Rotigotine effects on early morning motor function and sleep in Parkinson's disease: A double‐blind, randomized, placebo‐controlled study (RECOVER)
Identifieur interne : 000164 ( Main/Exploration ); précédent : 000163; suivant : 000165Rotigotine effects on early morning motor function and sleep in Parkinson's disease: A double‐blind, randomized, placebo‐controlled study (RECOVER)
Auteurs : Claudia Trenkwalder [Allemagne] ; Bryan Kies [Afrique du Sud] ; Monika Rudzinska [Pologne] ; Jennifer Fine [Afrique du Sud] ; Janos Nikl [Hongrie] ; Krystyna Honczarenko [Pologne] ; Peter Dioszeghy [Hongrie] ; Dennis Hill [États-Unis] ; Tim Anderson [Nouvelle-Zélande] ; Vilho Myllyla [Finlande] ; Jan Kassubek [Allemagne] ; Malcolm Steiger [Royaume-Uni] ; Marco Zucconi [Italie] ; Eduardo Tolosa [Espagne] ; Werner Poewe [Autriche] ; Erwin Surmann [Allemagne] ; John Whitesides [États-Unis] ; Babak Boroojerdi [Allemagne] ; Kallol Ray Chaudhuri [Royaume-Uni] ; the RECOVER Study GroupSource :
- Movement Disorders [ 0885-3185 ] ; 2011-01.
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- KwdEn :
Abstract
In a multinational, double‐blind, placebo‐controlled trial (NCT00474058), 287 subjects with Parkinson's disease (PD) and unsatisfactory early‐morning motor symptom control were randomized 2:1 to receive rotigotine (2–16 mg/24 hr [n = 190]) or placebo (n = 97). Treatment was titrated to optimal dose over 1–8 weeks with subsequent dose maintenance for 4 weeks. Early‐morning motor function and nocturnal sleep disturbance were assessed as coprimary efficacy endpoints using the Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Examination) measured in the early morning prior to any medication intake and the modified Parkinson's Disease Sleep Scale (PDSS‐2) (mean change from baseline to end of maintenance [EOM], last observation carried forward). At EOM, mean UPDRS Part III score had decreased by −7.0 points with rotigotine (from a baseline of 29.6 [standard deviation (SD) 12.3] and by −3.9 points with placebo (baseline 32.0 [13.3]). Mean PDSS‐2 total score had decreased by −5.9 points with rotigotine (from a baseline of 19.3 [SD 9.3]) and by −1.9 points with placebo (baseline 20.5 [10.4]). This represented a significantly greater improvement with rotigotine compared with placebo on both the UPDRS Part III (treatment difference: −3.55 [95% confidence interval (CI) −5.37, −1.73]; P = 0.0002) and PDSS‐2 (treatment difference: −4.26 [95% CI −6.08, −2.45]; P < 0.0001). The most frequently reported adverse events were nausea (placebo, 9%; rotigotine, 21%), application site reactions (placebo, 4%; rotigotine, 15%), and dizziness (placebo, 6%; rotigotine 10%). Twenty‐four‐hour transdermal delivery of rotigotine to PD patients with early‐morning motor dysfunction resulted in significant benefits in control of both motor function and nocturnal sleep disturbances. © 2010 Movement Disorder Society
Url:
DOI: 10.1002/mds.23441
Affiliations:
- Afrique du Sud, Allemagne, Autriche, Espagne, Finlande, Hongrie, Italie, Nouvelle-Zélande, Pologne, Royaume-Uni, États-Unis
- Angleterre, Bade-Wurtemberg, Caroline du Nord, District de Kassel, District de Tübingen, Grand Londres, Hesse (Land), Lombardie, Tyrol (Land)
- Cassel (Hesse), Innsbruck, Londres, Milan, Ulm
- Université d'Ulm, Université de médecine d'Innsbruck
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xml:lang="fr">Royaume-Uni</country><wicri:regionArea>NPF Centre of Excellence, Kings College Hospital and University Hospital Lewisham, Kings College and Institute of Psychiatry, 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="The Recover Study Group" sort="The Recover Study Group" uniqKey="The Recover Study Group" last="The Recover Study Group">the RECOVER Study Group</name></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="2011-01">2011-01</date><biblScope unit="volume">26</biblScope><biblScope unit="issue">1</biblScope><biblScope unit="page" from="90">90</biblScope><biblScope unit="page" to="99">99</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">5E16E1D432ED9110E7448651B48C08D89C1CCA1B</idno><idno type="DOI">10.1002/mds.23441</idno><idno type="ArticleID">MDS23441</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>dopamine agonist</term><term>motor function</term><term>quality of life</term><term>rotigotine</term><term>sleep</term><term>transdermal</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">In a multinational, double‐blind, placebo‐controlled trial (NCT00474058), 287 subjects with Parkinson's disease (PD) and unsatisfactory early‐morning motor symptom control were randomized 2:1 to receive rotigotine (2–16 mg/24 hr [n = 190]) or placebo (n = 97). Treatment was titrated to optimal dose over 1–8 weeks with subsequent dose maintenance for 4 weeks. Early‐morning motor function and nocturnal sleep disturbance were assessed as coprimary efficacy endpoints using the Unified Parkinson's Disease Rating Scale (UPDRS) Part III (Motor Examination) measured in the early morning prior to any medication intake