Eslicarbazepine acetate

(Aptiom®)

Aptiom®

Drug updated on 12/11/2024

Dosage FormTablet (oral; 200 mg, 400 mg, 600 mg, 800 mg)
Drug ClassAntiepileptics
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
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  • This summary is based on the review of 12 systematic review(s)/meta-analysis(es). [1-12]
  • Cenobamate demonstrated statistically significant higher responder rates (≥50% and 100%) and seizure freedom compared to other new-generation antiseizure medications (ASMs), particularly eslicarbazepine, indicating its superior effectiveness.
  • Eslicarbazepine acetate showed a significant ≥50% reduction in seizure frequency, with evidence suggesting increasing efficacy with higher doses, although it was less effective than cenobamate.
  • Moderate-certainty evidence indicates that eslicarbazepine may reduce seizure frequency in children aged 6 to 18 years, though the results remain inconclusive.
  • Cenobamate was identified as a valuable treatment option for patients with drug-resistant epilepsy, particularly in achieving higher responder rates and improving quality of life compared to third-generation ASMs.
  • Eslicarbazepine was associated with treatment-emergent adverse events (TEAEs) such as dizziness, nausea, somnolence, diplopia, and vomiting, and demonstrated a lower patient retention rate compared to placebo.
  • Cenobamate exhibited comparable TEAE withdrawal rates to other ASMs, while it had a higher probability of experiencing at least one TEAE compared to some other ASMs, though the differences were not statistically significant.
  • Eslicarbazepine showed a higher incidence of serious adverse events and adverse event-related withdrawals compared to placebo, with specific adverse events including vestibulocerebellar symptoms, hyponatremia, and rash, particularly at higher doses.
  • Eslicarbazepine may reduce seizure frequency in children aged 6 to 18 years, although the evidence remains inconclusive, while cenobamate is identified as a valuable treatment option for drug-resistant epilepsy (DRE) in adults, showing high efficacy compared to third-generation antiseizure medications.

Product Monograph / Prescribing Information

Document TitleYearSource
Aptiom (eslicarbazepine acetate) Prescribing Information.2019Sumitomo Pharma America, Inc., Marlborough, MA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Efficacy and safety of add-on antiseizure medications for focal epilepsy: A network meta-analysis2024Epilepsia Open
A comparison of cenobamate with other newer antiseizure medications for adjunctive treatment of focal-onset seizures: A systematic review and network meta-analysis2024Seizure
The efficacy and safety of third-generation antiseizure medications and non-invasive brain stimulation to treat refractory epilepsy: a systematic review and network meta-analysis study2023Frontiers in Neurology
Value contribution of cenobamate for the treatment of Focal-Onset Seizures (FOS) in patients with drug-resistant epilepsy (DRE) in Spain through reflective Multi-Criteria Decision Analysis (MCDA)2023Epilepsy & Behavior : E&B
Cost-effectiveness of cenobamate for focal seizures in people with drug-resistant epilepsy2023Epilepsia
Comparative antiseizure medications of adjunctive treatment for children with drug-resistant focal-onset seizures: A systematic review and network meta-analysis2022Frontiers in Pharmacology
Antiepileptic drug monotherapy for epilepsy: a network meta-analysis of individual participant data2022The Cochrane Database of Systematic Reviews
Third-Generation Antiseizure Medications for Adjunctive Treatment of Focal-Onset Seizures in Adults: A Systematic Review and Network Meta-analysis2022Drugs
Indirect treatment comparison of cenobamate to other ASMs for the treatment of uncontrolled focal seizures2022Epilepsy & Behavior : E&B
Suicidality Risk of Newer Antiseizure Medications: A Meta-analysis2021Jama Neurology
Eslicarbazepine acetate add-on therapy for drug-resistant focal epilepsy2021The Cochrane Database of Systematic Reviews
The tolerability and safety profile of eslicarbazepine acetate in neurological disorders2020Journal of The Neurological Sciences

Clinical Practice Guidelines