A comparison of sumanirole versus placebo or ropinirole for the treatment of patients with early Parkinson's disease.
Identifieur interne : 001B12 ( Ncbi/Curation ); précédent : 001B11; suivant : 001B13A comparison of sumanirole versus placebo or ropinirole for the treatment of patients with early Parkinson's disease.
Auteurs : Carlos Singer [États-Unis] ; Janice Lamb ; Amanda Ellis ; Gary LaytonSource :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 2007.
English descriptors
- KwdEn :
- Adult, Benzimidazoles (adverse effects), Benzimidazoles (therapeutic use), Demography, Dopamine Agonists (adverse effects), Dopamine Agonists (therapeutic use), Double-Blind Method, Drug Administration Schedule, Drug Tolerance, Early Diagnosis, Female, Humans, Indoles (adverse effects), Indoles (therapeutic use), Male, Parkinson Disease (diagnosis), Parkinson Disease (drug therapy).
- MESH :
- chemical , adverse effects : Benzimidazoles, Dopamine Agonists, Indoles.
- chemical , therapeutic use : Benzimidazoles, Dopamine Agonists, Indoles.
- diagnosis : Parkinson Disease.
- drug therapy : Parkinson Disease.
- Adult, Demography, Double-Blind Method, Drug Administration Schedule, Drug Tolerance, Early Diagnosis, Female, Humans, Male.
Abstract
To assess the safety and efficacy of sumanirole, a highly selective dopamine agonist, versus placebo and demonstrate its noninferiority to ropinirole, 614 patients with early Parkinson's disease (PD) were treated with sumanirole, 1 to 16 mg/day; ropinirole, 0.75 to 24 mg/day; or placebo. Primary end point in this flexible-dose, double-blind, double-dummy, parallel-group study of 40 weeks was the change in total sum of the United Parkinson's Disease Rating Scale (UPDRS) Parts II + III scores from baseline to end of maintenance. Approximately half the subjects in the sumanirole and placebo groups withdrew early from the study, most (51.8% and 68.5%, respectively) due to lack of efficacy. Of the ropinirole subjects who withdrew (50.5%), most discontinued because of adverse events. In sumanirole and ropinirole groups, mean changes from baseline of -2.48 and -5.20 in UPDRS II + III mean scores were significant versus 0.38 in the placebo group (P = 0.006). Sumanirole and ropinirole are effective in the treatment of patients with early PD when compared with placebo. Noninferiority of sumanirole to ropinirole was not demonstrated, with a difference of 2.70 (90% CI, 0.92-4.49). Sumanirole was better tolerated than ropinirole.
DOI: 10.1002/mds.21361
PubMed: 17318839
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pubmed:17318839Le document en format XML
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<author><name sortKey="Singer, Carlos" sort="Singer, Carlos" uniqKey="Singer C" first="Carlos" last="Singer">Carlos Singer</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Neurology, University of Miami, Miami, Florida, USA. csinger@med.miami.edu</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Neurology, University of Miami, Miami, Florida</wicri:regionArea>
<placeName><region type="state">Floride</region>
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<author><name sortKey="Lamb, Janice" sort="Lamb, Janice" uniqKey="Lamb J" first="Janice" last="Lamb">Janice Lamb</name>
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<author><name sortKey="Ellis, Amanda" sort="Ellis, Amanda" uniqKey="Ellis A" first="Amanda" last="Ellis">Amanda Ellis</name>
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<author><name sortKey="Layton, Gary" sort="Layton, Gary" uniqKey="Layton G" first="Gary" last="Layton">Gary Layton</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">A comparison of sumanirole versus placebo or ropinirole for the treatment of patients with early Parkinson's disease.</title>
<author><name sortKey="Singer, Carlos" sort="Singer, Carlos" uniqKey="Singer C" first="Carlos" last="Singer">Carlos Singer</name>
<affiliation wicri:level="2"><nlm:affiliation>Department of Neurology, University of Miami, Miami, Florida, USA. csinger@med.miami.edu</nlm:affiliation>
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<author><name sortKey="Lamb, Janice" sort="Lamb, Janice" uniqKey="Lamb J" first="Janice" last="Lamb">Janice Lamb</name>
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<author><name sortKey="Ellis, Amanda" sort="Ellis, Amanda" uniqKey="Ellis A" first="Amanda" last="Ellis">Amanda Ellis</name>
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<author><name sortKey="Layton, Gary" sort="Layton, Gary" uniqKey="Layton G" first="Gary" last="Layton">Gary Layton</name>
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<series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title>
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<term>Benzimidazoles (adverse effects)</term>
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<term>Demography</term>
<term>Dopamine Agonists (adverse effects)</term>
<term>Dopamine Agonists (therapeutic use)</term>
<term>Double-Blind Method</term>
<term>Drug Administration Schedule</term>
<term>Drug Tolerance</term>
<term>Early Diagnosis</term>
<term>Female</term>
<term>Humans</term>
<term>Indoles (adverse effects)</term>
<term>Indoles (therapeutic use)</term>
<term>Male</term>
<term>Parkinson Disease (diagnosis)</term>
<term>Parkinson Disease (drug therapy)</term>
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<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Benzimidazoles</term>
<term>Dopamine Agonists</term>
<term>Indoles</term>
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<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Benzimidazoles</term>
<term>Dopamine Agonists</term>
<term>Indoles</term>
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<keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Parkinson Disease</term>
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<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term>
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<term>Demography</term>
<term>Double-Blind Method</term>
<term>Drug Administration Schedule</term>
<term>Drug Tolerance</term>
<term>Early Diagnosis</term>
<term>Female</term>
<term>Humans</term>
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<front><div type="abstract" xml:lang="en">To assess the safety and efficacy of sumanirole, a highly selective dopamine agonist, versus placebo and demonstrate its noninferiority to ropinirole, 614 patients with early Parkinson's disease (PD) were treated with sumanirole, 1 to 16 mg/day; ropinirole, 0.75 to 24 mg/day; or placebo. Primary end point in this flexible-dose, double-blind, double-dummy, parallel-group study of 40 weeks was the change in total sum of the United Parkinson's Disease Rating Scale (UPDRS) Parts II + III scores from baseline to end of maintenance. Approximately half the subjects in the sumanirole and placebo groups withdrew early from the study, most (51.8% and 68.5%, respectively) due to lack of efficacy. Of the ropinirole subjects who withdrew (50.5%), most discontinued because of adverse events. In sumanirole and ropinirole groups, mean changes from baseline of -2.48 and -5.20 in UPDRS II + III mean scores were significant versus 0.38 in the placebo group (P = 0.006). Sumanirole and ropinirole are effective in the treatment of patients with early PD when compared with placebo. Noninferiority of sumanirole to ropinirole was not demonstrated, with a difference of 2.70 (90% CI, 0.92-4.49). Sumanirole was better tolerated than ropinirole.</div>
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