Population pharmacokinetics of levetiracetam in Japanese and Western adults

Clinical Pharmacokinetics

Volumn 46, Issue 6, 2007, Pages 503-512

  Pigeolet, Etienne ^a   Jacqmin, Philippe ^b   Sargentini Maier, Maria Laura ^a   Stockis, Armel ^a  

^a UCB PHARMA   (Belgium)

^b Exprimo NV   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

ACETAZOLAMIDE; ANTICONVULSIVE AGENT; BENZODIAZEPINE; CARBAMAZEPINE; CLOBAZAM; CLONAZEPAM; CREATININE; CYTOCHROME P450; ENZYME INDUCING AGENT; ETIRACETAM; GABAPENTIN; PHENOBARBITAL; PHENYTOIN; PLACEBO; VALPROIC ACID;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BODY WEIGHT; CAUCASIAN; COMPARTMENT MODEL; CONTROLLED STUDY; COVARIANCE; CREATININE CLEARANCE; DISTRIBUTION VOLUME; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG DOSE TITRATION; DRUG ELIMINATION; DRUG EXPOSURE; DRUG METABOLISM; DRUG SAFETY; EPILEPSY; ETHNICITY; EUROPE; FEMALE; FOCAL EPILEPSY; HUMAN; JAPANESE; MAJOR CLINICAL STUDY; MALE; NONLINEAR SYSTEM; POPULATION RESEARCH; PRIORITY JOURNAL; RECOMMENDED DRUG DOSE; SEX DIFFERENCE; STATISTICAL SIGNIFICANCE; STEADY STATE;

ADMINISTRATION, ORAL; ANTICONVULSANTS; BODY WEIGHT; CYTOCHROME P-450 ENZYME SYSTEM; DRUG ADMINISTRATION SCHEDULE; DRUG INTERACTIONS; EPILEPSY; ETHNIC GROUPS; EUROPE; HUMANS; JAPAN; METABOLIC CLEARANCE RATE; MODELS, BIOLOGICAL; PIRACETAM; REGRESSION ANALYSIS; UNITED STATES;

EID: 34249672290     PISSN: 03125963     EISSN: 03125963     Source Type: Journal    
DOI: 10.2165/00003088-200746060-00004     Document Type: Article

References (31)

