Movement Disorders (revue)

Attention, ce site est en cours de développement !
Attention, site généré par des moyens informatiques à partir de corpus bruts.
Les informations ne sont donc pas validées.

Randomized, Double-Blind, Multicenter Evaluation of Pramipexole Extended Release Once Daily in Early Parkinson's Disease

Identifieur interne : 000873 ( PascalFrancis/Checkpoint ); précédent : 000872; suivant : 000874

Randomized, Double-Blind, Multicenter Evaluation of Pramipexole Extended Release Once Daily in Early Parkinson's Disease

Auteurs : Robert A. Hauser [États-Unis] ; Anthony H. V. Schapira [Royaume-Uni] ; Olivier Rascol [France] ; Paolo Barone [Italie] ; Yoshikuni Mizuno [Japon] ; Laurence Salin [France] ; Monika Haaksma [Autriche] ; Nolwenn Juhel [France] ; Werner Poewe [Autriche]

Source :

RBID : Pascal:10-0512927

Descripteurs français

English descriptors

Abstract

The objective of this study was to evaluate the efficacy and satety ot pramipexote 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.


Affiliations:


Links toward previous steps (curation, corpus...)


Links to Exploration step

Pascal:10-0512927

Le document en format XML

<record>
<TEI>
<teiHeader>
<fileDesc>
<titleStmt>
<title xml:lang="en" level="a">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 wicri:level="4">
<inist:fA14 i1="01">
<s1>Department of Neurology, University of South Florida</s1>
<s2>Tampa, Florida</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName>
<region type="state">Floride</region>
<settlement type="city">Tampa</settlement>
</placeName>
<orgName type="university">Université de Floride du Sud</orgName>
</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 wicri:level="3">
<inist:fA14 i1="02">
<s1>University Department of Clinical Neurosciences, Institute of Neurology, University College London</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<placeName>
<settlement type="city">Londres</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Londres</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name>
<affiliation wicri:level="1">
<inist:fA14 i1="03">
<s1>Department of Clinical Pharmacology and Neurosciences, Clinical Investigation Center, INSERM CIC-9203 and UMR-825, Toulouse University Hospital</s1>
<s2>Toulouse</s2>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName>
<settlement type="city">Toulouse</settlement>
</placeName>
<placeName>
<settlement type="city">Toulouse</settlement>
<region type="region" nuts="2">Midi-Pyrénées</region>
</placeName>
<orgName type="university" n="3">Université Toulouse III - Paul Sabatier</orgName>
<orgName type="institution" wicri:auto="newGroup">Université de Toulouse</orgName>
</affiliation>
</author>
<author>
<name sortKey="Barone, Paolo" sort="Barone, Paolo" uniqKey="Barone P" first="Paolo" last="Barone">Paolo Barone</name>
<affiliation wicri:level="1">
<inist:fA14 i1="04">
<s1>Department of Neurological Sciences, University of Naples, Federico II and IDC-Her-mitage-Capodimonte</s1>
<s2>Naples</s2>
<s3>ITA</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>Italie</country>
<wicri:noRegion>Naples</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Mizuno, Yoshikuni" sort="Mizuno, Yoshikuni" uniqKey="Mizuno Y" first="Yoshikuni" last="Mizuno">Yoshikuni Mizuno</name>
<affiliation wicri:level="3">
<inist:fA14 i1="05">
<s1>Department of Neurology, Juntendo University School of Medicine</s1>
<s2>Bunkyo-ku, Tokyo</s2>
<s3>JPN</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>Japon</country>
<placeName>
<settlement type="city">Tokyo</settlement>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Salin, Laurence" sort="Salin, Laurence" uniqKey="Salin L" first="Laurence" last="Salin">Laurence Salin</name>
<affiliation wicri:level="1">
<inist:fA14 i1="06">
<s1>Division of Medicine, Department of Clinical Development, Boehringer Ingelheim France S.A.S.</s1>
<s2>Reims</s2>
<s3>FRA</s3>
<sZ>6 aut.</sZ>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName>
