Randomized, double‐blind, multicenter evaluation of pramipexole extended release once daily in early Parkinson's disease
Identifieur interne : 000200 ( France/Analysis ); précédent : 000199; suivant : 000201Randomized, 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 :
- Movement Disorders [ 0885-3185 ] ; 2010-11-15.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
- Aged, Antiparkinson Agents (administration & dosage), Antiparkinson Agents (adverse effects), Antiparkinson Agents (therapeutic use), Benzothiazoles (administration & dosage), Benzothiazoles (adverse effects), Benzothiazoles (therapeutic use), Delayed-Action Preparations (administration & dosage), Delayed-Action Preparations (adverse effects), Delayed-Action Preparations (therapeutic use), Dopamine agonist, Double-Blind Method, Drug Administration Schedule, Evaluation, Female, Humans, Levodopa (therapeutic use), Male, Middle Aged, Nervous system diseases, Parkinson Disease (drug therapy), Parkinson disease, Parkinson's disease, Patient Satisfaction, Pramipexole, Quality of Life, Release, Severity of Illness Index, Treatment, Treatment Outcome, dopamine agonist, pramipexole extended release, treatment.
- MESH :
- chemical , administration & dosage : Antiparkinson Agents, Benzothiazoles, Delayed-Action Preparations.
- chemical , adverse effects : Antiparkinson Agents, Benzothiazoles, Delayed-Action Preparations.
- chemical , therapeutic use : Antiparkinson Agents, Benzothiazoles, Delayed-Action Preparations, Levodopa.
- drug therapy : Parkinson Disease.
- Aged, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Patient Satisfaction, Quality of Life, Severity of Illness Index, Treatment Outcome.
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
Affiliations:
- Autriche, France, Italie, Japon, Royaume-Uni, États-Unis
- Angleterre, Floride, Grand Londres, Midi-Pyrénées, Tyrol (Land), Vienne (Autriche)
- Innsbruck, Londres, Reims, Tampa, Tokyo, Toulouse, Vienne (Autriche)
- Université Toulouse III - Paul Sabatier, Université de Floride du Sud, Université de Toulouse, Université de médecine d'Innsbruck
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ISTEX:6D17C7F9698CE3482504E8A130ED82080DB28D0CLe document en format XML
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Hauser</name><affiliation wicri:level="4"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Neurology, University of South Florida, Tampa, Florida</wicri:regionArea><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"><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>University Department of Clinical Neurosciences, Institute of Neurology, University College London, London</wicri:regionArea><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"><country xml:lang="fr">France</country><wicri:regionArea>Department of Clinical Pharmacology and Neurosciences, Clinical Investigation Center, INSERM CIC‐9203 and UMR‐825, Toulouse University Hospital, Toulouse</wicri:regionArea><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"><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Neurological Sciences, University of Naples, Federico II and IDC‐Hermitage‐Capodimonte, Naples</wicri:regionArea><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"><country xml:lang="fr">Japon</country><wicri:regionArea>Department of Neurology, Juntendo University School of Medicine, Bunkyo‐ku, Tokyo</wicri:regionArea><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"><country xml:lang="fr">France</country><wicri:regionArea>Division of Medicine, Department of Clinical Development, Boehringer Ingelheim France S.A.S., Reims</wicri:regionArea><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"><country xml:lang="fr">Autriche</country><wicri:regionArea>Medical Department, Boehringer Ingelheim Pharma RCV GmbH & Co. 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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="2010-11-15">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>Aged</term><term>Antiparkinson Agents (administration & dosage)</term><term>Antiparkinson Agents (adverse effects)</term><term>Antiparkinson Agents (therapeutic use)</term><term>Benzothiazoles (administration & dosage)</term><term>Benzothiazoles (adverse effects)</term><term>Benzothiazoles (therapeutic use)</term><term>Delayed-Action Preparations (administration & dosage)</term><term>Delayed-Action Preparations (adverse effects)</term><term>Delayed-Action Preparations (therapeutic use)</term><term>Dopamine agonist</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Evaluation</term><term>Female</term><term>Humans</term><term>Levodopa (therapeutic use)</term><term>Male</term><term>Middle Aged</term><term>Nervous system diseases</term><term>Parkinson Disease (drug therapy)</term><term>Parkinson disease</term><term>Parkinson's disease</term><term>Patient Satisfaction</term><term>Pramipexole</term><term>Quality of Life</term><term>Release</term><term>Severity of Illness Index</term><term>Treatment</term><term>Treatment Outcome</term><term>dopamine agonist</term><term>pramipexole extended release</term><term>treatment</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antiparkinson Agents</term><term>Benzothiazoles</term><term>Delayed-Action Preparations</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiparkinson Agents</term><term>Benzothiazoles</term><term>Delayed-Action Preparations</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</term><term>Benzothiazoles</term><term>Delayed-Action Preparations</term><term>Levodopa</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Patient Satisfaction</term><term>Quality of Life</term><term>Severity of Illness Index</term><term>Treatment Outcome</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Evaluation</term><term>Libération</term><term>Maladie de Parkinson</term><term>Pathologie du système nerveux</term><term>Pramipexole</term><term>Stimulant dopaminergique</term><term>Traitement</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><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)
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