Assessment of topiramate's efficacy and safety in epilepsy.

OBJECTIVE

To study the significance of topiramate (TPM) addition on seizure control in treatment of epilepsy.

DESIGN

A prospective open label add-on trial of TPM addition in patients with epilepsy was done. The events of baseline phase of 12 weeks followed by titration and maintenance phases were recorded. Assessment of the number of seizure and emergent adverse effects was done by a monthly visit for each case.

MAIN OUTCOME MEASURES

Reduction of more than 50% mean seizure frequency or response ratio of 0.33 was taken as the criteria for responders.

STATISTICAL ANALYSIS

Normal Z-test for significance of differences between two proportions and Chi-square test for presence of association was applied and mean age, median duration, sex ratio, percentage prevalence were depicted.

RESULTS

Significant responses to TPM in both partial as well as generalized seizures were observed (Z = 6.66, P < 0.001 and Z = 4.185, P < 0.01). The effect was more pronounced in patients with partial seizures. However, the overall response was highly significant (Z = 7.839, P < 0.001). The best response was noted at the dose of 200-300 mg/day (Z = 6.708, P < 0.001). More than 35% cases of partial and generalized seizures reported more than 75% reduction levels. The drug was well tolerated in more than 65% cases for side effects on psychosis, giddiness, and anorexia. Mild side effects were seen only in about less than 35% cases.

CONCLUSIONS

TPM was found as a significantly effective add-on anticonvulsant with some limitation or mild side effects.