Findings from a post-hoc pooled analysis showed that exit rates for eslicarbazepine acetate monotherapy were lower than the historical control threshold despite baseline antiepileptic drug use and region. The study is published in Neurology.

Researchers aimed to assess the safety and efficacy of eslicarbazepine acetate monotherapy by analyzing 2 randomized double-blind studies (093-045 and 093-046) that included adults with partial-onset seizures that were uncontrolled by 1 or 2 antiepileptic drugs. Eligible patients were randomized to receive eslicarbazepine acetate 1200mg once daily or 1600mg once daily for 18 weeks.

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The study’s primary endpoint was study exit by meeting predefined exit criteria indicating worsening seizure control. For each study, treatment was deemed effective if the upper 95% confidence limit for exit rate was lower than the control threshold (65.3%). 

In the eslicarbazepine acetate 1600mg group, the pooled exit rate was 20.6% (95% CI: 15.6-26.8%) vs. 30.8% (95% CI: 23.0-40.5%) in the 1200mg group. Risk of higher exit was seen with use of 2 baseline antiepileptic drugs or rescue medication, U.S. location, epilepsy duration ≥20 years, and higher maximum baseline seizure frequency. 

Reductions in standardized seizure frequency from baseline and the 18-week period were 43.2% for the eslicarbazepine acetate 1600mg group and 35.7% for the eslicarbazepine 1200mg group. Researchers noted that safety profiles were similar between the 1200mg and 1600mg dosage groups. 

Study authors concluded that this analysis provides Class IV evidence that eslicarbazepine acetate monotherapy is well tolerated and effective in adult patients with medically uncontrolled partial-onset seizures. Clinical factors and location impact treatment responses in conversion-to-monotherapy trials. 

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