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

Holtkamp, Martin; Delanty, Norman; Sales, Francisco; Serratosa, Joan; McMurray, Rob; Villanueva, Vicente

doi:10.1111/ane.13023

Cited by 8 publications

(17 citation statements)

References 27 publications

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“…The incidence of AEs and discontinuation rate because of AEs in the present study are in line with those reported in other studies of clinical practice and lower than the AEs and discontinuation rates observed in the Phase III monotherapy trial conducted in patients with newly diagnosed epilepsy (41% and 14%, respectively). Although there is potential for underreporting of AEs in observational studies, clinical trials can be prone to magnify the incidence of EAs probably as a result of a less flexible dose adjustment than that adopted in clinical practice.…”

Section: Discussionsupporting

confidence: 92%

“…These results are similar to those of the Phase III monotherapy trial that showed that 54% of patients remained seizure free on the first dose (800 mg/d) and 71% of patients were classified as seizure free at their last evaluated dose . In line with these results, seizure freedom rates of 88.2% at 12 months (ie, seizure free for the last 6 months) and 59% at last visit independently of the time point when it occurred were reported for 88 patients receiving ESL as initial monotherapy that were included in Euro‐Esli, a pooled analysis of 14 European clinical practice studies …”

Section: Discussionsupporting

confidence: 83%

“…There is limited published clinical practice experience with ESL monotherapy. A number of small open‐label and retrospective studies have included patients receiving ESL as monotherapy, most after conversion to monotherapy . Additionally, and to our knowledge, clinical experience with ESL monotherapy in the elderly has not been specifically addressed.…”

Section: Introductionmentioning

confidence: 99%

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Clinical outcomes of eslicarbazepine acetate monotherapy for focal‐onset seizures: A multicenter audit

et al. 2019

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Objective To assess the effectiveness and tolerability of eslicarbazepine acetate (ESL) monotherapy in routine clinical practice for the treatment of focal‐onset seizures. Methods Multicenter, retrospective, observational study conducted in patients older than 16 years treated with ESL as first‐line monotherapy or converted to ESL monotherapy from polytherapy or other monotherapy. Outcomes included 1‐year retention rate, seizure‐free rates after 6 and 12 months of monotherapy treatment, and safety/tolerability issues. Results A total of 256 patients were included (106 first‐line and 150 conversion to monotherapy; 56 patients aged >65 years). Overall, the 1‐year retention rate was 79% (72.7% in the ≥65 years subgroup) and seizure‐free rates at 6 and 12 months were 59.3% and 55.3% (72.2% and 67.3% in the ≥65 years subgroup), without significant differences when comparing first‐line vs conversion‐to‐ESL monotherapy groups (P = .979). However, the conversion group was heterogeneous and included 43 (29.1%) patients that were seizure free the year prior ESL introduction. A substantially higher proportion of patients remained seizure free for the entire follow‐up among those who initiated ESL due to tolerability problems compared with those treated due to inadequate seizure control (71.4% vs 37.3%). Overall, 62 of 256 (24.2%) patients reported AEs (39.3% in >65 years subgroup) and led to discontinuation in 20/256 (7.8%) patients (12.5% in >65 years subgroup). Commonly reported AEs were somnolence (6.6%), dizziness (6.3%), and headache (4.3%). Hyponatremia was recorded in five patients, the majority (4/5) of whom were older than 65 years. Conclusions Eslicarbazepine acetate was effective and well‐tolerated as first‐line or conversion to monotherapy in a clinical setting in adult and elderly patients with focal‐onset seizures.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 83%

Section: Introductionmentioning

confidence: 99%

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Clinical outcomes of eslicarbazepine acetate monotherapy for focal‐onset seizures: A multicenter audit

et al. 2019

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“…20 After 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. 21 The most common AEs were dizziness, somnolence, instability/ataxia, and fatigue. 21 In a further multicenter, prospective, clinical practice study, conducted in 17 hospitals in Spain (N = 117), the responder rate after 12 months of ESL monotherapy was 83.0%.…”

Section: Discussionmentioning

confidence: 99%

“…21 The most common AEs were dizziness, somnolence, instability/ataxia, and fatigue. 21 In a further multicenter, prospective, clinical practice study, conducted in 17 hospitals in Spain (N = 117), the responder rate after 12 months of ESL monotherapy was 83.0%. 22 The results reported in these clinical practice studies are generally comparable with those observed in the current study in terms of effectiveness and safety/tolerability.…”

Section: Discussionmentioning

confidence: 99%

Long‐term efficacy and safety of eslicarbazepine acetate monotherapy for adults with newly diagnosed focal epilepsy: An open‐label extension study

Trinka

Rocamora

Chaves³

et al. 2020

Epilepsia

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Objective: To assess the efficacy, safety, and tolerability of eslicarbazepine acetate (ESL) monotherapy during long-term treatment. Methods: An open-label extension (OLE) study was conducted in adults completing a phase 3, randomized, double-blind, noninferiority trial, during which they had received monotherapy with either once-daily ESL or twice-daily controlled-release carbamazepine (CBZ-CR) for newly diagnosed focal epilepsy. In the OLE study, all patients received ESL (800-1600 mg/d) for 2 years. Primary efficacy outcome was retention time (from baseline of the OLE study). Secondary efficacy assessments included seizure freedom rate (no seizures during the OLE study) and responder rate (≥50% seizure frequency reduction from baseline of double-blind trial). Safety assessments included evaluation of treatment-emergent adverse events (TEAEs). Results: Of 206 randomized patients, 96 who received ESL in the double-blind trial (ESL/ESL) and 88 who received CBZ-CR in the double-blind trial (CBZ-CR/ESL) were treated with ESL monotherapy (89.3% overall). Treatment retention time was similar between groups, with low probability of ESL withdrawal overall (<0.07 at any time). After 24 months, the probability of ESL withdrawal was 0.0638 (95% confidence interval [CI] = 0.0292-0.1366) in the ESL/ESL group and 0.0472 (95% CI = 0.0180-0.1210) in the CBZ-CR/ESL group. Seizure freedom rates were 90.6% (ESL/ ESL) and 80.7% (CBZ-CR/ESL; P = .0531). Responder rates remained >80% in both groups throughout the study. Incidence of serious TEAEs was similar between groups (7.3% vs 5.7%; 0% vs 1.1% possibly related), as were the incidences of TEAEs considered at least possibly related to treatment (17.7% vs 18.2%) and TEAEs leading to discontinuation (3.1% vs 4.5%). The types of TEAEs were generally consistent with the known safety profile of ESL. This is an open access article under the terms of the Creat ive Commo ns Attri bution-NonCo mmercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

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Eslicarbazepine Acetate: A Review in Focal-Onset Seizures

Heo

2020

CNS Drugs

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

Abstract: 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.

Cited by 8 publications

References 27 publications

Clinical outcomes of eslicarbazepine acetate monotherapy for focal‐onset seizures: A multicenter audit

Clinical outcomes of eslicarbazepine acetate monotherapy for focal‐onset seizures: A multicenter audit

Long‐term efficacy and safety of eslicarbazepine acetate monotherapy for adults with newly diagnosed focal epilepsy: An open‐label extension study

Eslicarbazepine Acetate: A Review in Focal-Onset Seizures

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