Randomized, double‐blind, multicenter evaluation of pramipexole extended release once daily in early Parkinson's disease
Identifieur interne : 000840 ( Istex/Corpus ); précédent : 000839; suivant : 000841Randomized, double‐blind, multicenter evaluation of pramipexole extended release once daily in early Parkinson's disease
Auteurs : Robert A. Hauser ; Anthony H. V. Schapira ; Olivier Rascol ; Paolo Barone ; Yoshikuni Mizuno ; Laurence Salin ; Monika Haaksma ; Nolwenn Juhel ; Werner PoeweSource :
- Movement Disorders [ 0885-3185 ] ; 2010-11-15.
English descriptors
Abstract
The objective of this study was to evaluate the efficacy and safety of pramipexole extended release (ER) administered once daily in early Parkinson's disease (PD). Pramipexole immediate release (IR) administered three times daily (TID) is an efficacious and generally well‐tolerated treatment for PD. A pramipexole ER formulation is now available. We performed a randomized, double‐blind, placebo and active comparator–controlled trial in subjects with early PD. The primary efficacy and safety evaluation of pramipexole ER compared with placebo took place at week 18. Two hundred fifty‐nine subjects were randomized 2:2:1 to treatment with pramipexole ER once daily, pramipexole IR TID, or placebo. Levodopa rescue was required by 7 subjects in the placebo group (14%), 3 subjects in the pramipexole ER group (2.9%, P = 0.0160), and 1 subject in the pramipexole IR group (1.0%, P = 0.0017). Adjusted mean [standard error (SE)] change in Unified Parkinson Disease Rating Scale (UPDRS) II [activities of daily living (ADL)] + III (motor) scores from baseline to week 18, including post‐levodopa rescue evaluations, was −5.1 (1.3) in the placebo group, −8.1 (1.1) in the pramipexole ER group (P = 0.0282), and −8.4 (1.1) in the pramipexole IR group (P = 0.0153). Adjusted mean (SE) change in UPDRS ADL + motor scores, censoring post‐levodopa rescue data, was −2.7 (1.3) in the placebo group, −7.4 (1.1) in the pramipexole ER group (P = 0.0010), and −7.5 (1.1) in the pramipexole IR group (P = 0.0006). Adverse events more common with pramipexole ER than placebo included somnolence, nausea, constipation, and fatigue. Pramipexole ER administered once daily was demonstrated to be efficacious compared with placebo and provided similar efficacy and tolerability as pramipexole IR administered TID. © 2010 Movement Disorder Society
Url:
DOI: 10.1002/mds.23317
Links to Exploration step
ISTEX:6D17C7F9698CE3482504E8A130ED82080DB28D0CLe document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Randomized, double‐blind, multicenter evaluation of pramipexole extended release once daily in early Parkinson's disease</title><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name><affiliation><mods:affiliation>Department of Neurology, University of South Florida, Tampa, Florida, USA</mods:affiliation></affiliation></author><author><name sortKey="Schapira, Anthony H V" sort="Schapira, Anthony H V" uniqKey="Schapira A" first="Anthony H. V." last="Schapira">Anthony H. V. Schapira</name><affiliation><mods:affiliation>University Department of Clinical Neurosciences, Institute of Neurology, University College London, London, United Kingdom</mods:affiliation></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation><mods:affiliation>Department of Clinical Pharmacology and Neurosciences, Clinical Investigation Center, INSERM CIC‐9203 and UMR‐825, Toulouse University Hospital, Toulouse, France</mods:affiliation></affiliation></author><author><name sortKey="Barone, Paolo" sort="Barone, Paolo" uniqKey="Barone P" first="Paolo" last="Barone">Paolo Barone</name><affiliation><mods:affiliation>Department of Neurological Sciences, University of Naples, Federico II and IDC‐Hermitage‐Capodimonte, Naples, Italy</mods:affiliation></affiliation></author><author><name sortKey="Mizuno, Yoshikuni" sort="Mizuno, Yoshikuni" uniqKey="Mizuno Y" first="Yoshikuni" last="Mizuno">Yoshikuni Mizuno</name><affiliation><mods:affiliation>Department of Neurology, Juntendo University School of Medicine, Bunkyo‐ku, Tokyo, Japan</mods:affiliation></affiliation></author><author><name sortKey="Salin, Laurence" sort="Salin, Laurence" uniqKey="Salin L" first="Laurence" last="Salin">Laurence Salin</name><affiliation><mods:affiliation>Division of Medicine, Department of Clinical Development, Boehringer