Melevodopa/carbidopa effervescent formulation in the treatment of motor fluctuations in advanced Parkinson's disease.
Identifieur interne : 001784 ( PubMed/Checkpoint ); précédent : 001783; suivant : 001785Melevodopa/carbidopa effervescent formulation in the treatment of motor fluctuations in advanced Parkinson's disease.
Auteurs : Fabrizio Stocchi [Italie] ; Mario Zappia ; Valentina Dall'Armi ; Jaime Kulisevsky ; Paolo Lamberti ; José Angel ObesoSource :
- Movement disorders : official journal of the Movement Disorder Society [ 1531-8257 ] ; 2010.
English descriptors
- KwdEn :
- Administration, Oral, Adult, Aged, Aged, 80 and over, Analysis of Variance, Antiparkinson Agents (administration & dosage), Antiparkinson Agents (therapeutic use), Carbidopa (administration & dosage), Carbidopa (therapeutic use), Double-Blind Method, Drug Administration Schedule, Drug Combinations, Female, Humans, Intention to Treat Analysis, Levodopa (administration & dosage), Levodopa (analogs & derivatives), Levodopa (therapeutic use), Male, Middle Aged, Parkinson Disease (drug therapy), Treatment Outcome.
- MESH :
- chemical , administration & dosage : Antiparkinson Agents, Carbidopa, Levodopa.
- chemical , analogs & derivatives : Levodopa.
- chemical , therapeutic use : Antiparkinson Agents, Carbidopa, Levodopa.
- drug therapy : Parkinson Disease.
- Administration, Oral, Adult, Aged, Aged, 80 and over, Analysis of Variance, Double-Blind Method, Drug Administration Schedule, Drug Combinations, Female, Humans, Intention to Treat Analysis, Male, Middle Aged, Treatment Outcome.
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.
DOI: 10.1002/mds.23206
PubMed: 20669296
Affiliations:
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Valentina" uniqKey="Dall Armi V" first="Valentina" last="Dall'Armi">Valentina Dall'Armi</name></author><author><name sortKey="Kulisevsky, Jaime" sort="Kulisevsky, Jaime" uniqKey="Kulisevsky J" first="Jaime" last="Kulisevsky">Jaime Kulisevsky</name></author><author><name sortKey="Lamberti, Paolo" sort="Lamberti, Paolo" uniqKey="Lamberti P" first="Paolo" last="Lamberti">Paolo Lamberti</name></author><author><name sortKey="Obeso, Jose Angel" sort="Obeso, Jose Angel" uniqKey="Obeso J" first="José Angel" last="Obeso">José Angel Obeso</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2010">2010</date><idno type="doi">10.1002/mds.23206</idno><idno type="RBID">pubmed:20669296</idno><idno type="pmid">20669296</idno><idno type="wicri:Area/PubMed/Corpus">001675</idno><idno type="wicri:Area/PubMed/Curation">001675</idno><idno type="wicri:Area/PubMed/Checkpoint">001784</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Melevodopa/carbidopa effervescent formulation in the treatment of motor fluctuations in advanced Parkinson's disease.</title><author><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name><affiliation wicri:level="3"><nlm:affiliation>Department of Neuroscience, Institute of Neurology, IRCCS San Raffaele Pisana, Roma, Italy. fabrizio.stocchi@fastwebnet.it</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>Department of Neuroscience, Institute of Neurology, IRCCS San Raffaele Pisana, Roma</wicri:regionArea><placeName><settlement type="city">Rome</settlement><region nuts="2">Latium</region></placeName></affiliation></author><author><name sortKey="Zappia, Mario" sort="Zappia, Mario" uniqKey="Zappia M" first="Mario" last="Zappia">Mario Zappia</name></author><author><name sortKey="Dall Armi, Valentina" sort="Dall Armi, Valentina" uniqKey="Dall Armi V" first="Valentina" last="Dall'Armi">Valentina Dall'Armi</name></author><author><name sortKey="Kulisevsky, Jaime" sort="Kulisevsky, Jaime" uniqKey="Kulisevsky J" first="Jaime" last="Kulisevsky">Jaime Kulisevsky</name></author><author><name sortKey="Lamberti, Paolo" sort="Lamberti, Paolo" uniqKey="Lamberti P" first="Paolo" last="Lamberti">Paolo Lamberti</name></author><author><name sortKey="Obeso, Jose Angel" sort="Obeso, Jose Angel" uniqKey="Obeso J" first="José Angel" last="Obeso">José Angel Obeso</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="eISSN">1531-8257</idno><imprint><date when="2010" type="published">2010</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Oral</term><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Analysis