Safety, tolerability and effectiveness of transition to eslicarbazepine acetate from carbamazepine or oxcarbazepine in clinical practice

Seizure. 2020 Feb:75:121-128. doi: 10.1016/j.seizure.2019.12.022. Epub 2019 Dec 23.

Abstract

Purpose: To assess the efficacy, safety and tolerability of eslicarbazepine acetate (ESL) in patients transitioning from carbamazepine or oxcarbazepine to ESL in clinical practice, by analysing data from the Euro-Esli study.

Methods: Euro-Esli was a pooled analysis of 14 European clinical practice studies. Effectiveness assessments included responder rate (≥50 % seizure frequency reduction) and seizure freedom rate (seizure freedom at least since prior visit), assessed after 3, 6 and 12 months of ESL treatment, and at the last visit. Safety and tolerability were assessed throughout follow-up by evaluating adverse events (AEs) and ESL discontinuation due to AEs, respectively. Data were analysed for cohorts of patients who transitioned from carbamazepine and oxcarbazepine to ESL either due to lack of efficacy or poor tolerability.

Results: Euro-Esli included 2058 patients, of whom 233 (11.3 %) transitioned from carbamazepine to ESL and 134 (6.5 %) transitioned from oxcarbazepine to ESL. After 12 months of ESL treatment, responder and seizure freedom rates for patients transitioning from carbamazepine due to lack of efficacy (n = 163) were 70.0 % and 30.9 %, respectively. Corresponding values for patients transitioning from oxcarbazepine due to lack of efficacy (n = 90) were 57.1 % and 25.0 %, respectively. Among patients who transitioned from carbamazepine and oxcarbazepine to ESL due to poor tolerability (n = 64 and n = 61, respectively), 26.6 % and 39.5 % experienced AEs, and 8.3 % and 6.8 % discontinued ESL due to AEs, respectively.

Conclusion: ESL was efficacious and generally well tolerated in patients transitioning from carbamazepine or oxcarbazepine in clinical practice due to inadequate seizure control or intolerable AEs with these agents.

Keywords: Carbamazepine; Clinical practice; Epilepsy; Eslicarbazepine acetate; Euro-Esli; Oxcarbazepine.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anticonvulsants / adverse effects
  • Anticonvulsants / pharmacology*
  • Carbamazepine / adverse effects
  • Carbamazepine / pharmacology*
  • Clinical Studies as Topic
  • Dibenzazepines / adverse effects
  • Dibenzazepines / pharmacology*
  • Drug Substitution
  • Drug-Related Side Effects and Adverse Reactions*
  • Europe
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Outcome Assessment, Health Care / statistics & numerical data*
  • Oxcarbazepine / adverse effects
  • Oxcarbazepine / pharmacology*
  • Young Adult

Substances

  • Anticonvulsants
  • Dibenzazepines
  • Carbamazepine
  • eslicarbazepine acetate
  • Oxcarbazepine