MovDisordV3, PascalFrancis, Corpus, bibRecord, 000282

Systematic Evaluation of Augmentation during Treatment with Ropinirole in Restless Legs Syndrome (Willis-Ekbom Disease): Results from a Prospective, Multicenter Study over 66 Weeks

Identifieur interne : 000282 ( PascalFrancis/Corpus ); précédent : 000281; suivant : 000283

Systematic Evaluation of Augmentation during Treatment with Ropinirole in Restless Legs Syndrome (Willis-Ekbom Disease): Results from a Prospective, Multicenter Study over 66 Weeks

Auteurs : Diego Garcia-Borreguero ; Birgit Högl ; Luigi Ferini-Strambi ; John Winkelman ; Christina Hill-Zabala ; Afsaneh Asgharian ; Richard Allen

Source :

Movement disorders [ 0885-3185 ] ; 2012.

RBID : Pascal:12-0113805

Descripteurs français

Pascal (Inist)
- Syndrome des jambes sans repos, Pathologie du système nerveux, Evaluation, Traitement, Ropinirole, Prospective, Etude multicentrique.

English descriptors

KwdEn :
- Evaluation, Multicenter study, Nervous system diseases, Prospective, Restless legs syndrome, Ropinirole, Treatment.

Abstract

The purpose of this study was to evaluate the incidence of augmentation over 66 weeks of treatment with ropinirole in patients with primary restless legs syndrome (RLS). Augmentation is the main complication of long-term dopaminergic treatment of RLS. Despite widespread use of ropinirole in RLS, no studies have prospectively and systematically assessed the incidence of augmentation with its use. The study consisted of 26 weeks of double-blind flexible-dose treatment with ropinirole or placebo, followed by 40 weeks of open-label ropinirole treatment.. Patients had no previous history of augmentation. Potential cases of augmentation were identified with the Structured Interview for the Diagnosis of Augmentation and the Augmentation Severity Rating Scale and through reporting of adverse events. Cases were blindly evaluated by an expert panel using the NIH diagnostic criteria for augmentation. Four hundred and four patients participated in the double-blind study and 269 in the open-label phase, with a discontinuation rate of 42%. IRLS baseline scores improved at the end of the double-blind (DB) phase (mean ± SE) by -15.9 ± 0.76 for ropinirole, by -13.4 ± 0.77 for placebo (P < .05) and by -20.4 ± 0.55 during the open-label phase. The incidence rates of augmentation were 3.5% for ropinirole and <1% for placebo during the DB phase and 3% during the open-label phase. Clinically significant augmentation occurred in 3%, <1%, and 2%, respectively. Discontinuation of treatment occurred in 50% of all patients (7 of 14) with augmentation. The incidence of augmentation was 3.1 % higher with ropinirole than with placebo. New patients with first episodes of augmentation continued to cumulate at a stable rate over the duration of this study.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

