MovDisordV3, PascalFrancis, Corpus, bibRecord, 001720

Cabergoline compared to levodopa in the treatment of patients with severe restless legs syndrome : Results from a multicenter, randomized, active controlled trial

Identifieur interne : 001720 ( PascalFrancis/Corpus ); précédent : 001719; suivant : 001721

Cabergoline compared to levodopa in the treatment of patients with severe restless legs syndrome : Results from a multicenter, randomized, active controlled trial

Auteurs : Claudia Trenkwalder ; Heike Benes ; Ludger Grote ; Svenja Happe ; Birgit Högl ; Johannes Mathis ; Gerda M. Saletu-Zyhlarz ; Ralf Kohnen

Source :

Movement disorders [ 0885-3185 ] ; 2007.

RBID : Pascal:07-0263037

Descripteurs français

Pascal (Inist)
- Système nerveux pathologie, Impatience membre inférieur syndrome, Cabergoline, Lévodopa, Traitement, Homme, Etude multicentrique.

English descriptors

KwdEn :
- Cabergoline, Human, Levodopa, Multicenter study, Nervous system diseases, Restless legs syndrome, Treatment.

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). Methods: 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.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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A08	`01`	`1`	`ENG`	`@1 Cabergoline compared to levodopa in the treatment of patients with severe restless legs syndrome : Results from a multicenter, randomized, active controlled trial`
A11	`01`	`1`		`@1 TRENKWALDER (Claudia)`
A11	`02`	`1`		`@1 BENES (Heike)`
A11	`03`	`1`		`@1 GROTE (Ludger)`
A11	`04`	`1`		`@1 HAPPE (Svenja)`
A11	`05`	`1`		`@1 HÖGL (Birgit)`
A11	`06`	`1`		`@1 MATHIS (Johannes)`
A11	`07`	`1`		`@1 SALETU-ZYHLARZ (Gerda M.)`
A11	`08`	`1`		`@1 KOHNEN (Ralf)`
A14	`01`			`@1 Paracelsus-Elena Hospital, University of Gottingen @2 Kassel @3 DEU @Z 1 aut.`
A14	`02`			`@1 Somni bene Institute for Clinical Research and Sleep Medicine @2 Schwerin @3 DEU @Z 2 aut.`
A14	`03`			`@1 Neurology Department, University of Rostock @3 DEU @Z 2 aut.`
A14	`04`			`@1 Department for Pulmonary Medicine and Allergology, Sahlgrenska Sjukhuset @2 Gothenburg @3 SWE @Z 3 aut.`
A14	`05`			`@1 Department of Clinical Neurophysiology, University of Goettingen @3 DEU @Z 4 aut.`
A14	`06`			`@1 Klinikum Bremen-Ost @2 Bremen @3 DEU @Z 4 aut.`
A14	`07`			`@1 Department of Neurology, Innsbruck Medical University @2 Innsbruck @3 AUT @Z 5 aut.`
A14	`08`			`@1 Department of Neurology, Inselspital @2 Bern @3 CHE @Z 6 aut.`
A14	`09`			`@1 University Hospital for Psychiatry @2 Vienna @3 AUT @Z 7 aut.`
A14	`10`			`@1 IMEREM Institute for Medical Research Management and Biometrics @2 Nuremberg @3 DEU @Z 8 aut.`
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A44				`@0 0000 @1 © 2007 INIST-CNRS. All rights reserved.`
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A61				`@0 A`
A64	`01`	`1`		`@0 Movement disorders`
A66	`01`			`@0 USA`
C01	`01`		`ENG`	@0 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). Methods: 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.
C02	`01`	`X`		`@0 002B17`
C02	`02`	`X`		`@0 002B17F`
C02	`03`	`X`		`@0 002B02Q`
C03	`01`	`X`	`FRE`	`@0 Système nerveux pathologie @5 01`
C03	`01`	`X`	`ENG`	`@0 Nervous system diseases @5 01`
C03	`01`	`X`	`SPA`	`@0 Sistema nervioso patología @5 01`
C03	`02`	`X`	`FRE`	`@0 Impatience membre inférieur syndrome @5 02`
C03	`02`	`X`	`ENG`	`@0 Restless legs syndrome @5 02`
C03	`02`	`X`	`SPA`	`@0 Acroparestesia nocturna @5 02`
C03	`03`	`X`	`FRE`	`@0 Cabergoline @2 NK @2 FR @5 09`
C03	`03`	`X`	`ENG`	`@0 Cabergoline @2 NK @2 FR @5 09`
C03	`03`	`X`	`SPA`	`@0 Cabergolina @2 NK @2 FR @5 09`
C03	`04`	`X`	`FRE`	`@0 Lévodopa @2 NK @2 FR @5 10`
C03	`04`	`X`	`ENG`	`@0 Levodopa @2 NK @2 FR @5 10`
C03	`04`	`X`	`SPA`	`@0 Levodopa @2 NK @2 FR @5 10`
C03	`05`	`X`	`FRE`	`@0 Traitement @5 11`
C03	`05`	`X`	`ENG`	`@0 Treatment @5 11`
C03	`05`	`X`	`SPA`	`@0 Tratamiento @5 11`
C03	`06`	`X`	`FRE`	`@0 Homme @5 12`
C03	`06`	`X`	`ENG`	`@0 Human @5 12`
C03	`06`	`X`	`SPA`	`@0 Hombre @5 12`
C03	`07`	`X`	`FRE`	`@0 Etude multicentrique @5 13`
C03	`07`	`X`	`ENG`	`@0 Multicenter study @5 13`
C03	`07`	`X`	`SPA`	`@0 Estudio multicéntrico @5 13`
C07	`01`	`X`	`FRE`	`@0 Trouble neurologique @5 37`
C07	`01`	`X`	`ENG`	`@0 Neurological disorder @5 37`
C07	`01`	`X`	`SPA`	`@0 Trastorno neurológico @5 37`
C07	`02`	`X`	`FRE`	`@0 Trouble sensibilité @5 38`
C07	`02`	`X`	`ENG`	`@0 Sensitivity disorder @5 38`
C07	`02`	`X`	`SPA`	`@0 Trastorno sensibilidad @5 38`
N21				`@1 176`
N44	`01`			`@1 OTO`
N82				`@1 OTO`