<settlement type="city">Reims</settlement>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Haaksma, Monika" sort="Haaksma, Monika" uniqKey="Haaksma M" first="Monika" last="Haaksma">Monika Haaksma</name>
<affiliation wicri:level="3">
<inist:fA14 i1="07">
<s1>Medical Department, Boehringer Ingelheim Pharma RCV GmbH & Co. KG</s1>
<s2>Vienna</s2>
<s3>AUT</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>Autriche</country>
<placeName>
<settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Juhel, Nolwenn" sort="Juhel, Nolwenn" uniqKey="Juhel N" first="Nolwenn" last="Juhel">Nolwenn Juhel</name>
<affiliation wicri:level="1">
<inist:fA14 i1="06">
<s1>Division of Medicine, Department of Clinical Development, Boehringer Ingelheim France S.A.S.</s1>
<s2>Reims</s2>
<s3>FRA</s3>
<sZ>6 aut.</sZ>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName>
<settlement type="city">Reims</settlement>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name>
<affiliation wicri:level="1">
<inist:fA14 i1="08">
<s1>Department of Neurology, Innsbruck Medical University</s1>
<s2>Innsbruck</s2>
<s3>AUT</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>Autriche</country>
<wicri:noRegion>Innsbruck</wicri:noRegion>
<placeName>
<settlement type="city">Innsbruck</settlement>
<region nuts="2" type="region">Tyrol (Land)</region>
</placeName>
<orgName type="university">Université de médecine d'Innsbruck</orgName>
</affiliation>
</author>
</titleStmt>
<publicationStmt>
<idno type="wicri:source">INIST</idno>
<idno type="inist">10-0512927</idno>
<date when="2010">2010</date>
<idno type="stanalyst">PASCAL 10-0512927 INIST</idno>
<idno type="RBID">Pascal:10-0512927</idno>
<idno type="wicri:Area/PascalFrancis/Corpus">000819</idno>
<idno type="wicri:Area/PascalFrancis/Curation">002500</idno>
<idno type="wicri:Area/PascalFrancis/Checkpoint">000873</idno>
</publicationStmt>
<sourceDesc>
<biblStruct>
<analytic>
<title xml:lang="en" level="a">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 wicri:level="4">
<inist:fA14 i1="01">
<s1>Department of Neurology, University of South Florida</s1>
<s2>Tampa, Florida</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName>
<region type="state">Floride</region>
<settlement type="city">Tampa</settlement>
</placeName>
<orgName type="university">Université de Floride du Sud</orgName>
</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 wicri:level="3">
<inist:fA14 i1="02">
<s1>University Department of Clinical Neurosciences, Institute of Neurology, University College London</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<placeName>
<settlement type="city">Londres</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Londres</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name>
<affiliation wicri:level="1">
<inist:fA14 i1="03">
<s1>Department of Clinical Pharmacology and Neurosciences, Clinical Investigation Center, INSERM CIC-9203 and UMR-825, Toulouse University Hospital</s1>
<s2>Toulouse</s2>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName>
<settlement type="city">Toulouse</settlement>
</placeName>
<placeName>
<settlement type="city">Toulouse</settlement>
<region type="region" nuts="2">Midi-Pyrénées</region>
</placeName>
<orgName type="university" n="3">Université Toulouse III - Paul Sabatier</orgName>
<orgName type="institution" wicri:auto="newGroup">Université de Toulouse</orgName>
</affiliation>
</author>
<author>
<name sortKey="Barone, Paolo" sort="Barone, Paolo" uniqKey="Barone P" first="Paolo" last="Barone">Paolo Barone</name>
<affiliation wicri:level="1">
<inist:fA14 i1="04">
<s1>Department of Neurological Sciences, University of Naples, Federico II and IDC-Her-mitage-Capodimonte</s1>
<s2>Naples</s2>
<s3>ITA</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
<country>Italie</country>
<wicri:noRegion>Naples</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Mizuno, Yoshikuni" sort="Mizuno, Yoshikuni" uniqKey="Mizuno Y" first="Yoshikuni" last="Mizuno">Yoshikuni Mizuno</name>
<affiliation wicri:level="3">
<inist:fA14 i1="05">
