A comparison of sumanirole versus placebo or ropinirole for the treatment of patients with early Parkinson's disease
Identifieur interne : 000E59 ( Main/Corpus ); précédent : 000E58; suivant : 000E60A comparison of sumanirole versus placebo or ropinirole for the treatment of patients with early Parkinson's disease
Auteurs : Carlos Singer ; Janice Lamb ; Amanda Ellis ; Gary LaytonSource :
- Movement Disorders [ 0885-3185 ] ; 2007-03-15.
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- KwdEn :
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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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><istex><corpusName>wiley</corpusName><author><json:item><name>Carlos Singer MD</name><affiliations><json:string>Department of Neurology, University of Miami, Miami, Florida, USA</json:string></affiliations></json:item><json:item><name>Janice Lamb PhD</name><affiliations><json:string>Pfizer Global Research and Development, Sandwich, Kent, United Kingdom</json:string></affiliations></json:item><json:item><name>Amanda Ellis MD</name><affiliations><json:string>Pfizer Global Research and Development, Sandwich, Kent, United Kingdom</json:string></affiliations></json:item><json:item><name>Gary Layton DSc</name><affiliations><json:string>Pfizer Global Research and Development, Sandwich, Kent, United Kingdom</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>Parkinson's disease</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>dopamine agonist</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>sumanirole</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>ropinirole</value></json:item></subject><articleId><json:string>MDS21361</json:string></articleId><language><json:string>eng</json:string></language><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). 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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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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 (<i>P</i> ≤ 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</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn1"><p>The authors have confirmed with the Editor that their work complies with the Journal's Editorial policy on ghost‐writing (<i>Movement Disorders</i> Vol 20, No. 12, 2005, p. 1536). The first‐named author has taken full responsibility for the data and the accuracy of the analysis. All authors had full access to the data.</p></note><note xml:id="fn2"><p>Members of the Sumanirole for Early Parkinson's Disease Study Group are listed as an <link href="#app1">Appendix</link></p></note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>A comparison of sumanirole versus placebo or ropinirole for the treatment of patients with early Parkinson's disease</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Sumanirole in Early Parkinson′s Disease</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>A comparison of sumanirole versus placebo or ropinirole for the treatment of patients with early Parkinson's disease</title></titleInfo><name type="personal"><namePart type="given">Carlos</namePart><namePart type="family">Singer</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, University of Miami, Miami, Florida, USA</affiliation><description>Correspondence: Department of Neurology, University of Miami, 1501 NW 9th Avenue, Miami, FL 33136</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Janice</namePart><namePart type="family">Lamb</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>Pfizer Global Research and Development, Sandwich, Kent, United Kingdom</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Amanda</namePart><namePart type="family">Ellis</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Pfizer Global Research and Development, Sandwich, Kent, United Kingdom</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Gary</namePart><namePart type="family">Layton</namePart><namePart type="termsOfAddress">DSc</namePart><affiliation>Pfizer Global Research and Development, Sandwich, Kent, United Kingdom</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="corporate"><namePart>Sumanirole for Early Parkinson's Disease Study Group</namePart><description>Department of Neurology, University of Miami, Miami, Florida, USAPfizer Global Research and Development, Sandwich, Kent, United Kingdom</description></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article"></genre><originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Hoboken</placeTerm></place><dateIssued encoding="w3cdtf">2007-03-15</dateIssued><dateCaptured encoding="w3cdtf">2006-09-14</dateCaptured><dateValid encoding="w3cdtf">2006-11-09</dateValid><copyrightDate encoding="w3cdtf">2007</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType><extent unit="figures">3</extent><extent unit="tables">4</extent><extent unit="references">31</extent><extent unit="words">4851</extent></physicalDescription><abstract 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</abstract><note type="content">*The authors have confirmed with the Editor that their work complies with the Journal's Editorial policy on ghost‐writing (Movement Disorders Vol 20, No. 12, 2005, p. 1536). The first‐named author has taken full responsibility for the data and the accuracy of the analysis. All authors had full access to the data.</note><note type="funding">Pfizer Inc.</note><subject lang="en"><genre>Keywords</genre><topic>Parkinson's disease</topic><topic>dopamine agonist</topic><topic>sumanirole</topic><topic>ropinirole</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title></titleInfo><titleInfo type="abbreviated"><title>Mov. Disord.</title></titleInfo><genre type="Journal">journal</genre><subject><genre>article category</genre><topic>Research Article</topic></subject><identifier type="ISSN">0885-3185</identifier><identifier type="eISSN">1531-8257</identifier><identifier type="DOI">10.1002/(ISSN)1531-8257</identifier><identifier type="PublisherID">MDS</identifier><part><date>2007</date><detail type="volume"><caption>vol.</caption><number>22</number></detail><detail type="issue"><caption>no.</caption><number>4</number></detail><extent unit="pages"><start>476</start><end>482</end><total>7</total></extent></part></relatedItem><identifier type="istex">E0E1FDA443BC906F8EC80F469290295CB3C71530</identifier><identifier type="DOI">10.1002/mds.21361</identifier><identifier type="ArticleID">MDS21361</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2007 Movement Disorder Society</accessCondition><recordInfo><recordContentSource>WILEY</recordContentSource><recordOrigin>Wiley Subscription Services, Inc., A Wiley Company</recordOrigin></recordInfo></mods></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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