2010, Number 6
<< Back Next >>
Rev Invest Clin 2010; 62 (6)
Effect of treatment and additional disease on pharmacokinetic of valproic acid in children with epilepsy
Juárez-Olguín H, Lugo-Goytia G, Flores-Murrieta F, Ruiz-García M, Lares AI, Flores PJ
Language: English
References: 34
Page: 516-523
PDF size: 75.61 Kb.
ABSTRACT
Background. Most of bayesian pharmacokinetic studies and the influence of clinical variables have been carried out in adults.
Purpose. The aim was to estimate populationbased pharmacokinetic of valproic acid (VPA) and to determine the effect of treatment and additional disease on its performance in children with epilepsy.
Material and methods. For the study steady-state serum concentrations of VPA were determined from 108 epileptic patients (44 females and 64 males) who were receiving the anticonvulsant as main drug of treatment with age range since 1 to 16 years (median 4y, 6m) and weight since 5.2 to 50 kg (median 17.5 kg). All patients had their renal, hepatic and nutritional functions normal. One compartment model using interactive two-stage Bayesian approach was employed in the analysis.
Results. Population estimates of CL/F and V/F for VPA were 0.022 ± 0.013 L/h and 0.217 ± 0.134 L/kg, respectively. These estimates were significantly affected by weight, age, carbamazepine (CBZ) and gastroesophageal reflux (GER). The final regression models were: CL/F (L/h) = 0.0696 + 0.0031(Age) + 0.0075(Weight); and V/F (L) = 0.674 + 0.0308(Age) + 0.0756(Weight). Prediction of VPA serum concentration in other validation group revealed an important improvement in the predictive performance of VPA concentrations in comparison with the basic model that did not include any co-variables.
Conclusions. Based on a population model of children with epilepsy, the pharmacokinetic of VPA could be altered by weight, age and the administration of CBZ and additional GER to epilepsy.
REFERENCES
Herranz JL, Argumosa A. Characteristics of drugs used in the treatment of acute convulsions and convulsive status. Rev Neurol 2003; 31: 757-62.
Bourgeois BF. New antiepileptic drugs in children: which ones for which seizures? Clin Neuropharmacol 2000; 23: 119-32.
Tatum WO, Galvez R, Benbadis S, Carrazana E. New antiepileptic drugs: into new millenium. Arch Fam Med 2000; 9: 1135-41.
Porter RJ, Meldrum BS. Anticonvulsant. In: Katzung BG (Ed.). Basic & Clinical Pharmacology. 10th Ed. The McGrow-Hill Company Inc; 2007, p. 385-406.
Ruiz-García M, Sosa de Martínez C, Rueda-Franco F. Clinicaletiological and therapeutic profile of 719 Mexican epileptic children. Child´s Nervous Children 2002; 55: 32-41.
Faught E. Pharmacokinetic consideration in prescribing antiepileptic drugs. Epilepsia 2001; 42(Suppl. 4): 19-23.
Reith DM, Hooper WD, Parke J, Charles B. Population pharmacokinetic modeling of steady state carbamazepine clearance in children, adolescents and adults. J Pharmacokinet Biopharm 2001; 28: 79-92.
Yukawa E. Investigation of phenobarbital-carbamazepine-valproic acid interactions using population pharmacokinetics analysis for optimization of antiepileptic drugs therapy an overview. Drug Metabol Drug Interact 2000; 16: 86-98.
Karlov VA, Bondareva IB, Andreeva OV. Optimization of dosing of finlepsin and finlepsin-retard in patients with epilepsy on the basis of population modeling and drug monitoring. Zh Nevrol Psikhiatr Im S S Korsakova 2002; 102:15-20.
Lugo GG, Pérez GG, Juárez OH. Lares AI. Farmacocinética bayesiana de cefuroxime en niños infectados gravemente enfermos. Rev Invest Clin 1998; 50: 311-16.
Lares AI, Lugo GG, Perez GG, Juárez OH. Predicción bayesiana de las concentraciones séricas de cloranfenicol en niños con sepsis y desnutrición. Rev Invest Clin 1999; 51: 159-65.
Valodia PN, Seymour MA, Kies BM, Folb PI. Optimization of phenytoin in adults with epilepsy in the Western Cape, South Africa. J Clin Pharm Ther 1999; 24: 381-5.
