ParkinsonFranceV1, PascalFrancis, Corpus, bibRecord, 000D54

Safety of entacapone and apomorphine coadministration in levodopa-treated Parkinson's disease patients: Pharmacokinetic and pharmacodynamic results of a multicenter, double-blind, placebo-controlled, cross-over study

Identifieur interne : 000D54 ( PascalFrancis/Corpus ); précédent : 000D53; suivant : 000D55

Safety of entacapone and apomorphine coadministration in levodopa-treated Parkinson's disease patients: Pharmacokinetic and pharmacodynamic results of a multicenter, double-blind, placebo-controlled, cross-over study

Auteurs : Jan C. M. Zijlmans ; Berengere Debilly ; Olivier Rascol ; Andrew J. Lees ; Franck Durif

Source :

Movement disorders [ 0885-3185 ] ; 2004.

RBID : Pascal:04-0549727

Descripteurs français

Pascal (Inist)
- Système nerveux pathologie, Sécurité, Entacapone, Parkinson maladie, Apomorphine, Lévodopa, Traitement, Homme, Pharmacocinétique, Placebo.

English descriptors

KwdEn :
- Entacapone, Human, Levodopa, Nervous system diseases, Parkinson disease, Pharmacokinetics, Placebo, Safety, Treatment.

Abstract

We investigated whether administration of the catechol-O-methyl transferase (COMT) inhibitor entacapone. at doses of 200 mg and 400 mg, alters the pharmacokinetics of apomorphine in Parkinson's disease patients experiencing severe motor fluctuations. In addition, the pharmacodynamics and safety of entacapone and apomorphine coadministration in these patients were examined. The study followed a three-sequence, three-period, crossover design. Patients were randomly assigned to one of three sequences that included single oral doses of entacapone 200 mg, entacapone 400 mg, and placebo in a predefined order. On 3 separate test days, study treatment was administered before apomorphine. The study evaluations (pharmacokinetics, tapping test, and dyskinesia evaluation [Abnormal Involuntary Movements Scale - AIMS]) were performed on these days. Furthermore, Unified Parkinson Disease Rating Scale (UPDRS) scores were evaluated at base-line and study end. Pharmacokinetic parameters for apomorphine (C_max AUC, t_max, t_1/2) were unchanged by the administration of entacapone, and changes in both the tapping test and AIMS score were similar with all treatments (entacapone 200 mg, entacapone 400 mg, and placebo). There was no significant difference in mean total UPDRS scores between baseline and study end. The administration of entacapone did not change the pharmacokinetic or pharmacodynamic effects of apomorphine in these patients or prolong the clinical effect of apomorphine. Thus, apomorphine may be safely administered to patients receiving therapy with levodopa and entacapone, providing a useful addition to treatment for patients with advanced Parkinsons disease.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

