Eslicarbazepine acetate as monotherapy in clinical practice: Outcomes from Euro-Esli

Fecha de publicación: 01/01/2019

Autores de IIS La Fe

• Vicente Enrique Villanueva Haba

  Autor

Participantes ajenos a IIS La Fe

• Holtkamp, M
• Delanty, N
• Sales, F
• Serratosa, J
• McMurray, R

Abstract

Objectives: To assess the effectiveness and safety/tolerability of eslicarbazepine acetate (ESL) monotherapy in clinical practice in Europe. Materials and methods: Euro-Esli was a pooled analysis of 14 European clinical practice studies. Responder rate (>= 50% seizure frequency reduction) and seizure freedom rate (seizure freedom at least since prior visit) were assessed after 3, 6 and 12 months of ESL treatment and at last visit. Adverse events (AEs) and AEs leading to ESL discontinuation were assessed throughout follow-up. A subanalysis was conducted to assess outcomes for patients treated initially with ESL monotherapy and for patients treated at the last visit with ESL monotherapy. Results: ESL was used as monotherapy in 88/2045 (4.3%) patients initially and in 229/1340 (17.1%) patients at the last visit. At 12 months, responder and seizure freedom rates were 94.1% and 88.2%, respectively, in patients treated initially with ESL monotherapy, and 93.2% and 77.4%, respectively, in patients treated at the last visit with ESL monotherapy. Corresponding values for patients treated initially with ESL adjunctive therapy were 74.8% and 39.0%, respectively; and for patients treated at the last visit with ESL adjunctive therapy, corresponding values were 70.4% and 25.9%, respectively. Safety and tolerability were generally comparable in patients treated with ESL as monotherapy or adjunctive therapy. The most commonly reported AEs (>= 5% of patients in any group) were dizziness, somnolence, instability/ataxia, and fatigue. Conclusions: These clinical practice data support the use of ESL as monotherapy, as well as adjunctive therapy, for focal-onset seizures, complementing evidence from clinical trials.

Keywords

• adjunctive therapy; antiepileptic drug; clinical practice; eslicarbazepine acetate; Euro-Esli; focal epilepsy; monotherapy