2005, Number 1
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Rev Invest Clin 2005; 57 (1)
Population pharmacokinetics of carbamazepine in adults with epilepsy
Romano-Moreno S, Medina-Rojas EL, Salas-Ortiz AL, Vargas-Morales JM, Pérez-Urizar JT, Rodríguez-Leyva I
Language: Spanish
References: 44
Page: 38-48
PDF size: 98.78 Kb.
ABSTRACT
The aim of the present study was to determinate the factors affecting carbamazepine (CBZ) clearance (CL) in adults with epilepsy using a mixed-effect model and sparse data collected during routine clinical care. The patient population comprised 104 adults receiving CBZ. A total of 161 CBZ steady state serum concentration samples were analyzed. Population CL was calculated by using NONMEM with a one compartment model with first-order absorption and elimination. The following covariates were tested for their influence on clearance (CL): total body weight, age, dose/day, sex, surface area (SA) and comedication with primidone (PRIM), valproic acid or phenytoin (DFH). The final regression model for carbamazepine clearance found best to describe the data was: CL = (0.614 SA + 0.0016 dose/day)(1 + 0.278 DFH)(1 + 0.326 PRIM)
REFERENCES
Goodman GA. Las bases farmacológicas de la terapéutica. Vol. 1. 9a. edición. España: Editorial Panamericana; 2000, p. 491-506.
Spina E, Pisani F, Perucca E. Clinically significant pharmacokinetic drug interactions with carbamazepine. An update. Clin Pharmacokinet 1996; 31: 198-214.
MacKichan JJ. Carbamazepine. In: Taylor WJ, Diers Caviness MH (Ed). A textbook for the clinical application of therapeutic drug monitoring. Irving, Texas: Abbott Laboratories, Diagnostic Division; 1986, p. 211-22.
Battino D, Estienne M, Avanzini G. Clinical pharmacokinetics of antiepileptic drugs in paediatric patients. Part II: Phenytoin, Carbamazepine, Sultiame, Lamotrigine, Vigabatrin, Oxcarbamazepine and Felbamate. Clin Pharmacokinet 1995; 29: 341-69.
Liu H, Delgado MR. Influence of sex, age, weight and carbamazepine dose on serum concentrations, concentration ratio and level/dose ratios of carbamazepine and its metabolites. Ther Drug Monit 1994; 16: 469-76.
Martin ES, Crismon ML, Godley PJ. Postinduction carbamazepine clearance in adult psychiatric population. Pharmacotherapy 1991; 11: 296-302.
Reith DM, Hooper W, Parke J, Charles B. Population pharmacokinetic modeling of steady state carbamazepine clearance in children, adolescents and adults. J Pharmacokinet Biopharm 2001; 28: 79-92.
Summers B, Summers RS. Carbamazepine clearance in paediatric epilepsy patients: Influence of body mass, dose, sex and co-medication. Clin Pharmacokinet 1989; 17: 208-16.
Suzuki Y, Cox S, Hayes J, Walson PD. Carbamazepine age-dose ratio relationship in children. Ther Drug Monit 1991; 13: 201-8.
Sheiner LB, Grasela TH. An introduction to mixed effect mod-eling: concepts, definitions and justification. J Pharmacokinet Biopharm 1991; 19: 11S-24S.
Grasela TH, Sheiner LB. Pharmacostatistical modelling for observational data. J Pharmacokin Biopharm 1991; 19: 25S-36S.
Karlsson MO, Thomson AH, McGovern EM, Chow P, Evan TJ, Kelman AW. Population pharmacokinetics of rectal theophyl-line in neonates. Ther Drug Monit 1991; 13: 1995-2000.
Romano S, Fernández de Gatta MM, Calvo V, Méndez E, Dominguez-Gil A, Lanao JM. Population pharmacokinetics of amikacin in patients with haematological malignancies. J Antimic Chemother 1999; 44: 235-42.
Serrano BB, García-Sánchez MJ, Otero MJ, Buelga DS, Serrano J, Domínguez-Gil A. Valproate population pharmacokinetics in children. J Clin Pharm Ther 1999; 24: 73-80.
Delgado I, Santos B, García MJ, Otero MJ, Falcao AC, Domínguez-Gil A. Carbamazepine population pharmacokinetics in children: Mixed-Effect Models. Ther Drug Monit 1997; 19: 132-9.
Chan E. Population pharmacokinetics of carbamazepine in Singapore epileptic patients. Br J Clin Pharmacol 2001; 51: 567-76.
Yukawa E, Aoyama T. Detection of carbamazepine drug inter-action by multiple peak approach screening using routine clinical pharmacokinetic data. J Clin Pharmacol 1996; 36: 752-9.
Graves NM. Population pharmacokinetics of carbamazepine in adults with epilepsy. Pharmacotherapy 1998; 18: 273-81.
