Subscribe to RSS
Comparison of efficacy and safety of divalproex sodium extended release tablets with sodium valproate for treatment of seizure disorder in children
12 December 2007
25 June 2008
30 July 2015 (online)
To assess the efficacy and safety of divalproex sodium extended-release (divalproex ER) tablets as compared with sodium valproate for treatment of seizure disorder in children, an open, prospective, switch-over trial was conducted in the outpatient department of a tertiary level teaching hospital in North India. Children with seizure disorder who were taking valproate either as a single drug or in combination with other anticonvulsants for at least 3 months and maintaining a seizure frequency chart were enrolled in the trial. Valproate was switched-over to divalproex ER in a once daily dose for period of 6 weeks. Efficacy was assessed by seizure control and serum valproate level. Fourteen children (median age 9.5 year, range 5.5–18 year) completed the trial. The seizure frequency was significantly lower with divalproex ER (P = 0.01). There was no significant difference in the serum levels of valproate and divalproex ER (P = 0.16) and compliance with both the drugs was 100%. Occurrence of adverse effects was uncommon with either drug. In conclusion, efficacy of divalproex ER in children with seizure disorder was found to be good over a period of 6 weeks and divalproex ER was well tolerated, although safety profile was limited.