Drug updated on 7/25/2024
Dosage Form | Tablet (oral; 200 mg, 400 mg, 600 mg, 800 mg) |
Drug Class | Anticonvulsants |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
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Summary
- Eslicarbazepine acetate (Aptiom) is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
- The information was derived from 8 systematic reviews/meta-analyses studies.
- In network meta-analysis, eslicarbazepine acetate showed effectiveness in decreasing seizure frequency but had a moderate safety profile compared to other ASMs like cenobamate, brivaracetam, lacosamide, and perampanel. Non-invasive brain stimulation therapies were less effective than ASMs.
- Real-world longitudinal studies demonstrated that eslicarbazepine acetate as initial or early monotherapy resulted in high seizure-free rates at 6 months (64.6%) and 12 months (56.6%), with retention rates at 95% and adverse events leading to discontinuation in some cases among adults with focal epilepsy.
- A Cochrane network meta-analysis could not include individual participant data for eslicarbazepine acetate; however, other drugs like lamotrigine performed better regarding treatment failure and achieving remission across children and adults with focal or generalized tonic-clonic seizures.
- Systematic review findings indicate that while eslicarbazepine acetate has acceptable safety profiles as an add-on therapy for drug-resistant focal epilepsy, it shows higher dropout rates due to adverse events when used among pediatric populations compared to drugs like lamotrigine and levetiracetam.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Aptiom (eslicarbazepine acetate) Prescribing Information. | 2019 | Sunovion Pharmaceuticals Inc. Marlborough, MA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Provincial Guidelines for the Management of Drug-Resistant Epilepsy in Adults and Children who are not Candidates for Epilepsy Surgery. | 2023 | Ontario Brain Institute |
Epilepsies in children, young people and adults. | 2022 | NICE |
SIGN159: Epilepsies in children and young people: investigative procedures and management. | 2021 | Healthcare Improvement Scotland |
Evidence-based anti-seizure monotherapy in newly diagnosed epilepsy: a new approach. | 2020 | Acta Neurologica Scandinavica |
Provincial Guidelines for the Management of Epilepsy in Adults and Children. | 2020 | Ontario Brain Institute |