A01	`01`	`1`		`@0 0885-3185`
A03		`1`		`@0 Mov. disord.`
A05				`@2 19`
A06				`@2 9`
A08	`01`	`1`	`ENG`	`@1 Safety of entacapone and apomorphine coadministration in levodopa-treated Parkinson's disease patients: Pharmacokinetic and pharmacodynamic results of a multicenter, double-blind, placebo-controlled, cross-over study`
A11	`01`	`1`		`@1 ZIJLMANS (Jan C. M.)`
A11	`02`	`1`		`@1 DEBILLY (Berengere)`
A11	`03`	`1`		`@1 RASCOL (Olivier)`
A11	`04`	`1`		`@1 LEES (Andrew J.)`
A11	`05`	`1`		`@1 DURIF (Franck)`
A14	`01`			`@1 National Hospital for Neurology and Neurosurgery @2 London @3 GBR @Z 1 aut. @Z 4 aut.`
A14	`02`			`@1 Department of Neurology, VU University Medical Centre @2 Amsterdam @3 NLD @Z 1 aut.`
A14	`03`			`@1 Federation de Neurologie, Hopital Gabriel Montpied @2 Clermont Ferrand @3 FRA @Z 2 aut. @Z 5 aut.`
A14	`04`			`@1 Clinical Investigation Centre, Department of Clinical Pharmacology, INSERM U 455, Toulouse University Hospital @3 FRA @Z 3 aut.`
A14	`05`			`@1 Reta Lila Weston Institute of Neurological Studies, University College London @3 GBR @Z 4 aut.`
A20				`@1 1006-1011`
A21				`@1 2004`
A23	`01`			`@0 ENG`
A43	`01`			`@1 INIST @2 20953 @5 354000122317190020`
A44				`@0 0000 @1 © 2004 INIST-CNRS. All rights reserved.`
A45				`@0 27 ref.`
A47	`01`	`1`		`@0 04-0549727`
A60				`@1 P`
A61				`@0 A`
A64	`01`	`1`		`@0 Movement disorders`
A66	`01`			`@0 USA`
C01	`01`		`ENG`	@0 We investigated whether administration of the catechol-O-methyl transferase (COMT) inhibitor entacapone. at doses of 200 mg and 400 mg, alters the pharmacokinetics of apomorphine in Parkinson's disease patients experiencing severe motor fluctuations. In addition, the pharmacodynamics and safety of entacapone and apomorphine coadministration in these patients were examined. The study followed a three-sequence, three-period, crossover design. Patients were randomly assigned to one of three sequences that included single oral doses of entacapone 200 mg, entacapone 400 mg, and placebo in a predefined order. On 3 separate test days, study treatment was administered before apomorphine. The study evaluations (pharmacokinetics, tapping test, and dyskinesia evaluation [Abnormal Involuntary Movements Scale - AIMS]) were performed on these days. Furthermore, Unified Parkinson Disease Rating Scale (UPDRS) scores were evaluated at base-line and study end. Pharmacokinetic parameters for apomorphine (C_max AUC, t_max, t_1/2) were unchanged by the administration of entacapone, and changes in both the tapping test and AIMS score were similar with all treatments (entacapone 200 mg, entacapone 400 mg, and placebo). There was no significant difference in mean total UPDRS scores between baseline and study end. The administration of entacapone did not change the pharmacokinetic or pharmacodynamic effects of apomorphine in these patients or prolong the clinical effect of apomorphine. Thus, apomorphine may be safely administered to patients receiving therapy with levodopa and entacapone, providing a useful addition to treatment for patients with advanced Parkinsons disease.
C02	`01`	`X`		`@0 002B17`
C02	`02`	`X`		`@0 002B17G`
C02	`03`	`X`		`@0 002B17F`
C03	`01`	`X`	`FRE`	`@0 Système nerveux pathologie @5 01`
C03	`01`	`X`	`ENG`	`@0 Nervous system diseases @5 01`
C03	`01`	`X`	`SPA`	`@0 Sistema nervioso patología @5 01`
C03	`02`	`X`	`FRE`	`@0 Sécurité @5 02`
C03	`02`	`X`	`ENG`	`@0 Safety @5 02`
C03	`02`	`X`	`SPA`	`@0 Seguridad @5 02`
C03	`03`	`X`	`FRE`	`@0 Entacapone @2 NK @2 FR @5 03`
C03	`03`	`X`	`ENG`	`@0 Entacapone @2 NK @2 FR @5 03`
C03	`03`	`X`	`SPA`	`@0 Entacapona @2 NK @2 FR @5 03`
C03	`04`	`X`	`FRE`	`@0 Parkinson maladie @5 04`
C03	`04`	`X`	`ENG`	`@0 Parkinson disease @5 04`
C03	`04`	`X`	`SPA`	`@0 Parkinson enfermedad @5 04`
C03	`05`	`X`	`FRE`	`@0 Apomorphine @2 NK @2 FR @5 05`
C03	`06`	`X`	`FRE`	`@0 Lévodopa @2 NK @2 FR @5 06`
C03	`06`	`X`	`ENG`	`@0 Levodopa @2 NK @2 FR @5 06`
C03	`06`	`X`	`SPA`	`@0 Levodopa @2 NK @2 FR @5 06`
C03	`07`	`X`	`FRE`	`@0 Traitement @5 08`
C03	`07`	`X`	`ENG`	`@0 Treatment @5 08`
C03	`07`	`X`	`SPA`	`@0 Tratamiento @5 08`
C03	`08`	`X`	`FRE`	`@0 Homme @5 09`
C03	`08`	`X`	`ENG`	`@0 Human @5 09`
C03	`08`	`X`	`SPA`	`@0 Hombre @5 09`
C03	`09`	`X`	`FRE`	`@0 Pharmacocinétique @5 11`
C03	`09`	`X`	`ENG`	`@0 Pharmacokinetics @5 11`
C03	`09`	`X`	`SPA`	`@0 Farmacocinética @5 11`
C03	`10`	`X`	`FRE`	`@0 Placebo @5 12`
C03	`10`	`X`	`ENG`	`@0 Placebo @5 12`
C03	`10`	`X`	`SPA`	`@0 Placebo @5 12`
C07	`01`	`X`	`FRE`	`@0 Antiparkinsonien @5 37`
C07	`01`	`X`	`ENG`	`@0 Antiparkinson agent @5 37`
C07	`01`	`X`	`SPA`	`@0 Antiparkinsoniano @5 37`
C07	`02`	`X`	`FRE`	`@0 Encéphale pathologie @5 38`
C07	`02`	`X`	`ENG`	`@0 Cerebral disorder @5 38`
C07	`02`	`X`	`SPA`	`@0 Encéfalo patología @5 38`
C07	`03`	`X`	`FRE`	`@0 Extrapyramidal syndrome @5 39`
C07	`03`	`X`	`ENG`	`@0 Extrapyramidal syndrome @5 39`
C07	`03`	`X`	`SPA`	`@0 Extrapiramidal síndrome @5 39`
C07	`04`	`X`	`FRE`	`@0 Maladie dégénérative @5 40`
C07	`04`	`X`	`ENG`	`@0 Degenerative disease @5 40`
C07	`04`	`X`	`SPA`	`@0 Enfermedad degenerativa @5 40`
C07	`05`	`X`	`FRE`	`@0 Système nerveux central pathologie @5 41`
C07	`05`	`X`	`ENG`	`@0 Central nervous system disease @5 41`
C07	`05`	`X`	`SPA`	`@0 Sistema nervosio central patología @5 41`
N21				`@1 313`
N44	`01`			`@1 OTO`
N82				`@1 OTO`