Ingelheim France S.A.S., Reims, France</mods:affiliation></affiliation></author><author><name sortKey="Haaksma, Monika" sort="Haaksma, Monika" uniqKey="Haaksma M" first="Monika" last="Haaksma">Monika Haaksma</name><affiliation><mods:affiliation>Medical Department, Boehringer Ingelheim Pharma RCV GmbH & Co. KG, Vienna, Austria</mods:affiliation></affiliation></author><author><name sortKey="Juhel, Nolwenn" sort="Juhel, Nolwenn" uniqKey="Juhel N" first="Nolwenn" last="Juhel">Nolwenn Juhel</name><affiliation><mods:affiliation>Division of Medicine, Department of Clinical Development, Boehringer Ingelheim France S.A.S., Reims, France</mods:affiliation></affiliation></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name><affiliation><mods:affiliation>Department of Neurology, Innsbruck Medical University, Innsbruck, Austria</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:6D17C7F9698CE3482504E8A130ED82080DB28D0C</idno><date when="2010" year="2010">2010</date><idno type="doi">10.1002/mds.23317</idno><idno type="url">https://api.istex.fr/document/6D17C7F9698CE3482504E8A130ED82080DB28D0C/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">000840</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Randomized, double‐blind, multicenter evaluation of pramipexole extended release once daily in early Parkinson's disease</title><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name><affiliation><mods:affiliation>Department of Neurology, University of South Florida, Tampa, Florida, USA</mods:affiliation></affiliation></author><author><name sortKey="Schapira, Anthony H V" sort="Schapira, Anthony H V" uniqKey="Schapira A" first="Anthony H. V." last="Schapira">Anthony H. V. Schapira</name><affiliation><mods:affiliation>University Department of Clinical Neurosciences, Institute of Neurology, University College London, London, United Kingdom</mods:affiliation></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation><mods:affiliation>Department of Clinical Pharmacology and Neurosciences, Clinical Investigation Center, INSERM CIC‐9203 and UMR‐825, Toulouse University Hospital, Toulouse, France</mods:affiliation></affiliation></author><author><name sortKey="Barone, Paolo" sort="Barone, Paolo" uniqKey="Barone P" first="Paolo" last="Barone">Paolo Barone</name><affiliation><mods:affiliation>Department of Neurological Sciences, University of Naples, Federico II and IDC‐Hermitage‐Capodimonte, Naples, Italy</mods:affiliation></affiliation></author><author><name sortKey="Mizuno, Yoshikuni" sort="Mizuno, Yoshikuni" uniqKey="Mizuno Y" first="Yoshikuni" last="Mizuno">Yoshikuni Mizuno</name><affiliation><mods:affiliation>Department of Neurology, Juntendo University School of Medicine, Bunkyo‐ku, Tokyo, Japan</mods:affiliation></affiliation></author><author><name sortKey="Salin, Laurence" sort="Salin, Laurence" uniqKey="Salin L" first="Laurence" last="Salin">Laurence Salin</name><affiliation><mods:affiliation>Division of Medicine, Department of Clinical Development, Boehringer Ingelheim France S.A.S., Reims, France</mods:affiliation></affiliation></author><author><name sortKey="Haaksma, Monika" sort="Haaksma, Monika" uniqKey="Haaksma M" first="Monika" last="Haaksma">Monika Haaksma</name><affiliation><mods:affiliation>Medical Department, Boehringer Ingelheim Pharma RCV GmbH & Co. KG, Vienna, Austria</mods:affiliation></affiliation></author><author><name sortKey="Juhel, Nolwenn" sort="Juhel, Nolwenn" uniqKey="Juhel N" first="Nolwenn" last="Juhel">Nolwenn Juhel</name><affiliation><mods:affiliation>Division of Medicine, Department of Clinical Development, Boehringer Ingelheim France S.A.S., Reims, France</mods:affiliation></affiliation></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name><affiliation><mods:affiliation>Department of Neurology, Innsbruck Medical University, Innsbruck, Austria</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. 