Melevodopa/carbidopa effervescent formulation in the treatment of motor fluctuations in advanced Parkinson's disease
Identifieur interne : 001735 ( Istex/Corpus ); précédent : 001734; suivant : 001736Melevodopa/carbidopa effervescent formulation in the treatment of motor fluctuations in advanced Parkinson's disease
Auteurs : Fabrizio Stocchi ; Mario Zappia ; Valentina Dall'Armi ; Jaime Kulisevsky ; Paolo Lamberti ; José Angel ObesoSource :
- Movement Disorders [ 0885-3185 ] ; 2010-09-15.
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Abstract
Melevodopa hydrochloride plus carbidopa in effervescent tablets (M/C) is a readily soluble antiparkinsonian tablet formulation. A total of 221 patients with Parkinson's disease and motor fluctuations entered a randomized, double‐blind, double‐dummy, controlled parallel group study, which compared the effectiveness of oral M/C effervescent tablets with standard oral formulation levodopa/carbidopa tablets (L/C; Sinemet) in reducing total daily OFF time. The difference of total daily OFF time (intention‐to‐treat population) between the two groups was not statistically significant (P = 0.07): −39.4 minutes (95%CI: −67.08 to −11.73) in M/C group vs. +3.5 minutes (95%CI: −36.19 to +43.26) in the L/C group. In the intragroup analysis, M/C significantly reduced the baseline daily OFF, which remained unchanged in the L/C group. There were no unexpected adverse events in either treatment arms, and discontinuation rates due to adverse events did not differ between the two groups [M/C: 2 patients (1.3%); L/C: 1 patient (1.4%)]. This study failed to meet the primary endpoint (P = 0.07); however, there was a trend in favour of the M/C preparation, which deserves further attention. © 2010 Movement Disorder Society
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DOI: 10.1002/mds.23206
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A total of 221 patients with Parkinson's disease and motor fluctuations entered a randomized, double‐blind, double‐dummy, controlled parallel group study, which compared the effectiveness of oral M/C effervescent tablets with standard oral formulation levodopa/carbidopa tablets (L/C; Sinemet) in reducing total daily OFF time. The difference of total daily OFF time (intention‐to‐treat population) between the two groups was not statistically significant (P = 0.07): −39.4 minutes (95%CI: −67.08 to −11.73) in M/C group vs. +3.5 minutes (95%CI: −36.19 to +43.26) in the L/C group. In the intragroup analysis, M/C significantly reduced the baseline daily OFF, which remained unchanged in the L/C group. There were no unexpected adverse events in either treatment arms, and discontinuation rates due to adverse events did not differ between the two groups [M/C: 2 patients (1.3%); L/C: 1 patient (1.4%)]. This study failed to meet the primary endpoint (P = 0.07); however, there was a trend in favour of the M/C preparation, which deserves further attention. © 2010 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Fabrizio Stocchi MD, PhD</name><affiliations><json:string>Department of Neuroscience, Institute of Neurology, IRCCS San Raffaele Pisana, Roma 00163, Italy</json:string></affiliations></json:item><json:item><name>Mario Zappia MD</name><affiliations><json:string>Neuroscience Department, University of Catania, Catania 95123, Italy</json:string></affiliations></json:item><json:item><name>Valentina Dall'Armi MSc</name><affiliations><json:string>Department of Clinical and Molecular Epidemiology, IRCCS San Raffaele Pisana, Roma 00163, Italy</json:string></affiliations></json:item><json:item><name>Jaime Kulisevsky MD</name><affiliations><json:string>Neurology Department, Movement Disorders Unit, Fundació de G. S. de l'Hospital de la Santa Creu Sant Pau, Barcelona, Spain</json:string></affiliations></json:item><json:item><name>Paolo Lamberti MD</name><affiliations><json:string>Department of Neurology, Ospedale Policlinico Consorziale, Bari 70124, Italy</json:string></affiliations></json:item><json:item><name>José Angel Obeso MD</name><affiliations><json:string>Department of Neurology, Neurology, Clinica Universitaria de Navarra, Pamplona 31008, Spain</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>melevodopa</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>levodopa methylester</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>Parkinson's disease</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>liquid formulation</value></json:item></subject><language><json:string>eng</json:string></language><abstract>Melevodopa hydrochloride plus carbidopa in effervescent tablets (M/C) is a readily soluble antiparkinsonian tablet formulation. A total of 221 patients with Parkinson's disease and motor fluctuations entered a randomized, double‐blind, double‐dummy, controlled parallel group study, which compared the effectiveness of oral M/C effervescent tablets with standard oral formulation levodopa/carbidopa tablets (L/C; Sinemet) in reducing total