Deleu D, Aarons L, Ahmed IA. Population pharmacokinetics of free carbamazepine in adult Omani epileptic patients. Eur J Clin Pharmacol 2001; 57: 243-8.
Zheng JZ, Zhong MK, Shi XJ, Hu M, Zhang JH. Population pharmacokinetics of carbamazepine in Chinese epilepsy patients. Ther Drug Monitor 2003; 25: 279-86.
Secretaría de Salud. Cuadro Básico y Catálogo de Medicamentos. Comisión Interinstitucional del Cuadro Básico de Insumos del Sector Salud. www.salud.gob.mx/unidades/csg/cuads_bas_cat2002/medica_2004.htm; 2004, p. 14-22.
Morselli PJ. Carbamazepine. Absorption, distribution and excretion. In: Levy RH, Dreifuss LE, Mattson RH, Meldrum BS, Penry JK, eds. Antiepileptic Drugs. Third Edition. New York (USA): Raven Press. Ltd.; 1989 p. 473-90.
Sheiner LB, Beal SL. Evaluation of methods for estimating population pharmacokinetic parameters. III. Monoexponential model: routine clinical pharmacokinetic data. J Pharmacokinet Bipharm 1983; 11: 303-19.
Whiting B, Kelman AW, Grevel J. Population pharmacokinetics. Theory and clinical application. Clin Pharmacokinet 1986; 11: 387-401.
Pynnönen S. Pharmacokinetics of carbamazepine in man: A review. Ther Drug Monitor 1979; 1: 409-31.
Mosteller RD. Simplified calculation of body-surface area. New Engl J Med 1987; p. 1098.
Beal SL, Sheiner LB. NONMEM User’s Guide, Part V: Introductory Guide. NONMEM Project Group. San Francisco: University of California; 1992.
Grasela TH. Population pharmacokinetics: application to clinical trials. In: Smith RB. Kroboth PD, Juhl RP, eds. Pharmacokinetics and pharmacodynamics. Research design and analysis. Cincinnati: Harvey Witney Books (USA); 1986, p. 85-103.
Lee P. Design and power of a population pharmacokinetic study. Pharmaceutical Research 2001; 18: 75-82.
Hartley R, Lucock MD, Forsythe WI, McLain B. Factors influencing plasma level/dose ratios of carbamazepine and its major metabolites in epileptic children. Ther Drug Monit 1990; 12: 438-44.
Kumps A. Dose dependency between carbamazepine serum lev-els and dosage in patients with epilepsy. Ther Drug Monit 1981; 3: 271-4.
Sánchez A, Duran JA, Serrano JS. Steady-state carbamazepine plasma concentration-dose ratios in epileptic patients. Clin Pharmacokinet 1986; 11: 283-6.
Lack JA, Stuart ME. Calculation of drug dosage and body surface area of children. Br J Anaesth 1997; 78: 601-5.
Carles J, Kohen E, Midy D, Saric J, Videau J. Appréciation du volume hépatique en function de la morphologie de l’individu. Bull Assoc Anatom 1993; 77: 9-13.
De Land FH, North WA. Relationship between liver size and body size. Radiology 1968; 91: 1195-8.
Battino D, Bossi L, Croci D, Francechetti S, Gomeni C. Carbamazepine plasma levels in children and adults: Influence of age, dose, and asociated therapy. Ther Drug Monit 1980; 2: 315-22.
Lanchote V, Bonato P, Campo G, Rodrigues E. Factors influencing plasma concentrations of carbamazepine and carbamazepine-10-11-epoxide in epileptic children and adults. Ther Drug Monit 1995; 17: 47-52.
Bertilsson L, Tomson T. Clinical pharmacokinetics and pharmacological effects of carbamazepine and carbamazepine-10,11-epoxide. Clin Pharmacokinet 1986; 11: 177-98.
Eichelbaum M, Kothe KW, Hoffman F, Van Unruh G. Kinetic and metabolism of carbamazepine during combined antiepileptic drug therapy. Clin Pharmacol Ther 1979; 26: 366-71.
Rambeck B, May T, Juergens U. Serum concentrations of carbamazepine and its epoxide and diol metabolites in epileptic patients: the influence of dose and co-medications. Ther Drug Monit 1987; 9: 198-203.
Riva A, Contin M, Albani F. Free concentration of carbamazepine and carbamazepine-10-11-epoxide in children and adults: influence of age and phenobarbitone co-medication. Clin Pharmacokin 1985; 10: 524-31.
Levy RH, Bradley MK. Clinical pharmacokinetics of carbamazepine. J Clin Psychiatry 1988; 49(Suppl.4): 58-62.
Baciewicz AM. Carbamazepine drug interaction. Ther Drug Monit 1986; 8: 305-17.
Chang SL, Levy RH. Inhibitory effect of valproic acid on the disposition of carbamazepine and carbamazepine-10-11-epoxide in the rate. Drug Metabol Dispos 1986; 14: 281-6.