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="2010-11-15">2010-11-15</date><biblScope unit="vol">25</biblScope><biblScope unit="issue">15</biblScope><biblScope unit="page" from="2542">2542</biblScope><biblScope unit="page" to="2549">2549</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">6D17C7F9698CE3482504E8A130ED82080DB28D0C</idno><idno type="DOI">10.1002/mds.23317</idno><idno type="ArticleID">MDS23317</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>treatment</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The objective of this study was to evaluate the efficacy and safety of pramipexole extended release (ER) administered once daily in early Parkinson's disease (PD). Pramipexole immediate release (IR) administered three times daily (TID) is an efficacious and generally well‐tolerated treatment for PD. A pramipexole ER formulation is now available. We performed a randomized, double‐blind, placebo and active comparator–controlled trial in subjects with early PD. The primary efficacy and safety evaluation of pramipexole ER compared with placebo took place at week 18. Two hundred fifty‐nine subjects were randomized 2:2:1 to treatment with pramipexole ER once daily, pramipexole IR TID, or placebo. Levodopa rescue was required by 7 subjects in the placebo group (14%), 3 subjects in the pramipexole ER group (2.9%, P = 0.0160), and 1 subject in the pramipexole IR group (1.0%, P = 0.0017). Adjusted mean [standard error (SE)] change in Unified Parkinson Disease Rating Scale (UPDRS) II [activities of daily living (ADL)] + III (motor) scores from baseline to week 18, including post‐levodopa rescue evaluations, was −5.1 (1.3) in the placebo group, −8.1 (1.1) in the pramipexole ER group (P = 0.0282), and −8.4 (1.1) in the pramipexole IR group (P = 0.0153). Adjusted mean (SE) change in UPDRS ADL + motor scores, censoring post‐levodopa rescue data, was −2.7 (1.3) in the placebo group, −7.4 (1.1) in the pramipexole ER group (P = 0.0010), and −7.5 (1.1) in the pramipexole IR group (P = 0.0006). Adverse events more common with pramipexole ER than placebo included somnolence, nausea, constipation, and fatigue. Pramipexole ER administered once daily was demonstrated to be efficacious compared with placebo and provided similar efficacy and tolerability as pramipexole IR administered TID. © 2010 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><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>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>Olivier Rascol MD, PhD</name><affiliations><json:string>Department of Clinical Pharmacology and Neurosciences, Clinical Investigation Center, INSERM CIC‐9203 and UMR‐825, Toulouse University Hospital, Toulouse, France</json:string></affiliations></json:item><json:item><name>Paolo Barone MD</name><affiliations><json:string>Department of Neurological Sciences, University of Naples, Federico II and IDC‐Hermitage‐Capodimonte, Naples, Italy</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>Laurence Salin MD</name><affiliations><json:string>Division of Medicine, Department of Clinical Development, Boehringer Ingelheim France S.A.S., Reims, France</json:string></affiliations></json:item><json:item><name>Monika Haaksma MD</name><affiliations><json:string>Medical Department, Boehringer Ingelheim Pharma RCV GmbH & Co. KG, Vienna, Austria</json:string></affiliations></json:item><json:item><name>Nolwenn Juhel</name><affiliations><json:string>Division of Medicine, Department of Clinical Development, Boehringer Ingelheim France S.A.S., Reims, France</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></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>treatment</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>The objective of this study was to evaluate the efficacy and safety of pramipexole extended release (ER) administered once daily in early Parkinson's disease (PD). Pramipexole immediate release (IR) administered three times daily (TID) is an efficacious and generally well‐tolerated treatment for PD. A pramipexole ER formulation is now available. We performed a randomized, double‐blind, placebo and active comparator–controlled trial in subjects with early PD. The primary efficacy and safety evaluation of pramipexole ER compared with placebo took place at week 18. Two hundred fifty‐nine subjects were randomized 2:2:1 to treatment with pramipexole ER once daily, pramipexole IR TID, or placebo. Levodopa rescue was required by 7 subjects in the placebo group (14%), 3 subjects in the pramipexole ER group (2.9%, P = 0.0160), and 1 subject in the pramipexole IR group (1.0%, P = 0.0017). Adjusted mean [standard error (SE)] change in Unified Parkinson Disease Rating Scale (UPDRS) II [activities of daily living (ADL)] + III (motor) scores from baseline to week 