and the modified Parkinson's Disease Sleep Scale (PDSS‐2) (mean change from baseline to end of maintenance [EOM], last observation carried forward). At EOM, mean UPDRS Part III score had decreased by −7.0 points with rotigotine (from a baseline of 29.6 [standard deviation (SD) 12.3] and by −3.9 points with placebo (baseline 32.0 [13.3]). Mean PDSS‐2 total score had decreased by −5.9 points with rotigotine (from a baseline of 19.3 [SD 9.3]) and by −1.9 points with placebo (baseline 20.5 [10.4]). This represented a significantly greater improvement with rotigotine compared with placebo on both the UPDRS Part III (treatment difference: −3.55 [95% confidence interval (CI) −5.37, −1.73]; P = 0.0002) and PDSS‐2 (treatment difference: −4.26 [95% CI −6.08, −2.45]; P < 0.0001). The most frequently reported adverse events were nausea (placebo, 9%; rotigotine, 21%), application site reactions (placebo, 4%; rotigotine, 15%), and dizziness (placebo, 6%; rotigotine 10%). Twenty‐four‐hour transdermal delivery of rotigotine to PD patients with early‐morning motor dysfunction resulted in significant benefits in control of both motor function and nocturnal sleep disturbances. © 2010 Movement Disorder Society</div></front></TEI><affiliations><list><country><li>Afrique du Sud</li><li>Allemagne</li><li>Autriche</li><li>Espagne</li><li>Finlande</li><li>Hongrie</li><li>Italie</li><li>Nouvelle-Zélande</li><li>Pologne</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Bade-Wurtemberg</li><li>Caroline du Nord</li><li>District de Kassel</li><li>District de Tübingen</li><li>Grand Londres</li><li>Hesse (Land)</li><li>Lombardie</li><li>Tyrol (Land)</li></region><settlement><li>Cassel (Hesse)</li><li>Innsbruck</li><li>Londres</li><li>Milan</li><li>Ulm</li></settlement><orgName><li>Université d'Ulm</li><li>Université de médecine d'Innsbruck</li></orgName></list><tree><noCountry><name sortKey="The Recover Study Group" sort="The Recover Study Group" uniqKey="The Recover Study Group" last="The Recover Study Group">the RECOVER Study Group</name></noCountry><country name="Allemagne"><region name="Hesse (Land)"><name sortKey="Trenkwalder, Claudia" sort="Trenkwalder, Claudia" uniqKey="Trenkwalder C" first="Claudia" last="Trenkwalder">Claudia Trenkwalder</name></region><name sortKey="Boroojerdi, Babak" sort="Boroojerdi, Babak" uniqKey="Boroojerdi B" first="Babak" last="Boroojerdi">Babak Boroojerdi</name><name sortKey="Kassubek, Jan" sort="Kassubek, Jan" uniqKey="Kassubek J" first="Jan" last="Kassubek">Jan Kassubek</name><name sortKey="Surmann, Erwin" sort="Surmann, Erwin" uniqKey="Surmann E" first="Erwin" last="Surmann">Erwin Surmann</name></country><country name="Afrique du Sud"><noRegion><name sortKey="Kies, Bryan" sort="Kies, Bryan" uniqKey="Kies B" first="Bryan" last="Kies">Bryan Kies</name></noRegion><name sortKey="Fine, Jennifer" sort="Fine, Jennifer" uniqKey="Fine J" first="Jennifer" last="Fine">Jennifer Fine</name></country><country name="Pologne"><noRegion><name sortKey="Rudzinska, Monika" sort="Rudzinska, Monika" uniqKey="Rudzinska M" first="Monika" last="Rudzinska">Monika Rudzinska</name></noRegion><name sortKey="Honczarenko, Krystyna" sort="Honczarenko, Krystyna" uniqKey="Honczarenko K" first="Krystyna" last="Honczarenko">Krystyna Honczarenko</name></country><country name="Hongrie"><noRegion><name sortKey="Nikl, Janos" sort="Nikl, Janos" uniqKey="Nikl J" first="Janos" last="Nikl">Janos Nikl</name></noRegion><name sortKey="Dioszeghy, Peter" sort="Dioszeghy, Peter" uniqKey="Dioszeghy P" first="Peter" last="Dioszeghy">Peter Dioszeghy</name></country><country name="États-Unis"><region name="Caroline du Nord"><name sortKey="Hill, Dennis" sort="Hill, Dennis" uniqKey="Hill D" first="Dennis" last="Hill">Dennis Hill</name></region><name sortKey="Whitesides, John" sort="Whitesides, John" uniqKey="Whitesides J" first="John" last="Whitesides">John Whitesides</name></country><country name="Nouvelle-Zélande"><noRegion><name sortKey="Anderson, Tim" sort="Anderson, Tim" uniqKey="Anderson T" first="Tim" last="Anderson">Tim Anderson</name></noRegion></country><country name="Finlande"><noRegion><name sortKey="Myllyla, Vilho" sort="Myllyla, Vilho" uniqKey="Myllyla V" first="Vilho" last="Myllyla">Vilho Myllyla</name></noRegion></country><country name="Royaume-Uni"><noRegion><name sortKey="Steiger, Malcolm" sort="Steiger, Malcolm" uniqKey="Steiger M" first="Malcolm" last="Steiger">Malcolm Steiger</name></noRegion><name sortKey="Chaudhuri, Kallol Ray" sort="Chaudhuri, Kallol Ray" uniqKey="Chaudhuri K" first="Kallol Ray" last="Chaudhuri">Kallol Ray Chaudhuri</name></country><country name="Italie"><region name="Lombardie"><name sortKey="Zucconi, Marco" sort="Zucconi, Marco" uniqKey="Zucconi M" first="Marco" last="Zucconi">Marco Zucconi</name></region></country><country name="Espagne"><noRegion><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</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></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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