Efficacy of pramipexole in restless legs syndrome: A six‐week, multicenter, randomized, double‐blind study (effect‐RLS study)
Identifieur interne : 002E64 ( Main/Exploration ); précédent : 002E63; suivant : 002E65Efficacy of pramipexole in restless legs syndrome: A six‐week, multicenter, randomized, double‐blind study (effect‐RLS study)
Auteurs : Wolfgang H. Oertel [Allemagne] ; Karin Stiasny-Kolster [Allemagne] ; Bettina Bergtholdt [Allemagne] ; Yngve Hallström [Suède] ; Jaan Albo [Suède] ; Lena Leissner [Suède] ; Thomas Schindler [Allemagne] ; Juergen Koester [Allemagne] ; Juergen Reess [Allemagne]Source :
- Movement Disorders [ 0885-3185 ] ; 2007-01-15.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Aged, 80 and over, Antiparkinson Agents (therapeutic use), Benzothiazoles (therapeutic use), Clinical trial, Demography, Dopamine agonist, Double blind study, Double-Blind Method, Female, Humans, Male, Middle Aged, Multicenter study, Nervous system diseases, Pramipexole, Restless Legs Syndrome (diagnosis), Restless Legs Syndrome (drug therapy), Restless Legs Syndrome (physiopathology), Restless legs syndrome, Severity of Illness Index, Time Factors, clinical trial, dopamine agonist, pramipexole, restless legs syndrome.
- MESH :
- chemical , therapeutic use : Antiparkinson Agents, Benzothiazoles.
- diagnosis : Restless Legs Syndrome.
- drug therapy : Restless Legs Syndrome.
- physiopathology : Restless Legs Syndrome.
- Adolescent, Adult, Aged, Aged, 80 and over, Demography, Double-Blind Method, Female, Humans, Male, Middle Aged, Severity of Illness Index, Time Factors.
Abstract
We evaluated the efficacy of pramipexole versus placebo in restless legs syndrome (RLS) for 6 weeks. Overall, 345 patients were randomly assigned in a 1:2 ratio to receive either placebo (n = 115) or pramipexole (n = 230) with a starting dose of 0.125 mg/day. The dose was individually optimized according to the Patient Global Impression (PGI) assessment, up to a maximum of 0.75 mg/day. The primary endpoint consisted of two assessments: the change from baseline in the International RLS Study Group Rating Scale (IRLS) and the proportion of patients with Clinical Global Impressions‐Improvement (CGI‐I) assessments of “much/very much improved” (CGI‐I responders) at week 6. Secondary endpoints included PGI and IRLS responder rates. Patient demographics and baseline characteristics were comparable between treatment groups. At baseline, mean IRLS scores were 24.9 (placebo) and 24.7 (pramipexole), representing severely affected patients. After 6 weeks, adjusted mean reductions (±SE) in IRLS score were 5.7 (±0.9) for placebo (median dose 0.47 mg/day) and 12.3 (±0.6) for pramipexole (median dose 0.35 mg/day; P < 0.0001). CGI‐I responder rates were 32.5% (placebo) and 62.9% (pramipexole) (P < 0.0001). For all secondary endpoints, pramipexole showed superior results. Pramipexole was well tolerated throughout the study. © 2006 Movement Disorder Society
Url:
DOI: 10.1002/mds.21261
Affiliations:
Links toward previous steps (curation, corpus...)