Format Inist (serveur)

NO :	PASCAL 04-0549727 INIST
ET :	Safety of entacapone and apomorphine coadministration in levodopa-treated Parkinson's disease patients: Pharmacokinetic and pharmacodynamic results of a multicenter, double-blind, placebo-controlled, cross-over study
AU :	ZIJLMANS (Jan C. M.); DEBILLY (Berengere); RASCOL (Olivier); LEES (Andrew J.); DURIF (Franck)
AF :	National Hospital for Neurology and Neurosurgery/London/Royaume-Uni (1 aut., 4 aut.); Department of Neurology, VU University Medical Centre/Amsterdam/Pays-Bas (1 aut.); Federation de Neurologie, Hopital Gabriel Montpied/Clermont Ferrand/France (2 aut., 5 aut.); Clinical Investigation Centre, Department of Clinical Pharmacology, INSERM U 455, Toulouse University Hospital/France (3 aut.); Reta Lila Weston Institute of Neurological Studies, University College London/Royaume-Uni (4 aut.)
DT :	Publication en série; Niveau analytique
SO :	Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2004; Vol. 19; No. 9; Pp. 1006-1011; Bibl. 27 ref.
LA :	Anglais
EA :	We investigated whether administration of the catechol-O-methyl transferase (COMT) inhibitor entacapone. at doses of 200 mg and 400 mg, alters the pharmacokinetics of apomorphine in Parkinson's disease patients experiencing severe motor fluctuations. In addition, the pharmacodynamics and safety of entacapone and apomorphine coadministration in these patients were examined. The study followed a three-sequence, three-period, crossover design. Patients were randomly assigned to one of three sequences that included single oral doses of entacapone 200 mg, entacapone 400 mg, and placebo in a predefined order. On 3 separate test days, study treatment was administered before apomorphine. The study evaluations (pharmacokinetics, tapping test, and dyskinesia evaluation [Abnormal Involuntary Movements Scale - AIMS]) were performed on these days. Furthermore, Unified Parkinson Disease Rating Scale (UPDRS) scores were evaluated at base-line and study end. Pharmacokinetic parameters for apomorphine (C_max AUC, t_max, t_1/2) were unchanged by the administration of entacapone, and changes in both the tapping test and AIMS score were similar with all treatments (entacapone 200 mg, entacapone 400 mg, and placebo). There was no significant difference in mean total UPDRS scores between baseline and study end. The administration of entacapone did not change the pharmacokinetic or pharmacodynamic effects of apomorphine in these patients or prolong the clinical effect of apomorphine. Thus, apomorphine may be safely administered to patients receiving therapy with levodopa and entacapone, providing a useful addition to treatment for patients with advanced Parkinsons disease.
CC :	002B17; 002B17G; 002B17F
FD :	Système nerveux pathologie; Sécurité; Entacapone; Parkinson maladie; Apomorphine; Lévodopa; Traitement; Homme; Pharmacocinétique; Placebo
FG :	Antiparkinsonien; Encéphale pathologie; Extrapyramidal syndrome; Maladie dégénérative; Système nerveux central pathologie
ED :	Nervous system diseases; Safety; Entacapone; Parkinson disease; Levodopa; Treatment; Human; Pharmacokinetics; Placebo
EG :	Antiparkinson agent; Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease
SD :	Sistema nervioso patología; Seguridad; Entacapona; Parkinson enfermedad; Levodopa; Tratamiento; Hombre; Farmacocinética; Placebo
LO :	INIST-20953.354000122317190020
ID :	04-0549727

