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Eslicarbazepine Acetate: A Review of Its Use as Adjunctive Therapy in Refractory Partial-Onset Seizures

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Abstract

Eslicarbazepine acetate (Aptiom®, Zebinix®) is approved for the adjunctive treatment of partial-onset seizures in adults aged ≥18 years. Adjunctive therapy with oral eslicarbazepine acetate 800 or 1,200 mg once daily was associated with a significantly lower standardized seizure frequency (primary endpoint) than placebo in patients aged ≥18 years with refractory partial-onset seizures in three, randomized, double-blind, multinational, phase III trials. In a fourth randomized, double-blind, multinational, phase III trial in patients aged ≥16 years with refractory partial-onset seizures, adjunctive eslicarbazepine acetate 1,200 mg once daily, but not 800 mg once daily, was associated with a significantly lower standardized seizure frequency (primary endpoint). Responder rates were significantly higher with eslicarbazepine acetate 1,200 mg once daily than with placebo in these four trials, and with eslicarbazepine acetate 800 mg once daily than with placebo in two trials. The efficacy of eslicarbazepine acetate was maintained in the longer term, according to the results of 1-year extension studies. Adjunctive therapy with oral eslicarbazepine acetate was generally well tolerated in patients with refractory partial-onset seizures, with most adverse events being of mild to moderate severity. In conclusion, eslicarbazepine acetate is a useful option for the adjunctive treatment of patients with refractory partial-onset seizures.

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Disclosure

The preparation of this review was not supported by any external funding. Gillian Keating is a salaried employee of Adis/Springer. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit.

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  1. Adis, Level 1, 5 The Warehouse Way, Northcote 0627, Private Bag 65901, Mairangi Bay 0754, Auckland, New Zealand

    Gillian M. Keating

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Keating, G.M. Eslicarbazepine Acetate: A Review of Its Use as Adjunctive Therapy in Refractory Partial-Onset Seizures. CNS Drugs 28, 583–600 (2014). https://doi.org/10.1007/s40263-014-0182-2

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