Factors influencing valproic acid trough levels in epileptic children

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Published Oct 8, 2024
https://doi.org/10.62438/tunismed.v102i10.4881
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Vol. 102 No. 10 (2024): Tunis Med oct 2024

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Khouloud Ferchichi
National Center Chalbi Belkahia of Pharmacovigilance, Department of Clinical Pharmacology. University of Tunis El Manar, Faculty of de Medicine of Tunis. Tunisia
Rim Charfi
National Center Chalbi Belkahia of Pharmacovigilance, Department of Clinical Pharmacology. Research Laboratory of Clinical and Experimental Pharmacology (LR16SP02), Tunis .University of Tunis El Manar, Faculty of de Medicine of Tunis. Tunisia
Syrine Ben Hammamia
National Center Chalbi Belkahia of Pharmacovigilance, Department of Clinical Pharmacology. Research Laboratory of Clinical and Experimental Pharmacology (LR16SP02), Tunis .University of Tunis El Manar, Faculty of de Medicine of Tunis. Tunisia
Mouna Ben Sassi
National Center Chalbi Belkahia of Pharmacovigilance, Department of Clinical Pharmacology. Research Laboratory of Clinical and Experimental Pharmacology (LR16SP02), Tunis .University of Tunis El Manar, Faculty of de Medicine of Tunis. Tunisia
Emna Gaies
National Center Chalbi Belkahia of Pharmacovigilance, Department of Clinical Pharmacology. Research Laboratory of Clinical and Experimental Pharmacology (LR16SP02), Tunis .University of Tunis El Manar, Faculty of de Medicine of Tunis. Tunisia
Mouna Daldoul
National Center Chalbi Belkahia of Pharmacovigilance, Department of Clinical Pharmacology. Research Laboratory of Clinical and Experimental Pharmacology (LR16SP02), Tunis. Tunisia
Riadh Daghfous
National Center Chalbi Belkahia of Pharmacovigilance, Department of Clinical Pharmacology. Research Laboratory of Clinical and Experimental Pharmacology (LR16SP02), Tunis .University of Tunis El Manar, Faculty of de Medicine of Tunis. Tunisia
Sameh Trabelsi
National Center Chalbi Belkahia of Pharmacovigilance, Department of Clinical Pharmacology. Research Laboratory of Clinical and Experimental Pharmacology (LR16SP02), Tunis .University of Tunis El Manar, Faculty of de Medicine of Tunis. Tunisia

Abstract

Objective: In this study, we aimed to assess main factors influencing the Valproic Acid (V.Acid) plasma trough levels (C0) and to determine their degree of influence on V.Acid C0 in children with epilepsy who had Therapeutic Drug Monitoring (TDM).


Methods: We conducted an observational study in the Department of Clinical Pharmacology including patients with generalized seizures’ epilepsy aged between two and 18 years. Only the children that had benefited from at least two V.Acid C0 determinations were included. First, we assessed daily dose optimization, performed by the practitioners. Then we divided our population into two groups: group A with a final V.Acid C0 in the therapeutic range (TR) and group B with a final V. Acid C0 outside the TR to find out factors influencing V.Acid C0 journey.


Results: We included 805 patients (2537 V.Acid C0). The median age was 6.24 years and the sex ratio (M/F) was 1.45. The median V.Acid normalized daily dose was 27.27mg/kg/day and the median V.Acid C0 was 57µg/mL. The children’s first V.Acid C0 was in the TR in 59.4% and V.Acid daily dose optimization was performed by the practitioners in 72.3%. Comparing GroupA and B, we found that age and the number of V.Acid C0 determinations increases the chance to reach the TR by respectively 3.79% and 7.39%.


Conclusion: Older children who benefit from higher number of performed V.Acid C0 were more likely to reach the TR. In children who beneficiate from a TDM of V.Acid, close follow-up is mandatory.....(abstract truncated at 250 words).

Keywords:

epilepsy, valproic acid, plasma concentration, therapeutic drug monitoring, children

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