Efficacy, safety, and tolerability of overnight switching from immediate‐ to once daily extended‐release pramipexole in early Parkinson's disease
Identifieur interne : 001D19 ( Main/Exploration ); précédent : 001D18; suivant : 001D20Efficacy, safety, and tolerability of overnight switching from immediate‐ to once daily extended‐release pramipexole in early Parkinson's disease
Auteurs : Olivier Rascol [France] ; Paolo Barone [Italie] ; Robert A. Hauser [États-Unis] ; Yoshikuni Mizuno [Japon] ; Werner Poewe [Autriche] ; Anthony H. V. Schapira [Royaume-Uni] ; Laurence Salin [France] ; Mandy Sohr [Allemagne] ; Catherine Debieuvre [France]Source :
- Movement Disorders [ 0885-3185 ] ; 2010-10-30.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
- Aged, Antiparkinson Agents (administration & dosage), Antiparkinson Agents (adverse effects), Benzothiazoles (administration & dosage), Benzothiazoles (adverse effects), Confidence Intervals, Delayed-Action Preparations (therapeutic use), Dopamine agonist, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Nervous system diseases, Parkinson Disease (drug therapy), Parkinson disease, Parkinson's disease, Pramipexole, Release, Safety, Severity of Illness Index, Time Factors, dopamine agonist, pramipexole‐extended release, switch trial.
- MESH :
- chemical , administration & dosage : Antiparkinson Agents, Benzothiazoles.
- chemical , adverse effects : Antiparkinson Agents, Benzothiazoles.
- chemical , therapeutic use : Delayed-Action Preparations.
- drug therapy : Parkinson Disease.
- Aged, Confidence Intervals, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Severity of Illness Index, Time Factors.
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
Url:
DOI: 10.1002/mds.23262
Affiliations:
- Allemagne, Autriche, France, Italie, Japon, Royaume-Uni, États-Unis
- Angleterre, Floride, Grand Londres, Midi-Pyrénées, Tyrol (Land)
- Innsbruck, Londres, Reims, Tampa, Tokyo, Toulouse
- Université Toulouse III - Paul Sabatier, Université de Floride du Sud, Université de Toulouse, Université de médecine d'Innsbruck
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Le 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>Aged</term><term>Antiparkinson Agents (administration & dosage)</term><term>Antiparkinson Agents (adverse effects)</term><term>Benzothiazoles (administration & dosage)</term><term>Benzothiazoles (adverse effects)</term><term>Confidence Intervals</term><term>Delayed-Action Preparations (therapeutic use)</term><term>Dopamine agonist</term><term>Dose-Response Relationship, Drug</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>Nervous system diseases</term><term>Parkinson Disease (drug therapy)</term><term>Parkinson disease</term><term>Parkinson's disease</term><term>Pramipexole</term><term>Release</term><term>Safety</term><term>Severity of Illness Index</term><term>Time Factors</term><term>dopamine agonist</term><term>pramipexole‐extended release</term><term>switch trial</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antiparkinson Agents</term><term>Benzothiazoles</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiparkinson Agents</term><term>Benzothiazoles</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Delayed-Action Preparations</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>Confidence Intervals</term><term>Dose-Response Relationship, Drug</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>Severity of Illness Index</term><term>Time Factors</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Libération</term><term>Maladie de Parkinson</term><term>Pathologie du système nerveux</term><term>Pramipexole</term><term>Stimulant dopaminergique</term><term>Sécurité</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><affiliations><list><country><li>Allemagne</li><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></region><settlement><li>Innsbruck</li><li>Londres</li><li>Reims</li><li>Tampa</li><li>Tokyo</li><li>Toulouse</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="France"><region name="Midi-Pyrénées"><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name></region><name sortKey="Debieuvre, Catherine" sort="Debieuvre, Catherine" uniqKey="Debieuvre C" first="Catherine" last="Debieuvre">Catherine Debieuvre</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="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="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="Tyrol (Land)"><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</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="Allemagne"><noRegion><name sortKey="Sohr, Mandy" sort="Sohr, Mandy" uniqKey="Sohr M" first="Mandy" last="Sohr">Mandy Sohr</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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