A01	`01`	`1`		`@0 0885-3185`
A03		`1`		`@0 Mov. disord.`
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A08	`01`	`1`	`ENG`	`@1 Systematic Evaluation of Augmentation during Treatment with Ropinirole in Restless Legs Syndrome (Willis-Ekbom Disease): Results from a Prospective, Multicenter Study over 66 Weeks`
A11	`01`	`1`		`@1 GARCIA-BORREGUERO (Diego)`
A11	`02`	`1`		`@1 HÖGL (Birgit)`
A11	`03`	`1`		`@1 FERINI-STRAMBI (Luigi)`
A11	`04`	`1`		`@1 WINKELMAN (John)`
A11	`05`	`1`		`@1 HILL-ZABALA (Christina)`
A11	`06`	`1`		`@1 ASGHARIAN (Afsaneh)`
A11	`07`	`1`		`@1 ALLEN (Richard)`
A14	`01`			`@1 Sleep Research Institute @2 Madrid @3 ESP @Z 1 aut.`
A14	`02`			`@1 Department of Neurology, Innsbruck Medical University @2 Innsbruck @3 AUT @Z 2 aut.`
A14	`03`			`@1 Università Vita-Salute San Raffaele, Sleep Disorders Center @2 Milan @3 ITA @Z 3 aut.`
A14	`04`			`@1 Division of Sleep Medicine, Brigham & Women's Hospital, Harvard Medical School @2 Boston, Massachusetts @3 USA @Z 4 aut.`
A14	`05`			`@1 GlaxoSmithKline Research and Development, Research Triangle Park @2 North Carolina @3 USA @Z 5 aut. @Z 6 aut.`
A14	`06`			`@1 Department of Neurology, Johns Hopkins University @2 Baltimore, Maryland @3 USA @Z 7 aut.`
A20				`@1 277-283`
A21				`@1 2012`
A23	`01`			`@0 ENG`
A43	`01`			`@1 INIST @2 20953 @5 354000508698420170`
A44				`@0 0000 @1 © 2012 INIST-CNRS. All rights reserved.`
A45				`@0 21 ref.`
A47	`01`	`1`		`@0 12-0113805`
A60				`@1 P`
A61				`@0 A`
A64	`01`	`1`		`@0 Movement disorders`
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C01	`01`		`ENG`	@0 The purpose of this study was to evaluate the incidence of augmentation over 66 weeks of treatment with ropinirole in patients with primary restless legs syndrome (RLS). Augmentation is the main complication of long-term dopaminergic treatment of RLS. Despite widespread use of ropinirole in RLS, no studies have prospectively and systematically assessed the incidence of augmentation with its use. The study consisted of 26 weeks of double-blind flexible-dose treatment with ropinirole or placebo, followed by 40 weeks of open-label ropinirole treatment.. Patients had no previous history of augmentation. Potential cases of augmentation were identified with the Structured Interview for the Diagnosis of Augmentation and the Augmentation Severity Rating Scale and through reporting of adverse events. Cases were blindly evaluated by an expert panel using the NIH diagnostic criteria for augmentation. Four hundred and four patients participated in the double-blind study and 269 in the open-label phase, with a discontinuation rate of 42%. IRLS baseline scores improved at the end of the double-blind (DB) phase (mean ± SE) by -15.9 ± 0.76 for ropinirole, by -13.4 ± 0.77 for placebo (P < .05) and by -20.4 ± 0.55 during the open-label phase. The incidence rates of augmentation were 3.5% for ropinirole and <1% for placebo during the DB phase and 3% during the open-label phase. Clinically significant augmentation occurred in 3%, <1%, and 2%, respectively. Discontinuation of treatment occurred in 50% of all patients (7 of 14) with augmentation. The incidence of augmentation was 3.1 % higher with ropinirole than with placebo. New patients with first episodes of augmentation continued to cumulate at a stable rate over the duration of this study.
C02	`01`	`X`		`@0 002B17`
C02	`02`	`X`		`@0 002B17G`
C03	`01`	`X`	`FRE`	`@0 Syndrome des jambes sans repos @5 01`
C03	`01`	`X`	`ENG`	`@0 Restless legs syndrome @5 01`
C03	`01`	`X`	`SPA`	`@0 Acroparestesia nocturna @5 01`
C03	`02`	`X`	`FRE`	`@0 Pathologie du système nerveux @5 02`
C03	`02`	`X`	`ENG`	`@0 Nervous system diseases @5 02`
C03	`02`	`X`	`SPA`	`@0 Sistema nervioso patología @5 02`
C03	`03`	`X`	`FRE`	`@0 Evaluation @5 09`
C03	`03`	`X`	`ENG`	`@0 Evaluation @5 09`
C03	`03`	`X`	`SPA`	`@0 Evaluación @5 09`
C03	`04`	`X`	`FRE`	`@0 Traitement @5 10`
C03	`04`	`X`	`ENG`	`@0 Treatment @5 10`
C03	`04`	`X`	`SPA`	`@0 Tratamiento @5 10`
C03	`05`	`X`	`FRE`	`@0 Ropinirole @2 NK @2 FR @5 11`
C03	`05`	`X`	`ENG`	`@0 Ropinirole @2 NK @2 FR @5 11`
C03	`05`	`X`	`SPA`	`@0 Ropinirol @2 NK @2 FR @5 11`
C03	`06`	`X`	`FRE`	`@0 Prospective @5 12`
C03	`06`	`X`	`ENG`	`@0 Prospective @5 12`
C03	`06`	`X`	`SPA`	`@0 Prospectiva @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 38`
C07	`01`	`X`	`ENG`	`@0 Neurological disorder @5 38`
C07	`01`	`X`	`SPA`	`@0 Trastorno neurológico @5 38`
C07	`02`	`X`	`FRE`	`@0 Trouble de la sensibilité @5 39`
C07	`02`	`X`	`ENG`	`@0 Sensitivity disorder @5 39`
C07	`02`	`X`	`SPA`	`@0 Trastorno sensibilidad @5 39`
N21				`@1 086`
N44	`01`			`@1 OTO`
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Format Inist (serveur)

