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

Trinka, Eugen; Rocamora, Rodrigo; Chaves, João; Moreira, Joana; Ikedo, F.; Soares-da-Silva, Patrı́cio

doi:10.1111/epi.16666

Cited by 7 publications

(11 citation statements)

References 24 publications

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“…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 [8].…”

Section: Efficacy and Safety Of Eslicarbazepine Acetate Monotherapy In Adults With Partial-onset Seizuressupporting

confidence: 70%

Eslicarbazepine acetate: An efficacy and safety as an antiepileptic drug in clinical trials and open studies

Stefaniak

Pietrzak

Dzikowski

et al. 2022

J Educ Health Sport

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Eslicarbazepine acetate (Zebinix®, ESL), a voltage-gated sodium channel blocker, is a once-daily, orally administered anti-seizure medication available in the EU for use as monotherapy in adults with newly diagnosed partial-onset seizures and as adjunctive therapy in adults, adolescents, and children aged > 6 years with partial-onset seizures. It was approved by the European Medicines Agency and launched onto the European market in 2009. This study aimed to assess the efficacy and safety of ESL in the treatment of focal-onset seizures. Our study material consisted of publications, which were found in PubMed, Google Scholar, and Embase databases. In order to find the proper publications, the search has been conducted with the use of a combination of keywords like: “eslicarbazepine acetate", "focal-onset seizures treatment", "epilepsy treatment", "eslicarbazepine acetate pharmacokinetics”. The first step was to find proper publications from the last 10 years. The second step was to carry out an overview of the found publications. Results of mentioned studies proved that for adults with medically uncontrolled partial-onset seizures, ESL monotherapy is well tolerated and effective over the long term, including the patients who transitioned from CBZ-CR monotherapy. Adjunctive ESL demonstrated a sustained therapeutic effect and was well-tolerated, safe, and efficacious during the treatment of adults with partial-onset seizures. Both 800 mg and 1200 mg once-daily doses were well tolerated. Moreover, significant improvements in depressive symptoms and quality of life domains were observed under long-term treatment with ESL.

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Section: Efficacy and Safety Of Eslicarbazepine Acetate Monotherapy In Adults With Partial-onset Seizuressupporting

confidence: 70%

Eslicarbazepine acetate: An efficacy and safety as an antiepileptic drug in clinical trials and open studies

Stefaniak

Pietrzak

Dzikowski

et al. 2022

J Educ Health Sport

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“… 70 – 74 Its FDA 75 (2013) and EMA (2009) 76 approval comprises monotherapy and adjunctive treatment for focal epilepsies. 77 – 80 Until 2018, 79 pregnancies with exposure to eslicarbazepine acetate were documented: 28 during clinical trials and 51 from 8 years of postmarketing surveillance. Congenital anomalies were identified in five cases.…”

Section: Management Of Epilepsy During Pregnancy and Anti-seizure Med...mentioning

confidence: 99%

Treatment and care of women with epilepsy before, during, and after pregnancy: a practical guide

Nucera

Brigo

Trinka

et al. 2022

Ther Adv Neurol Disord

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Women with epilepsy (WWE) wishing for a child represent a highly relevant subgroup of epilepsy patients. The treating epileptologist needs to delineate the epilepsy syndrome and choose the appropriate anti-seizure medication (ASM) considering the main goal of seizure freedom, teratogenic risks, changes in drug metabolism during pregnancy and postpartum, demanding for up-titration during and down-titration after pregnancy. Folic acid or vitamin K supplements and breastfeeding are also discussed in this review. Lamotrigine and levetiracetam have the lowest teratogenic potential. Data on teratogenic risks are also favorable for oxcarbazepine, whereas topiramate tends to have an unfavorable profile. Valproate needs special emphasis. It is most effective in generalized seizures but should be avoided whenever possible due to its teratogenic effects and the negative impact on neuropsychological development of in utero-exposed children. Valproate still has its justification in patients not achieving seizure freedom with other ASMs or if a woman decides to or cannot become pregnant for any reason. When valproate is the most appropriate treatment option, the patient and caregiver must be fully informed of the risks associated with its use during pregnancies. Folate supplementation is recommended to reduce the risk of major congenital malformations. However, there is insufficient information to address the optimal dose and it is unclear whether higher doses offer greater protection. There is currently no general recommendation for a peripartum vitamin K prophylaxis. During pregnancy most ASMs (e.g. lamotrigine, oxcarbazepine, and levetiracetam) need to be increased to compensate for the decline in serum levels; exceptions are valproate and carbamazepine. Postpartum, baseline levels are reached relatively fast, and down-titration is performed empirically. Many ASMs in monotherapy are (moderately) safe for breastfeeding and women should be encouraged to do so. This review provides a practically oriented overview of the complex management of WWE before, during, and after pregnancy.

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“…Balancing the efficacy and tolerability of the drug, ESL at 800 mg/d is effective and well-tolerated as adjunctive treatment for adults with FOE, which is consistent with the current recommendations. Consistently, several longterm extension studies also support the long-term efficacy and tolerability of ESL for adults of FOE (36,37), even with ESL mono therapy (38,39). Besides, it has been also suggested by some retrospective cohort studies that early adjunctive treatment with ESL in adults of FOE may be more cost effective than later add-on of the drug (40,41).…”

Section: Discussionmentioning

confidence: 63%

Adjunctive Treatment With Eslicarbazepine Acetate for Adults and Children With Focal-Onset Epilepsy: A Meta-Analysis

2022

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BackgroundThe efficacy and tolerability of eslicarbazepine acetate (ESL) in adults and children with focal-onset epilepsy (FOE) according to the dose remain to be validated. A meta-analysis based on randomized controlled trials (RCTs) was therefore conducted as a summary.MethodsRelevant RCTs were collected by systematic searching the electronic databases of PubMed, Cochrane's Library, Embase, Wanfang and CNKI from inception to May 16, 2022. The random-effect model was adopted to pool the results by incorporating the possible heterogeneity. Efficacy outcomes including responsive rate and effective rate, defined as cases with 50 and ≥75% reduction in seizure frequency compared to baseline, were determined, respectively. Incidence of severe adverse events (AE) leading to drug discontinuation was also evaluated.ResultsTen studies including 2,565 people with epilepsy contributed to the meta-analysis. For adults, ESL 400 mg/d did not improve the response rate or the effective rate; ESL 800 mg/d was associated with improved response rate (odds ratio [OR] 2.16, 95% confidence interval [CI]: 1.65–2.83, p < 0.001) and effective rate (OR 2.16, 95% CI: 1.41–3.30, p < 0.001) without significantly increased severe AE (OR 1.58, 95% CI: 0.90–2.78, p = 0.11); ESL 1,200 mg/d improved response rate (OR 2.49, p < 0.001) and effective rate (OR 3.09, p = 0.04), but significantly increased severe AE (OR 3.72, p < 0.001). For children, ESL also did not significantly improve the response rate (OR 1.76, p = 0.22) or the effective rate (OR 2.17, p = 0.13).ConclusionESL 800 mg/d is effective and well-tolerated as adjuvants for adults with FOE. Efficacy of ESL in children with FOE should be further evaluated.

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

Cited by 7 publications

References 24 publications

Eslicarbazepine acetate: An efficacy and safety as an antiepileptic drug in clinical trials and open studies

Eslicarbazepine acetate: An efficacy and safety as an antiepileptic drug in clinical trials and open studies

Treatment and care of women with epilepsy before, during, and after pregnancy: a practical guide

Adjunctive Treatment With Eslicarbazepine Acetate for Adults and Children With Focal-Onset Epilepsy: A Meta-Analysis

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