Format Inist (serveur)

NO :	PASCAL 07-0263037 INIST
ET :	Cabergoline compared to levodopa in the treatment of patients with severe restless legs syndrome : Results from a multicenter, randomized, active controlled trial
AU :	TRENKWALDER (Claudia); BENES (Heike); GROTE (Ludger); HAPPE (Svenja); HÖGL (Birgit); MATHIS (Johannes); SALETU-ZYHLARZ (Gerda M.); KOHNEN (Ralf)
AF :	Paracelsus-Elena Hospital, University of Gottingen/Kassel/Allemagne (1 aut.); Somni bene Institute for Clinical Research and Sleep Medicine/Schwerin/Allemagne (2 aut.); Neurology Department, University of Rostock/Allemagne (2 aut.); Department for Pulmonary Medicine and Allergology, Sahlgrenska Sjukhuset/Gothenburg/Suède (3 aut.); Department of Clinical Neurophysiology, University of Goettingen/Allemagne (4 aut.); Klinikum Bremen-Ost/Bremen/Allemagne (4 aut.); Department of Neurology, Innsbruck Medical University/Innsbruck/Autriche (5 aut.); Department of Neurology, Inselspital/Bern/Suisse (6 aut.); University Hospital for Psychiatry/Vienna/Autriche (7 aut.); IMEREM Institute for Medical Research Management and Biometrics/Nuremberg/Allemagne (8 aut.)
DT :	Publication en série; Niveau analytique
SO :	Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2007; Vol. 22; No. 5; Pp. 696-703; Bibl. 33 ref.
LA :	Anglais
EA :	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). Methods: 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.
CC :	002B17; 002B17F; 002B02Q
FD :	Système nerveux pathologie; Impatience membre inférieur syndrome; Cabergoline; Lévodopa; Traitement; Homme; Etude multicentrique
FG :	Trouble neurologique; Trouble sensibilité
ED :	Nervous system diseases; Restless legs syndrome; Cabergoline; Levodopa; Treatment; Human; Multicenter study
EG :	Neurological disorder; Sensitivity disorder
SD :	Sistema nervioso patología; Acroparestesia nocturna; Cabergolina; Levodopa; Tratamiento; Hombre; Estudio multicéntrico
LO :	INIST-20953.354000149439720150
ID :	07-0263037

