EARLY-ESLI study: Long-term experience with eslicarbazepine acetate after first monotherapy failure

Villanueva, Vicente; Bermejo, Pedro Emilio; Montoya, Jhon Williams; Toledo, Manuel; Gómez‐Ibáñez, Asier; Garcés, Mercedes; Vilella, Laura; López‐González, Francisco Javier; Rodríguez‐Osorio, Xiana; Campos, Dulce; Martínez, P. Campoy; Giner, P.; Zurita, Jorge; Rodríguez-Uranga, J.; Ojeda, Joaquín; Camacho, J.L.; Ruiz-Giménez, Jesús; Poza, Juan José; Massot‐Tarrús, Andreu; Galiano, M. L.; Bonet, Macarena

doi:10.1111/ane.12720

Cited by 14 publications

(18 citation statements)

References 37 publications

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“…10,11 At 6 months, responder and seizure-freedom rates were 27.8% and 7.0% in one, 10 and 35.1% and 8.8% in the other study. 18,19 Responder rates in the current study were also consistent with those in the BRV RCTs. 9 As with other AEDs, an inverse relationship between response, and the number of lifetime AEDs was observed.…”

Section: Discussionsupporting

confidence: 84%

“…9 As with other AEDs, an inverse relationship between response, and the number of lifetime AEDs was observed. 18,19 Responder rates in the current study were also consistent with those in the BRV RCTs. In an analysis of data pooled from Seizure -free patients (%)…”

Section: Discussionsupporting

confidence: 84%

“…These results are in keeping with findings of the three aforementioned retrospective series, [9][10][11] and with those of a meta-analysis, which found BRV, LEV, and gabapentin to have the best tolerability profiles among newer AEDs. 24 Adverse events reported by ≥5% of patients were somnolence, dizziness, headache, and fatigue in the BRV pivotal trials 18 and somnolence, irritability, dizziness, and fatigue in the current study. Importantly, no unexpected AEs, such as laboratory test and cardiac abnormalities, or DRESS syndrome, were observed.…”

Section: Months 6 Months 12 Monthsmentioning

confidence: 70%

“…The most common PAE in the current report and in BRV RCTs was irritability; 6.6% and 3.2%, respectively. 18 The higher incidence in this study is likely due to the large proportion of patients with psychiatric comorbidity (44.2%)-such patients are typically excluded from RCTs. 26 Median BRV dosage on the first day was 50 mg.…”

Section: Months 6 Months 12 Monthsmentioning

confidence: 92%

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BRIVA-LIFE-A multicenter retrospective study of the long-term use of brivaracetam in clinical practice

et al. 2018

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Objectives: Evaluate long-term effectiveness and tolerability of brivaracetam in clinical practice in patients with focal epilepsy. Materials and Methods:This was a multicenter retrospective study. Patients aged ≥16 years were started on brivaracetam from November 2016 to June 2017 and followed over 1 year. Data were obtained from medical records at 3, 6 and 12 months after treatment initiation for evaluation of safety-and seizure-related outcomes.Results: A total of 575 patients were included in analyses; most had been treated with ≥4 lifetime antiepileptic drugs. Target dosage was achieved by 30.6% of patients on the first day. Analysis of primary variables at 12 months revealed that mean reduction in seizure frequency was 36.0%, 39.7% of patients were ≥50% responders and 17.5% were seizure-free. Seizure-freedom was achieved by 37.5% of patients aged ≥65 years. Incidence of adverse events (AEs) and psychiatric AEs (PAEs) was 39.8% and 14.3%, respectively, and discontinuation due to these was 8.9% and 3.7%, respectively. Somnolence, irritability, and dizziness were the most frequently reported AEs. At baseline, 228 (39.7%) patients were being treated with levetiracetam; most switched to brivaracetam (dose ratio 1:10-15). Among those who switched because of PAEs (n = 53), 9 (17%) reported PAEs on brivaracetam, and 3 (5.7%) discontinued because of PAEs. Tolerability was not highly affected among patients with learning disability or psychiatric comorbidity. Conclusions:In a large population of patients with predominantly drug-resistant epilepsy, brivaracetam was effective and well-tolerated; no unexpected AEs occurred over 1 year, and the incidence of PAEs was lower compared with levetiracetam.

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Section: Discussionsupporting

confidence: 84%

Section: Discussionsupporting

confidence: 84%

Section: Months 6 Months 12 Monthsmentioning

confidence: 70%

Section: Months 6 Months 12 Monthsmentioning

confidence: 92%

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BRIVA-LIFE-A multicenter retrospective study of the long-term use of brivaracetam in clinical practice

et al. 2018

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“…The Euro-Esli study was an exploratory, retrospective, pooled analysis of data from European clinical practice studies, [9][10][11][12][13][14][15][16][17][18][19][20][21] conducted to audit the effectiveness, safety, and tolerability of ESL as an adjunctive treatment for focal-onset seizures in clinical practice, details of which have been published previously. 8 In brief, effectiveness was assessed after 3, 6, and 12 months of ESL treatment and at final follow-up, and safety and tolerability were assessed for the duration of ESL treatment.…”

Section: Methodsmentioning

confidence: 99%

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

et al. 2018

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Euro-Esli: a European audit of real-world use of eslicarbazepine acetate as a treatment for partial-onset seizures

et al. 2017

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The Euro-Esli study was an exploratory pooled analysis of data from 14 European clinical practice studies, which was conducted to audit the real-world effectiveness, safety, and tolerability of eslicarbazepine acetate (ESL) as an adjunctive treatment for partial-onset seizures. Retention and effectiveness were assessed after 3, 6, and 12 months of ESL treatment, and at the final visit. Safety and tolerability were assessed throughout ESL treatment by evaluating adverse events (AEs) and ESL discontinuation due to AEs. Data from 2058 patients (52.1% male; mean age 44.0 years) were included. All 2058 patients were assessed for safety and 1975 (96.0%) patients were assessed for effectiveness. After 12 months, retention, responder (≥50% seizure frequency reduction), and seizure freedom rates were 73.4, 75.6, and 41.3%, respectively. AEs were reported for 34.0% of patients and led to discontinuation in 13.6% of patients. The most frequently reported AEs were dizziness (6.7% of patients), fatigue (5.4%), and somnolence (5.1%). No unexpected safety signals emerged over a median duration of follow-up of >5 years. Subgroup analyses revealed that ESL was significantly more effective in patients aged ≥65 versus <65 years, in patients who were not receiving treatment with other sodium channel blockers versus those who were receiving treatment with other sodium channel blockers, and in patients who were receiving <2 versus ≥2 concomitant antiepileptic drugs at baseline. Euro-Esli is the largest ESL clinical practice study conducted to date. This study provides strong and reassuring evidence of ESL’s safety profile, and complements the data from clinical trials.

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EARLY-ESLI study: Long-term experience with eslicarbazepine acetate after first monotherapy failure

Abstract: Use of ESL after first monotherapy failure was associated with an optimal seizure control and tolerability profile. Over half of patients were converted to ESL monotherapy during follow-up.

Cited by 14 publications

References 37 publications

BRIVA-LIFE-A multicenter retrospective study of the long-term use of brivaracetam in clinical practice

BRIVA-LIFE-A multicenter retrospective study of the long-term use of brivaracetam in clinical practice

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

Euro-Esli: a European audit of real-world use of eslicarbazepine acetate as a treatment for partial-onset seizures

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