Melevodopa/carbidopa effervescent formulation in the treatment of motor fluctuations in advanced Parkinson's disease.
Identifieur interne : 002D42 ( Ncbi/Curation ); précédent : 002D41; suivant : 002D43Melevodopa/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
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pubmed:20669296Le document en format XML
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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><idno type="wicri:Area/Ncbi/Merge">002D42</idno><idno 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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></record>Pour manipuler ce document sous Unix (Dilib)
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