Cabergoline compared to levodopa in the treatment of patients with severe restless legs syndrome: Results from a multi‐center, randomized, active controlled trial
Identifieur interne : 002F76 ( Main/Exploration ); précédent : 002F75; suivant : 002F77Cabergoline compared to levodopa in the treatment of patients with severe restless legs syndrome: Results from a multi‐center, randomized, active controlled trial
Auteurs : Claudia Trenkwalder [Allemagne] ; Heike Benes [Allemagne] ; Ludger Grote [Suède] ; Svenja Happe [Allemagne] ; Birgit Högl [Autriche] ; Johannes Mathis [Suisse] ; Gerda M. Saletu-Zyhlarz [Autriche] ; Ralf Kohnen [Allemagne]Source :
- Movement Disorders [ 0885-3185 ] ; 2007-04-15.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
- Adult, Aged, Antiparkinson Agents (adverse effects), Antiparkinson Agents (therapeutic use), Cabergoline, Dopamine Agonists (adverse effects), Dopamine Agonists (therapeutic use), Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Ergolines (adverse effects), Ergolines (therapeutic use), Europe, Female, Human, Humans, Levodopa, Levodopa (adverse effects), Levodopa (therapeutic use), Male, Middle Aged, Multicenter study, Nervous system diseases, Neurologic Examination (drug effects), Restless Legs Syndrome (drug therapy), Restless legs syndrome, Treatment, augmentation, cabergoline, levodopa, restless legs syndrome, therapy.
- MESH :
- chemical , adverse effects : Antiparkinson Agents, Dopamine Agonists, Ergolines, Levodopa.
- chemical , therapeutic use : Antiparkinson Agents, Dopamine Agonists, Ergolines, Levodopa.
- geographic : Europe.
- drug effects : Neurologic Examination.
- drug therapy : Restless Legs Syndrome.
- Adult, Aged, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Middle Aged.
Abstract
We report the first large‐scale double‐blind, randomly assigned study to compare two active dopaminergic therapies for Restless Legs Syndrome (RLS), the dopamine agonist cabergoline (CAB) and levodopa/benserazide (levodopa). Patients with idiopathic RLS were treated with fixed daily doses of 2 or 3 mg CAB or 200 or 300 mg levodopa for 30 weeks. Efficacy was assessed by changes in the IRLS (International RLS Severity Scale) and by time to discontinuation of treatment due to loss of efficacy or augmentation. 361 of 418 screened patients (age 58 ± 12 years, 71% females) were randomly assigned and treated (CAB: n = 178; levodopa: n = 183) in 51 centers of four European countries. Baseline IRLS total score was 25.7 ± 6.8. The baseline‐adjusted mean change from baseline to week 6 in IRLS sum score was d = −16.1 in the CAB group and d = −9.5 in the levodopa group (d = −6.6, P < 0.0001). More patients in the levodopa group (24.0%) than in the CAB group (11.9%, P = 0.0029, log‐rank test) discontinued because of loss of efficacy (14.2% vs. 7.9%, P = 0.0290) or augmentation (9.8% vs. 4.0%, P = 0.0412). Adverse events (AEs) occurred in 83.1% of the CAB group and in 77.6% of the levodopa group. In both groups, most frequent AEs were gastrointestinal symptoms (CAB: 55.6%, levodopa: 30.6%, P < 0.0001). This first large‐scale active controlled study in RLS showed superior efficacy of cabergoline versus levodopa after a 30‐week long‐term therapy. Tolerability was found more favorable with levodopa than with cabergoline. © 2007 Movement Disorder Society
Url:
DOI: 10.1002/mds.21401
Affiliations:
- Allemagne, Autriche, Suisse, Suède
- Brême (Land), Canton de Berne, District de Kassel, Hesse (Land), Vienne (Autriche)
- Berne, Brême, Cassel (Hesse), Vienne (Autriche)
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Le document en format XML
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wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Neurology Department, University of Rostock</wicri:regionArea><wicri:noRegion>University of Rostock</wicri:noRegion><wicri:noRegion>University of Rostock</wicri:noRegion></affiliation></author><author><name sortKey="Grote, Ludger" sort="Grote, Ludger" uniqKey="Grote L" first="Ludger" last="Grote">Ludger Grote</name><affiliation wicri:level="1"><country xml:lang="fr">Suède</country><wicri:regionArea>Department for Pulmonary Medicine and Allergology, Sahlgrenska Sjukhuset, Gothenburg</wicri:regionArea><wicri:noRegion>Gothenburg</wicri:noRegion></affiliation></author><author><name sortKey="Happe, Svenja" sort="Happe, Svenja" uniqKey="Happe S" first="Svenja" last="Happe">Svenja Happe</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Clinical Neurophysiology, University of Goettingen</wicri:regionArea><wicri:noRegion>University of Goettingen</wicri:noRegion><wicri:noRegion>University of Goettingen</wicri:noRegion></affiliation><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Klinikum Bremen‐Ost, Bremen</wicri:regionArea><placeName><region type="land" nuts="3">Brême (Land)</region><settlement type="city">Brême</settlement></placeName></affiliation></author><author><name sortKey="Hogl, Birgit" sort="Hogl, Birgit" uniqKey="Hogl B" first="Birgit" last="Högl">Birgit Högl</name><affiliation wicri:level="1"><country xml:lang="fr">Autriche</country><wicri:regionArea>Department of Neurology, Innsbruck Medical University, Innsbruck</wicri:regionArea><wicri:noRegion>Innsbruck</wicri:noRegion></affiliation></author><author><name sortKey="Mathis, Johannes" sort="Mathis, Johannes" uniqKey="Mathis J" first="Johannes" last="Mathis">Johannes Mathis</name><affiliation wicri:level="3"><country xml:lang="fr">Suisse</country><wicri:regionArea>Department of Neurology, Inselspital, 