Zydis selegiline reduces off time in Parkinson's disease patients with motor fluctuations: A 3‐month, randomized, placebo‐controlled study
Identifieur interne : 002937 ( Main/Corpus ); précédent : 002936; suivant : 002938Zydis selegiline reduces off time in Parkinson's disease patients with motor fluctuations: A 3‐month, randomized, placebo‐controlled study
Auteurs : Cheryl H. Waters ; Kapil D. Sethi ; Robert A. Hauser ; Eric Molho ; John M. BertoniSource :
- Movement Disorders [ 0885-3185 ] ; 2004-04.
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Abstract
Zydis selegiline dissolves on contact with saliva and undergoes pregastric absorption. This minimizes first‐pass metabolism and provides high plasma concentrations of selegiline. In this study, the efficacy and safety of Zydis selegiline was assessed in Parkinson's disease (PD) patients who were experiencing motor fluctuations with levodopa. Patients were randomly assigned to either drug or placebo in a 2:1 ratio in this double‐blind, multicenter trial. Significant reductions in daily off time occurred at 4 to 6 weeks with the 1.25 mg dose (9.9%, P = 0.003) and 10 to 12 weeks with the 2.5 mg dose (13.2%, P < 0.001). The total number of off hours was reduced by 2.2 hours at Week 12 from baseline (compared with 0.6 hours in the placebo group). The average number of dyskinesia‐free on hours for the Zydis selegiline patients increased by 1.8 hours at Week 12. There was no change in mean percentage of “Asleep” time throughout the study. No apparent differences were detected in the occurrence of drug‐related adverse events between the Zydis selegiline group and placebo‐treated groups. Adverse events were consistent with known effects of levodopa therapy. Zydis selegiline safely reduces daily off time when used as adjunctive therapy with levodopa in patients with PD. © 2004 Movement Disorder Society
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DOI: 10.1002/mds.20036
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Waters</name><affiliation><mods:affiliation>Department of Neurology, Columbia University, New York, New York, USA</mods:affiliation></affiliation></author><author><name sortKey="Sethi, Kapil D" sort="Sethi, Kapil D" uniqKey="Sethi K" first="Kapil D." last="Sethi">Kapil D. Sethi</name><affiliation><mods:affiliation>Department of Neurology, Medical College of Georgia, Augusta, Georgia, USA</mods:affiliation></affiliation></author><author><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. 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This minimizes first‐pass metabolism and provides high plasma concentrations of selegiline. In this study, the efficacy and safety of Zydis selegiline was assessed in Parkinson's disease (PD) patients who were experiencing motor fluctuations with levodopa. Patients were randomly assigned to either drug or placebo in a 2:1 ratio in this double‐blind, multicenter trial. Significant reductions in daily off time occurred at 4 to 6 weeks with the 1.25 mg dose (9.9%, P = 0.003) and 10 to 12 weeks with the 2.5 mg dose (13.2%, P < 0.001). The total number of off hours was reduced by 2.2 hours at Week 12 from baseline (compared with 0.6 hours in the placebo group). The average number of dyskinesia‐free on hours for the Zydis selegiline patients increased by 1.8 hours at Week 12. There was no change in mean percentage of “Asleep” time throughout the study. No apparent differences were detected in the occurrence of drug‐related adverse events between the Zydis selegiline group and placebo‐treated groups. Adverse events were consistent with known effects of levodopa therapy. Zydis selegiline safely reduces daily off time when used as adjunctive therapy with levodopa in patients with PD. © 2004 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Cheryl H. Waters MD</name><affiliations><json:string>Department of Neurology, Columbia University, New York, New York, USA</json:string></affiliations></json:item><json:item><name>Kapil D. Sethi MD</name><affiliations><json:string>Department of Neurology, Medical College of Georgia, Augusta, Georgia, USA</json:string></affiliations></json:item><json:item><name>Robert A. Hauser MD</name><affiliations><json:string>Movement Disorder Center, University of South Florida, Tampa, Florida, USA</json:string></affiliations></json:item><json:item><name>Eric Molho MD</name><affiliations><json:string>Parkinson's Disease and Movement Disorder Center of Albany Medical Center, Albany, New York, USA</json:string></affiliations></json:item><json:item><name>John M. Bertoni MD, PhD</name><affiliations><json:string>Department of Neurology, Creighton University Medical Center, Omaha, Nebraska, USA</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>Zydis selegiline</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>motor fluctuations</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>safety</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>efficacy</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>MAO‐B inhibition</value></json:item></subject><articleId><json:string>MDS20036</json:string></articleId><language><json:string>eng</json:string></language><abstract>Zydis selegiline dissolves on contact with saliva and undergoes pregastric absorption. This minimizes first‐pass metabolism and provides high plasma concentrations of selegiline. In this study, the efficacy and safety of Zydis selegiline was assessed in Parkinson's disease (PD) patients who were experiencing motor fluctuations with levodopa. Patients were randomly assigned to either drug or placebo in a 2:1 ratio in this double‐blind, multicenter trial. Significant reductions in daily off time occurred at 4 to 6 weeks with the 1.25 mg dose (9.9%, P = 0.003) and 10 to 12 weeks with the 2.5 mg dose (13.2%, P > 0.001). The total number of off hours was reduced by 2.2 hours at Week 12 from baseline (compared with 0.6 hours in the placebo group). The average number of dyskinesia‐free on hours for the Zydis selegiline patients increased by 1.8 hours at Week 12. There was no change in mean percentage of “Asleep” time throughout the study. No apparent differences were detected in the occurrence of drug‐related adverse events between the Zydis selegiline group and placebo‐treated groups. Adverse events were consistent with known effects of levodopa therapy. 