A comparison of sumanirole versus placebo or ropinirole for the treatment of patients with early Parkinson's disease
Identifieur interne : 003062 ( Main/Exploration ); précédent : 003061; suivant : 003063A comparison of sumanirole versus placebo or ropinirole for the treatment of patients with early Parkinson's disease
Auteurs : Carlos Singer [États-Unis] ; Janice Lamb [Royaume-Uni] ; Amanda Ellis [Royaume-Uni] ; Gary Layton [Royaume-Uni]Source :
- Movement Disorders [ 0885-3185 ] ; 2007-03-15.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
- Adult, Benzimidazoles (adverse effects), Benzimidazoles (therapeutic use), Comparative study, Demography, Dopamine Agonists (adverse effects), Dopamine Agonists (therapeutic use), Dopamine agonist, Double-Blind Method, Drug Administration Schedule, Drug Tolerance, Early Diagnosis, Female, Human, Humans, Indoles (adverse effects), Indoles (therapeutic use), Male, Nervous system diseases, Parkinson Disease (diagnosis), Parkinson Disease (drug therapy), Parkinson disease, Parkinson's disease, Placebo, Ropinirole, Sumanirole, Treatment, dopamine agonist, ropinirole, sumanirole.
- 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 to16 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. © 2007 Movement Disorder Society
Url:
DOI: 10.1002/mds.21361
Affiliations:
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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="2007-03-15">2007-03-15</date><biblScope unit="vol">22</biblScope><biblScope unit="issue">4</biblScope><biblScope unit="page" from="476">476</biblScope><biblScope unit="page" to="482">482</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">E0E1FDA443BC906F8EC80F469290295CB3C71530</idno><idno type="DOI">10.1002/mds.21361</idno><idno type="ArticleID">MDS21361</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Benzimidazoles (adverse effects)</term><term>Benzimidazoles (therapeutic use)</term><term>Comparative study</term><term>Demography</term><term>Dopamine Agonists (adverse effects)</term><term>Dopamine Agonists (therapeutic use)</term><term>Dopamine agonist</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Drug Tolerance</term><term>Early Diagnosis</term><term>Female</term><term>Human</term><term>Humans</term><term>Indoles (adverse effects)</term><term>Indoles (therapeutic use)</term><term>Male</term><term>Nervous system diseases</term><term>Parkinson Disease (diagnosis)</term><term>Parkinson Disease (drug therapy)</term><term>Parkinson disease</term><term>Parkinson's disease</term><term>Placebo</term><term>Ropinirole</term><term>Sumanirole</term><term>Treatment</term><term>dopamine agonist</term><term>ropinirole</term><term>sumanirole</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Benzimidazoles</term><term>Dopamine Agonists</term><term>Indoles</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Benzimidazoles</term><term>Dopamine Agonists</term><term>Indoles</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><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><term>Male</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Etude comparative</term><term>Homme</term><term>Parkinson maladie</term><term>Placebo</term><term>Ropinirole</term><term>Stimulant dopaminergique</term><term>Sumanirole</term><term>Système nerveux pathologie</term><term>Traitement</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><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 to16 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. © 2007 Movement Disorder Society</div></front></TEI><affiliations><list><country><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Floride</li></region></list><tree><country name="États-Unis"><region name="Floride"><name sortKey="Singer, Carlos" sort="Singer, Carlos" uniqKey="Singer C" first="Carlos" last="Singer">Carlos Singer</name></region></country><country name="Royaume-Uni"><noRegion><name sortKey="Lamb, Janice" sort="Lamb, Janice" uniqKey="Lamb J" first="Janice" last="Lamb">Janice Lamb</name></noRegion><name sortKey="Ellis, Amanda" sort="Ellis, Amanda" uniqKey="Ellis A" first="Amanda" last="Ellis">Amanda Ellis</name><name sortKey="Layton, Gary" sort="Layton, Gary" uniqKey="Layton G" first="Gary" last="Layton">Gary Layton</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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