- to stream Istex, to step Corpus: 001246
- to stream Istex, to step Curation: 001246
- to stream Istex, to step Checkpoint: 001972
- to stream PubMed, to step Corpus: 002955
- to stream PubMed, to step Curation: 002955
- to stream PubMed, to step Checkpoint: 002836
- to stream Ncbi, to step Merge: 001984
- to stream Ncbi, to step Curation: 001984
- to stream Ncbi, to step Checkpoint: 001984
- to stream Main, to step Merge: 003D86
- to stream PascalFrancis, to step Corpus: 001806
- to stream PascalFrancis, to step Curation: 001515
- to stream PascalFrancis, to step Checkpoint: 001688
- to stream Main, to step Merge: 004278
- to stream Main, to step Curation: 002E64
Le document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Efficacy of pramipexole in restless legs syndrome: A six‐week, multicenter, randomized, double‐blind study (effect‐RLS study)</title><author><name sortKey="Oertel, Wolfgang H" sort="Oertel, Wolfgang H" uniqKey="Oertel W" first="Wolfgang H." last="Oertel">Wolfgang H. Oertel</name></author><author><name sortKey="Stiasny Olster, Karin" sort="Stiasny Olster, Karin" uniqKey="Stiasny Olster K" first="Karin" last="Stiasny-Kolster">Karin Stiasny-Kolster</name></author><author><name sortKey="Bergtholdt, Bettina" sort="Bergtholdt, Bettina" uniqKey="Bergtholdt B" first="Bettina" last="Bergtholdt">Bettina Bergtholdt</name></author><author><name sortKey="Hallstrom, Yngve" sort="Hallstrom, Yngve" uniqKey="Hallstrom Y" first="Yngve" last="Hallström">Yngve Hallström</name></author><author><name sortKey="Albo, Jaan" sort="Albo, Jaan" uniqKey="Albo J" first="Jaan" last="Albo">Jaan Albo</name></author><author><name sortKey="Leissner, Lena" sort="Leissner, Lena" uniqKey="Leissner L" first="Lena" last="Leissner">Lena Leissner</name></author><author><name sortKey="Schindler, Thomas" sort="Schindler, Thomas" uniqKey="Schindler T" first="Thomas" last="Schindler">Thomas Schindler</name></author><author><name sortKey="Koester, Juergen" sort="Koester, Juergen" uniqKey="Koester J" first="Juergen" last="Koester">Juergen Koester</name></author><author><name sortKey="Reess, Juergen" sort="Reess, Juergen" uniqKey="Reess J" first="Juergen" last="Reess">Juergen Reess</name></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:CEC7F3437FDC1CEC349A93DA7242C8F7DC309C33</idno><date when="2007" year="2007">2007</date><idno type="doi">10.1002/mds.21261</idno><idno type="url">https://api.istex.fr/document/CEC7F3437FDC1CEC349A93DA7242C8F7DC309C33/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">001246</idno><idno type="wicri:Area/Istex/Curation">001246</idno><idno type="wicri:Area/Istex/Checkpoint">001972</idno><idno type="wicri:doubleKey">0885-3185:2007:Oertel W:efficacy:of:pramipexole</idno><idno type="wicri:source">PubMed</idno><idno type="RBID">pubmed:17133582</idno><idno type="wicri:Area/PubMed/Corpus">002955</idno><idno type="wicri:Area/PubMed/Curation">002955</idno><idno type="wicri:Area/PubMed/Checkpoint">002836</idno><idno type="wicri:Area/Ncbi/Merge">001984</idno><idno type="wicri:Area/Ncbi/Curation">001984</idno><idno type="wicri:Area/Ncbi/Checkpoint">001984</idno><idno type="wicri:doubleKey">0885-3185:2007:Oertel W:efficacy:of:pramipexole</idno><idno type="wicri:Area/Main/Merge">003D86</idno><idno type="wicri:source">INIST</idno><idno type="RBID">Pascal:07-0133246</idno><idno type="wicri:Area/PascalFrancis/Corpus">001806</idno><idno type="wicri:Area/PascalFrancis/Curation">001515</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">001688</idno><idno type="wicri:doubleKey">0885-3185:2007:Oertel W:efficacy:of:pramipexole</idno><idno type="wicri:Area/Main/Merge">004278</idno><idno type="wicri:Area/Main/Curation">002E64</idno><idno type="wicri:Area/Main/Exploration">002E64</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Efficacy of pramipexole in restless legs syndrome: A six‐week, multicenter, randomized, double‐blind study (effect‐RLS study)</title><author><name sortKey="Oertel, Wolfgang H" sort="Oertel, Wolfgang H" uniqKey="Oertel W" first="Wolfgang H." last="Oertel">Wolfgang H. Oertel</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Philipps‐University Marburg, Marburg</wicri:regionArea><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Giessen</region><settlement