Sodium Valproate Versus Levetiracetam in Pediatric Generalized Epilepsy: A Comparative Study.

Aim and objectives Generalized epilepsy impacts a significant portion of the pediatric population. Safety and efficacy are key considerations in the treatment of epileptic seizures in children. New generation anti-seizure medications (ASMs) promise to fulfil this need. Thus, this study was planned to compare the efficacy, safety, and tolerability of sodium valproate (VPA) and levetiracetam (LEV) in children with generalized epilepsy. Material and methods A total of 211 pediatric patients aged 2-14 years with generalized seizures were prospectively enrolled and randomized either to receive VPA (n=107) or LEV (n=104) as per the recommended protocol up to six months. Seizure-free duration and seizure-free outcomes were assessed at six months. Adverse events, drug tolerability, and compliance were recorded. The data was statistically analyzed. Results Of the 211 participants, 187 completed the study (VPA group: 94; LEV group: 93). The two groups were comparable for demographic and clinical profiles at the time of start of treatment. The seizure-free duration was significantly longer in the VPA group (153.61 ± 53.12 days) compared to the LEV group (135.82 ± 68.79 days). Seizure-free outcome rates at three and six months were 88.3% and 79.8% in the VPA group, and 81.7% and 66.7% in the LEV group, respectively, with a statistically significant difference between the groups at six months. The VPA group had significantly shorter mean hospital need (1.68 days) as compared to the LEV group (2.82 days). Post-treatment increase in SGPT was significantly higher in the VPA group. Nausea/vomiting and weight gain were significantly more common in the VPA group, while behavioral adverse effects were significantly more common in the LEV group. Conclusion VPA was found to be more efficacious in controlling seizures in children with generalized epilepsy than LEV. With respect to safety, both treatments had specific issues.