Ropinirole is effective in the long-term management of restless legs syndrome: a randomized controlled trial.
Identifieur interne : 002B02 ( PubMed/Checkpoint ); précédent : 002B01; suivant : 002B03Ropinirole is effective in the long-term management of restless legs syndrome: a randomized controlled trial.
Auteurs : Jacques Montplaisir [Canada] ; Jeff Karrasch ; Jean Haan ; Dieter VolcSource :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 2006.
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Dopamine Agonists (adverse effects), Dopamine Agonists (therapeutic use), Double-Blind Method, Drug Therapy, Combination, Drug-Related Side Effects and Adverse Reactions, Female, Humans, Indoles (adverse effects), Indoles (therapeutic use), Long-Term Care, Male, Middle Aged, Restless Legs Syndrome (drug therapy), Single-Blind Method, Treatment Outcome.
- MESH :
- chemical , adverse effects : Dopamine Agonists, Indoles.
- chemical , therapeutic use : Dopamine Agonists, Indoles.
- drug therapy : Restless Legs Syndrome.
- Adolescent, Adult, Aged, Double-Blind Method, Drug Therapy, Combination, Drug-Related Side Effects and Adverse Reactions, Female, Humans, Long-Term Care, Male, Middle Aged, Single-Blind Method, Treatment Outcome.
Abstract
The objective of this study was to investigate the long-term efficacy of ropinirole in patients with restless legs syndrome (RLS) and to assess the potential for relapse after the discontinuation of active treatment. Patients with primary RLS (n = 202) received single-blind ropinirole for 24 weeks. Patients meeting treatment continuation criteria were randomized to double-blind treatment with ropinirole or placebo for a further 12 weeks. The primary efficacy variable was the proportion of patients relapsing during double-blind treatment. Additional efficacy measures included time to relapse, withdrawals due to lack of efficacy, improvement on the Clinical Global Impression-Improvement (CGI-I) scale, change in International Restless Legs Scale (IRLS) score during double-blind treatment, and changes in sleep and quality of life (QoL) parameters. Significantly fewer patients relapsed on ropinirole than on placebo (32.6% vs. 57.8%; P = 0.0156). Time to relapse was longer with ropinirole and more patients withdrew due to lack of efficacy with placebo. Patients showed improvements in IRLS and CGI-I scores, sleep and QoL parameters with single-blind ropinirole, which were better maintained when ropinirole was continued during the double-blind phase, but reduced with placebo. Ropinirole was well tolerated; adverse events were typical for dopamine agonists. Ropinirole was highly effective and well tolerated in the long-term management of RLS, with pharmacological effect over 36 weeks.
DOI: 10.1002/mds.21050
PubMed: 16874755
Affiliations:
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pubmed:16874755Le document en format XML
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<wicri:regionArea>Sleep Disorders Clinic, Hôpital du Sacré-Coeur de Montréal, Montréal, Quebec</wicri:regionArea>
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<author><name sortKey="Karrasch, Jeff" sort="Karrasch, Jeff" uniqKey="Karrasch J" first="Jeff" last="Karrasch">Jeff Karrasch</name>
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<author><name sortKey="Haan, Jean" sort="Haan, Jean" uniqKey="Haan J" first="Jean" last="Haan">Jean Haan</name>
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<author><name sortKey="Volc, Dieter" sort="Volc, Dieter" uniqKey="Volc D" first="Dieter" last="Volc">Dieter Volc</name>
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<author><name sortKey="Montplaisir, Jacques" sort="Montplaisir, Jacques" uniqKey="Montplaisir J" first="Jacques" last="Montplaisir">Jacques Montplaisir</name>
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<author><name sortKey="Karrasch, Jeff" sort="Karrasch, Jeff" uniqKey="Karrasch J" first="Jeff" last="Karrasch">Jeff Karrasch</name>
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<author><name sortKey="Haan, Jean" sort="Haan, Jean" uniqKey="Haan J" first="Jean" last="Haan">Jean Haan</name>
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<term>Adult</term>
<term>Aged</term>
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<term>Dopamine Agonists (therapeutic use)</term>
<term>Double-Blind Method</term>
<term>Drug Therapy, Combination</term>
<term>Drug-Related Side Effects and Adverse Reactions</term>
<term>Female</term>
<term>Humans</term>
<term>Indoles (adverse effects)</term>
<term>Indoles (therapeutic use)</term>