18, including post‐levodopa rescue evaluations, was −5.1 (1.3) in the placebo group, −8.1 (1.1) in the pramipexole ER group (P = 0.0282), and −8.4 (1.1) in the pramipexole IR group (P = 0.0153). Adjusted mean (SE) change in UPDRS ADL + motor scores, censoring post‐levodopa rescue data, was −2.7 (1.3) in the placebo group, −7.4 (1.1) in the pramipexole ER group (P = 0.0010), and −7.5 (1.1) in the pramipexole IR group (P = 0.0006). Adverse events more common with pramipexole ER than placebo included somnolence, nausea, constipation, and fatigue. Pramipexole ER administered once daily was demonstrated to be efficacious compared with placebo and provided similar efficacy and tolerability as pramipexole IR administered TID. © 2010 Movement Disorder Society</abstract><qualityIndicators><score>7.193</score><pdfVersion>1.3</pdfVersion><pdfPageSize>612 x 810 pts</pdfPageSize><refBibsNative>true</refBibsNative><abstractCharCount>1827</abstractCharCount><pdfWordCount>4193</pdfWordCount><pdfCharCount>27489</pdfCharCount><pdfPageCount>8</pdfPageCount><abstractWordCount>282</abstractWordCount></qualityIndicators><title>Randomized, double‐blind, multicenter evaluation of pramipexole extended release once daily in early Parkinson's disease</title><genre><json:string>Serial article</json:string></genre><host><volume>25</volume><pages><total>8</total><last>2549</last><first>2542</first></pages><issn><json:string>0885-3185</json:string></issn><issue>15</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.23317</json:string></doi><id>6D17C7F9698CE3482504E8A130ED82080DB28D0C</id><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/6D17C7F9698CE3482504E8A130ED82080DB28D0C/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/6D17C7F9698CE3482504E8A130ED82080DB28D0C/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/6D17C7F9698CE3482504E8A130ED82080DB28D0C/fulltext/tei"><teiHeader type="text"><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Randomized, double‐blind, multicenter evaluation of pramipexole extended release once daily 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">*There were no ghost writers and this manuscript complies with the Movement Disorders policy on ghost writing.</note><note type="content">*Potential Conflict of Interest: Drs. Robert Hauser, Anthony Schapira, Olivier Rascol, Paolo Barone, Yoshikuni Mizuno, and Werner Poewe have received financial support to disclose for this study. Drs. Laurence Salin, Monika Haaksma, and Mrs. Nolwenn Juhel are employees of Boehringer Ingelheim.</note><note>Boehringer Ingelheim International</note><note>Michael Feirtag of the Curry Rockefeller Group, Tarrytown, NY</note><note>American Academy of Neurology (AAN)</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Randomized, double‐blind, multicenter evaluation of pramipexole extended release once daily in early Parkinson's disease</title><author><persName><forename type="first">Robert A.</forename><surname>Hauser</surname><roleName type="degree">MD</roleName></persName><note type="correspondence"><p>Correspondence: Parkinson's Disease and Movement Disorders Center, University of South Florida, 5 Tampa General Circle, Suite 410, Tampa, Florida 33606</p></note><affiliation>Department of Neurology, University of South Florida, Tampa, Florida, USA</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">Olivier</forename><surname>Rascol</surname><roleName type="degree">MD, PhD</roleName></persName><affiliation>Department of Clinical Pharmacology and Neurosciences, Clinical Investigation Center, INSERM CIC‐9203 and UMR‐825, Toulouse University Hospital, 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, Federico II and IDC‐Hermitage‐Capodimonte, Naples, Italy</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">Laurence</forename><surname>Salin</surname><roleName type="degree">MD</roleName></persName><affiliation>Division of Medicine, Department of Clinical Development, Boehringer Ingelheim France S.A.S., Reims, France</affiliation></author><author><persName><forename type="first">Monika</forename><surname>Haaksma</surname><roleName type="degree">MD</roleName></persName><affiliation>Medical Department, Boehringer Ingelheim Pharma RCV GmbH & Co. KG, Vienna, Austria</affiliation></author><author><persName><forename type="first">Nolwenn</forename><surname>Juhel</surname></persName><affiliation>Division