Comparison of levetiracetam and sodium valproate monotherapy in childhood epilepsy-An open label randomized trial

Abstract

Objectives: To compare the efficacy of oral levetiracetam and valproate in childhood epilepsy by comparing number of repeat seizures for 6 months, side effect profile, retention rates and time to first seizure. Setting-The study was conducted in tertiary care hospital of North India. Participants-Hundred children, 3-12 years of newly diagnosed epilepsy (generalised or focal motor). Intervention-Children were randomly allocated to receive oral valproate or levetiracetam in a dose of 20 mg/kg/day after initial loading dose (n=50 in each group). Drug levels were estimated by ELISA method at steady state, end of therapy and in case of any seizure activity. Side effect and repeat seizures were recorded till 6 months. Outcome measures-No repeat seizure activity for 6 months, side effect profile, achievement of therapeutic drug levels at steady state and 6 months were studied. Results: Two groups were comparable in basic demographic data. In 6 months, 8 children in valproate group and 12 in levetiracetam gr oup had r epeat seizur e (p=0.317). Mean time to first seizur e was similar in two groups (p=0.930). Mean survival time was 145.16(127.39 ± 162.93) days with levetiracetam and 159.80(145.77 ± 173.82) with valproate. The hazard ratio of valproate for treatment failure was lower. There was 38% more reduction in hazard of treatment failure with valproate compared to levetiracetam though not statistically significant (p=0.297). Overall side effects were comparable (p=0.341). Behavioural side effects were significantly more with levetiracetam (p=0.021). Conclusion: First line therapy with oral levetiracetam or valproate is comparable in efficacy and side effects in childhood epilepsy.