Clinicopharmacological study to compare efficacy and safety of clobazam as adjunctive with phenytoin or sodium valproate in generalized tonic clonic seizure patients: A prospective study

Abstract

Background: Epilepsy is a common neurological abnormality affecting about more than 50 million of world population. Combination therapy is used when monotherapy found insufficient to control seizure attacks. Objective: The present study was planned to compare the efficacy and safety of clobazam with phenytoin or sodium valproate in generalized tonic clonic seizure patients. Methodology: A comparative, prospective and open label study was conducted for a period of 6 months on generalized tonic clonic seizure (GTCS) patients attending neurology OPD at tertiary care hospital, Gwalior (M.P.), Patients enrolled in group 1(n=45) received phenytoin plus clobazam and group 2(n=45) received sodium valproate plus clobazam . Follow up was done at 3 and 6 months interval after initiation of study for mean seizure count, patient responses to treatment and adverse effects. Results: Statistically significant (p <0.01) reduction was observed in mean seizure count in both groups as compared to baseline while on intergroup comparison, no statistically significant reduction was seen . 38% patients in group 1and 49% patients in group 2 were total seizure free while 58% patients in group1 and 49% patients in group 2 showed good response and 4% patients in group 1while 2% patients in group 2 showed poor responses. Statistically significant difference was observed for GI distress (p<0.05) and rest of the adverse effects were reported mild in both groups. Conclusion: Clobazam was found effective and safe adjuvant with phenytoin and sodium valproate in treating GTCS. Sodium valproate plus clobazam treated patients showed clinically better results as compared to phenytoin plus clobazam.