of Medicine, Department of Clinical Development, Boehringer Ingelheim France S.A.S., Reims, France</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></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="2010-11-15"></date><biblScope unit="vol">25</biblScope><biblScope unit="issue">15</biblScope><biblScope unit="page" from="2542">2542</biblScope><biblScope unit="page" to="2549">2549</biblScope></imprint></monogr><idno type="istex">6D17C7F9698CE3482504E8A130ED82080DB28D0C</idno><idno type="DOI">10.1002/mds.23317</idno><idno type="ArticleID">MDS23317</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2010</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>The objective of this study was to evaluate the efficacy and safety of pramipexole extended release (ER) administered once daily in early Parkinson's disease (PD). Pramipexole immediate release (IR) administered three times daily (TID) is an efficacious and generally well‐tolerated treatment for PD. A pramipexole ER formulation is now available. We performed a randomized, double‐blind, placebo and active comparator–controlled trial in subjects with early PD. The primary efficacy and safety evaluation of pramipexole ER compared with placebo took place at week 18. Two hundred fifty‐nine subjects were randomized 2:2:1 to treatment with pramipexole ER once daily, pramipexole IR TID, or placebo. Levodopa rescue was required by 7 subjects in the placebo group (14%), 3 subjects in the pramipexole ER group (2.9%, P = 0.0160), and 1 subject in the pramipexole IR group (1.0%, P = 0.0017). Adjusted mean [standard error (SE)] change in Unified Parkinson Disease Rating Scale (UPDRS) II [activities of daily living (ADL)] + III (motor) scores from baseline to week 18, including post‐levodopa rescue evaluations, was −5.1 (1.3) in the placebo group, −8.1 (1.1) in the pramipexole ER group (P = 0.0282), and −8.4 (1.1) in the pramipexole IR group (P = 0.0153). Adjusted mean (SE) change in UPDRS ADL + motor scores, censoring post‐levodopa rescue data, was −2.7 (1.3) in the placebo group, −7.4 (1.1) in the pramipexole ER group (P = 0.0010), and −7.5 (1.1) in the pramipexole IR group (P = 0.0006). Adverse events more common with pramipexole ER than placebo included somnolence, nausea, constipation, and fatigue. Pramipexole ER administered once daily was demonstrated to be efficacious compared with placebo and provided similar efficacy and tolerability as pramipexole IR administered TID. © 2010 Movement Disorder Society</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>pramipexole extended release</term></item><item><term>Parkinson's disease</term></item><item><term>treatment</term></item><item><term>dopamine agonist</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>Article category</head><item><term>Research Article</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2010-02-02">Received</change><change when="2010-06-01">Registration</change><change when="2010-11-15">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/6D17C7F9698CE3482504E8A130ED82080DB28D0C/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>Wiley Subscription Services, Inc., A Wiley Company</publisherName><publisherLoc>Hoboken</publisherLoc></publisherInfo><doi registered="yes">10.1002/(ISSN)1531-8257</doi><issn type="print">0885-3185</issn><issn type="electronic">1531-8257</issn><idGroup><id type="product" value="MDS"></id></idGroup><titleGroup><title type="main" xml:lang="en" sort="MOVEMENT DISORDERS">Movement Disorders</title><title type="short">Mov. Disord.</title></titleGroup></publicationMeta><publicationMeta level="part" position="150"><doi origin="wiley" registered="yes">10.1002/mds.v25:15</doi><numberingGroup><numbering type="journalVolume" number="25">25</numbering><numbering type="journalIssue">15</numbering></numberingGroup><coverDate startDate="2010-11-15">15 November 2010</coverDate></publicationMeta><publicationMeta level="unit" type="article" position="100" status="forIssue"><doi origin="wiley" registered="yes">10.1002/mds.23317</doi><idGroup><id type="unit" value="MDS23317"></id></idGroup><countGroup><count type="pageTotal" number="8"></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="2010-02-02"></event><event type="manuscriptRevised" date="2010-04-09"></event><event type="manuscriptAccepted" date="2010-06-01"></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:3.1.9 mode:FullText" date="2013-01-24"></event><event type="publishedOnlineFinalForm" date="2010-11-10"></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">2542</numbering><numbering type="pageLast">2549</numbering></numberingGroup><correspondenceTo>Parkinson's Disease and Movement Disorders Center, University of South Florida, 5 Tampa General Circle, Suite 410, Tampa, Florida 33606</correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:MDS.MDS23317.