Subscribe to RSS
DOI: 10.1055/s-0040-1719160
Experience with Eslicarbazepine Acetate Treatment at a Pediatric Epilepsy Center
Funding This study was funded by an investigator-initiated grant by Sunovion.Abstract
Eslicarbazepine acetate (ESL) is a novel, once-daily antiseizure medication. We evaluated the efficacy and safety profile of ESL treatment in epilepsy patients at a single tertiary epilepsy center. In this retrospective observational study, we included 32 patients with pharmacologically intractable epilepsy receiving ESL at Boston Children's Hospital from June 2014 to June 2018. We assessed treatment outcome in terms of efficacy and tolerability at first and last follow-up (f/u). Median age was 17 (interquartile range: 10.8–20.7; range: 6.5–36) years. Twelve (37.5%) patients, including three with seizure freedom, were responders at last f/u. Eleven patients discontinued ESL due to seizure worsening (9, 28%), adverse events (AEs) (2, 6%) or both (4, 12%). Responders showed greater seizure reduction at last f/u with fewer AEs as compared with nonresponders. Ten (31%) patients developed AEs, the most common being sleep problems (5, 15%). One-year retention rate with ESL treatment was 54%. In conclusion, ESL had a good response rate in patients with pharmacologically intractable epilepsy, with about one-third of patients developing AEs.
Publication History
Received: 02 September 2020
Accepted: 02 October 2020
Article published online:
07 December 2020
© 2020. Thieme. All rights reserved.
Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany
-
References
- 1 National Clinical Guideline C. National Institute for Health and Clinical Excellence. Guidance. The Epilepsies: The Diagnosis and Management of the Epilepsies in Adults and Children in Primary and Secondary Care: Pharmacological Update of Clinical Guideline 20. London: Royal College of Physicians (UK) National Clinical Guideline Centre; 2012
- 2 Lattanzi S, Brigo F, Cagnetti C, Verrotti A, Zaccara G, Silvestrini M. Eslicarbazepine acetate in the treatment of adults with partial-onset epilepsy: an evidence-based review of efficacy, safety and place in therapy. Core Evid 2018; 13: 21-31
- 3 Cockerell OC, Johnson AL, Sander JW, Hart YM, Shorvon SD. Remission of epilepsy: results from the National General Practice Study of Epilepsy. Lancet 1995; 346 (8968): 140-144
- 4 Zack MM, Kobau R. National and state estimates of the numbers of adults and children with active epilepsy - United States, 2015. MMWR Morb Mortal Wkly Rep 2017; 66 (31) 821-825
- 5 Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med 2000; 342 (05) 314-319
- 6 Benes J, Parada A, Figueiredo AA. et al. Anticonvulsant and sodium channel-blocking properties of novel 10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide derivatives. J Med Chem 1999; 42 (14) 2582-2587
- 7 Biton V, Rogin JB, Krauss G. et al; Study 301, 302 and 304 Investigators. Adjunctive eslicarbazepine acetate: a pooled analysis of three phase III trials. Epilepsy Behav 2017; 72: 127-134
- 8 Keating GM. Eslicarbazepine acetate: a review of its use as adjunctive therapy in refractory partial-onset seizures. CNS Drugs 2014; 28 (07) 583-600
- 9 Willems LM, Zöllner JP, Paule E, Schubert-Bast S, Rosenow F, Strzelczyk A. Eslicarbazepine acetate in epilepsies with focal and secondary generalised seizures: systematic review of current evidence. Expert Rev Clin Pharmacol 2018; 11 (03) 309-324
- 10 Lattanzi S, Brigo F, Grillo E. et al. Adjunctive eslicarbazepine acetate in pediatric patients with focal epilepsy: a systematic review and meta-analysis. CNS Drugs 2018; 32 (03) 189-196
- 11 Bialer M, Soares-da-Silva P. Pharmacokinetics and drug interactions of eslicarbazepine acetate. Epilepsia 2012; 53 (06) 935-946
- 12 Correia FD, Freitas J, Magalhães R. et al. Two-year follow-up with eslicarbazepine acetate: a consecutive, retrospective, observational study. Epilepsy Res 2014; 108 (08) 1399-1405
- 13 Scheffer IE, Berkovic S, Capovilla G. et al. ILAE classification of the epilepsies: position paper of the ILAE commission for classification and terminology. Epilepsia 2017; 58 (04) 512-521
- 14 Kanner AM, Ashman E, Gloss D. et al. Practice guideline update summary: Efficacy and tolerability of the new antiepileptic drugs II: Treatment-resistant epilepsy: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology 2018; 91 (02) 82-90
- 15 Pathway N. Anti-epileptic drugs to offer based on presenting epilepsy seizure type(s). In: Excellent NIfHaC, ed. Available at: https://pathways.nice.org.uk/pathways/epilepsy 2018: 1-18
- 16 Russell GR, Phelps SJ, Shelton CM, Wheless JW. Impact of drug interactions on clobazam and N-desmethylclobazam concentrations in pediatric patients with epilepsy. Ther Drug Monit 2018; 40 (04) 452-462
- 17 Halász P, Cramer JA, Hodoba D. et al; BIA-2093-301 Study Group. Long-term efficacy and safety of eslicarbazepine acetate: results of a 1-year open-label extension study in partial-onset seizures in adults with epilepsy. Epilepsia 2010; 51 (10) 1963-1969
- 18 Incidence of treatment-emergent adverse events (TEAES) according to baseline antiepileptic drug (AED) use: a pooled analysis of data from phase ii/iii trials of adjunctive eslicarbazepine acetate (ESL) in children. Neurology. 2018 ;Conference: 70th Annual Meeting of the American Academy of Neurology, AAN 2018. United States. 90(15 Supplement 1)
- 19 Mintz M, Pina-Garza J, Wolf S. et al. Safety and tolerability of adjunctive eslicarbazepine acetate (ESL) in pediatric patients (aged 4–17 years) with partial-onset (FOCAL) seizures (POS). Neurology 2018;90(15)
- 20 Kwok CS, Johnson EL, Krauss GL. Comparing safety and efficacy of “third-generation” antiepileptic drugs: long-term extension and post-marketing treatment. CNS Drugs 2017; 31 (11) 959-974
- 21 Wechsler RT, Radtke RA, Smith M. et al. Serum sodium levels and related treatment-emergent adverse events during eslicarbazepine acetate use in adults with epilepsy. Epilepsia 2019; 60 (07) 1341-1352