Efficacy of pramipexole in restless legs syndrome: a six-week, multicenter, randomized, double-blind study (effect-RLS study).
Identifieur interne : 001984 ( Ncbi/Checkpoint ); précédent : 001983; suivant : 001985Efficacy 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 ; Bettina Bergtholdt ; Yngve Hallström ; Jaan Albo ; Lena Leissner ; Thomas Schindler ; Juergen Koester ; Juergen ReessSource :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 2007.
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Aged, 80 and over, Antiparkinson Agents (therapeutic use), Benzothiazoles (therapeutic use), Demography, Double-Blind Method, Female, Humans, Male, Middle Aged, Restless Legs Syndrome (diagnosis), Restless Legs Syndrome (drug therapy), Restless Legs Syndrome (physiopathology), Severity of Illness Index, Time Factors.
- 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.
DOI: 10.1002/mds.21261
PubMed: 17133582
Affiliations:
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Oertel</name><affiliation wicri:level="3"><nlm:affiliation>Philipps-University Marburg, Marburg, Germany. oertelw@med.uni-marburg.de</nlm:affiliation><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 Kolster, Karin" sort="Stiasny Kolster, Karin" uniqKey="Stiasny Kolster 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">PubMed</idno><date when="2007">2007</date><idno type="doi">10.1002/mds.21261</idno><idno type="RBID">pubmed:17133582</idno><idno type="pmid">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></publicationStmt><sourceDesc><biblStruct><analytic><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><affiliation wicri:level="3"><nlm:affiliation>Philipps-University Marburg, Marburg, Germany. oertelw@med.uni-marburg.de</nlm:affiliation><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 Kolster, Karin" sort="Stiasny Kolster, Karin" uniqKey="Stiasny Kolster 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></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="ISSN">0885-3185</idno><imprint><date when="2007" type="published">2007</date></imprint></series></biblStruct></sourceDesc></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>Demography</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Restless Legs Syndrome (diagnosis)</term><term>Restless Legs Syndrome (drug therapy)</term><term>Restless Legs Syndrome (physiopathology)</term><term>Severity of Illness Index</term><term>Time Factors</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></textClass></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.</div></front></TEI><affiliations><list><country><li>Allemagne</li></country><region><li>District de Giessen</li><li>Hesse (Land)</li></region><settlement><li>Marbourg</li></settlement></list><tree><noCountry><name sortKey="Albo, Jaan" sort="Albo, Jaan" uniqKey="Albo J" first="Jaan" last="Albo">Jaan Albo</name><name sortKey="Bergtholdt, Bettina" sort="Bergtholdt, Bettina" uniqKey="Bergtholdt B" first="Bettina" last="Bergtholdt">Bettina Bergtholdt</name><name sortKey="Hallstrom, Yngve" sort="Hallstrom, Yngve" uniqKey="Hallstrom Y" first="Yngve" last="Hallström">Yngve Hallström</name><name sortKey="Koester, Juergen" sort="Koester, Juergen" uniqKey="Koester J" first="Juergen" last="Koester">Juergen Koester</name><name sortKey="Leissner, Lena" sort="Leissner, Lena" uniqKey="Leissner L" first="Lena" last="Leissner">Lena Leissner</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 Kolster, Karin" sort="Stiasny Kolster, Karin" uniqKey="Stiasny Kolster K" first="Karin" last="Stiasny-Kolster">Karin Stiasny-Kolster</name></noCountry><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. 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