<s1>Department of Neurology, Juntendo University School of Medicine</s1>
<s2>Bunkyo-ku, Tokyo</s2>
<s3>JPN</s3>
<sZ>5 aut.</sZ>
</inist:fA14>
<country>Japon</country>
<placeName>
<settlement type="city">Tokyo</settlement>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Salin, Laurence" sort="Salin, Laurence" uniqKey="Salin L" first="Laurence" last="Salin">Laurence Salin</name>
<affiliation wicri:level="1">
<inist:fA14 i1="06">
<s1>Division of Medicine, Department of Clinical Development, Boehringer Ingelheim France S.A.S.</s1>
<s2>Reims</s2>
<s3>FRA</s3>
<sZ>6 aut.</sZ>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName>
<settlement type="city">Reims</settlement>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Haaksma, Monika" sort="Haaksma, Monika" uniqKey="Haaksma M" first="Monika" last="Haaksma">Monika Haaksma</name>
<affiliation wicri:level="3">
<inist:fA14 i1="07">
<s1>Medical Department, Boehringer Ingelheim Pharma RCV GmbH & Co. KG</s1>
<s2>Vienna</s2>
<s3>AUT</s3>
<sZ>7 aut.</sZ>
</inist:fA14>
<country>Autriche</country>
<placeName>
<settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Juhel, Nolwenn" sort="Juhel, Nolwenn" uniqKey="Juhel N" first="Nolwenn" last="Juhel">Nolwenn Juhel</name>
<affiliation wicri:level="1">
<inist:fA14 i1="06">
<s1>Division of Medicine, Department of Clinical Development, Boehringer Ingelheim France S.A.S.</s1>
<s2>Reims</s2>
<s3>FRA</s3>
<sZ>6 aut.</sZ>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName>
<settlement type="city">Reims</settlement>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name>
<affiliation wicri:level="1">
<inist:fA14 i1="08">
<s1>Department of Neurology, Innsbruck Medical University</s1>
<s2>Innsbruck</s2>
<s3>AUT</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>Autriche</country>
<wicri:noRegion>Innsbruck</wicri:noRegion>
<placeName>
<settlement type="city">Innsbruck</settlement>
<region nuts="2" type="region">Tyrol (Land)</region>
</placeName>
<orgName type="university">Université de médecine d'Innsbruck</orgName>
</affiliation>
</author>
</analytic>
<series>
<title level="j" type="main">Movement disorders</title>
<title level="j" type="abbreviated">Mov. disord.</title>
<idno type="ISSN">0885-3185</idno>
<imprint>
<date when="2010">2010</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt>
<title level="j" type="main">Movement disorders</title>
<title level="j" type="abbreviated">Mov. disord.</title>
<idno type="ISSN">0885-3185</idno>
</seriesStmt>
</fileDesc>
<profileDesc>
<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Dopamine agonist</term>
<term>Evaluation</term>
<term>Nervous system diseases</term>
<term>Parkinson disease</term>
<term>Pramipexole</term>
<term>Release</term>
<term>Treatment</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Maladie de Parkinson</term>
<term>Pathologie du système nerveux</term>
<term>Evaluation</term>
<term>Pramipexole</term>
<term>Libération</term>
<term>Traitement</term>
<term>Stimulant dopaminergique</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front>
<div type="abstract" xml:lang="en">The objective of this study was to evaluate the efficacy and satety ot pramipexote 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.</div>
</front>
</TEI>
<inist>
<standard h6="B">
<pA>
<fA01 i1="01" i2="1">
<s0>0885-3185</s0>
</fA01>
<fA03 i2="1">
<s0>Mov. disord.</s0>
</fA03>
<fA05>
<s2>25</s2>
</fA05>
<fA06>
<s2>15</s2>
</fA06>
<fA08 i1="01" i2="1" l="ENG">
<s1>Randomized, Double-Blind, Multicenter Evaluation of Pramipexole Extended Release Once Daily in Early Parkinson's Disease</s1>
</fA08>
<fA11 i1="01" i2="1">
<s1>HAUSER (Robert A.)</s1>
</fA11>
<fA11 i1="02" i2="1">
<s1>SCHAPIRA (Anthony H. V.)</s1>
</fA11>
<fA11 i1="03" i2="1">
<s1>RASCOL (Olivier)</s1>
</fA11>
<fA11 i1="04" i2="1">
<s1>BARONE (Paolo)</s1>
</fA11>
<fA11 i1="05" i2="1">
<s1>MIZUNO (Yoshikuni)</s1>
</fA11>
<fA11 i1="06" i2="1">
<s1>SALIN (Laurence)</s1>
</fA11>
<fA11 i1="07" i2="1">
<s1>HAAKSMA (Monika)</s1>
</fA11>
<fA11 i1="08" i2="1">