Links to Exploration step

Pascal:04-0549727

Le document en format XML

<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Safety of entacapone and apomorphine coadministration in levodopa-treated Parkinson's disease patients: Pharmacokinetic and pharmacodynamic results of a multicenter, double-blind, placebo-controlled, cross-over study</title>
<author><name sortKey="Zijlmans, Jan C M" sort="Zijlmans, Jan C M" uniqKey="Zijlmans J" first="Jan C. M." last="Zijlmans">Jan C. M. Zijlmans</name>
<affiliation><inist:fA14 i1="01"><s1>National Hospital for Neurology and Neurosurgery</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>1 aut.</sZ>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation><inist:fA14 i1="02"><s1>Department of Neurology, VU University Medical Centre</s1>
<s2>Amsterdam</s2>
<s3>NLD</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Debilly, Berengere" sort="Debilly, Berengere" uniqKey="Debilly B" first="Berengere" last="Debilly">Berengere Debilly</name>
<affiliation><inist:fA14 i1="03"><s1>Federation de Neurologie, Hopital Gabriel Montpied</s1>
<s2>Clermont Ferrand</s2>
<s3>FRA</s3>
<sZ>2 aut.</sZ>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name>
<affiliation><inist:fA14 i1="04"><s1>Clinical Investigation Centre, Department of Clinical Pharmacology, INSERM U 455, Toulouse University Hospital</s1>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Lees, Andrew J" sort="Lees, Andrew J" uniqKey="Lees A" first="Andrew J." last="Lees">Andrew J. Lees</name>
<affiliation><inist:fA14 i1="01"><s1>National Hospital for Neurology and Neurosurgery</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>1 aut.</sZ>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation><inist:fA14 i1="05"><s1>Reta Lila Weston Institute of Neurological Studies, University College London</s1>
<s3>GBR</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Durif, Franck" sort="Durif, Franck" uniqKey="Durif F" first="Franck" last="Durif">Franck Durif</name>
<affiliation><inist:fA14 i1="03"><s1>Federation de Neurologie, Hopital Gabriel Montpied</s1>
<s2>Clermont Ferrand</s2>
<s3>FRA</s3>
<sZ>2 aut.</sZ>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">INIST</idno>
<idno type="inist">04-0549727</idno>
<date when="2004">2004</date>
<idno type="stanalyst">PASCAL 04-0549727 INIST</idno>
<idno type="RBID">Pascal:04-0549727</idno>
<idno type="wicri:Area/PascalFrancis/Corpus">000D54</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Safety of entacapone and apomorphine coadministration in levodopa-treated Parkinson's disease patients: Pharmacokinetic and pharmacodynamic results of a multicenter, double-blind, placebo-controlled, cross-over study</title>
<author><name sortKey="Zijlmans, Jan C M" sort="Zijlmans, Jan C M" uniqKey="Zijlmans J" first="Jan C. M." last="Zijlmans">Jan C. M. Zijlmans</name>
<affiliation><inist:fA14 i1="01"><s1>National Hospital for Neurology and Neurosurgery</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>1 aut.</sZ>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation><inist:fA14 i1="02"><s1>Department of Neurology, VU University Medical Centre</s1>
<s2>Amsterdam</s2>
<s3>NLD</s3>
<sZ>1 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Debilly, Berengere" sort="Debilly, Berengere" uniqKey="Debilly B" first="Berengere" last="Debilly">Berengere Debilly</name>
<affiliation><inist:fA14 i1="03"><s1>Federation de Neurologie, Hopital Gabriel Montpied</s1>
<s2>Clermont Ferrand</s2>
<s3>FRA</s3>
<sZ>2 aut.</sZ>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name>
<affiliation><inist:fA14 i1="04"><s1>Clinical Investigation Centre, Department of Clinical Pharmacology, INSERM U 455, Toulouse University Hospital</s1>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Lees, Andrew J" sort="Lees, Andrew J" uniqKey="Lees A" first="Andrew J." last="Lees">Andrew J. Lees</name>
<affiliation><inist:fA14 i1="01"><s1>National Hospital for Neurology and Neurosurgery</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>1 aut.</sZ>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
<affiliation><inist:fA14 i1="05"><s1>Reta Lila Weston Institute of Neurological Studies, University College London</s1>
<s3>GBR</s3>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Durif, Franck" sort="Durif, Franck" uniqKey="Durif F" first="Franck" last="Durif">Franck Durif</name>
<affiliation><inist:fA14 i1="03"><s1>Federation de Neurologie, Hopital Gabriel Montpied</s1>
<s2>Clermont Ferrand</s2>
<s3>FRA</s3>
<sZ>2 aut.</sZ>