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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="2007-04-15">2007-04-15</date><biblScope unit="vol">22</biblScope><biblScope unit="issue">5</biblScope><biblScope unit="page" from="696">696</biblScope><biblScope unit="page" to="703">703</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">BA98AF6C265F3861C7D0A7B1AA20FC6A85ABC08D</idno><idno type="DOI">10.1002/mds.21401</idno><idno type="ArticleID">MDS21401</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Antiparkinson Agents (adverse effects)</term><term>Antiparkinson Agents (therapeutic use)</term><term>Cabergoline</term><term>Dopamine Agonists (adverse effects)</term><term>Dopamine Agonists (therapeutic use)</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Ergolines (adverse effects)</term><term>Ergolines (therapeutic use)</term><term>Europe</term><term>Female</term><term>Human</term><term>Humans</term><term>Levodopa</term><term>Levodopa (adverse effects)</term><term>Levodopa (therapeutic use)</term><term>Male</term><term>Middle Aged</term><term>Multicenter study</term><term>Nervous system diseases</term><term>Neurologic Examination (drug effects)</term><term>Restless Legs Syndrome (drug therapy)</term><term>Restless legs syndrome</term><term>Treatment</term><term>augmentation</term><term>cabergoline</term><term>levodopa</term><term>restless legs syndrome</term><term>therapy</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiparkinson Agents</term><term>Dopamine Agonists</term><term>Ergolines</term><term>Levodopa</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</term><term>Dopamine Agonists</term><term>Ergolines</term><term>Levodopa</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Europe</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Neurologic Examination</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Restless Legs Syndrome</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</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></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Cabergoline</term><term>Etude multicentrique</term><term>Homme</term><term>Impatience membre inférieur syndrome</term><term>Lévodopa</term><term>Système nerveux pathologie</term><term>Traitement</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">We report the first large‐scale double‐blind, randomly assigned study to compare two active dopaminergic therapies for Restless Legs Syndrome (RLS), the dopamine agonist cabergoline (CAB) and levodopa/benserazide (levodopa). Patients with idiopathic RLS were treated with fixed daily doses of 2 or 3 mg CAB or 200 or 300 mg levodopa for 30 weeks. Efficacy was assessed by changes in the IRLS (International RLS Severity Scale) and by time to discontinuation of treatment due to loss of efficacy or augmentation. 361 of 418 screened patients (age 58 ± 12 years, 71% females) were randomly assigned and treated (CAB: n = 178; levodopa: n = 183) in 51 centers of four European countries. Baseline IRLS total score was 25.7 ± 6.8. The baseline‐adjusted mean change from baseline to week 6 in IRLS sum score was d = −16.1 in the CAB group and d = −9.5 in the levodopa group (d = −6.6, P < 0.0001). More patients in the levodopa group (24.0%) than in the CAB group (11.9%, P = 0.0029, log‐rank test) discontinued because of loss of efficacy (14.2% vs. 7.9%, P = 0.0290) or augmentation (9.8% vs. 4.0%, P = 0.0412). Adverse events (AEs) occurred in 83.1% of the CAB group and in 77.6% of the levodopa group. In both groups, most frequent AEs were gastrointestinal symptoms (CAB: 55.6%, levodopa: 30.6%, P < 0.0001). This first large‐scale active controlled study in RLS showed superior efficacy of cabergoline versus levodopa after a 30‐week long‐term therapy. Tolerability was found more favorable with levodopa than with cabergoline. © 2007 Movement Disorder Society</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Autriche</li><li>Suisse</li><li>Suède</li></country><region><li>Brême (Land)</li><li>Canton de Berne</li><li>District de Kassel</li><li>Hesse (Land)</li><li>Vienne (Autriche)</li></region><settlement><li>Berne</li><li>Brême</li><li>Cassel (Hesse)</li><li>Vienne (Autriche)</li></settlement></list><tree><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="Benes, Heike" sort="Benes, Heike" uniqKey="Benes H" first="Heike" last="Benes">Heike Benes</name><name sortKey="Benes, Heike" sort="Benes, Heike" uniqKey="Benes H" first="Heike" last="Benes">Heike Benes</name><name sortKey="Happe, Svenja" sort="Happe, Svenja" uniqKey="Happe S" first="Svenja" last="Happe">Svenja Happe</name><name sortKey="Happe, Svenja" sort="Happe, Svenja" uniqKey="Happe S" first="Svenja" last="Happe">Svenja Happe</name><name sortKey="Kohnen, Ralf" sort="Kohnen, Ralf" uniqKey="Kohnen R" first="Ralf" last="Kohnen">Ralf Kohnen</name></country><country name="Suède"><noRegion><name sortKey="Grote, Ludger" sort="Grote, Ludger" uniqKey="Grote L" first="Ludger" last="Grote">Ludger Grote</name></noRegion></country><country name="Autriche"><noRegion><name sortKey="Hogl, Birgit" sort="Hogl, Birgit" uniqKey="Hogl B" first="Birgit" last="Högl">Birgit Högl</name></noRegion><name sortKey="Saletu Yhlarz, Gerda M" sort="Saletu Yhlarz, Gerda M" uniqKey="Saletu Yhlarz G" first="Gerda M." last="Saletu-Zyhlarz">Gerda M. Saletu-Zyhlarz</name></country><country name="Suisse"><region name="Canton de Berne"><name sortKey="Mathis, Johannes" sort="Mathis, Johannes" uniqKey="Mathis J" first="Johannes" last="Mathis">Johannes Mathis</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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