Drug updated on 9/4/2024
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.
Latest News
Summary
- Aptiom (eslicarbazepine acetate) is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
- This summary is based on the review of eight systematic review(s)/meta-analysis(es). [1-8]
- Eslicarbazepine acetate (ESL) was generally effective in reducing seizure frequency and achieving a ≥50% responder rate, particularly in adults with focal epilepsy. However, it was less effective compared to cenobamate (CNB) and brivaracetam in achieving seizure freedom.
- ESL showed dose-dependent effectiveness in adults, with higher effectiveness observed at 800 mg/day, but it did not significantly improve outcomes in children, where higher dropout rates and lower effectiveness were noted compared to other antiseizure medications.
- ESL was associated with fewer adverse events compared to placebo but had higher treatment-emergent adverse events (TEAEs) and dropout rates due to adverse events compared to other antiseizure medications (ASMs) such as brivaracetam and lacosamide.
- In children, ESL showed higher dropout rates due to adverse events compared to other ASMs, and at a higher dose (1200 mg/d), it significantly increased the risk of severe adverse events.
- There is no population types or subgroups information available in the reviewed studies.
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 |