<sZ>5 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Movement disorders</title>
<title level="j" type="abbreviated">Mov. disord.</title>
<idno type="ISSN">0885-3185</idno>
<imprint><date when="2004">2004</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Movement disorders</title>
<title level="j" type="abbreviated">Mov. disord.</title>
<idno type="ISSN">0885-3185</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Entacapone</term>
<term>Human</term>
<term>Levodopa</term>
<term>Nervous system diseases</term>
<term>Parkinson disease</term>
<term>Pharmacokinetics</term>
<term>Placebo</term>
<term>Safety</term>
<term>Treatment</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Système nerveux pathologie</term>
<term>Sécurité</term>
<term>Entacapone</term>
<term>Parkinson maladie</term>
<term>Apomorphine</term>
<term>Lévodopa</term>
<term>Traitement</term>
<term>Homme</term>
<term>Pharmacocinétique</term>
<term>Placebo</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">We investigated whether administration of the catechol-O-methyl transferase (COMT) inhibitor entacapone. at doses of 200 mg and 400 mg, alters the pharmacokinetics of apomorphine in Parkinson's disease patients experiencing severe motor fluctuations. In addition, the pharmacodynamics and safety of entacapone and apomorphine coadministration in these patients were examined. The study followed a three-sequence, three-period, crossover design. Patients were randomly assigned to one of three sequences that included single oral doses of entacapone 200 mg, entacapone 400 mg, and placebo in a predefined order. On 3 separate test days, study treatment was administered before apomorphine. The study evaluations (pharmacokinetics, tapping test, and dyskinesia evaluation [Abnormal Involuntary Movements Scale - AIMS]) were performed on these days. Furthermore, Unified Parkinson Disease Rating Scale (UPDRS) scores were evaluated at base-line and study end. Pharmacokinetic parameters for apomorphine (C<sub>max</sub>
 AUC, t<sub>max</sub>
, t<sub>1/2</sub>
) were unchanged by the administration of entacapone, and changes in both the tapping test and AIMS score were similar with all treatments (entacapone 200 mg, entacapone 400 mg, and placebo). There was no significant difference in mean total UPDRS scores between baseline and study end. The administration of entacapone did not change the pharmacokinetic or pharmacodynamic effects of apomorphine in these patients or prolong the clinical effect of apomorphine. Thus, apomorphine may be safely administered to patients receiving therapy with levodopa and entacapone, providing a useful addition to treatment for patients with advanced Parkinsons disease.</div>
</front>
</TEI>
<inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0885-3185</s0>
</fA01>
<fA03 i2="1"><s0>Mov. disord.</s0>
</fA03>
<fA05><s2>19</s2>
</fA05>
<fA06><s2>9</s2>
</fA06>
<fA08 i1="01" i2="1" l="ENG"><s1>Safety of entacapone and apomorphine coadministration in levodopa-treated Parkinson's disease patients: Pharmacokinetic and pharmacodynamic results of a multicenter, double-blind, placebo-controlled, cross-over study</s1>
</fA08>
<fA11 i1="01" i2="1"><s1>ZIJLMANS (Jan C. M.)</s1>
</fA11>
<fA11 i1="02" i2="1"><s1>DEBILLY (Berengere)</s1>
</fA11>
<fA11 i1="03" i2="1"><s1>RASCOL (Olivier)</s1>
</fA11>
<fA11 i1="04" i2="1"><s1>LEES (Andrew J.)</s1>
</fA11>
<fA11 i1="05" i2="1"><s1>DURIF (Franck)</s1>
</fA11>
<fA14 i1="01"><s1>National Hospital for Neurology and Neurosurgery</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>1 aut.</sZ>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>Department of Neurology, VU University Medical Centre</s1>
<s2>Amsterdam</s2>
<s3>NLD</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Federation de Neurologie, Hopital Gabriel Montpied</s1>
<s2>Clermont Ferrand</s2>
<s3>FRA</s3>
<sZ>2 aut.</sZ>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Clinical Investigation Centre, Department of Clinical Pharmacology, INSERM U 455, Toulouse University Hospital</s1>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Reta Lila Weston Institute of Neurological Studies, University College London</s1>
<s3>GBR</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA20><s1>1006-1011</s1>
</fA20>
<fA21><s1>2004</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
</fA23>
<fA43 i1="01"><s1>INIST</s1>
<s2>20953</s2>
<s5>354000122317190020</s5>
</fA43>
<fA44><s0>0000</s0>
<s1>© 2004 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45><s0>27 ref.</s0>
</fA45>
<fA47 i1="01" i2="1"><s0>04-0549727</s0>
</fA47>