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="2"></count><count type="tableTotal" number="4"></count><count type="referenceTotal" number="17"></count><count type="wordTotal" number="5650"></count></countGroup><titleGroup><title type="main" xml:lang="en">Randomized, double‐blind, multicenter evaluation of pramipexole extended release once daily in early Parkinson's disease<link href="#fn1"></link> <link href="#fn4"></link></title><title type="short" xml:lang="en">Pramipexole ER in Early PD</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes"><personName><givenNames>Robert A.</givenNames><familyName>Hauser</familyName><degrees>MD</degrees></personName><contactDetails><email>rhauser@health.usf.edu</email></contactDetails></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#af2"><personName><givenNames>Anthony H.V.</givenNames><familyName>Schapira</familyName><degrees>MD, DSc, FRCP, FMedSci</degrees></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#af3"><personName><givenNames>Olivier</givenNames><familyName>Rascol</familyName><degrees>MD, PhD</degrees></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#af4"><personName><givenNames>Paolo</givenNames><familyName>Barone</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au5" creatorRole="author" affiliationRef="#af5"><personName><givenNames>Yoshikuni</givenNames><familyName>Mizuno</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au6" creatorRole="author" affiliationRef="#af6"><personName><givenNames>Laurence</givenNames><familyName>Salin</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au7" creatorRole="author" affiliationRef="#af7"><personName><givenNames>Monika</givenNames><familyName>Haaksma</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au8" creatorRole="author" affiliationRef="#af6"><personName><givenNames>Nolwenn</givenNames><familyName>Juhel</familyName></personName></creator><creator xml:id="au9" creatorRole="author" affiliationRef="#af8"><personName><givenNames>Werner</givenNames><familyName>Poewe</familyName><degrees>MD</degrees></personName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, University of South Florida, Tampa, Florida, USA</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="GB" type="organization"><unparsedAffiliation>University Department of Clinical Neurosciences, Institute of Neurology, University College London, London, United Kingdom</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="FR" type="organization"><unparsedAffiliation>Department of Clinical Pharmacology and Neurosciences, Clinical Investigation Center, INSERM CIC‐9203 and UMR‐825, Toulouse University Hospital, Toulouse, France</unparsedAffiliation></affiliation><affiliation xml:id="af4" countryCode="IT" type="organization"><unparsedAffiliation>Department of Neurological Sciences, University of Naples, Federico II and IDC‐Hermitage‐Capodimonte, Naples, Italy</unparsedAffiliation></affiliation><affiliation xml:id="af5" countryCode="JP" type="organization"><unparsedAffiliation>Department of Neurology, Juntendo University School of Medicine, Bunkyo‐ku, Tokyo, Japan</unparsedAffiliation></affiliation><affiliation xml:id="af6" countryCode="FR" type="organization"><unparsedAffiliation>Division of Medicine, Department of Clinical Development, Boehringer Ingelheim France S.A.S., Reims, France</unparsedAffiliation></affiliation><affiliation xml:id="af7" countryCode="AT" type="organization"><unparsedAffiliation>Medical Department, Boehringer Ingelheim Pharma RCV GmbH & Co. KG, Vienna, Austria</unparsedAffiliation></affiliation><affiliation xml:id="af8" countryCode="AT" type="organization"><unparsedAffiliation>Department of Neurology, Innsbruck Medical University, Innsbruck, Austria</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">treatment</keyword><keyword xml:id="kwd4">dopamine