Nonparametric population modeling of valproate pharmacokinetics in epileptic patients using routine serum monitoring data: Implications for dosage

Journal of Clinical Pharmacy and Therapeutics

Volumn 29, Issue 2, 2004, Pages 105-120

  Bondareva, I B ^a,d   Jelliffe, R W ^b   Sokolov, A V ^c   Tischenkova, I F ^c  

^a FEDERAL RESEARCH AND CLINICAL CENTER OF PHYSICAL CHEMICAL MEDICINE OF FEDERAL MEDICAL BIOLOGICAL AGENCY   (Russian Federation)

^b UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^c PIROGOV RUSSIAN NATIONAL RESEARCH MEDICAL UNIVERSITY   (Russian Federation)

^d NONE   (Russian Federation)

Author keywords

Bayesian adaptive control; Epilepsy; Individualizing dosage regimen; Population modeling; Therapeutic drug monitoring; Valproate pharmacokinetics

Indexed keywords

VALPROIC ACID;

ADULT; AGE DISTRIBUTION; ARTICLE; BAYES THEOREM; CHILD; COMPUTER PROGRAM; CONTROLLED STUDY; DOSE RESPONSE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG COATING; DRUG DOSE REGIMEN; DRUG MONITORING; EPILEPSY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MATHEMATICAL MODEL; MONOTHERAPY; STATISTICAL SIGNIFICANCE; SUSTAINED RELEASE FORMULATION;

ADOLESCENT; ADULT; ANTICONVULSANTS; BAYES THEOREM; CHILD; CHILD, PRESCHOOL; DRUG MONITORING; EPILEPSY; FEMALE; HUMANS; INFANT; MALE; MIDDLE AGED; PREDICTIVE VALUE OF TESTS; RETROSPECTIVE STUDIES; STATISTICS, NONPARAMETRIC; VALPROIC ACID;

EID: 1842734434     PISSN: 02694727     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1365-2710.2003.00538.x     Document Type: Article

References (40)