NO :	PASCAL 12-0113805 INIST
ET :	Systematic Evaluation of Augmentation during Treatment with Ropinirole in Restless Legs Syndrome (Willis-Ekbom Disease): Results from a Prospective, Multicenter Study over 66 Weeks
AU :	GARCIA-BORREGUERO (Diego); HÖGL (Birgit); FERINI-STRAMBI (Luigi); WINKELMAN (John); HILL-ZABALA (Christina); ASGHARIAN (Afsaneh); ALLEN (Richard)
AF :	Sleep Research Institute/Madrid/Espagne (1 aut.); Department of Neurology, Innsbruck Medical University/Innsbruck/Autriche (2 aut.); Università Vita-Salute San Raffaele, Sleep Disorders Center/Milan/Italie (3 aut.); Division of Sleep Medicine, Brigham & Women's Hospital, Harvard Medical School/Boston, Massachusetts/Etats-Unis (4 aut.); GlaxoSmithKline Research and Development, Research Triangle Park/North Carolina/Etats-Unis (5 aut., 6 aut.); Department of Neurology, Johns Hopkins University/Baltimore, Maryland/Etats-Unis (7 aut.)
DT :	Publication en série; Niveau analytique
SO :	Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2012; Vol. 27; No. 2; Pp. 277-283; Bibl. 21 ref.
LA :	Anglais
EA :	The purpose of this study was to evaluate the incidence of augmentation over 66 weeks of treatment with ropinirole in patients with primary restless legs syndrome (RLS). Augmentation is the main complication of long-term dopaminergic treatment of RLS. Despite widespread use of ropinirole in RLS, no studies have prospectively and systematically assessed the incidence of augmentation with its use. The study consisted of 26 weeks of double-blind flexible-dose treatment with ropinirole or placebo, followed by 40 weeks of open-label ropinirole treatment.. Patients had no previous history of augmentation. Potential cases of augmentation were identified with the Structured Interview for the Diagnosis of Augmentation and the Augmentation Severity Rating Scale and through reporting of adverse events. Cases were blindly evaluated by an expert panel using the NIH diagnostic criteria for augmentation. Four hundred and four patients participated in the double-blind study and 269 in the open-label phase, with a discontinuation rate of 42%. IRLS baseline scores improved at the end of the double-blind (DB) phase (mean ± SE) by -15.9 ± 0.76 for ropinirole, by -13.4 ± 0.77 for placebo (P < .05) and by -20.4 ± 0.55 during the open-label phase. The incidence rates of augmentation were 3.5% for ropinirole and <1% for placebo during the DB phase and 3% during the open-label phase. Clinically significant augmentation occurred in 3%, <1%, and 2%, respectively. Discontinuation of treatment occurred in 50% of all patients (7 of 14) with augmentation. The incidence of augmentation was 3.1 % higher with ropinirole than with placebo. New patients with first episodes of augmentation continued to cumulate at a stable rate over the duration of this study.
CC :	002B17; 002B17G
FD :	Syndrome des jambes sans repos; Pathologie du système nerveux; Evaluation; Traitement; Ropinirole; Prospective; Etude multicentrique
FG :	Trouble neurologique; Trouble de la sensibilité
ED :	Restless legs syndrome; Nervous system diseases; Evaluation; Treatment; Ropinirole; Prospective; Multicenter study
EG :	Neurological disorder; Sensitivity disorder
SD :	Acroparestesia nocturna; Sistema nervioso patología; Evaluación; Tratamiento; Ropinirol; Prospectiva; Estudio multicéntrico
LO :	INIST-20953.354000508698420170
ID :	12-0113805

