New data shows that eslicarbazepine acetate is effective and well-tolerated in epilepsy: the ESLADOBA study
Epilepsy affects around 50 million people worldwide, representing a huge health and financial burden. Despite the availability of numerous antiepileptic drugs, about 30% of adults and 25% of children with epilepsy still fail to control their seizures. Therefore, new antiepileptic drugs are needed. Eslicarbazepine acetate is currently approved in Europe as adjunctive therapy in adults with focal-onset seizures, with or without secondary generalisation. Eslicarbazepine acetate is a voltage-gated sodium channel blocker. It selectively targets the slow inactivated state of the sodium ion channel, preventing it from returning to the active state, and thus reduces repetitive neuronal firing. A number of Phase III trials have demonstrated the efficacy and safety of eslicarbazepine acetate, and it has received regulatory approval from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) as an add-on medication to treat seizures associated with epilepsy. However, these trials had strict inclusion criteria and patients with comorbidities were excluded. Phase IV trials reflect more closely actual clinical practice.
The ESLADOBA (Eslicarbazepine Acetate Add-On Treatment to One Baseline Antiepileptic Drug study) was a Phase IV trial including 52 patients whose seizures were not controlled with one antiepileptic drug and had initiated eslicarbazepine acetate as adjunctive treatment. Its aims were to assess seizure control and tolerability of eslicarbazepine acetate when it is added to another antiepileptic drug. The primary endpoint of the study was the retention rate. Secondary endpoints included the proportion of responders (patients with at least 50% reduction in seizure frequency compared to baseline), proportion of seizure-free patients and the change in frequency for partial seizures with or without secondary generalisation.
The results of this study were recently presented at the American Epilepsy Society (AES) Annual Meeting in Houston, Texas. At the final assessment, the retention rate was 73.0%, the responder rate was 71.1%, and the rate of seizure freedom was 39.5%. The study also included clinical global impression scales, which reflect the impact of the drug on the patients’ everyday lives. According to the global clinical impression of change (CGI-C) and severity (CGI-S), reduction in epilepsy severity was observed in 42.1% of patients, and 73.6% of patients considered their epilepsy ‘much improved’ or ‘very much improved.’ In terms of safety findings, 23.1% of patients experienced at least one adverse event (AE) and 19.2% had at least one AE related to the study drug; 3.9% had at least one serious AE. However, most AEs were considered mild to moderate in severity and all had been reported in previous studies.
The leading investigator, Dr João Chaves, of Santo António Hospital, Centro Hospitalar Porto, Portugal, commented that eslicarbazepine acetate is 'very well tolerated, has good efficacy, and it is a good option to add to if the patients are under one antiepileptic drug and are not controlled.'
Support: This article and interview have been initiated and funded by Eisai.