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Pascal:07-0263037

Le document en format XML

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<keywords scheme="Pascal" xml:lang="fr"><term>Système nerveux pathologie</term>
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<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). Methods: 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.</div>
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<fA11 i1="01" i2="1"><s1>TRENKWALDER (Claudia)</s1>
</fA11>
<fA11 i1="02" i2="1"><s1>BENES (Heike)</s1>
</fA11>
<fA11 i1="03" i2="1"><s1>GROTE (Ludger)</s1>
</fA11>
<fA11 i1="04" i2="1"><s1>HAPPE (Svenja)</s1>
</fA11>
<fA11 i1="05" i2="1"><s1>HÖGL (Birgit)</s1>
</fA11>
<fA11 i1="06" i2="1"><s1>MATHIS (Johannes)</s1>
</fA11>
<fA11 i1="07" i2="1"><s1>SALETU-ZYHLARZ (Gerda M.)</s1>
</fA11>
<fA11 i1="08" i2="1"><s1>KOHNEN (Ralf)</s1>
</fA11>
<fA14 i1="01"><s1>Paracelsus-Elena Hospital, University of Gottingen</s1>
<s2>Kassel</s2>
<s3>DEU</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>Somni bene Institute for Clinical Research and Sleep Medicine</s1>
<s2>Schwerin</s2>
<s3>DEU</s3>
<sZ>2 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Neurology Department, University of Rostock</s1>
<s3>DEU</s3>
<sZ>2 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Department for Pulmonary Medicine and Allergology, Sahlgrenska Sjukhuset</s1>
<s2>Gothenburg</s2>
<s3>SWE</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Department of Clinical Neurophysiology, University of Goettingen</s1>
<s3>DEU</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Klinikum Bremen-Ost</s1>
<s2>Bremen</s2>
<s3>DEU</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>Department of Neurology, Innsbruck Medical University</s1>
<s2>Innsbruck</s2>
<s3>AUT</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>Department of Neurology, Inselspital</s1>
<s2>Bern</s2>
<s3>CHE</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="09"><s1>University Hospital for Psychiatry</s1>
<s2>Vienna</s2>
<s3>AUT</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="10"><s1>IMEREM Institute for Medical Research Management and Biometrics</s1>
<s2>Nuremberg</s2>
<s3>DEU</s3>
<sZ>8 aut.</sZ>
</fA14>
<fA17 i1="01" i2="1"><s1>CALDIR study group</s1>
<s3>INC</s3>
</fA17>
<fA20><s1>696-703</s1>
</fA20>
<fA21><s1>2007</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
</fA23>
<fA43 i1="01"><s1>INIST</s1>
<s2>20953</s2>
<s5>354000149439720150</s5>
</fA43>
<fA44><s0>0000</s0>
<s1>© 2007 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45><s0>33 ref.</s0>
</fA45>
<fA47 i1="01" i2="1"><s0>07-0263037</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>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). Methods: 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.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002B17</s0>
</fC02>
<fC02 i1="02" i2="X"><s0>002B17F</s0>
</fC02>
<fC02 i1="03" i2="X"><s0>002B02Q</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Système nerveux pathologie</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Nervous system diseases</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Sistema nervioso patología</s0>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Impatience membre inférieur syndrome</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Restless legs syndrome</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>Acroparestesia nocturna</s0>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Cabergoline</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Cabergoline</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Cabergolina</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>09</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Lévodopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Levodopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Levodopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>10</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Traitement</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Treatment</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Tratamiento</s0>
<s5>11</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Homme</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Human</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Hombre</s0>
<s5>12</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Etude multicentrique</s0>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Multicenter study</s0>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Estudio multicéntrico</s0>
<s5>13</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Trouble neurologique</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Neurological disorder</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Trastorno neurológico</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Trouble sensibilité</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Sensitivity disorder</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Trastorno sensibilidad</s0>
<s5>38</s5>
</fC07>
<fN21><s1>176</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
<server><NO>PASCAL 07-0263037 INIST</NO>
<ET>Cabergoline compared to levodopa in the treatment of patients with severe restless legs syndrome : Results from a multicenter, randomized, active controlled trial</ET>
<AU>TRENKWALDER (Claudia); BENES (Heike); GROTE (Ludger); HAPPE (Svenja); HÖGL (Birgit); MATHIS (Johannes); SALETU-ZYHLARZ (Gerda M.); KOHNEN (Ralf)</AU>
<AF>Paracelsus-Elena Hospital, University of Gottingen/Kassel/Allemagne (1 aut.); Somni bene Institute for Clinical Research and Sleep Medicine/Schwerin/Allemagne (2 aut.); Neurology Department, University of Rostock/Allemagne (2 aut.); Department for Pulmonary Medicine and Allergology, Sahlgrenska Sjukhuset/Gothenburg/Suède (3 aut.); Department of Clinical Neurophysiology, University of Goettingen/Allemagne (4 aut.); Klinikum Bremen-Ost/Bremen/Allemagne (4 aut.); Department of Neurology, Innsbruck Medical University/Innsbruck/Autriche (5 aut.); Department of Neurology, Inselspital/Bern/Suisse (6 aut.); University Hospital for Psychiatry/Vienna/Autriche (7 aut.); IMEREM Institute for Medical Research Management and Biometrics/Nuremberg/Allemagne (8 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2007; Vol. 22; No. 5; Pp. 696-703; Bibl. 33 ref.</SO>
<LA>Anglais</LA>
<EA>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). Methods: 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.</EA>
<CC>002B17; 002B17F; 002B02Q</CC>
<FD>Système nerveux pathologie; Impatience membre inférieur syndrome; Cabergoline; Lévodopa; Traitement; Homme; Etude multicentrique</FD>
<FG>Trouble neurologique; Trouble sensibilité</FG>
<ED>Nervous system diseases; Restless legs syndrome; Cabergoline; Levodopa; Treatment; Human; Multicenter study</ED>
<EG>Neurological disorder; Sensitivity disorder</EG>
<SD>Sistema nervioso patología; Acroparestesia nocturna; Cabergolina; Levodopa; Tratamiento; Hombre; Estudio multicéntrico</SD>
<LO>INIST-20953.354000149439720150</LO>
<ID>07-0263037</ID>
</server>
</inist>
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	Movement Disorders (revue)
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Movement Disorders (revue)

Cabergoline compared to levodopa in the treatment of patients with severe restless legs syndrome : Results from a multicenter, randomized, active controlled trial

Cabergoline compared to levodopa in the treatment of patients with severe restless legs syndrome : Results from a multicenter, randomized, active controlled trial

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