agonist</keyword></keywordGroup><fundingInfo><fundingAgency>Boehringer Ingelheim International</fundingAgency></fundingInfo><fundingInfo><fundingAgency>Michael Feirtag of the Curry Rockefeller Group, Tarrytown, NY</fundingAgency></fundingInfo><fundingInfo><fundingAgency>American Academy of Neurology (AAN)</fundingAgency></fundingInfo><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>The objective of this study was to evaluate the efficacy and safety of pramipexole extended release (ER) administered once daily in early Parkinson's disease (PD). Pramipexole immediate release (IR) administered three times daily (TID) is an efficacious and generally well‐tolerated treatment for PD. A pramipexole ER formulation is now available. We performed a randomized, double‐blind, placebo and active comparator–controlled trial in subjects with early PD. The primary efficacy and safety evaluation of pramipexole ER compared with placebo took place at week 18. Two hundred fifty‐nine subjects were randomized 2:2:1 to treatment with pramipexole ER once daily, pramipexole IR TID, or placebo. Levodopa rescue was required by 7 subjects in the placebo group (14%), 3 subjects in the pramipexole ER group (2.9%, <i>P</i> = 0.0160), and 1 subject in the pramipexole IR group (1.0%, <i>P</i> = 0.0017). Adjusted mean [standard error (SE)] change in Unified Parkinson Disease Rating Scale (UPDRS) II [activities of daily living (ADL)] + III (motor) scores from baseline to week 18, including post‐levodopa rescue evaluations, was −5.1 (1.3) in the placebo group, −8.1 (1.1) in the pramipexole ER group (<i>P</i> = 0.0282), and −8.4 (1.1) in the pramipexole IR group (<i>P</i> = 0.0153). Adjusted mean (SE) change in UPDRS ADL + motor scores, censoring post‐levodopa rescue data, was −2.7 (1.3) in the placebo group, −7.4 (1.1) in the pramipexole ER group (<i>P</i> = 0.0010), and −7.5 (1.1) in the pramipexole IR group (<i>P</i> = 0.0006). Adverse events more common with pramipexole ER than placebo included somnolence, nausea, constipation, and fatigue. Pramipexole ER administered once daily was demonstrated to be efficacious compared with placebo and provided similar efficacy and tolerability as pramipexole IR administered TID. © 2010 Movement Disorder Society</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn1"><p>There were no ghost writers and this manuscript complies with the <i>Movement Disorders</i> policy on ghost writing.</p></note><note xml:id="fn4"><p>Potential Conflict of Interest: Drs. Robert Hauser, Anthony Schapira, Olivier Rascol, Paolo Barone, Yoshikuni Mizuno, and Werner Poewe have received financial support to disclose for this study. Drs. Laurence Salin, Monika Haaksma, and Mrs. Nolwenn Juhel 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>Randomized, double‐blind, multicenter evaluation of pramipexole extended release once daily in early Parkinson's disease</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Pramipexole ER in Early PD</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Randomized, double‐blind, multicenter evaluation of pramipexole extended release once daily in early Parkinson's disease</title></titleInfo><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><description>Correspondence: Parkinson's Disease and Movement Disorders Center, University of South Florida, 5 Tampa General Circle, Suite 410, Tampa, Florida 33606</description><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">Olivier</namePart><namePart type="family">Rascol</namePart><namePart type="termsOfAddress">MD, PhD</namePart><affiliation>Department of Clinical Pharmacology and Neurosciences, Clinical Investigation Center, INSERM CIC‐9203 and UMR‐825, Toulouse University Hospital, Toulouse, France</affiliation><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, Federico II and IDC‐Hermitage‐Capodimonte, Naples, Italy</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">Laurence</namePart><namePart type="family">Salin</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Division of Medicine, Department of Clinical Development, Boehringer Ingelheim France S.A.S., Reims, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Monika</namePart><namePart type="family">Haaksma</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Medical Department, Boehringer Ingelheim Pharma RCV GmbH & Co. KG, Vienna, Austria</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Nolwenn</namePart><namePart type="family">Juhel</namePart><affiliation>Division of Medicine, Department of Clinical Development, Boehringer Ingelheim France S.A.S., Reims, France</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><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">2010-11-15</dateIssued><dateCaptured encoding="w3cdtf">2010-02-02</dateCaptured><dateValid encoding="w3cdtf">2010-06-01</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">2</extent><extent unit="tables">4</extent><extent unit="references">17</extent><extent unit="words">5650</extent></physicalDescription><abstract lang="en">The objective of this study was to evaluate the efficacy and safety of pramipexole extended release (ER) administered once daily in early Parkinson's disease (PD). Pramipexole immediate release (IR) administered three times daily (TID) is an efficacious and generally well‐tolerated treatment for PD. A pramipexole ER formulation is now available. We performed a randomized, double‐blind, placebo and active comparator–controlled trial in subjects with early PD. The primary efficacy and safety evaluation of pramipexole ER compared with placebo took place at week 18. Two hundred fifty‐nine subjects were randomized 2:2:1 to treatment with pramipexole ER once daily, pramipexole IR TID, or placebo. Levodopa rescue was required by 7 subjects in the placebo group (14%), 3 subjects in the pramipexole ER group (2.9%, P = 0.0160), and 1 subject in the pramipexole IR group (1.0%, P = 0.0017). Adjusted mean [standard error (SE)] change in Unified Parkinson Disease Rating Scale (UPDRS) II [activities of daily living (ADL)] + III (motor) scores from baseline to week 18, including post‐levodopa rescue evaluations, was −5.1 (1.3) in the placebo group, −8.1 (1.1) in the pramipexole ER group (P = 0.0282), and −8.4 (1.1) in the pramipexole IR group (P = 0.0153). Adjusted mean (SE) change in UPDRS ADL + motor scores, censoring post‐levodopa rescue data, was −2.7 (1.3) in the placebo group, −7.4 (1.1) in the pramipexole ER group (P = 0.0010), and −7.5 (1.1) in the pramipexole IR group (P = 0.0006). Adverse events more common with pramipexole ER than placebo included somnolence, nausea, constipation, and fatigue. Pramipexole ER administered once daily was demonstrated to be efficacious compared with placebo and provided similar efficacy and tolerability as pramipexole IR administered TID. © 2010 Movement Disorder Society</abstract><note type="content">*There were no ghost writers and this manuscript complies with the Movement Disorders policy on ghost writing.</note><note type="content">*Potential Conflict of Interest: Drs. Robert Hauser, Anthony Schapira, Olivier Rascol, Paolo Barone, Yoshikuni Mizuno, and Werner Poewe have received financial support to disclose for this study. Drs. Laurence Salin, Monika Haaksma, and Mrs. Nolwenn Juhel are employees of Boehringer Ingelheim.</note><note type="funding">Boehringer Ingelheim International</note><note type="funding">Michael Feirtag of the Curry Rockefeller Group, Tarrytown, NY</note><note type="funding">American Academy of Neurology (AAN)</note><subject lang="en"><genre>Keywords</genre><topic>pramipexole extended release</topic><topic>Parkinson's disease</topic><topic>treatment</topic><topic>dopamine agonist</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>15</number></detail><extent unit="pages"><start>2542</start><end>2549</end><total>8</total></extent></part></relatedItem><identifier type="istex">6D17C7F9698CE3482504E8A130ED82080DB28D0C</identifier><identifier type="DOI">10.1002/mds.23317</identifier><identifier type="ArticleID">MDS23317</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)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Santé/explor/MovDisordV3/Data/Istex/Corpus
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000840 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Istex/Corpus/biblio.hfd -nk 000840 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Santé
|area= MovDisordV3
|flux= Istex
|étape= Corpus
|type= RBID
|clé= ISTEX:6D17C7F9698CE3482504E8A130ED82080DB28D0C
|texte= Randomized, double‐blind, multicenter evaluation of pramipexole extended release once daily in early Parkinson's disease
}}
| This area was generated with Dilib version V0.6.23. |  |