of Variance</term><term>Antiparkinson Agents (administration & dosage)</term><term>Antiparkinson Agents (therapeutic use)</term><term>Carbidopa (administration & dosage)</term><term>Carbidopa (therapeutic use)</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Drug Combinations</term><term>Female</term><term>Humans</term><term>Intention to Treat Analysis</term><term>Levodopa (administration & dosage)</term><term>Levodopa (analogs & derivatives)</term><term>Levodopa (therapeutic use)</term><term>Male</term><term>Middle Aged</term><term>Parkinson Disease (drug therapy)</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antiparkinson Agents</term><term>Carbidopa</term><term>Levodopa</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Levodopa</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</term><term>Carbidopa</term><term>Levodopa</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Administration, Oral</term><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Analysis of Variance</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Drug Combinations</term><term>Female</term><term>Humans</term><term>Intention to Treat Analysis</term><term>Male</term><term>Middle Aged</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml: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.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">20669296</PMID><DateCreated><Year>2010</Year><Month>09</Month><Day>14</Day></DateCreated><DateCompleted><Year>2010</Year><Month>12</Month><Day>28</Day></DateCompleted><DateRevised><Year>2013</Year><Month>11</Month><Day>21</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1531-8257</ISSN><JournalIssue CitedMedium="Internet"><Volume>25</Volume><Issue>12</Issue><PubDate><Year>2010</Year><Month>Sep</Month><Day>15</Day></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>Melevodopa/carbidopa effervescent formulation in the treatment of motor fluctuations in advanced Parkinson's disease.</ArticleTitle><Pagination><MedlinePgn>1881-7</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1002/mds.23206</ELocationID><Abstract><AbstractText>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.</AbstractText><CopyrightInformation>© 2010 Movement Disorder Society.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Stocchi</LastName><ForeName>Fabrizio</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Department of Neuroscience, Institute of Neurology, IRCCS San Raffaele Pisana, Roma, Italy. fabrizio.stocchi@fastwebnet.it</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zappia</LastName><ForeName>Mario</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Dall'Armi</LastName><ForeName>Valentina</ForeName><Initials>V</Initials></Author><Author ValidYN="Y"><LastName>Kulisevsky</LastName><ForeName>Jaime</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Lamberti</LastName><ForeName>Paolo</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Obeso</LastName><ForeName>José Angel</ForeName><Initials>JA</Initials></Author><Author ValidYN="Y"><CollectiveName>Melevodopa Plus Carbidopa Study Group</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Mov Disord</MedlineTA><NlmUniqueID>8610688</NlmUniqueID><ISSNLinking>0885-3185</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000978">Antiparkinson Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D004338">Drug Combinations</NameOfSubstance></Chemical><Chemical><RegistryNumber>46627O600J</RegistryNumber><NameOfSubstance UI="D007980">Levodopa</NameOfSubstance></Chemical><Chemical><RegistryNumber>M30686U4X4</RegistryNumber><NameOfSubstance UI="C035420">levodopa methyl ester</NameOfSubstance></Chemical><Chemical><RegistryNumber>MNX7R8C5VO</RegistryNumber><NameOfSubstance UI="D002230">Carbidopa</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000284">Administration, Oral</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000328">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000368">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000369">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000704">Analysis of 