">MDS23262</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2010 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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