<fA60><s1>P</s1>
</fA60>
<fA61><s0>A</s0>
</fA61>
<fA64 i1="01" i2="1"><s0>Movement disorders</s0>
</fA64>
<fA66 i1="01"><s0>USA</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>We investigated whether administration of the catechol-O-methyl transferase (COMT) inhibitor entacapone. at doses of 200 mg and 400 mg, alters the pharmacokinetics of apomorphine in Parkinson's disease patients experiencing severe motor fluctuations. In addition, the pharmacodynamics and safety of entacapone and apomorphine coadministration in these patients were examined. The study followed a three-sequence, three-period, crossover design. Patients were randomly assigned to one of three sequences that included single oral doses of entacapone 200 mg, entacapone 400 mg, and placebo in a predefined order. On 3 separate test days, study treatment was administered before apomorphine. The study evaluations (pharmacokinetics, tapping test, and dyskinesia evaluation [Abnormal Involuntary Movements Scale - AIMS]) were performed on these days. Furthermore, Unified Parkinson Disease Rating Scale (UPDRS) scores were evaluated at base-line and study end. Pharmacokinetic parameters for apomorphine (C<sub>max</sub>
 AUC, t<sub>max</sub>
, t<sub>1/2</sub>
) were unchanged by the administration of entacapone, and changes in both the tapping test and AIMS score were similar with all treatments (entacapone 200 mg, entacapone 400 mg, and placebo). There was no significant difference in mean total UPDRS scores between baseline and study end. The administration of entacapone did not change the pharmacokinetic or pharmacodynamic effects of apomorphine in these patients or prolong the clinical effect of apomorphine. Thus, apomorphine may be safely administered to patients receiving therapy with levodopa and entacapone, providing a useful addition to treatment for patients with advanced Parkinsons disease.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002B17</s0>
</fC02>
<fC02 i1="02" i2="X"><s0>002B17G</s0>
</fC02>
<fC02 i1="03" i2="X"><s0>002B17F</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Système nerveux pathologie</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Nervous system diseases</s0>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Sistema nervioso patología</s0>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Sécurité</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Safety</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>Seguridad</s0>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Entacapone</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Entacapone</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Entacapona</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>03</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Parkinson maladie</s0>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Parkinson disease</s0>
<s5>04</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Parkinson enfermedad</s0>
<s5>04</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Apomorphine</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>05</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Lévodopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Levodopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>06</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Levodopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>06</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Traitement</s0>
<s5>08</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Treatment</s0>
<s5>08</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Tratamiento</s0>
<s5>08</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Homme</s0>
<s5>09</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Human</s0>
<s5>09</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Hombre</s0>
<s5>09</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Pharmacocinétique</s0>
<s5>11</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Pharmacokinetics</s0>
<s5>11</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Farmacocinética</s0>
<s5>11</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE"><s0>Placebo</s0>
<s5>12</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG"><s0>Placebo</s0>
<s5>12</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA"><s0>Placebo</s0>