1. Margineanu DG, Klitgaard H. Levetiracetam mechanism of action in antiepileptic drugs. In: Levy RH, Mattson RH, Meldrum BS, et al., editors. Antiepileptic drugs. 5th ed. Philadelphia (PA): Lippincott Williams & Wilkins, 2002: 419-27
2. Lynch BA, Lambeng N, Nocka K, et al. The synaptic vesicle protein SV2A is the binding site for the antiepileptic drug levetiracetam. Proc Natl Acad Sci USA 2004; 101: 9861-6
3. Cereghino JJ, Biton V, Abou-Khalil B, et al. Levetiracetam for partial seizures: results of a double-blind, randomized clinical trial. Neurology 2000; 55: 236-42
4. Shorvon SD, Löwenthal A, Janz D, et al. Multicenter double-blind, randomized, placebo-controlled trial of levetiracetam as add-on therapy in patients with refractory partial seizures. Epilepsia 2000; 41: 1179-86
5. Boon P, Chauvel P, Pohlmann-Eden B, et al. Dose-response effect of levetiracetam 1000 and 2000 mg/day in partial epilepsy. Epilepsy Res 2002; 48: 77-89
6. Ben-Menachem E, Edrich P, Van Vleymen B, et al. Evidence for sustained efficacy of levetiracetam as add-on epilepsy therapy. Epilepsy Res 2003; 53: 56-64
7. Glauser TA, Ayala R, Elterman RD, et al. A double-blind randomized placebo-controlled trial of levetiracetam adjunctive therapy in children with partial seizures. Neurology 2006; 66: 1654-60
8. Patsalos PN. Pharmacokinetics profile of levetiracetam: toward ideal characteristics. Pharmacol Ther 2000; 85: 77-85
9. Radtke RA. Pharmacokinetics of levetiracetam. Epilepsia 2001; 42 Suppl. 4: 24-7
10. Strolin Benedetti M, Whomsley R, Nicolas JM, et al. Pharmacokinetics and metabolism of 14C-levetiracetam, a new antiepileptic agent, in healthy volunteers. Eur J Clin Pharmacol 2003; 59: 621-30
11. Gidal B, Baltes E, Otoul C, et al. Effect of levetiracetam on the pharmacokinetics of adjunctive antiepileptic drugs: a pooled analysis of data from randomized clinical trials. Epilepsy Res 2005; 64: 1-11
12. Perucca E, Gidal BE, Baltes E. Effects of antiepileptic comedication on levetiracetam pharmacokinetics: a pooled analysis of data from randomized adjunctive therapy trials. Epilepsy Res 2003; 53: 47-56
13. Johannessen SI, Battino D, Berry DJ, et al. Therapeutic drug monitoring of the newer antiepileptic drugs. Ther Drug Monit 2003; 25: 347-63
14. Bjornsson TD, Wagner JA, Donahue SR, et al. A review and assessment of potential sources of ethnic differences in drug responsiveness. J Clin Pharmacol 2003; 43: 943-67
15. Cockroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976; 16: 31-41
16. Murasaki M. UCB L059 phase-I clinical trial: single administration study. Tokyo: UCB Japan Ltd, 1998. (Data on file)
17. Murasaki M. UCB L059 phase-I clinical trial: repeated administration study. Tokyo: UCB Japan Ltd, 1998. (Data on file)
18. Murasaki M. UCB L059 phase-I clinical trial: food interaction study. Tokyo: UCB Japan Ltd, 1998. (Data on file)
19. Murasaki M. Double blind bridging efficacy study of UCB L059 (levetiracetam) in patients with epilepsy. Tokyo: UCB Japan Ltd, 2005. (Data on file)
20. Murasaki M. Open label follow up study of UCB L059 (levetiracetam) in epileptic patients with partial onset seizures. Tokyo: UCB Japan Ltd, 2005. (Data on file)
21. Abou-Khalil B, Schaich L. Long term efficacy of levetiracetam for partial seizures. Seizure 2005; 14: 577-85
22. Coupez R, Nicolas JM, Browne TR. Levetiracetam, a new antiepileptic agent: lack of in vitro and in vivo pharmacokinetic interaction with valproic acid. Epilepsia 2003; 44: 171-8
23. Beal SL, Sheiner LB. NONMEM Project Group. NONMEM user's guide. San Francisco (CA): University of California, 1992
24. El Desoky E, Fuseau E, El Din Amry S, et al. Pharmacokinetic modeling of valproic acid from routine clinical data in Egyptian epileptic patients. Eur J Clin Pharmacol 2004; 59: 783-90
25. Mahmood I. Interspecies scaling: predicting volumes, mean residence time and elimination half-life. Some suggestions. J Pharm Pharmacol 1998; 50: 493-9
26. West GB, Brown JH, Enquist BJ. A general model for the origin of allometric scaling laws in biology. Science 1997; 276: 122-6
27. May TW, Rambeck B, Jurgens U. Serum concentrations of levetiracetam in epileptic patients: the influence of dose and co-medication. Ther Drug Monit 2003; 25: 690-9
28. Contin M, Albani F, Riva R, et al. Levetiracetam therapeutic monitoring in patients with epilepsy: effect of concomitant antiepileptic drugs. Ther Drug Monit 2004; 26: 375-9
29. Ramael S, De Smedt F, Toublanc N, et al. Single-dose bioavailability of levetiracetam intravenous infusion relative to oral tablets and multiple-dose pharmacokinetics and tolerability of levetiracetam intravenous infusion compared with placebo in healthy subjects. Clin Ther 2006; 28: 734-44
30. Genton P, Gelisse P. Valproic acid: adverse effects. In: Levy RH, Mattson RH, Meldrum BS, et al., editors. Antiepileptic drugs. 5th ed. Philadelphia (PA): Lippincott Williams and Wilkins, 2002: 837-51
31. Betts T, Waegemans T, Crawford P. A multicentre, double-blind, randomized, parallel-group study to evaluate the tolerability and efficacy of two oral doses of levetiracetam, 2000mg daily and 4000mg daily, without titration in patients with refractory epilepsy. Seizure 2000; 9: 80-7