A comparison of sumanirole versus placebo or ropinirole for the treatment of patients with early Parkinson's disease
Identifieur interne : 001140 ( Main/Exploration ); précédent : 001139; suivant : 001141A 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.
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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
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DOI: 10.1002/mds.21361
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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="volume">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>Parkinson's disease</term><term>dopamine agonist</term><term>ropinirole</term><term>sumanirole</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). 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