Abstracts

RATIONALE: The objective of this trial was to evaluate the efficacy and safety of topiramate (TPM) as an add-on therapy in children below 12 years of age.
METHODS: Pooled data from 207 patients from this open, prospective and pragmatic study have been analysed. Efficacy was assessed, according to epileptic syndromes, age, duration of epilepsy before TPM, and doses of TPM, as well as tolerability
RESULTS: The mean TPM dose was 4.7 Kg/mg/day with an initial dose of 1 mg/Kg/day and slow titration at 1mg/Kg/day/2 weeks.
After a median follow-up with TPM of 5.6 months (range: 0.2-30.7 months), the overall seizure frequency had significantly decreased (p[lt]0.05): seizure frequency was reduced by 50 % or more in 48 % (9% seizure free) of the patients without effect of the dose used and 34 % were non responders,
TPM was effective in partial and generalized epilepsy, with respectively 50 % responders among 128 patients and 44 % among 79. For the last, responders were more frequent in generalized symptomatic epilepsy, severe myoclonic epilepsy and myoclono-astatic epilepsy.
For all patients, improvement was well maintained during the treatment period. Worsening of seizure frequency concerned 13 % of patient with partial epilepsy and 17 % with generalized. It led to withdrawal of treatment from 8 % of them.
The commonest reported adverse events were moderate neurobehavioral and gastrointestinal disorders. Adverse events led to withdrawal of treatment from 13.5 % of patients. Children less than 4 years had a good tolerability.
CONCLUSIONS: These results confirm that TPM is effective and well tolerated for a broad range of childhood epilepsy before 12 years of age, including refractory partial and, symptomatic and myoclonic generalized epilepsy. It has to be considered for children less than 4 years of age. Slow and progressive titration is important for its use.
[Supported by: This work was done with the support of Janssen-Cilag France]