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Pascal:12-0113805

Le document en format XML

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<front><div type="abstract" xml:lang="en">The purpose of this study was to evaluate the incidence of augmentation over 66 weeks of treatment with ropinirole in patients with primary restless legs syndrome (RLS). Augmentation is the main complication of long-term dopaminergic treatment of RLS. Despite widespread use of ropinirole in RLS, no studies have prospectively and systematically assessed the incidence of augmentation with its use. The study consisted of 26 weeks of double-blind flexible-dose treatment with ropinirole or placebo, followed by 40 weeks of open-label ropinirole treatment.. Patients had no previous history of augmentation. Potential cases of augmentation were identified with the Structured Interview for the Diagnosis of Augmentation and the Augmentation Severity Rating Scale and through reporting of adverse events. Cases were blindly evaluated by an expert panel using the NIH diagnostic criteria for augmentation. Four hundred and four patients participated in the double-blind study and 269 in the open-label phase, with a discontinuation rate of 42%. IRLS baseline scores improved at the end of the double-blind (DB) phase (mean ± SE) by -15.9 ± 0.76 for ropinirole, by -13.4 ± 0.77 for placebo (P < .05) and by -20.4 ± 0.55 during the open-label phase. The incidence rates of augmentation were 3.5% for ropinirole and <1% for placebo during the DB phase and 3% during the open-label phase. Clinically significant augmentation occurred in 3%, <1%, and 2%, respectively. Discontinuation of treatment occurred in 50% of all patients (7 of 14) with augmentation. The incidence of augmentation was 3.1 % higher with ropinirole than with placebo. New patients with first episodes of augmentation continued to cumulate at a stable rate over the duration of this study.</div>
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<fC01 i1="01" l="ENG"><s0>The purpose of this study was to evaluate the incidence of augmentation over 66 weeks of treatment with ropinirole in patients with primary restless legs syndrome (RLS). Augmentation is the main complication of long-term dopaminergic treatment of RLS. Despite widespread use of ropinirole in RLS, no studies have prospectively and systematically assessed the incidence of augmentation with its use. The study consisted of 26 weeks of double-blind flexible-dose treatment with ropinirole or placebo, followed by 40 weeks of open-label ropinirole treatment.. Patients had no previous history of augmentation. Potential cases of augmentation were identified with the Structured Interview for the Diagnosis of Augmentation and the Augmentation Severity Rating Scale and through reporting of adverse events. Cases were blindly evaluated by an expert panel using the NIH diagnostic criteria for augmentation. Four hundred and four patients participated in the double-blind study and 269 in the open-label phase, with a discontinuation rate of 42%. IRLS baseline scores improved at the end of the double-blind (DB) phase (mean ± SE) by -15.9 ± 0.76 for ropinirole, by -13.4 ± 0.77 for placebo (P < .05) and by -20.4 ± 0.55 during the open-label phase. The incidence rates of augmentation were 3.5% for ropinirole and <1% for placebo during the DB phase and 3% during the open-label phase. Clinically significant augmentation occurred in 3%, <1%, and 2%, respectively. Discontinuation of treatment occurred in 50% of all patients (7 of 14) with augmentation. The incidence of augmentation was 3.1 % higher with ropinirole than with placebo. New patients with first episodes of augmentation continued to cumulate at a stable rate over the duration of this study.</s0>
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<fC03 i1="03" i2="X" l="FRE"><s0>Evaluation</s0>
<s5>09</s5>
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<fC03 i1="03" i2="X" l="ENG"><s0>Evaluation</s0>
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<s2>FR</s2>
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<fC03 i1="05" i2="X" l="ENG"><s0>Ropinirole</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Ropinirol</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>11</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Prospective</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Prospective</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Prospectiva</s0>
<s5>12</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Etude multicentrique</s0>
<s5>13</s5>
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<fC03 i1="07" i2="X" l="ENG"><s0>Multicenter study</s0>
<s5>13</s5>