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therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D016896">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><InvestigatorList><Investigator ValidYN="Y"><LastName>Ruggieri</LastName></Investigator><Investigator ValidYN="Y"><LastName>Stocchi</LastName></Investigator><Investigator ValidYN="Y"><LastName>Toso</LastName></Investigator><Investigator ValidYN="Y"><LastName>Bartolomei</LastName></Investigator><Investigator ValidYN="Y"><LastName>Onofrj</LastName></Investigator><Investigator ValidYN="Y"><LastName>Thomas</LastName></Investigator><Investigator ValidYN="Y"><LastName>Nordera</LastName></Investigator><Investigator ValidYN="Y"><LastName>Valzania</LastName></Investigator><Investigator ValidYN="Y"><LastName>Tropeani</LastName></Investigator><Investigator ValidYN="Y"><LastName>Bonuccelli</LastName></Investigator><Investigator ValidYN="Y"><LastName>Del Dotto</LastName></Investigator><Investigator ValidYN="Y"><LastName>Gigli</LastName></Investigator><Investigator ValidYN="Y"><LastName>Brotini</LastName></Investigator><Investigator ValidYN="Y"><LastName>Scarzella</LastName></Investigator><Investigator ValidYN="Y"><LastName>Tamma</LastName></Investigator><Investigator ValidYN="Y"><LastName>Caputo</LastName></Investigator><Investigator ValidYN="Y"><LastName>Piccolo</LastName></Investigator><Investigator ValidYN="Y"><LastName>Albanese</LastName></Investigator><Investigator ValidYN="Y"><LastName>Abbruzzese</LastName></Investigator><Investigator ValidYN="Y"><LastName>Martignoni</LastName></Investigator><Investigator ValidYN="Y"><LastName>Riboldazzi</LastName></Investigator><Investigator ValidYN="Y"><LastName>Calandrella</LastName></Investigator><Investigator ValidYN="Y"><LastName>Scaglioni</LastName></Investigator><Investigator ValidYN="Y"><LastName>Bianchi</LastName></Investigator><Investigator ValidYN="Y"><LastName>Lamberti</LastName></Investigator><Investigator 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ValidYN="Y"><LastName>Pascual</LastName></Investigator><Investigator ValidYN="Y"><LastName>Campolongo</LastName></Investigator><Investigator ValidYN="Y"><LastName>Gonzalez Maldonado</LastName></Investigator><Investigator ValidYN="Y"><LastName>Chacón</LastName></Investigator><Investigator ValidYN="Y"><LastName>García Moreno</LastName></Investigator><Investigator ValidYN="Y"><LastName>Velazquez</LastName></Investigator><Investigator ValidYN="Y"><LastName>Lopez</LastName></Investigator><Investigator ValidYN="Y"><LastName>Castro</LastName></Investigator><Investigator ValidYN="Y"><LastName>Sesar</LastName></Investigator><Investigator ValidYN="Y"><LastName>Catalán</LastName></Investigator><Investigator ValidYN="Y"><LastName>Del Val</LastName></Investigator><Investigator ValidYN="Y"><LastName>Pin</LastName></Investigator><Investigator ValidYN="Y"><LastName>Vela</LastName></Investigator><Investigator ValidYN="Y"><LastName>Mateo</LastName></Investigator><Investigator 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PubStatus="pubmed"><Year>2010</Year><Month>7</Month><Day>30</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2010</Year><Month>12</Month><Day>29</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="doi">10.1002/mds.23206</ArticleId><ArticleId IdType="pubmed">20669296</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Italie</li></country><region><li>Latium</li></region><settlement><li>Rome</li></settlement></list><tree><noCountry><name sortKey="Dall Armi, Valentina" sort="Dall Armi, Valentina" uniqKey="Dall Armi V" first="Valentina" last="Dall'Armi">Valentina Dall'Armi</name><name sortKey="Kulisevsky, Jaime" sort="Kulisevsky, Jaime" uniqKey="Kulisevsky J" first="Jaime" last="Kulisevsky">Jaime Kulisevsky</name><name sortKey="Lamberti, Paolo" sort="Lamberti, Paolo" uniqKey="Lamberti P" first="Paolo" last="Lamberti">Paolo Lamberti</name><name sortKey="Obeso, Jose Angel" sort="Obeso, Jose Angel" uniqKey="Obeso J" first="José Angel" last="Obeso">José Angel Obeso</name><name sortKey="Zappia, Mario" sort="Zappia, Mario" uniqKey="Zappia M" first="Mario" last="Zappia">Mario Zappia</name></noCountry><country name="Italie"><region name="Latium"><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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