daily OFF time. The difference of total daily OFF time (intention‐to‐treat population) between the two groups was not statistically significant (P = 0.07): −39.4 minutes (95%CI: −67.08 to −11.73) in M/C group vs. +3.5 minutes (95%CI: −36.19 to +43.26) in the L/C group. In the intragroup analysis, M/C significantly reduced the baseline daily OFF, which remained unchanged in the L/C group. There were no unexpected adverse events in either treatment arms, and discontinuation rates due to adverse events did not differ between the two groups [M/C: 2 patients (1.3%); L/C: 1 patient (1.4%)]. This study failed to meet the primary endpoint (P = 0.07); however, there was a trend in favour of the M/C preparation, which deserves further attention. © 2010 Movement Disorder Society</abstract><qualityIndicators><score>6.09</score><pdfVersion>1.3</pdfVersion><pdfPageSize>612 x 810 pts</pdfPageSize><refBibsNative>true</refBibsNative><abstractCharCount>1218</abstractCharCount><pdfWordCount>3942</pdfWordCount><pdfCharCount>25791</pdfCharCount><pdfPageCount>7</pdfPageCount><abstractWordCount>179</abstractWordCount></qualityIndicators><title>Melevodopa/carbidopa effervescent formulation in the treatment of motor fluctuations in advanced Parkinson's disease</title><corporate><json:item><name></name></json:item></corporate><genre><json:string>Serial article</json:string></genre><host><volume>25</volume><pages><total>7</total><last>1887</last><first>1881</first></pages><issn><json:string>0885-3185</json:string></issn><issue>12</issue><subject><json:item><value>Research Article</value></json:item></subject><genre></genre><language><json:string>unknown</json:string></language><title>Movement Disorders</title><doi><json:string>10.1002/(ISSN)1531-8257</json:string></doi></host><publicationDate>2010</publicationDate><copyrightDate>2010</copyrightDate><doi><json:string>10.1002/mds.23206</json:string></doi><id>B0D014BA674B90BB022B6487F09CC2F105FFA647</id><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/B0D014BA674B90BB022B6487F09CC2F105FFA647/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/B0D014BA674B90BB022B6487F09CC2F105FFA647/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/B0D014BA674B90BB022B6487F09CC2F105FFA647/fulltext/tei"><teiHeader type="text"><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Melevodopa/carbidopa effervescent formulation in the treatment of motor fluctuations in advanced Parkinson's disease</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><availability><p>Wiley Subscription Services, Inc., A Wiley Company</p></availability><date>2010</date></publicationStmt><notesStmt><note type="content">*See appendix for a complete list of participating investigators.</note><note type="content">*Potential conflict of interest: This trial was a trial sponsored by Chiesi pharma Italy. F.S. and J.O. has served as a paid consultant for Chiesi pharma. The authors have complied with all rules regarding journal ghost‐writing policies. The manuscript has been written by the authors, no ghost writer has been employed in preparing the manuscript. All the authors, but Valentina Dall'Armi, received a research grant from Chiesi Pharma for the conduction of the study.</note><note>The data analysis and Anita Chadha‐Patel</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Melevodopa/carbidopa effervescent formulation in the treatment of motor fluctuations in advanced Parkinson's disease</title><author><orgName>on behalf of the Melevodopa Plus Carbidopa Study Group</orgName></author><author><persName><forename type="first">Fabrizio</forename><surname>Stocchi</surname><roleName type="degree">MD, PhD</roleName></persName><note type="correspondence"><p>Correspondence: Institute of Neurology, IRCCS San Raffaele, Via della Pisana 235, 00163 Roma, Italy</p></note><affiliation>Department of Neuroscience, Institute of Neurology, IRCCS San Raffaele Pisana, Roma 00163, Italy</affiliation></author><author><persName><forename type="first">Mario</forename><surname>Zappia</surname><roleName type="degree">MD</roleName></persName><affiliation>Neuroscience Department, University of Catania, Catania 95123, Italy</affiliation></author><author><persName><forename type="first">Valentina</forename><surname>Dall'Armi</surname><roleName type="degree">MSc</roleName></persName><affiliation>Department of Clinical and Molecular Epidemiology, IRCCS San Raffaele Pisana, Roma 00163, Italy</affiliation></author><author><persName><forename type="first">Jaime</forename><surname>Kulisevsky</surname><roleName type="degree">MD</roleName></persName><affiliation>Neurology Department, Movement Disorders Unit, Fundació de G. 