Abstract
Objectives. To measure and compare free fraction of serum levels of VPA (valproic acid) between non-malnourished and malnourished epileptic children and to evaluate the adverse effects (myopathy, hepatotoxicity). Material and methods. It is a prospective comparative observational case control study in which forty epileptic children (malnourished: 18 male/8 female, age 8.3±2.5, non-malnourished: 8 male/6 female, age 8.1±2.1) who fulfilled the inclusion criteria were recruited as study group and twenty children as control group (12male/8 female, age 6.0±2.8). Outcome measures monitored are serum VPA levels (total and free fraction of serum VPA), serum CK (creatinine kinase), SGOT (serum glutamic oxaloacetic transaminase) and SGPT (serum glutamic pyruvic-transaminase). Using screening tool for the assessment of malnutrition in pediatrics (STAMP©), subjects are categorized into mild, moderate, severe malnourished as -1SD, -2SD, -3SD respectively Outcomes. There is an elevation in mean free fraction of VPA is 17.3±6.4 μg/ml whereas in non-malnourished group it was found to be 8.7±4.2 μg/ml with P= <0.001. While mean total drug concentration in malnourished and non-malnourished was found to be 88.6±49.9 μg/ml, 70.8±33.9 μg/ml respectively. Mean CK, SGOT, SGPT in control is 29.3±9.9IU/L, 28.5±5.4 IU/L,24.5±4.2 IU/L respectively. whereas mean CK, SGOT, SGPT in malnourished subjects is 16.9±9.1 IU/L, 28.8±8.5 IU/L,25.9±9.1 IU/L Correspondingly .while Mean CK, SGOT, SGPT in non-malnourished individuals is 15.7±11.3 IU/L,32.4±8.8 IU/L, 28.7±7.8 IU/L respectively. No correlation was observed between elevated serum drug concentrations, clinical response and side effects. Conclusion. We observed that clinical response and side effects are serum concentration independent hence our research make unnecessary to monitor serum drug concentration for every individual and drug monitoring should be restricted to subjects with severe ADR’s. Our data also suggest Valproate unveiled mitochondrial myopathy is limited to subgroup of population.
Highlights
Sodium valproate is the most commonly used drug in pediatrics with epilepsy because of its low toxic profile and broad spectrum of activity against different kind of seizures [1]
Subjects who are diagnosed with epilepsy by the physician and who are on sodium valproate 400 mg/day for a minimum of one month were recruited for the study as per the guidelines of declaration of Helsinki
A total of 76 subjects were screened in the study who are between 2 to 12 years of age, out of whom 20 are control and remaining forty who meet the inclusion criteria were included, among them 26 are with malnutrition and remaining 14 are non-malnutrition. 16 patients who do not meet the requirements of inclusion criteria were excluded
Summary
Sodium valproate is the most commonly used drug in pediatrics with epilepsy because of its low toxic profile and broad spectrum of activity against different kind of seizures [1]. It is a highly protein bound (78-94%) with time to peak level of 3-6 hours, half-life of about 11-20 hours and time to attain steady state concentration of 2-4 days [2]. There is a deficiency of data correlation between serum VPA levels SGOT and SGPT levels, our work is aimed to fulfill this deficiency
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