Affiliations: Department of Pediatrics, All India Institute of
Medical Sciences, New Delhi, India
Note: [] Correspondence: Prof. Veena Kalra, M.D., Department of
Pediatrics, AIIMS, Ansari Nagar, New Delhi, India. Tel.: +91 11 26593209; Fax:
+91 11 26588663; E-mail: [email protected]
Abstract: 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.