type="city">Marbourg</settlement></placeName></affiliation></author><author><name sortKey="Stiasny Olster, Karin" sort="Stiasny Olster, Karin" uniqKey="Stiasny Olster K" first="Karin" last="Stiasny-Kolster">Karin Stiasny-Kolster</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Philipps‐University Marburg, Marburg</wicri:regionArea><placeName><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Giessen</region><settlement type="city">Marbourg</settlement></placeName></affiliation></author><author><name sortKey="Bergtholdt, Bettina" sort="Bergtholdt, Bettina" uniqKey="Bergtholdt B" first="Bettina" last="Bergtholdt">Bettina Bergtholdt</name><affiliation wicri:level="3"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Emovis GmbH, Berlin</wicri:regionArea><placeName><region type="land" nuts="3">Berlin</region><settlement type="city">Berlin</settlement></placeName></affiliation></author><author><name sortKey="Hallstrom, Yngve" sort="Hallstrom, Yngve" uniqKey="Hallstrom Y" first="Yngve" last="Hallström">Yngve Hallström</name><affiliation wicri:level="3"><country xml:lang="fr">Suède</country><wicri:regionArea>Neuro Center, Stockholm</wicri:regionArea><placeName><settlement type="city">Stockholm</settlement><region nuts="2">Svealand</region></placeName></affiliation></author><author><name sortKey="Albo, Jaan" sort="Albo, Jaan" uniqKey="Albo J" first="Jaan" last="Albo">Jaan Albo</name><affiliation wicri:level="1"><country xml:lang="fr">Suède</country><wicri:regionArea>Läkarhuset Vällingby, Vällingby</wicri:regionArea><wicri:noRegion>Vällingby</wicri:noRegion></affiliation></author><author><name sortKey="Leissner, Lena" sort="Leissner, Lena" uniqKey="Leissner L" first="Lena" last="Leissner">Lena Leissner</name><affiliation wicri:level="1"><country xml:lang="fr">Suède</country><wicri:regionArea>Neurologiska Kliniken, Örebro</wicri:regionArea><wicri:noRegion>Örebro</wicri:noRegion></affiliation></author><author><name sortKey="Schindler, Thomas" sort="Schindler, Thomas" uniqKey="Schindler T" first="Thomas" last="Schindler">Thomas Schindler</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Boehringer Ingelheim Pharma GmbH & Co. KG</wicri:regionArea></affiliation></author><author><name sortKey="Koester, Juergen" sort="Koester, Juergen" uniqKey="Koester J" first="Juergen" last="Koester">Juergen Koester</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Boehringer Ingelheim Pharma GmbH & Co. KG</wicri:regionArea></affiliation></author><author><name sortKey="Reess, Juergen" sort="Reess, Juergen" uniqKey="Reess J" first="Juergen" last="Reess">Juergen Reess</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>Boehringer Ingelheim Pharma GmbH & Co. KG</wicri:regionArea></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="sub">Official Journal of the Movement Disorder Society</title><title level="j" type="abbrev">Mov. 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="2007-01-15">2007-01-15</date><biblScope unit="vol">22</biblScope><biblScope unit="issue">2</biblScope><biblScope unit="page" from="213">213</biblScope><biblScope unit="page" to="219">219</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">CEC7F3437FDC1CEC349A93DA7242C8F7DC309C33</idno><idno type="DOI">10.1002/mds.21261</idno><idno type="ArticleID">MDS21261</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>Aged, 80 and over</term><term>Antiparkinson Agents (therapeutic use)</term><term>Benzothiazoles (therapeutic use)</term><term>Clinical trial</term><term>Demography</term><term>Dopamine agonist</term><term>Double blind study</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Multicenter study</term><term>Nervous system diseases</term><term>Pramipexole</term><term>Restless Legs Syndrome (diagnosis)</term><term>Restless Legs Syndrome (drug therapy)</term><term>Restless Legs Syndrome (physiopathology)</term><term>Restless legs syndrome</term><term>Severity of Illness Index</term><term>Time Factors</term><term>clinical trial</term><term>dopamine agonist</term><term>pramipexole</term><term>restless legs syndrome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</term><term>Benzothiazoles</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Restless