<term>Long-Term Care</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Restless Legs Syndrome (drug therapy)</term>
<term>Single-Blind Method</term>
<term>Treatment Outcome</term>
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<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Dopamine Agonists</term>
<term>Indoles</term>
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<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Dopamine Agonists</term>
<term>Indoles</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Restless Legs Syndrome</term>
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<keywords scheme="MESH" xml:lang="en"><term>Adolescent</term>
<term>Adult</term>
<term>Aged</term>
<term>Double-Blind Method</term>
<term>Drug Therapy, Combination</term>
<term>Drug-Related Side Effects and Adverse Reactions</term>
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<term>Humans</term>
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<front><div type="abstract" xml:lang="en">The objective of this study was to investigate the long-term efficacy of ropinirole in patients with restless legs syndrome (RLS) and to assess the potential for relapse after the discontinuation of active treatment. Patients with primary RLS (n = 202) received single-blind ropinirole for 24 weeks. Patients meeting treatment continuation criteria were randomized to double-blind treatment with ropinirole or placebo for a further 12 weeks. The primary efficacy variable was the proportion of patients relapsing during double-blind treatment. Additional efficacy measures included time to relapse, withdrawals due to lack of efficacy, improvement on the Clinical Global Impression-Improvement (CGI-I) scale, change in International Restless Legs Scale (IRLS) score during double-blind treatment, and changes in sleep and quality of life (QoL) parameters. Significantly fewer patients relapsed on ropinirole than on placebo (32.6% vs. 57.8%; P = 0.0156). Time to relapse was longer with ropinirole and more patients withdrew due to lack of efficacy with placebo. Patients showed improvements in IRLS and CGI-I scores, sleep and QoL parameters with single-blind ropinirole, which were better maintained when ropinirole was continued during the double-blind phase, but reduced with placebo. Ropinirole was well tolerated; adverse events were typical for dopamine agonists. Ropinirole was highly effective and well tolerated in the long-term management of RLS, with pharmacological effect over 36 weeks.</div>
</front>
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<Title>Movement disorders : official journal of the Movement Disorder Society</Title>
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<ArticleTitle>Ropinirole is effective in the long-term management of restless legs syndrome: a randomized controlled trial.</ArticleTitle>
<Pagination><MedlinePgn>1627-35</MedlinePgn>
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<Abstract><AbstractText>The objective of this study was to investigate the long-term efficacy of ropinirole in patients with restless legs syndrome (RLS) and to assess the potential for relapse after the discontinuation of active treatment. Patients with primary RLS (n = 202) received single-blind ropinirole for 24 weeks. Patients meeting treatment continuation criteria were randomized to double-blind treatment with ropinirole or placebo for a further 12 weeks. The primary efficacy variable was the proportion of patients relapsing during double-blind treatment. Additional efficacy measures included time to relapse, withdrawals due to lack of efficacy, improvement on the Clinical Global Impression-Improvement (CGI-I) scale, change in International Restless Legs Scale (IRLS) score during double-blind treatment, and changes in sleep and quality of life (QoL) parameters. Significantly fewer patients relapsed on ropinirole than on placebo (32.6% vs. 57.8%; P = 0.0156). Time to relapse was longer with ropinirole and more patients withdrew due to lack of efficacy with placebo. Patients showed improvements in IRLS and CGI-I scores, sleep and QoL parameters with single-blind ropinirole, which were better maintained when ropinirole was continued during the double-blind phase, but reduced with placebo. Ropinirole was well tolerated; adverse events were typical for dopamine agonists. Ropinirole was highly effective and well tolerated in the long-term management of RLS, with pharmacological effect over 36 weeks.</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Montplaisir</LastName>
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