Melevodopa/carbidopa effervescent formulation in the treatment of motor fluctuations in advanced Parkinson's disease
Identifieur interne : 001B87 ( Main/Exploration ); précédent : 001B86; suivant : 001B88Melevodopa/carbidopa effervescent formulation in the treatment of motor fluctuations in advanced Parkinson's disease
Auteurs : Fabrizio Stocchi [Italie] ; Mario Zappia [Italie] ; Valentina Dall'Armi [Italie] ; Jaime Kulisevsky [Espagne] ; Paolo Lamberti [Italie] ; José Angel Obeso [Espagne]Source :
- Movement Disorders [ 0885-3185 ] ; 2010-09-15.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
- Administration, Oral, Adult, Advanced stage, Aged, Aged, 80 and over, Analysis of Variance, Antiparkinson Agents (administration & dosage), Antiparkinson Agents (therapeutic use), Carbidopa, Carbidopa (administration & dosage), Carbidopa (therapeutic use), Double-Blind Method, Drug Administration Schedule, Drug Combinations, Female, Fluctuations, Formulation, Humans, Intention to Treat Analysis, Levodopa, Levodopa (administration & dosage), Levodopa (analogs & derivatives), Levodopa (therapeutic use), Male, Melevodopa, Middle Aged, Nervous system diseases, Parkinson Disease (drug therapy), Parkinson disease, Parkinson's disease, Treatment, Treatment Outcome, levodopa methylester, liquid formulation, melevodopa, motor fluctuations.
- 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. © 2010 Movement Disorder Society
Url:
DOI: 10.1002/mds.23206
Affiliations:
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Le document en format XML
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Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2010-09-15">2010-09-15</date><biblScope unit="vol">25</biblScope><biblScope unit="issue">12</biblScope><biblScope unit="page" from="1881">1881</biblScope><biblScope unit="page" to="1887">1887</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">B0D014BA674B90BB022B6487F09CC2F105FFA647</idno><idno type="DOI">10.1002/mds.23206</idno><idno type="ArticleID">MDS23206</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Oral</term><term>Adult</term><term>Advanced stage</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</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>Fluctuations</term><term>Formulation</term><term>Humans</term><term>Intention to Treat Analysis</term><term>Levodopa</term><term>Levodopa (administration & dosage)</term><term>Levodopa (analogs & derivatives)</term><term>Levodopa (therapeutic use)</term><term>Male</term><term>Melevodopa</term><term>Middle Aged</term><term>Nervous system diseases</term><term>Parkinson Disease (drug therapy)</term><term>Parkinson disease</term><term>Parkinson's disease</term><term>Treatment</term><term>Treatment Outcome</term><term>levodopa methylester</term><term>liquid formulation</term><term>melevodopa</term><term>motor fluctuations</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><keywords scheme="Pascal" xml:lang="fr"><term>Carbidopa</term><term>Fluctuation</term><term>Formulation</term><term>Lévodopa</term><term>Maladie de Parkinson</term><term>Mélévodopa</term><term>Pathologie du système nerveux</term><term>Stade avancé</term><term>Traitement</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></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. © 2010 Movement Disorder Society</div></front></TEI><affiliations><list><country><li>Espagne</li><li>Italie</li></country><region><li>Catalogne</li><li>Communauté forale de Navarre</li><li>Latium</li></region><settlement><li>Barcelone</li><li>Rome</li></settlement></list><tree><country name="Italie"><region name="Latium"><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name></region><name sortKey="Dall Armi, Valentina" sort="Dall Armi, Valentina" uniqKey="Dall Armi V" first="Valentina" last="Dall'Armi">Valentina Dall'Armi</name><name sortKey="Lamberti, Paolo" sort="Lamberti, Paolo" uniqKey="Lamberti P" first="Paolo" last="Lamberti">Paolo Lamberti</name><name sortKey="Zappia, Mario" sort="Zappia, Mario" uniqKey="Zappia M" first="Mario" last="Zappia">Mario Zappia</name></country><country name="Espagne"><region name="Catalogne"><name sortKey="Kulisevsky, Jaime" sort="Kulisevsky, Jaime" uniqKey="Kulisevsky J" first="Jaime" last="Kulisevsky">Jaime Kulisevsky</name></region><name sortKey="Obeso, Jose Angel" sort="Obeso, Jose Angel" uniqKey="Obeso J" first="José Angel" last="Obeso">José Angel Obeso</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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