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Observational Study
. 2022 Oct;36(10):1113-1119.
doi: 10.1007/s40263-022-00954-w. Epub 2022 Sep 30.

Eslicarbazepine Acetate as Adjunctive Therapy for Primary Generalized Tonic-Clonic Seizures in Adults: A Prospective Observational Study

Yaroslav Winter  1   2 , Katharina Sandner  3 , Thomas Ludger Vieth  4 , Nico Melzer  5 , Sven Klimpe  6 , Sven G Meuth  5 , Sergiu Groppa  7
Affiliations
Observational Study

Eslicarbazepine Acetate as Adjunctive Therapy for Primary Generalized Tonic-Clonic Seizures in Adults: A Prospective Observational Study

Yaroslav Winter et al. CNS Drugs. 2022 Oct.

Abstract

Background: Eslicarbazepine acetate (ESL), a novel sodium channel blocker, is approved for mono and adjunctive treatment of partial epileptic seizures with or without secondary generalization. Its efficacy in primary generalized seizures has not yet been evaluated.

Objective: To evaluate the efficacy and safety of ESL in primary generalized tonic-clonic seizures (PGTCS) in an observational study.

Methods: The data were collected from a prospective population-based register. Effectiveness was measured as relative reduction in standardized seizure frequency (SSF), responder rate (≥ 50% reduction in SSF), and seizure freedom rate at 6 and 12 months after initiation of ESL. Safety and tolerability were evaluated using patients' diaries.

Results: Fifty-six adult patients with PGTCS were treated with ESL as adjunctive therapy. Of these, 30.4% (n = 17) had myoclonic seizures in addition to PGTCS. The retention rate after 12 months was 80.4% (n = 45). After initiating ESL therapy, reduction in SSF for PGTCS on ESL was 56.0% after 6 months and 56.9% after 12 months (p < 0.01), whereas myoclonic seizures did not show any significant improvement in frequency. The responder rate for PGTCS was 64.3% after 6 months and 66.1% after 12 months, and seizure freedom was achieved in 32.1% and 35.7%, respectively. Forty-three patients (73.2%) reported no side effects. Among the reported side effects of ESL therapy, headache (7.1%), dizziness (8.9%), tiredness (7.1%), nausea (5.4%), and hyponatremia (5.4%) were the most prevalent.

Conclusions: Our data suggest that ESL may provide additional benefits in the treatment of patients with PGTCS and motivate randomized controlled trials in this indication.

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Conflict of interest statement

YW reports honoraria for educational presentations and consultations from Arvelle Therapeutics, Bayer AG, BIAL, Eisai, LivaNova, Novartis, and UCB Pharma. SG received compensation for professional services from Abbott, AbbVie, Bial, Medtronic, UCB, and Zambon; research grants from Abbott, Boston Scientific, MagVenture, German Research Council, Innovations Fund and German Ministry of Education and Health. NM has received honoraria for lecturing and travel expenses for attending meetings from Biogen Idec, GlaxoSmith Kline, Teva, Novartis Pharma, Bayer Healthcare, Genzyme, Alexion Pharamceuticals, Fresenius Medical Care, Diamed, UCB Pharma, and BIAL, has received royalties for consulting from UCB Pharma, and Alexion Pharmaceuticals, and has received financial research support from Euroimmun, Fresenius Medical Care, Diamed, Alexion Pharmaceuticals, and Novartis Pharma. SK has received honoraria for presentations and teaching courses from UCB Pharma and Novartis Pharma, and has been invited to congresses and educational meetings by UCB Pharma and Eisai Pharma. SGM received honoraria for lecturing and travel expenses for attending meetings from Almirall, Amicus Therapeutics Germany, Bayer Health Care, Biogen, Celgene, Diamed, Genzyme, MedDay Pharmaceuticals, Merck Serono, Novartis, Novo Nordisk, ONO Pharma, Roche, Sanofi-Aventis, Chugai Pharma, QuintilesIMS, and Teva. His research is funded by the German Ministry for Education and Research (BMBF), Deutsche Forschungsgemeinschaft (DFG), Else Kröner Fresenius Foundation, German Academic Exchange Service, Hertie Foundation, Interdisciplinary Center for Clinical Studies (IZKF) Muenster, German Foundation Neurology, and by Almirall, Amicus Therapeutics Germany, Biogen, Diamed, Fresenius Medical Care, Genzyme, Merck Serono, Novartis, ONO Pharma, Roche, and Teva. KS and TV declare no conflicts of interest.

Figures

Fig. 1
Fig. 1
Freedom of seizures, responder rate, and seizure reduction 6 and 12 months after initiation of eslicarbazepine acetate. *Statistically significant difference of p < 0.05 in group comparison between all seizures and PGTCS with myoclonic seizures at 6 and 12 months, respectively. PGTCS primary generalized tonic-clonic seizure, SSF standardized seizure frequency
Fig. 2
Fig. 2
Responder rate in primary generalized tonic-clonic seizures by adjunctive medication 6 and 12 months after initiation of eslicarbazepine acetate. **Statistically significant difference at p < 0.01 in the responder rate of PGTCS in comparison with LEV. 1Responder defined as a patient with a reduction in seizure frequency of ≥ 50% compared to baseline. LEV levetiracetam, LTG lamotrigine, VPA valproate
See this image and copyright information in PMC

References

    1. Scheffer IE, Berkovic S, Capovilla G, Connolly MB, French J, Guilhoto L, et al. ILAE classification of the epilepsies: position paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017;58(4):512–521. doi: 10.1111/epi.13709. - DOI - PMC - PubMed
    1. Beydoun A, D'Souza J. Treatment of idiopathic generalized epilepsy—a review of the evidence. Expert Opin Pharmacother. 2012;13(9):1283–1298. doi: 10.1517/14656566.2012.685162. - DOI - PubMed
    1. Benbadis SR. Practical management issues for idiopathic generalized epilepsies. Epilepsia. 2005;46(Suppl 9):125–132. doi: 10.1111/j.1528-1167.2005.00324.x. - DOI - PubMed
    1. Camfield C, Camfield P. Management guidelines for children with idiopathic generalized epilepsy. Epilepsia. 2005;46(Suppl 9):112–116. doi: 10.1111/j.1528-1167.2005.00322.x. - DOI - PubMed
    1. Cerulli Irelli E, Morano A, Barone FA, Fisco G, Fanella M, Orlando B, et al. Persistent treatment resistance in genetic generalized epilepsy: a long-term outcome study in a tertiary epilepsy center. Epilepsia. 2020;61(11):2452–2460. doi: 10.1111/epi.16708. - DOI - PubMed

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