Objective: To compare the differences in the efficacy and safety of the commonly prescribed AEDs in the management of epilepsy in children when using divided doses of adult solid oral formulations (DDSF) with the liquid oral formulations (LFs).
Materials and methods: Patients who had one or more seizures per month and prescribed with DDSF were recruited. Initially the patients were continued on DDSF for 4 months following which they were switched over to LF for the subsequent 4 months. Seizure frequencies and adverse drug effects (ADRs) were recorded every month for 8 months and plasma AED levels were estimated at the end of 4th and 8th months.
Results: A total of 200 patients completed the study protocol. The median seizure frequencies per month with DDSF and LF were: partial seizures (20.5, 9.0; P < 0.001), generalized tonic-clonic seizures (6.5, 2.0; P < 0.001), myoclonic seizures (58.5, 29.0; P < 0.001). Mean plasma drug levels ± SD (μg/ml) with DDSF and LF were: sodium valproate (48.2 ± 13.7, 69.1 ± 16.3; P < 0.001), phenytoin sodium (5.0 ± 2.4, 12.8 ± 3.8; P < 0.001), carbamazepine (4.5 ± 2.0, 11.5 ± 4.8; P < 0.001) and phenobarbitone (14.1 ± 5.2, 25.4 ± 12.3, P < 0.001). The incidence of treatment emergent ADRs was poor scholastic performance (25.5%), behavioral problems and dizziness/sedation (21.0%), somnolence/sleep disorders (19.5%).
Conclusion: Patients treated with LF had better seizure control and optimal therapeutic drug levels and less adverse effects when compared to DDSF.
Keywords: Antiepileptic drugs; epilepsy; tablet splitting; therapeutic drug monitoring.