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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.
Mov Disord. 2004 Sep; 19(9):1006-1011.MD

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 baseline 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 Parkinson's disease.

Authors+Show Affiliations

National Hospital for Neurology and Neurosurgery, London, United Kingdom.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15372589

Citation

Zijlmans, Jan C M., et al. "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." Movement Disorders : Official Journal of the Movement Disorder Society, vol. 19, no. 9, 2004, pp. 1006-1011.
Zijlmans JC, Debilly B, Rascol O, et al. 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. Mov Disord. 2004;19(9):1006-1011.
Zijlmans, J. C., Debilly, B., Rascol, O., Lees, A. J., & Durif, F. (2004). 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. Movement Disorders : Official Journal of the Movement Disorder Society, 19(9), 1006-1011.
Zijlmans JC, et al. 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. Mov Disord. 2004;19(9):1006-1011. PubMed PMID: 15372589.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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, AU - Debilly,Berengere, AU - Rascol,Olivier, AU - Lees,Andrew J, AU - Durif,Franck, PY - 2004/9/17/pubmed PY - 2004/12/22/medline PY - 2004/9/17/entrez SP - 1006 EP - 1011 JF - Movement disorders : official journal of the Movement Disorder Society JO - Mov Disord VL - 19 IS - 9 N2 - 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 baseline 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 Parkinson's disease. SN - 0885-3185 UR - https://www.unboundmedicine.com/medline/citation/15372589/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_ L2 - https://doi.org/10.1002/mds.20188 DB - PRIME DP - Unbound Medicine ER -