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A total of 221 patients with Parkinson's disease and motor fluctuations entered a randomized, double‐blind, double‐dummy, controlled parallel group study, which compared the effectiveness of oral M/C effervescent tablets with standard oral formulation levodopa/carbidopa tablets (L/C; Sinemet) in reducing total daily OFF time. The difference of total daily OFF time (intention‐to‐treat population) between the two groups was not statistically significant (P = 0.07): −39.4 minutes (95%CI: −67.08 to −11.73) in M/C group vs. +3.5 minutes (95%CI: −36.19 to +43.26) in the L/C group. In the intragroup analysis, M/C significantly reduced the baseline daily OFF, which remained unchanged in the L/C group. There were no unexpected adverse events in either treatment arms, and discontinuation rates due to adverse events did not differ between the two groups [M/C: 2 patients (1.3%); L/C: 1 patient (1.4%)]. 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S. de l'Hospital de la Santa Creu Sant Pau, Barcelona, Spain</unparsedAffiliation></affiliation><affiliation xml:id="af5" countryCode="IT" type="organization"><unparsedAffiliation>Department of Neurology, Ospedale Policlinico Consorziale, Bari 70124, Italy</unparsedAffiliation></affiliation><affiliation xml:id="af6" countryCode="ES" type="organization"><unparsedAffiliation>Department of Neurology, Neurology, Clinica Universitaria de Navarra, Pamplona 31008, Spain</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">melevodopa</keyword><keyword xml:id="kwd2">levodopa methylester</keyword><keyword xml:id="kwd3">motor fluctuations</keyword><keyword xml:id="kwd4">Parkinson's disease</keyword><keyword xml:id="kwd5">liquid formulation</keyword></keywordGroup><fundingInfo><fundingAgency>The data analysis and Anita Chadha‐Patel</fundingAgency></fundingInfo><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>Melevodopa hydrochloride plus carbidopa in effervescent tablets (M/C) is a readily soluble antiparkinsonian tablet formulation. A total of 221 patients with Parkinson's disease and motor fluctuations entered a randomized, double‐blind, double‐dummy, controlled parallel group study, which compared the effectiveness of oral M/C effervescent tablets with standard oral formulation levodopa/carbidopa tablets (L/C; Sinemet) in reducing total daily OFF time. The difference of total daily OFF time (intention‐to‐treat population) between the two groups was not statistically significant (<i>P</i> = 0.07): −39.4 minutes (95%CI: −67.08 to −11.73) in M/C group vs. +3.5 minutes (95%CI: −36.19 to +43.26) in the L/C group. In the intragroup analysis, M/C significantly reduced the baseline daily OFF, which remained unchanged in the L/C group. There were no unexpected adverse events in either treatment arms, and discontinuation rates due to adverse events did not differ between the two groups [M/C: 2 patients (1.3%); L/C: 1 patient (1.4%)]. This study failed to meet the primary endpoint (<i>P</i> = 0.07); however, there was a trend in favour of the M/C preparation, which deserves further attention. © 2010 Movement Disorder Society</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn1"><p>See appendix for a complete list of participating investigators.</p></note><note xml:id="fn2"><p>Potential conflict of interest: This trial was a trial sponsored by Chiesi pharma Italy. F.S. and J.O. has served as a paid consultant for Chiesi pharma. The authors have complied with all rules regarding journal ghost‐writing policies. The manuscript has been written by the authors, no ghost writer has been employed in preparing the manuscript. All the authors, but Valentina Dall'Armi, received a research grant from Chiesi Pharma for the conduction of the study.</p></note></noteGroup></header></component></istex:document></istex:metadataXml><!--Version 0.6 générée le 3-12-2015--><mods version="3.6"><titleInfo lang="en"><title>Melevodopa/carbidopa effervescent formulation in the treatment of motor fluctuations in advanced Parkinson's disease</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Effervescent Melevodopa in Parkinson's Disease</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Melevodopa/carbidopa effervescent formulation in the treatment of motor fluctuations in advanced Parkinson's disease</title></titleInfo><name type="personal"><namePart type="given">Fabrizio</namePart><namePart type="family">Stocchi</namePart><namePart type="termsOfAddress">MD, PhD</namePart><affiliation>Department of Neuroscience, Institute of Neurology, IRCCS San Raffaele Pisana, Roma 00163, Italy</affiliation><description>Correspondence: Institute of Neurology, IRCCS San Raffaele, Via della Pisana 235, 00163 Roma, Italy</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Mario</namePart><namePart type="family">Zappia</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Neuroscience Department, University of Catania, Catania 95123, Italy</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Valentina</namePart><namePart type="family">Dall'Armi</namePart><namePart type="termsOfAddress">MSc</namePart><affiliation>Department of Clinical and Molecular Epidemiology, IRCCS San Raffaele Pisana, Roma 00163, Italy</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Jaime</namePart><namePart