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In this study, the efficacy and safety of Zydis selegiline was assessed in Parkinson's disease (PD) patients who were experiencing motor fluctuations with levodopa. Patients were randomly assigned to either drug or placebo in a 2:1 ratio in this double‐blind, multicenter trial. Significant reductions in daily off time occurred at 4 to 6 weeks with the 1.25 mg dose (9.9%, P = 0.003) and 10 to 12 weeks with the 2.5 mg dose (13.2%, P < 0.001). The total number of off hours was reduced by 2.2 hours at Week 12 from baseline (compared with 0.6 hours in the placebo group). The average number of dyskinesia‐free on hours for the Zydis selegiline patients increased by 1.8 hours at Week 12. There was no change in mean percentage of “Asleep” time throughout the study. No apparent differences were detected in the occurrence of drug‐related adverse events between the Zydis selegiline group and placebo‐treated groups. Adverse events were consistent with known effects of levodopa therapy. Zydis selegiline safely reduces daily off time when used as adjunctive therapy with levodopa in patients with PD. © 2004 Movement Disorder Society</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>Parkinson's disease</term></item><item><term>Zydis selegiline</term></item><item><term>motor fluctuations</term></item><item><term>safety</term></item><item><term>efficacy</term></item><item><term>MAO‐B inhibition</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>article category</head><item><term>Research Article</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2003-06-17">Received</change><change when="2003-11-14">Registration</change><change when="2004-04">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/34804F14A74A295F7D9F066389878EC0EC2F1742/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>Wiley Subscription Services, Inc., A Wiley Company</publisherName><publisherLoc>Hoboken</publisherLoc></publisherInfo><doi registered="yes">10.1002/(ISSN)1531-8257</doi><issn type="print">0885-3185</issn><issn type="electronic">1531-8257</issn><idGroup><id type="product" value="MDS"></id></idGroup><titleGroup><title type="main" xml:lang="en" sort="MOVEMENT DISORDERS">Movement Disorders</title><title type="subtitle">Official Journal of the Movement Disorder Society</title><title type="short">Mov. 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href="file:MDS.MDS20036.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="2"></count><count type="tableTotal" number="2"></count><count type="referenceTotal" number="36"></count><count type="wordTotal" number="4131"></count></countGroup><titleGroup><title type="main" xml:lang="en">Zydis selegiline reduces <i>off</i> time in Parkinson's disease patients with motor fluctuations: A 3‐month, randomized, placebo‐controlled study</title><title type="short" xml:lang="en">Zydis Selegiline Reduces <fi>off</fi> Time in PD</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes"><personName><givenNames>Cheryl H.</givenNames><familyName>Waters</familyName><degrees>MD</degrees></personName><contactDetails><email>cw345@columbia.edu</email></contactDetails></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#af2"><personName><givenNames>Kapil D.</givenNames><familyName>Sethi</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#af3"><personName><givenNames>Robert A.</givenNames><familyName>Hauser</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#af4"><personName><givenNames>Eric</givenNames><familyName>Molho</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au5" creatorRole="author" affiliationRef="#af5"><personName><givenNames>John M.</givenNames><familyName>Bertoni</familyName><degrees>MD, PhD</degrees></personName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, Columbia University, New York, New York, USA</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, Medical College of Georgia, Augusta, Georgia, USA</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="US" type="organization"><unparsedAffiliation>Movement Disorder Center, University of South Florida, Tampa, Florida, USA</unparsedAffiliation></affiliation><affiliation xml:id="af4" countryCode="US" type="organization"><unparsedAffiliation>Parkinson's Disease and Movement Disorder Center of Albany Medical Center, Albany, New York, USA</unparsedAffiliation></affiliation><affiliation xml:id="af5" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, Creighton University Medical Center, Omaha, Nebraska, USA</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">Parkinson's disease</keyword><keyword xml:id="kwd2">Zydis selegiline</keyword><keyword xml:id="kwd3">motor fluctuations</keyword><keyword xml:id="kwd4">safety</keyword><keyword xml:id="kwd5">efficacy</keyword><keyword xml:id="kwd6">MAO‐B inhibition</keyword></keywordGroup><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>Zydis selegiline dissolves on contact with saliva and undergoes pregastric absorption. This minimizes first‐pass metabolism and