Blanco Serrano B, Otero MJ, Santos Buelga D, García Sánchez MJ, Serrano J, Domínguez Gil A. Population estimation of valproic acid clearance in adult patients using routine clinical pharmacokinetic data. Biopharm Drug Dispos 1999; 20: 233-40.
Yasuda K, Sugita K, Nakasa H, Niimi H. Clinical usefulness of pediatric population parameter of slow-releasing preparation of sodium valproate. No To Hattatsu 1995; 27: 282-5.
Bondareva IB, Jelliffe RW, Sokolov AV, Tischenkova IF. Nonparametric population modeling of valproate pharmacokinetics in epileptic patients using routine serum monitoring data: implications for dosage. J Clin Pharm Ther 2004; 29: 105-20.
Jiang DC, Wang L, Wang YQ, Li L, Lu W, Bai XR. Population pharmacokinetics of valproate in Chinese children with epilepsy. Acta Pharmacol Sin 2007; 28: 1677-84.
Oberg A, Davidian M. Estimating data transformations in nonlinear mixed effects models. Biometrics 2000; 56: 65-72.
Denaro C, Revenscroft P. Comparison of Sawchuck-Zaske and Bayesian forecasting for aminoglycosides in seriuosly ill patients. Br J Clin Pharmacol 1989; 28: 308-25.
Wilson JT, Kearns GL, Mrphy D, Yaffe JS. Pediatric labeling requirements: implications for pharmacokinetic studies. Clin Pharmacokinet 1994; 26: 308-25.
Collart L, Blaschke TF, Boucher F, Prober CG. Potential of populations pharmacokinetics to reduce the frequency of blood sampling required for estimating kinetic parameters in neonates. Ved Pharmacol Ther 1992; 18: 71-80.
Thompson AH, Whiting B. Bayesian parameter estimation and population pharmacokinetics. Clin Pharmacokinet 1992; 22: 447-67.
Blanco-Serrano B, Otero MJ, Santos Buelga D, García-Sanchez MJ, Serrano J, Domínguez-Gil A. Valproate population pharmacokinetics in children. J Clin Pharm Ther 1999; 24: 73-80.
Sheiner LB, Beal S. Some suggestions for measuring predictive performance. J Pharmacokinet Biopharm 1981; 9: 503-12.
Pryka RD, Rodvold KA, Erdman SM. An update comparison of drugs dosing methods (P1): phenytoin. Clin Pharmacokinet 1991; 20: 209-17.
Fernández-de-Gatta MM, García JM, Lanao JM, Dominguez Gil A. Bayesian forecasting in pediatric population. Clin Pharmacokinet 1996; 31: 431-6.
Meibohm B, Läer S, Panetta JC, Barrett JS. Population pharmacokinetic studies in pediatrics: issues in design and analysis. AAPSJ 2005; 7: 475-87.
Correa T, Rodríguez I, Romano S. Population pharmacokinetics of valproate in Mexican children with epilepsy. Biopharm Drug Dispos 2008; 29: 511-20.
Sánchez-Alcaraz A, Quintana MB, Rodríguez I. Valproic acid clearance in children with epilepsy. J Clin Pharm Ther 1998; 23: 31-4.
Jiang D, Wang L. Population pharmacokinetic model of valproate and prediction of valproate serum concentrations in children with epilepsy. Acta Pharmacol Sin 2004; 25: 1576-83.
Gugler R. Disposition of valproic acid in man. Eur J Clin Pharm 1977; 12: 12-5.
Dutta S, Reed RC. Distinct absorption characteristics of oral formulations of valproic acid/divalproex available in the United States. Epilepsy Res 2007; 73: 275-83.
Bauer L. in Applied Clinical Pharmacokinetics. 2nd Ed. New York: McGraw Hill; 2008, p 563.
Chiba K, Suganuma T, Ishizake T, Iriki T, Hori M. Comparison of steady-state pharmacokinetics of valproic acid in children between monotherapy and multiple antiepileptic drug therapy. J Pediatr 1985; 106: 653-8.
Summers B, Summers RS. Carbamazepina clearance in pediatric epilepsy patients: influence of body mass, dose, sex, and co-medication. Clin Pharmacokinet 1989; 17: 208-16.