<s5>12</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Antiparkinsonien</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Antiparkinson agent</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Antiparkinsoniano</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Encéphale pathologie</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Cerebral disorder</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Encéfalo patología</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Extrapyramidal syndrome</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Extrapyramidal syndrome</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Extrapiramidal síndrome</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Maladie dégénérative</s0>
<s5>40</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Degenerative disease</s0>
<s5>40</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Enfermedad degenerativa</s0>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="FRE"><s0>Système nerveux central pathologie</s0>
<s5>41</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG"><s0>Central nervous system disease</s0>
<s5>41</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA"><s0>Sistema nervosio central patología</s0>
<s5>41</s5>
</fC07>
<fN21><s1>313</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
<server><NO>PASCAL 04-0549727 INIST</NO>
<ET>Safety of entacapone and apomorphine coadministration in levodopa-treated Parkinson's disease patients: Pharmacokinetic and pharmacodynamic results of a multicenter, double-blind, placebo-controlled, cross-over study</ET>
<AU>ZIJLMANS (Jan C. M.); DEBILLY (Berengere); RASCOL (Olivier); LEES (Andrew J.); DURIF (Franck)</AU>
<AF>National Hospital for Neurology and Neurosurgery/London/Royaume-Uni (1 aut., 4 aut.); Department of Neurology, VU University Medical Centre/Amsterdam/Pays-Bas (1 aut.); Federation de Neurologie, Hopital Gabriel Montpied/Clermont Ferrand/France (2 aut., 5 aut.); Clinical Investigation Centre, Department of Clinical Pharmacology, INSERM U 455, Toulouse University Hospital/France (3 aut.); Reta Lila Weston Institute of Neurological Studies, University College London/Royaume-Uni (4 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2004; Vol. 19; No. 9; Pp. 1006-1011; Bibl. 27 ref.</SO>
<LA>Anglais</LA>
<EA>We investigated whether administration of the catechol-O-methyl transferase (COMT) inhibitor entacapone. at doses of 200 mg and 400 mg, alters the pharmacokinetics of apomorphine in Parkinson's disease patients experiencing severe motor fluctuations. In addition, the pharmacodynamics and safety of entacapone and apomorphine coadministration in these patients were examined. The study followed a three-sequence, three-period, crossover design. Patients were randomly assigned to one of three sequences that included single oral doses of entacapone 200 mg, entacapone 400 mg, and placebo in a predefined order. On 3 separate test days, study treatment was administered before apomorphine. The study evaluations (pharmacokinetics, tapping test, and dyskinesia evaluation [Abnormal Involuntary Movements Scale - AIMS]) were performed on these days. Furthermore, Unified Parkinson Disease Rating Scale (UPDRS) scores were evaluated at base-line and study end. Pharmacokinetic parameters for apomorphine (C<sub>max</sub>
 AUC, t<sub>max</sub>
, t<sub>1/2</sub>
) were unchanged by the administration of entacapone, and changes in both the tapping test and AIMS score were similar with all treatments (entacapone 200 mg, entacapone 400 mg, and placebo). There was no significant difference in mean total UPDRS scores between baseline and study end. The administration of entacapone did not change the pharmacokinetic or pharmacodynamic effects of apomorphine in these patients or prolong the clinical effect of apomorphine. Thus, apomorphine may be safely administered to patients receiving therapy with levodopa and entacapone, providing a useful addition to treatment for patients with advanced Parkinsons disease.</EA>
<CC>002B17; 002B17G; 002B17F</CC>
<FD>Système nerveux pathologie; Sécurité; Entacapone; Parkinson maladie; Apomorphine; Lévodopa; Traitement; Homme; Pharmacocinétique; Placebo</FD>
<FG>Antiparkinsonien; Encéphale pathologie; Extrapyramidal syndrome; Maladie dégénérative; Système nerveux central pathologie</FG>
<ED>Nervous system diseases; Safety; Entacapone; Parkinson disease; Levodopa; Treatment; Human; Pharmacokinetics; Placebo</ED>
<EG>Antiparkinson agent; Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease</EG>
<SD>Sistema nervioso patología; Seguridad; Entacapona; Parkinson enfermedad; Levodopa; Tratamiento; Hombre; Farmacocinética; Placebo</SD>
<LO>INIST-20953.354000122317190020</LO>
<ID>04-0549727</ID>
</server>
</inist>
</record>