Legs Syndrome</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Restless Legs Syndrome</term></keywords><keywords scheme="MESH" qualifier="physiopathology" 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>Aged, 80 and over</term><term>Demography</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Severity of Illness Index</term><term>Time Factors</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Essai clinique</term><term>Etude double insu</term><term>Etude multicentrique</term><term>Impatience membre inférieur syndrome</term><term>Pramipexole</term><term>Stimulant dopaminergique</term><term>Système nerveux pathologie</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">We evaluated the efficacy of pramipexole versus placebo in restless legs syndrome (RLS) for 6 weeks. Overall, 345 patients were randomly assigned in a 1:2 ratio to receive either placebo (n = 115) or pramipexole (n = 230) with a starting dose of 0.125 mg/day. The dose was individually optimized according to the Patient Global Impression (PGI) assessment, up to a maximum of 0.75 mg/day. The primary endpoint consisted of two assessments: the change from baseline in the International RLS Study Group Rating Scale (IRLS) and the proportion of patients with Clinical Global Impressions‐Improvement (CGI‐I) assessments of “much/very much improved” (CGI‐I responders) at week 6. Secondary endpoints included PGI and IRLS responder rates. Patient demographics and baseline characteristics were comparable between treatment groups. At baseline, mean IRLS scores were 24.9 (placebo) and 24.7 (pramipexole), representing severely affected patients. After 6 weeks, adjusted mean reductions (±SE) in IRLS score were 5.7 (±0.9) for placebo (median dose 0.47 mg/day) and 12.3 (±0.6) for pramipexole (median dose 0.35 mg/day; P < 0.0001). CGI‐I responder rates were 32.5% (placebo) and 62.9% (pramipexole) (P < 0.0001). For all secondary endpoints, pramipexole showed superior results. Pramipexole was well tolerated throughout the study. © 2006 Movement Disorder Society</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Suède</li></country><region><li>Berlin</li><li>District de Giessen</li><li>Hesse (Land)</li><li>Svealand</li></region><settlement><li>Berlin</li><li>Marbourg</li><li>Stockholm</li></settlement></list><tree><country name="Allemagne"><region name="Hesse (Land)"><name sortKey="Oertel, Wolfgang H" sort="Oertel, Wolfgang H" uniqKey="Oertel W" first="Wolfgang H." last="Oertel">Wolfgang H. Oertel</name></region><name sortKey="Bergtholdt, Bettina" sort="Bergtholdt, Bettina" uniqKey="Bergtholdt B" first="Bettina" last="Bergtholdt">Bettina Bergtholdt</name><name sortKey="Koester, Juergen" sort="Koester, Juergen" uniqKey="Koester J" first="Juergen" last="Koester">Juergen Koester</name><name sortKey="Reess, Juergen" sort="Reess, Juergen" uniqKey="Reess J" first="Juergen" last="Reess">Juergen Reess</name><name sortKey="Schindler, Thomas" sort="Schindler, Thomas" uniqKey="Schindler T" first="Thomas" last="Schindler">Thomas Schindler</name><name sortKey="Stiasny Olster, Karin" sort="Stiasny Olster, Karin" uniqKey="Stiasny Olster K" first="Karin" last="Stiasny-Kolster">Karin Stiasny-Kolster</name></country><country name="Suède"><region name="Svealand"><name sortKey="Hallstrom, Yngve" sort="Hallstrom, Yngve" uniqKey="Hallstrom Y" first="Yngve" last="Hallström">Yngve Hallström</name></region><name sortKey="Albo, Jaan" sort="Albo, Jaan" uniqKey="Albo J" first="Jaan" last="Albo">Jaan Albo</name><name sortKey="Leissner, Lena" sort="Leissner, Lena" uniqKey="Leissner L" first="Lena" last="Leissner">Lena Leissner</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Santé/explor/MovDisordV3/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 002E64 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 002E64 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Santé
|area= MovDisordV3
|flux= Main
|étape= Exploration
|type= RBID
|clé= ISTEX:CEC7F3437FDC1CEC349A93DA7242C8F7DC309C33
|texte= Efficacy of pramipexole in restless legs syndrome: A six‐week, multicenter, randomized, double‐blind study (effect‐RLS study)
}}
| This area was generated with Dilib version V0.6.23. |  |