MovDisordV3, Main, Merge, bibRecord, 002557

Melevodopa/Carbidopa Effervescent Formulation in the Treatment of Motor Fluctuations in Advanced Parkinson's Disease

Identifieur interne : 002557 ( Main/Merge ); précédent : 002556; suivant : 002558

Melevodopa/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.

RBID : Pascal:10-0446313

Descripteurs français

Pascal (Inist)
- Maladie de Parkinson, Pathologie du système nerveux, Mélévodopa, Carbidopa, Formulation, Traitement, Fluctuation, Stade avancé, Lévodopa.

English descriptors

KwdEn :
- Advanced stage, Carbidopa, Fluctuations, Formulation, Levodopa, Melevodopa, Nervous system diseases, Parkinson disease, Treatment.

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°70)]. 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.

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Pascal:10-0446313

Le document en format XML

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<author><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Melevodopa/Carbidopa Effervescent Formulation in the Treatment of Motor Fluctuations in Advanced Parkinson's Disease</title>
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<author><name sortKey="Zappia, Mario" sort="Zappia, Mario" uniqKey="Zappia M" first="Mario" last="Zappia">Mario Zappia</name>
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<author><name sortKey="Dall Armi, Valentina" sort="Dall Armi, Valentina" uniqKey="Dall Armi V" first="Valentina" last="Dall'Armi">Valentina Dall'Armi</name>
<affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Department of Clinical and Molecular Epidemiology, IRCCS San Raffaele Pisana</s1>
<s2>Roma 00163</s2>
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<author><name sortKey="Kulisevsky, Jaime" sort="Kulisevsky, Jaime" uniqKey="Kulisevsky J" first="Jaime" last="Kulisevsky">Jaime Kulisevsky</name>
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<s3>ESP</s3>
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<author><name sortKey="Lamberti, Paolo" sort="Lamberti, Paolo" uniqKey="Lamberti P" first="Paolo" last="Lamberti">Paolo Lamberti</name>
<affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Department of Neurology, Ospedale Policlinico Consorziale</s1>
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<term>Nervous system diseases</term>
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<term>Treatment</term>
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<term>Mélévodopa</term>
<term>Carbidopa</term>
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<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°70)]. 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>
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<tree><country name="Italie"><region name="Latium"><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name>
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<name sortKey="Dall Armi, Valentina" sort="Dall Armi, Valentina" uniqKey="Dall Armi V" first="Valentina" last="Dall'Armi">Valentina Dall'Armi</name>
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<name sortKey="Zappia, Mario" sort="Zappia, Mario" uniqKey="Zappia M" first="Mario" last="Zappia">Mario Zappia</name>
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<country name="Espagne"><region name="Catalogne"><name sortKey="Kulisevsky, Jaime" sort="Kulisevsky, Jaime" uniqKey="Kulisevsky J" first="Jaime" last="Kulisevsky">Jaime Kulisevsky</name>
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	Movement Disorders (revue)
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Movement Disorders (revue)

Melevodopa/Carbidopa Effervescent Formulation in the Treatment of Motor Fluctuations in Advanced Parkinson's Disease

Melevodopa/Carbidopa Effervescent Formulation in the Treatment of Motor Fluctuations in Advanced Parkinson's Disease

Source :

Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

Links to Exploration step

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri