Real‐world data on eslicarbazepine acetate as add‐on to antiepileptic monotherapy

Abstract

ObjectiveTo assess retention, tolerability, and safety, efficacy and effects on quality of life (QoL) of eslicarbazepine acetate (ESL) add‐on treatment over 6 months in a real‐world adult population with partial‐onset seizures.MethodsThis non‐interventional, multicenter, prospective study was performed in eight European countries. Adult patients (n = 247) for whom the physician had decided to initiate ESL as add‐on to an existing antiepileptic drug (AED) monotherapy were invited to participate. The study comprised three visits: baseline, and after 3 and 6 months. Data on ESL retention, efficacy, tolerability, safety, and QoL were collected.ResultsAfter 6 months, the retention rate of ESL was 82.2%, and 81.8% of patients reported a reduction of seizure frequency of at least 50%; 39.2% of patients reported seizure freedom at this time. The mean QOLIE‐10 score improved from 2.9 (SD ± 0.8) at baseline to 2.1 (SD ± 0.8) after 6 months. 109 adverse events (AEs) were reported in 57 patients (26.0%); the majority were rated as related to ESL by the investigator and led to a discontinuation of ESL in 25 patients (11.4%). Eight patients (3.7%) suffered at least one serious AE. The most frequently reported AEs were dizziness, headache, convulsion, and fatigue.ConclusionsThis study shows that ESL was well tolerated and efficacious as add‐on therapy to one baseline AED. The use of ESL in patients less refractory than those included in previous clinical trials led to higher responder and seizure freedom rates. No new safety issues were observed.

Eslicarbazepine acetate as adjunctive therapy in clinical practice: ESLADOBA study

“…These results are in accordance with EPOS study,17 in which VPA and CBZ were also the concomitant AEDs presenting the greatest percentage of responders.…”

“…The overall rate of AEs in our study was 23.1%. Compared to other studies that use ESL as adjunctive therapy, this rate is lower than the ones reported in EPOS study (26.0%),17 Correia et al. (42.1%),16 and that obtained in a pooled analysis of three phase III trials (62.7% and 67.5% in the ESL 800 mg and 1.200 mg groups, respectively) 9.…”

“…The proportion of responders is lower than the one reported in EPOS study,17 in which 81.8% of patients presented a reduction in seizure frequency of at least 50% at 6 months. These results might be explained by the fact that EPOS population seemed to be less refractory in comparison to our study, as suggested by a shorter mean time since epilepsy diagnosis (12.3±12.1 years in EPOS19 vs 18.5±14.8 years in this study).…”

“…Additionally, 9.6% of the patients discontinued ESL due to AEs, which is lower than the percentages reported in EPOS (11.4%),17 in Villanueva et al. (13.4%),18 and in Correia et al.…”

“…This study showed RR of 73.0% at the Vfinal. At 6 months, higher RR was found in a similar non‐interventional prospective study (EPOS)17 (82.2%), in a 1‐year retrospective study18 (80.1%), and in a 2‐year retrospective study16 (82.9%). The lower RR obtained in this study may be due to an underestimation, as a worst scenario was used by classifying those patients that did not perform the final assessment as failures.…”