type="family">Kulisevsky</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Neurology Department, Movement Disorders Unit, Fundació de G. S. de l'Hospital de la Santa Creu Sant Pau, Barcelona, Spain</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Paolo</namePart><namePart type="family">Lamberti</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Ospedale Policlinico Consorziale, Bari 70124, Italy</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">José Angel</namePart><namePart type="family">Obeso</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Neurology, Clinica Universitaria de Navarra, Pamplona 31008, Spain</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="corporate"><namePart>on behalf of the Melevodopa Plus Carbidopa Study Group</namePart><description>Department of Neuroscience, Institute of Neurology, IRCCS San Raffaele Pisana, Roma 00163, ItalyNeuroscience Department, University of Catania, Catania 95123, ItalyDepartment of Clinical and Molecular Epidemiology, IRCCS San Raffaele Pisana, Roma 00163, ItalyNeurology Department, Movement Disorders Unit, Fundació de G. S. de l'Hospital de la Santa Creu Sant Pau, Barcelona, SpainDepartment of Neurology, Ospedale Policlinico Consorziale, Bari 70124, ItalyDepartment of Neurology, Neurology, Clinica Universitaria de Navarra, Pamplona 31008, Spain</description></name><typeOfResource>text</typeOfResource><genre authority="originalCategForm">article</genre><originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Hoboken</placeTerm></place><dateIssued encoding="w3cdtf">2010-09-15</dateIssued><dateCaptured encoding="w3cdtf">2009-01-26</dateCaptured><dateValid encoding="w3cdtf">2010-03-30</dateValid><copyrightDate encoding="w3cdtf">2010</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">3</extent><extent unit="references">18</extent><extent unit="words">5627</extent></physicalDescription><abstract lang="en">Melevodopa hydrochloride plus carbidopa in effervescent tablets (M/C) is a readily soluble antiparkinsonian tablet formulation. A total of 221 patients with Parkinson's disease and motor fluctuations entered a randomized, double‐blind, double‐dummy, controlled parallel group study, which compared the effectiveness of oral M/C effervescent tablets with standard oral formulation levodopa/carbidopa tablets (L/C; Sinemet) in reducing total daily OFF time. The difference of total daily OFF time (intention‐to‐treat population) between the two groups was not statistically significant (P = 0.07): −39.4 minutes (95%CI: −67.08 to −11.73) in M/C group vs. +3.5 minutes (95%CI: −36.19 to +43.26) in the L/C group. In the intragroup analysis, M/C significantly reduced the baseline daily OFF, which remained unchanged in the L/C group. There were no unexpected adverse events in either treatment arms, and discontinuation rates due to adverse events did not differ between the two groups [M/C: 2 patients (1.3%); L/C: 1 patient (1.4%)]. This study failed to meet the primary endpoint (P = 0.07); however, there was a trend in favour of the M/C preparation, which deserves further attention. © 2010 Movement Disorder Society</abstract><note type="content">*See appendix for a complete list of participating investigators.</note><note type="content">*Potential conflict of interest: This trial was a trial sponsored by Chiesi pharma Italy. F.S. and J.O. has served as a paid consultant for Chiesi pharma. The authors have complied with all rules regarding journal ghost‐writing policies. The manuscript has been written by the authors, no ghost writer has been employed in preparing the manuscript. All the authors, but Valentina Dall'Armi, received a research grant from Chiesi Pharma for the conduction of the study.</note><note type="funding">The data analysis and Anita Chadha‐Patel</note><subject lang="en"><genre>Keywords</genre><topic>melevodopa</topic><topic>levodopa methylester</topic><topic>motor fluctuations</topic><topic>Parkinson's disease</topic><topic>liquid formulation</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title></titleInfo><titleInfo type="abbreviated"><title>Mov. Disord.</title></titleInfo><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>2010</date><detail type="volume"><caption>vol.</caption><number>25</number></detail><detail type="issue"><caption>no.</caption><number>12</number></detail><extent unit="pages"><start>1881</start><end>1887</end><total>7</total></extent></part></relatedItem><identifier type="istex">B0D014BA674B90BB022B6487F09CC2F105FFA647</identifier><identifier type="DOI">10.1002/mds.23206</identifier><identifier type="ArticleID">MDS23206</identifier><accessCondition type="use and reproduction" contentType="copyright">Published 2010 Wiley‐Liss, Inc.</accessCondition><recordInfo><recordOrigin>Wiley Subscription Services, Inc., A Wiley Company</recordOrigin><recordContentSource>WILEY</recordContentSource></recordInfo></mods></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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