1. Dean JCh (1997) Valproate. In: Wyllie E, ed. The treatment of epilepsy: principles and practice, 2nd edn. Baltimore: Williams & Wilkins, 824-832.
2. Winkelman C (1999) A review of pharmacodynamics and pharmacokinetics in seizure management. The Journal of Neuroscience Nursing, 31, 50-53.
3. Loscher W (1999) Valproate: a reappraisal of its pharmacodynamic properties and mechanisms of action. Progress in Neurobiology, 58, 31-59.
4. Loiseau P (1993) Sustained release valproate - a review. Valproate in epilepsy - present and future. A Sanofi Winthrop Satellite Symposium presented at the Bethel-Cleveland Conference Bielefild, Germany, 10 March 1993.
5. Guider R, Schell A, Eichelbaum M, Froscher W, Schulz H-U (1977) Disposition of valproic acid in man. European Journal of Clinical Pharmacology, 12, 125-132.
6. Shen DD (1999) Absorption, distribution, and excretion. In: Loscher W, ed. Valproate. Basel: Birkhauser Verlag, 77-90.
7. Perucca E, Gatti G, Frigo GM, Crema A (1978) Disposition of sodium valproate in epileptic patients. British Journal of Clinical Pharmacology, 5, 313-318.
8. Gibaldi M (1991) Biopharmaceutics and clinical pharmacokinetics. Philadelphia: Lea & Febiger.
9. Glauser TA, Pippenger CE (2000) Controversies in blood-level monitoring: reexamining its role in the treatment of epilepsy. Epilepsia, 41(Suppl. 8), S6-S15.
10. Boggs J, Waterhouse E, DeLorenzo RJ (1997) The use of antiepileptic medications in renal and liver disease. In: Wyllie E, ed. The treatment of epilepsy: principles and practice, 2nd edn. Baltimore: Williams & Wilkins, 753-763.
11. Bourgeois BFD (1997) Pharmacokinetics and pharmacodynamics in clinical practice. In: Wyllie E, ed. The treatment of epilepsy: principles and practice, 2nd edn. Baltimore: Williams & Wilkins, 728-737.
12. French JA, Gidal BE (2000) Antiepileptic drug interactions. Epilepsia, 41(Suppl. 8), S30-S36.
13. Clancy RR (1990) Valproate: an update - the challenge of modern pediatric seizures management. Current Problems in Pediatric and Adolescent Health Care, 20, 161-233.
14. Graves NH, Ramsay RE (1997) Phenytoin and fosphenytoin. In: Wyllie E, ed. The treatment of epilepsy: principles and practice, 2nd edn. Baltimore: Williams & Wilkins, 833-844.
15. McKauge L, Tyrer JH, Eadie MJ (1981) Factors influencing simultaneous concentrations of CBZ and its epoxide in plasma. Therapeutic Drug Monitoring, 3, 63-70.
16. Gugler R, von Unruh GE (1980) Clinical pharmacokinetics of valproic acid. Clinical Pharmacokinetics, 5, 67-72.
17. Rowan AJ, Binnie CD, de Beer-Pawlikowski NKB et al. (1979) Sodium valproate: serial monitoring of EEG and serum levels. Neurology, 29, 1450-1459.
18. Levy RH, Wilensky AJ, Anderson GD (1992) 'Carbamazepine, valproic acid, phenobarbital, and ethosuximide'. In: Evans WE, Schentag JJ, Jusko WJ, eds. Applied pharmacokinetics. Principles of TDM, Chapter 26. Vancouver, WA: Applied Therapeutics, Inc.
19. Blanco-Serrano B, Garsia-Sanchez MJ, Otero MJ et al. (1999) Valproate population pharmacokinetics in children. Journal of Clinical Pharmacy and Therapeutics, 24, 73-80.
20. Jelliffe RW, Schumitzky A, Van Guilder M, Jiang F (1996) User manual for version 10.7 of USC*PACK collection of PC programs. Los Angeles, CA: Laboratory of Applied Pharmacokinetics, School of Medicine, University of Southern California.
21. Gatti R, Carvini V, Roveri P (1992) 2-Bromoacetyl-6-methoxynaphthalene: a useful fluorescent labelling reagent for HPLC analysis of carboxylic acids. Chromatographya, 33, 13-18.
22. Lucarelli C, Villa P, Lombaradi E, Prandini P, Brega A (1991) HPLC method for the simultaneous analysis of valproic acid and other common anticonvulsant drugs in human plasma or serum. Chromatographya, 33, 37-40.
23. Jelliffe R. (1990) Explicit determination of laboratory assay error patterns - a useful aid in therapeutic drug monitoring, Check Sample Series. Drug Monitoring and Toxicology, American Society of Clinical Pathologists Continuing Education Program, No. DM 89-4 (DM-56), Chicago, IL, Vol. 10(4), pp. 1-6.
24. Jelliffe RW, Schumitzky A, Van Guilder M et al. (1993) Individualizing drug dosage regimens: roles of population pharmacokinetic and dynamic models, Bayesian fitting, and adaptive control. Therapeutic Drug Monitoring, 15, 380-393.
25. DeGroot M (1986) Probability and statistics, Addison-Wesley Series in Statistics, Addison-Wesley Publishing Company, Reading, MA, USA, 2nd edn, 420-424.
26. Schumitzky A (1991) Nonparametric EM algorithms for estimating prior distributions. Applied Mathematics and Computation, 45, 143-157.
27. Leary R, Jelliffe R, Schumitzky A, Van Guilder M (2002) A unified parametric/nonparametric approach to population PK/PD modeling. Presented at the Annual Meeting of the Population Approach Group in Europe, Paris, France, June 6-7.
28. D'Argenio DZ, Schumitzky A (1992) ADAPT II users guide. Biomedical simulations resource. Los Angeles: University of Southern California.
29. Cloyd JC, Birnbaum AK, Kreil RL (1997) Pharmacokinetics in infancy, childhood, and adolescence. In: Wyllie E, ed. The treatment of epilepsy: principles and practice, 2nd edn. Baltimore: Williams & Wilkins, 737-747.
30. Puentes E, Puzantian T, Lum BL (1999) Prediction of valproate serum concentrations in adult psychiatric patients using Bayesian model estimations with NPEM2 population pharmacokinetic parameters. Therapeutic Drug Monitoring, 21, 351-354.
31. D'Argenio DZ (1981) Optimal sampling times for pharmacokinetic experiments. Journal of Pharmacokinetics and Biopharmaceutics, 9, 739-756.
32. Blanco-Serrano B, Otero MJ, Santos-Buelga D, Garsia-Sanchez MJ, Serrano J, Dominguez-Gil A (1999) Population estimation of valproic acid clearance in adult patients using routine clinical pharmacokinetic data. Biopharmaceutics & Drug Disposition, 20, 233-240.
33. Yukawa E, Honda T, Ohdo S, Higuchi S, Aoyama T (1997) Detection of carbamazepine-induced changes in valproic acid relative clearance in man by simple pharmacokinetic screening. The Journal of Pharmacy and Pharmacology, 49, 751-756.
34. Yukawa E, To H, Ohdo S, Higuchi S, Aoyama T (1997) Population-based investigation of valproic acid relative clearance using nonlinear mixed effects modeling: influence of drug-drug interaction and patient characteristics. Journal of Clinical Pharmacology, 37, 1160-1167.
35. Sheiner LB (1992) Population pharmacokinetics/ dynamics. Annual Review of Pharmacology and Toxicology, 32, 185-209.
36. Davis R, Peters DH, McTavish D (1994) Valproic acid: a reappraisal of its pharmacological properties and clinical efficacy in epilepsy. Drugs, 47, 332-372.
37. Zini R, Riant P, Barre J, Tillement J-P (1990) Disease-induced variations in plasma protein levels. Implications for drug dosage regimens. Clinical Pharmacokinetics, Part I: 19, 147-159, Part II: 19, 218-229.
38. Zini R, Riant P, Barre J, Tillement J-P (1990) Disease-induced variations in plasma protein levels. Implications for drug dosage regimens. Clinical Pharmacokinetics, Part I: 19, 147-159, Part II: 19, 218-229.
39. Froscher W, Burr W, Penin H, Vohl J, Bulau P, Kreiten K (1985) Free level monitoring of carbamazepine and valproic acid: clinical significance. Clinical Neuropharmacology, 8, 362-366.
40. van Lent-Evers N, Mathot R, Geus W, van Hout B, and Vinks A (1999) Impact of goal-oriented and model-based clinical pharmacokinetic dosing of aminoglycosides on clinical outcome: a cost-effectiveness analysis. Therapeutic Drug Monitoring, 21, 63-73.