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<s5>13</s5>
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<fC07 i1="01" i2="X" l="FRE"><s0>Trouble neurologique</s0>
<s5>38</s5>
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<s5>38</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Trastorno neurológico</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Trouble de la sensibilité</s0>
<s5>39</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Sensitivity disorder</s0>
<s5>39</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Trastorno sensibilidad</s0>
<s5>39</s5>
</fC07>
<fN21><s1>086</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
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<server><NO>PASCAL 12-0113805 INIST</NO>
<ET>Systematic Evaluation of Augmentation during Treatment with Ropinirole in Restless Legs Syndrome (Willis-Ekbom Disease): Results from a Prospective, Multicenter Study over 66 Weeks</ET>
<AU>GARCIA-BORREGUERO (Diego); HÖGL (Birgit); FERINI-STRAMBI (Luigi); WINKELMAN (John); HILL-ZABALA (Christina); ASGHARIAN (Afsaneh); ALLEN (Richard)</AU>
<AF>Sleep Research Institute/Madrid/Espagne (1 aut.); Department of Neurology, Innsbruck Medical University/Innsbruck/Autriche (2 aut.); Università Vita-Salute San Raffaele, Sleep Disorders Center/Milan/Italie (3 aut.); Division of Sleep Medicine, Brigham & Women's Hospital, Harvard Medical School/Boston, Massachusetts/Etats-Unis (4 aut.); GlaxoSmithKline Research and Development, Research Triangle Park/North Carolina/Etats-Unis (5 aut., 6 aut.); Department of Neurology, Johns Hopkins University/Baltimore, Maryland/Etats-Unis (7 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2012; Vol. 27; No. 2; Pp. 277-283; Bibl. 21 ref.</SO>
<LA>Anglais</LA>
<EA>The purpose of this study was to evaluate the incidence of augmentation over 66 weeks of treatment with ropinirole in patients with primary restless legs syndrome (RLS). Augmentation is the main complication of long-term dopaminergic treatment of RLS. Despite widespread use of ropinirole in RLS, no studies have prospectively and systematically assessed the incidence of augmentation with its use. The study consisted of 26 weeks of double-blind flexible-dose treatment with ropinirole or placebo, followed by 40 weeks of open-label ropinirole treatment.. Patients had no previous history of augmentation. Potential cases of augmentation were identified with the Structured Interview for the Diagnosis of Augmentation and the Augmentation Severity Rating Scale and through reporting of adverse events. Cases were blindly evaluated by an expert panel using the NIH diagnostic criteria for augmentation. Four hundred and four patients participated in the double-blind study and 269 in the open-label phase, with a discontinuation rate of 42%. IRLS baseline scores improved at the end of the double-blind (DB) phase (mean ± SE) by -15.9 ± 0.76 for ropinirole, by -13.4 ± 0.77 for placebo (P < .05) and by -20.4 ± 0.55 during the open-label phase. The incidence rates of augmentation were 3.5% for ropinirole and <1% for placebo during the DB phase and 3% during the open-label phase. Clinically significant augmentation occurred in 3%, <1%, and 2%, respectively. Discontinuation of treatment occurred in 50% of all patients (7 of 14) with augmentation. The incidence of augmentation was 3.1 % higher with ropinirole than with placebo. New patients with first episodes of augmentation continued to cumulate at a stable rate over the duration of this study.</EA>
<CC>002B17; 002B17G</CC>
<FD>Syndrome des jambes sans repos; Pathologie du   système nerveux; Evaluation; Traitement; Ropinirole; Prospective; Etude multicentrique</FD>
<FG>Trouble neurologique; Trouble de la sensibilité</FG>
<ED>Restless legs syndrome; Nervous system diseases; Evaluation; Treatment; Ropinirole; Prospective; Multicenter study</ED>
<EG>Neurological disorder; Sensitivity disorder</EG>
<SD>Acroparestesia nocturna; Sistema nervioso patología; Evaluación; Tratamiento; Ropinirol; Prospectiva; Estudio multicéntrico</SD>
<LO>INIST-20953.354000508698420170</LO>
<ID>12-0113805</ID>
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	Movement Disorders (revue)
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Movement Disorders (revue)

Systematic Evaluation of Augmentation during Treatment with Ropinirole in Restless Legs Syndrome (Willis-Ekbom Disease): Results from a Prospective, Multicenter Study over 66 Weeks

Systematic Evaluation of Augmentation during Treatment with Ropinirole in Restless Legs Syndrome (Willis-Ekbom Disease): Results from a Prospective, Multicenter Study over 66 Weeks

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