<s1>JUHEL (Nolwenn)</s1>
</fA11>
<fA11 i1="09" i2="1">
<s1>POEWE (Werner)</s1>
</fA11>
<fA14 i1="01">
<s1>Department of Neurology, University of South Florida</s1>
<s2>Tampa, Florida</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="02">
<s1>University Department of Clinical Neurosciences, Institute of Neurology, University College London</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>2 aut.</sZ>
</fA14>
<fA14 i1="03">
<s1>Department of Clinical Pharmacology and Neurosciences, Clinical Investigation Center, INSERM CIC-9203 and UMR-825, Toulouse University Hospital</s1>
<s2>Toulouse</s2>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="04">
<s1>Department of Neurological Sciences, University of Naples, Federico II and IDC-Her-mitage-Capodimonte</s1>
<s2>Naples</s2>
<s3>ITA</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="05">
<s1>Department of Neurology, Juntendo University School of Medicine</s1>
<s2>Bunkyo-ku, Tokyo</s2>
<s3>JPN</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="06">
<s1>Division of Medicine, Department of Clinical Development, Boehringer Ingelheim France S.A.S.</s1>
<s2>Reims</s2>
<s3>FRA</s3>
<sZ>6 aut.</sZ>
<sZ>8 aut.</sZ>
</fA14>
<fA14 i1="07">
<s1>Medical Department, Boehringer Ingelheim Pharma RCV GmbH & Co. KG</s1>
<s2>Vienna</s2>
<s3>AUT</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="08">
<s1>Department of Neurology, Innsbruck Medical University</s1>
<s2>Innsbruck</s2>
<s3>AUT</s3>
<sZ>9 aut.</sZ>
</fA14>
<fA20>
<s1>2542-2549</s1>
</fA20>
<fA21>
<s1>2010</s1>
</fA21>
<fA23 i1="01">
<s0>ENG</s0>
</fA23>
<fA43 i1="01">
<s1>INIST</s1>
<s2>20953</s2>
<s5>354000191411680100</s5>
</fA43>
<fA44>
<s0>0000</s0>
<s1>© 2010 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45>
<s0>17 ref.</s0>
</fA45>
<fA47 i1="01" i2="1">
<s0>10-0512927</s0>
</fA47>
<fA60>
<s1>P</s1>
</fA60>
<fA61>
<s0>A</s0>
</fA61>
<fA64 i1="01" i2="1">
<s0>Movement disorders</s0>
</fA64>
<fA66 i1="01">
<s0>USA</s0>
</fA66>
<fC01 i1="01" l="ENG">
<s0>The objective of this study was to evaluate the efficacy and satety ot pramipexote 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.</s0>
</fC01>
<fC02 i1="01" i2="X">
<s0>002B17</s0>
</fC02>
<fC02 i1="02" i2="X">
<s0>002B17G</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE">
<s0>Maladie de Parkinson</s0>
<s2>NM</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG">
<s0>Parkinson disease</s0>
<s2>NM</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA">
<s0>Parkinson enfermedad</s0>
<s2>NM</s2>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE">
<s0>Pathologie du système nerveux</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG">
<s0>Nervous system diseases</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA">
<s0>Sistema nervioso patología</s0>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE">
<s0>Evaluation</s0>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG">
<s0>Evaluation</s0>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA">
<s0>Evaluación</s0>
<s5>09</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE">
<s0>Pramipexole</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG">
<s0>Pramipexole</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA">
<s0>Pramipexol</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>10</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE">
<s0>Libération</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG">
<s0>Release</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA">
<s0>Liberación</s0>
<s5>11</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE">
<s0>Traitement</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG">
<s0>Treatment</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA">
<s0>Tratamiento</s0>
<s5>12</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE">
<s0>Stimulant dopaminergique</s0>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG">
<s0>Dopamine agonist</s0>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA">
<s0>Estimulante dopaminérgico</s0>
