Serum sodium changes in children with focal epilepsy receiving carbamazepine or oxcarbazepine therapy: a randomized controlled trial
DOI:
https://doi.org/10.18203/2349-3291.ijcp20262405Keywords:
Focal epilepsy, Children, Carbamazepine, Oxcarbazepine, HyponatremiaAbstract
Background: Carbamazepine and oxcarbazepine are commonly used antiseizure medications for focal epilepsy in children. Both drugs may alter serum sodium, but comparative pediatric data, particularly from South Asian settings, remain limited. The objective of this study was to compare serum sodium changes, the incidence of hyponatremia, and adverse effect profiles between children with focal epilepsy receiving carbamazepine and those receiving oxcarbazepine therapy.
Methods: This prospective, single-centre, open-label randomized controlled trial was conducted in the Department of Paediatric Neurology, National Institute of Neurosciences and Hospital, Dhaka, Bangladesh, from January to June 2020. Children aged 1 to 15 years with newly diagnosed focal epilepsy were randomized to receive either carbamazepine or oxcarbazepine. Serum sodium was measured before treatment and at 1 month, 3 months, and 6 months after treatment initiation. Hyponatremia was defined as serum sodium ≤135 mEq/l, and severe hyponatremia as serum sodium ≤128 mEq/l. The final analysis included 86 children, 42 in the carbamazepine group and 44 in the oxcarbazepine group.
Results: Baseline serum sodium was similar between groups, 136.73±1.66 mmol/l with carbamazepine and 136.09±2.54 mmol/l with oxcarbazepine, p=0.158. At 1 month, serum sodium remained comparable, p=0.845. Mean serum sodium was significantly lower in the oxcarbazepine group at 3 months, 137.15±2.49 versus 138.22±2.24 mmol/l, p=0.036, and at 6 months, 137.56±2.54 versus 138.95±2.20 mmol/l, p=0.006. Hyponatremia at 6 months occurred in 15.9% of children receiving oxcarbazepine and 4.8% receiving carbamazepine, risk ratio 3.34, 95% CI 0.74 to 15.18, p=0.157. Severe hyponatremia occurred in one child in the oxcarbazepine group, and no symptomatic hyponatremia, hospitalization, or treatment-attributable death was reported.
Conclusions: Oxcarbazepine was associated with significantly lower mean serum sodium than carbamazepine at 3 and 6 months, although categorical hyponatremia was not significantly different. Routine serum sodium monitoring should be considered during oxcarbazepine therapy in children with focal epilepsy.
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