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 : 000D55Safety 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 DurifSource :
- Movement disorders [ 0885-3185 ] ; 2004.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
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 (Cmax AUC, tmax, t1/2) 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.
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Format Inist (serveur)
NO : | PASCAL 04-0549727 INIST |
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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 (Cmax AUC, tmax, t1/2) 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 |
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Pascal:04-0549727Le document en format XML
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<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>
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</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>
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<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>
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