<s5>13</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE">
<s0>Pathologie de l'encéphale</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG">
<s0>Cerebral disorder</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA">
<s0>Encéfalo patología</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE">
<s0>Syndrome extrapyramidal</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG">
<s0>Extrapyramidal syndrome</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA">
<s0>Extrapiramidal síndrome</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE">
<s0>Maladie dégénérative</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG">
<s0>Degenerative disease</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA">
<s0>Enfermedad degenerativa</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE">
<s0>Pathologie du système nerveux central</s0>
<s5>40</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG">
<s0>Central nervous system disease</s0>
<s5>40</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA">
<s0>Sistema nervosio central patología</s0>
<s5>40</s5>
</fC07>
<fN21>
<s1>347</s1>
</fN21>
<fN44 i1="01">
<s1>OTO</s1>
</fN44>
<fN82>
<s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
<affiliations>
<list>
<country>
<li>Autriche</li>
<li>France</li>
<li>Italie</li>
<li>Japon</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
<region>
<li>Angleterre</li>
<li>Floride</li>
<li>Grand Londres</li>
<li>Midi-Pyrénées</li>
<li>Tyrol (Land)</li>
<li>Vienne (Autriche)</li>
</region>
<settlement>
<li>Innsbruck</li>
<li>Londres</li>
<li>Reims</li>
<li>Tampa</li>
<li>Tokyo</li>
<li>Toulouse</li>
<li>Vienne (Autriche)</li>
</settlement>
<orgName>
<li>Université Toulouse III - Paul Sabatier</li>
<li>Université de Floride du Sud</li>
<li>Université de Toulouse</li>
<li>Université de médecine d'Innsbruck</li>
</orgName>
</list>
<tree>
<country name="États-Unis">
<region name="Floride">
<name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name>
</region>
</country>
<country name="Royaume-Uni">
<region name="Angleterre">
<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>
</region>
</country>
<country name="France">
<noRegion>
<name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name>
</noRegion>
<name sortKey="Juhel, Nolwenn" sort="Juhel, Nolwenn" uniqKey="Juhel N" first="Nolwenn" last="Juhel">Nolwenn Juhel</name>
<name sortKey="Salin, Laurence" sort="Salin, Laurence" uniqKey="Salin L" first="Laurence" last="Salin">Laurence Salin</name>
</country>
<country name="Italie">
<noRegion>
<name sortKey="Barone, Paolo" sort="Barone, Paolo" uniqKey="Barone P" first="Paolo" last="Barone">Paolo Barone</name>
</noRegion>
</country>
<country name="Japon">
<noRegion>
<name sortKey="Mizuno, Yoshikuni" sort="Mizuno, Yoshikuni" uniqKey="Mizuno Y" first="Yoshikuni" last="Mizuno">Yoshikuni Mizuno</name>
</noRegion>
</country>
<country name="Autriche">
<region name="Vienne (Autriche)">
<name sortKey="Haaksma, Monika" sort="Haaksma, Monika" uniqKey="Haaksma M" first="Monika" last="Haaksma">Monika Haaksma</name>
</region>
<name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name>
</country>
</tree>
</affiliations>
</record>

Pour manipuler ce document sous Unix (Dilib)

EXPLOR_STEP=$WICRI_ROOT/Wicri/Santé/explor/MovDisordV3/Data/PascalFrancis/Checkpoint
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000873 | SxmlIndent | more

Ou

HfdSelect -h $EXPLOR_AREA/Data/PascalFrancis/Checkpoint/biblio.hfd -nk 000873 | SxmlIndent | more

Pour mettre un lien sur cette page dans le réseau Wicri

{{Explor lien
   |wiki=    Wicri/Santé
   |area=    MovDisordV3
   |flux=    PascalFrancis
   |étape=   Checkpoint
   |type=    RBID
   |clé=     Pascal:10-0512927
   |texte=   Randomized, Double-Blind, Multicenter Evaluation of Pramipexole Extended Release Once Daily in Early Parkinson's Disease
}}

Wicri

This area was generated with Dilib version V0.6.23.
Data generation: Sun Jul 3 12:29:32 2016. Site generation: Wed Feb 14 10:52:30 2024