Drug updated on 4/24/2024
| 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.
Summary
- Eslicarbazepine acetate (Aptiom) is indicated for the treatment of partial-onset seizures in patients 4 years of age and older, demonstrating efficacy in decreasing seizure frequency from baseline when compared to other antiseizure medications such as brivaracetam, cenobamate, lacosamide, and perampanel.
- The information was derived from a total of 8 systematic reviews/meta-analyses studies that provided comprehensive insights into eslicarbazepine acetate's comparative effectiveness and safety across various populations.
- In comparison with placebo treatments during network meta-analysis settings, eslicarbazepine acetate showed significantly higher efficacy in controlling seizures with fewer adverse events reported.
- For adults with focal-onset epilepsy specifically, eslicarbazepine acetate demonstrated dose-dependent efficacy where an 800 mg/d dose was effective without significantly increasing severe adverse events unlike the larger dosage of 1,200 mg/d which raised incidence rates.
- When considering pediatric populations suffering from drug-resistant focal-onset seizures, levetiracetam ranked highest for efficacy, while further evaluation is needed to clarify the relative efficacy of eslicarbazepine acetate within this subgroup.
- An analysis including cenobamate against a cohort including eslicarbazepine acetate suggested that although cenobamate may be more efficacious overall, Aptiom remains a viable option particularly when balancing both its effectiveness alongside tolerability considerations.
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 |
|---|---|---|
| Eslicarbazepine Acetate. | 2023 | Epilepsy Foundation |
| 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 |