provides high plasma concentrations of selegiline. In this study, the efficacy and safety of Zydis selegiline was assessed in Parkinson's disease (PD) patients who were experiencing motor fluctuations with levodopa. Patients were randomly assigned to either drug or placebo in a 2:1 ratio in this double‐blind, multicenter trial. Significant reductions in daily <i>off</i> time occurred at 4 to 6 weeks with the 1.25 mg dose (9.9%, <i>P</i> = 0.003) and 10 to 12 weeks with the 2.5 mg dose (13.2%, <i>P</i> < 0.001). The total number of <i>off</i> hours was reduced by 2.2 hours at Week 12 from baseline (compared with 0.6 hours in the placebo group). The average number of <i>dyskinesia‐free on</i> hours for the Zydis selegiline patients increased by 1.8 hours at Week 12. There was no change in mean percentage of “Asleep” time throughout the study. No apparent differences were detected in the occurrence of drug‐related adverse events between the Zydis selegiline group and placebo‐treated groups. Adverse events were consistent with known effects of levodopa therapy. Zydis selegiline safely reduces daily <i>off</i> time when used as adjunctive therapy with levodopa in patients with PD. © 2004 Movement Disorder Society</p></abstract></abstractGroup></contentMeta></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Zydis selegiline reduces off time in Parkinson's disease patients with motor fluctuations: A 3‐month, randomized, placebo‐controlled study</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Zydis Selegiline Reduces off Time in PD</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Zydis selegiline reduces</title></titleInfo><name type="personal"><namePart type="given">Cheryl H.</namePart><namePart type="family">Waters</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Columbia University, New York, New York, USA</affiliation><description>Correspondence: Department of Neurology, Columbia University, 710 W. 168th Street, New York, NY 10032</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Kapil D.</namePart><namePart type="family">Sethi</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Medical College of Georgia, Augusta, Georgia, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Robert A.</namePart><namePart type="family">Hauser</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Movement Disorder Center, University of South Florida, Tampa, Florida, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Eric</namePart><namePart type="family">Molho</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Parkinson's Disease and Movement Disorder Center of Albany Medical Center, Albany, New York, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">John M.</namePart><namePart type="family">Bertoni</namePart><namePart type="termsOfAddress">MD, PhD</namePart><affiliation>Department of Neurology, Creighton University Medical Center, Omaha, Nebraska, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></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">2004-04</dateIssued><dateCaptured encoding="w3cdtf">2003-06-17</dateCaptured><dateValid encoding="w3cdtf">2003-11-14</dateValid><copyrightDate encoding="w3cdtf">2004</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">2</extent><extent unit="tables">2</extent><extent unit="references">36</extent><extent unit="words">4131</extent></physicalDescription><abstract lang="en">Zydis selegiline dissolves on contact with saliva and undergoes pregastric absorption. This minimizes first‐pass metabolism and provides high plasma concentrations of selegiline. In this study, the efficacy and safety of Zydis selegiline was assessed in Parkinson's disease (PD) patients who were experiencing motor fluctuations with levodopa. Patients were randomly assigned to either drug or placebo in a 2:1 ratio in this double‐blind, multicenter trial. Significant reductions in daily off time occurred at 4 to 6 weeks with the 1.25 mg dose (9.9%, P = 0.003) and 10 to 12 weeks with the 2.5 mg dose (13.2%, P < 0.001). The total number of off hours was reduced by 2.2 hours at Week 12 from baseline (compared with 0.6 hours in the placebo group). The average number of dyskinesia‐free on hours for the Zydis selegiline patients increased by 1.8 hours at Week 12. There was no change in mean percentage of “Asleep” time throughout the study. No apparent differences were detected in the occurrence of drug‐related adverse events between the Zydis selegiline group and placebo‐treated groups. Adverse events were consistent with known effects of levodopa therapy. Zydis selegiline safely reduces daily off time when used as adjunctive therapy with levodopa in patients with PD. © 2004 Movement Disorder Society</abstract><subject lang="en"><genre>Keywords</genre><topic>Parkinson's disease</topic><topic>Zydis selegiline</topic><topic>motor fluctuations</topic><topic>safety</topic><topic>efficacy</topic><topic>MAO‐B inhibition</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title><subTitle>Official Journal of the Movement Disorder Society</subTitle></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>2004</date><detail type="volume"><caption>vol.</caption><number>19</number></detail><detail type="issue"><caption>no.</caption><number>4</number></detail><extent unit="pages"><start>426</start><end>432</end><total>7</total></extent></part></relatedItem><identifier type="istex">34804F14A74A295F7D9F066389878EC0EC2F1742</identifier><identifier type="DOI">10.1002/mds.20036</identifier><identifier type="ArticleID">MDS20036</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2004 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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