Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: A 12‐week, double‐blind, randomized, parallel‐group, placebo‐controlled study
Identifieur interne : 003B40 ( Main/Exploration ); précédent : 003B39; suivant : 003B41Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: A 12‐week, double‐blind, randomized, parallel‐group, placebo‐controlled study
Auteurs : Arthur S. Walters [États-Unis] ; William G. Ondo [États-Unis] ; Tilman Dreykluft [Allemagne] ; Ron Grunstein [Australie] ; Daniel Lee [États-Unis] ; Kapil Sethi [États-Unis]Source :
- Movement Disorders [ 0885-3185 ] ; 2004-12.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Dopamine Agents (adverse effects), Dopamine Agents (therapeutic use), Double-Blind Method, Female, Humans, Indoles (adverse effects), Indoles (therapeutic use), Male, Middle Aged, Nervous system diseases, Placebo, Quality of Life, RLS, Restless Legs Syndrome (drug therapy), Restless legs syndrome, Ropinirole, Treatment, quality of life, ropinirole, sleep.
- MESH :
- chemical , adverse effects : Dopamine Agents, Indoles.
- chemical , therapeutic use : Dopamine Agents, Indoles.
- drug therapy : Restless Legs Syndrome.
- Adolescent, Adult, Aged, Double-Blind Method, Female, Humans, Male, Middle Aged, Quality of Life.
Abstract
Restless legs syndrome (RLS) is a neurological condition with significant impact on sleep and quality of life (QoL). This double‐blind, randomized, 12‐week, multinational study compared the efficacy and safety of ropinirole and placebo in RLS. In total, 267 outpatients with moderate‐to‐severe RLS were randomly assigned to ropinirole (0.25–4.0 mg/day) or placebo, 1 to 3 hours before bedtime. The primary endpoint was the change in International Restless Legs Scale (IRLS) score at week 12. Key secondary endpoints were the percentage of patients showing significant improvement on the Clinical Global Impression‐Improvement (CGI‐I) scale at week 12 and changes in IRLS and CGI‐I scale scores at week 1. Other measures included the Medical Outcomes Study sleep scale and Restless Legs Syndrome Quality of Life questionnaire. Improvements were significantly greater for ropinirole than placebo for change in IRLS score at week 12 (−11.2 [SE 0.76] vs. −8.7 [0.75], respectively; adjusted treatment difference −2.5 [95% confidence interval [CI], −4.6, −0.4], P = 0.0197); all key secondary endpoints; sleep and QoL parameters. Adverse events were typical for dopamine agonists; disease augmentation, although not directly assessed, was not reported during treatment. Ropinirole improves symptoms, associated sleep disturbance, and QoL of RLS patients and is generally well tolerated. © 2004 Movement Disorder Society
Url:
DOI: 10.1002/mds.20257
Affiliations:
- Allemagne, Australie, États-Unis
- Berlin, Caroline du Nord, Géorgie (États-Unis), New Jersey, Texas
- Berlin
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Le document en format XML
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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="2004-12">2004-12</date><biblScope unit="vol">19</biblScope><biblScope unit="issue">12</biblScope><biblScope unit="page" from="1414">1414</biblScope><biblScope unit="page" to="1423">1423</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">70EE5FD9C5A225C904205DF37D47F9246108CA6E</idno><idno type="DOI">10.1002/mds.20257</idno><idno type="ArticleID">MDS20257</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Dopamine Agents (adverse effects)</term><term>Dopamine Agents (therapeutic use)</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Indoles (adverse effects)</term><term>Indoles (therapeutic use)</term><term>Male</term><term>Middle Aged</term><term>Nervous system diseases</term><term>Placebo</term><term>Quality of Life</term><term>RLS</term><term>Restless Legs Syndrome (drug therapy)</term><term>Restless legs syndrome</term><term>Ropinirole</term><term>Treatment</term><term>quality of life</term><term>ropinirole</term><term>sleep</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Dopamine Agents</term><term>Indoles</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Dopamine Agents</term><term>Indoles</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Restless Legs Syndrome</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adolescent</term><term>Adult</term><term>Aged</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Quality of Life</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Impatience membre inférieur syndrome</term><term>Placebo</term><term>Ropinirole</term><term>Système nerveux pathologie</term><term>Traitement</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Restless legs syndrome (RLS) is a neurological condition with significant impact on sleep and quality of life (QoL). This double‐blind, randomized, 12‐week, multinational study compared the efficacy and safety of ropinirole and placebo in RLS. In total, 267 outpatients with moderate‐to‐severe RLS were randomly assigned to ropinirole (0.25–4.0 mg/day) or placebo, 1 to 3 hours before bedtime. The primary endpoint was the change in International Restless Legs Scale (IRLS) score at week 12. Key secondary endpoints were the percentage of patients showing significant improvement on the Clinical Global Impression‐Improvement (CGI‐I) scale at week 12 and changes in IRLS and CGI‐I scale scores at week 1. Other measures included the Medical Outcomes Study sleep scale and Restless Legs Syndrome Quality of Life questionnaire. Improvements were significantly greater for ropinirole than placebo for change in IRLS score at week 12 (−11.2 [SE 0.76] vs. −8.7 [0.75], respectively; adjusted treatment difference −2.5 [95% confidence interval [CI], −4.6, −0.4], P = 0.0197); all key secondary endpoints; sleep and QoL parameters. Adverse events were typical for dopamine agonists; disease augmentation, although not directly assessed, was not reported during treatment. Ropinirole improves symptoms, associated sleep disturbance, and QoL of RLS patients and is generally well tolerated. © 2004 Movement Disorder Society</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>États-Unis</li></country><region><li>Berlin</li><li>Caroline du Nord</li><li>Géorgie (États-Unis)</li><li>New Jersey</li><li>Texas</li></region><settlement><li>Berlin</li></settlement></list><tree><country name="États-Unis"><region name="New Jersey"><name sortKey="Walters, Arthur S" sort="Walters, Arthur S" uniqKey="Walters A" first="Arthur S." last="Walters">Arthur S. Walters</name></region><name sortKey="Lee, Daniel" sort="Lee, Daniel" uniqKey="Lee D" first="Daniel" last="Lee">Daniel Lee</name><name sortKey="Ondo, William G" sort="Ondo, William G" uniqKey="Ondo W" first="William G." last="Ondo">William G. Ondo</name><name sortKey="Sethi, Kapil" sort="Sethi, Kapil" uniqKey="Sethi K" first="Kapil" last="Sethi">Kapil Sethi</name></country><country name="Allemagne"><region name="Berlin"><name sortKey="Dreykluft, Tilman" sort="Dreykluft, Tilman" uniqKey="Dreykluft T" first="Tilman" last="Dreykluft">Tilman Dreykluft</name></region></country><country name="Australie"><noRegion><name sortKey="Grunstein, Ron" sort="Grunstein, Ron" uniqKey="Grunstein R" first="Ron" last="Grunstein">Ron Grunstein</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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