Pour manipuler ce document sous Unix (Dilib)

EXPLOR_STEP=$WICRI_ROOT/Wicri/Sante/explor/ParkinsonFranceV1/Data/PascalFrancis/Corpus

HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000D54 | SxmlIndent | more

HfdSelect -h $EXPLOR_AREA/Data/PascalFrancis/Corpus/biblio.hfd -nk 000D54 | SxmlIndent | more

Pour mettre un lien sur cette page dans le réseau Wicri

{{Explor lien
   |wiki=    Wicri/Sante
   |area=    ParkinsonFranceV1
   |flux=    PascalFrancis
   |étape=   Corpus
   |type=    RBID
   |clé=     Pascal:04-0549727
   |texte=   Safety of entacapone and apomorphine coadministration in levodopa-treated Parkinson's disease patients: Pharmacokinetic and pharmacodynamic results of a multicenter, double-blind, placebo-controlled, cross-over study
}}

This area was generated with Dilib version V0.6.29.
Data generation: Wed May 17 19:46:39 2017. Site generation: Mon Mar 4 15:48:15 2024

	La maladie de Parkinson en France (serveur d'exploration)
	Attention, ce site est en cours de développement ! Attention, site généré par des moyens informatiques à partir de corpus bruts. Les informations ne sont donc pas validées.

La maladie de Parkinson en France (serveur d'exploration)

Safety of entacapone and apomorphine coadministration in levodopa-treated Parkinson's disease patients: Pharmacokinetic and pharmacodynamic results of a multicenter, double-blind, placebo-controlled, cross-over study

Safety of entacapone and apomorphine coadministration in levodopa-treated Parkinson's disease patients: Pharmacokinetic and pharmacodynamic results of a multicenter, double-blind, placebo-controlled, cross-over study

Source :

Descripteurs français

English descriptors

Abstract

Notice en format standard (ISO 2709)

Format Inist (serveur)

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