Literature DB >> 29649684

The ROME (Retrospective Observational Multicenter study on Eslicarbazepine) study: Efficacy and behavioural effects of Eslicarbazepine acetate as adjunctive therapy for adults with partial onset seizures in real life.

G Assenza1, O Mecarelli2, J Lanzone3, F Assenza3, M Tombini3, V Di Lazzaro3, P Pulitano2.   

Abstract

PURPOSE: Eslicarbazepine acetate (ESL) is a third-generation member of the dibenzazepine family approved in 2009 by the European Medicines Agency with the indication of adjunctive therapy in adult people with partial-onset seizures (PPOS). We aimed at assessing the ESL impact on seizure frequency and quality of life in PPOS with a particular attention to sleepiness and depression.
METHODS: We evaluated 50 adult PPOS (>18 years; 48 ± 14 years-old; 23 males) treated with adjunctive ESL for ≥2months with a retrospective multi-centric design. Clinical files of the last 2 years were reviewed checking for monthly seizure frequency, treatment retention rate, adverse drug reactions (ADRs), concomitant anti-epileptic drugs and behavioural scales for sleepiness (Stanford Sleepiness Scale, SSS, and Epworth Sleepiness Scale, ESS), depression (Beck Depression Inventory-II, BDI) and overall quality of life (QOLIE-31).
RESULTS: At the end of 96 ± 28 days of ESL treatment, the mean seizure reduction was 56%; 60% of patients had seizure reduction above 50%, with a 31% of the whole population becoming seizure free. We reported 16 ADRs with 4 hyponatremia. Retention rate was 76%. Patient reported less sleepiness after ESL (SSS, p = 0.031; ESS, p = 0.0000002). Before ESL, 38% of patients had pathologic BDI scores, which normalized in most of them (73%) after ESL (BDI improvement, p = 0.000012). These scores resulted in an amelioration of quality of life (QOLIE-31, p = 0.000002).
CONCLUSIONS: ESL is a safe and effective anti-epileptic drug in a real life scenario, with an excellent behavioural profile for the overall quality of life and, in particular, for sleepiness and depression.
Copyright © 2018 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

Entities:  

Keywords:  Anti-epileptic drug; Beck depression inventory II; Drug-resistant; Epilpepsy; Epworth sleepiness scale; Eslicarbazepine; Partial onset seizures; Quality of life

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Year:  2018        PMID: 29649684     DOI: 10.1016/j.seizure.2018.03.028

Source DB:  PubMed          Journal:  Seizure        ISSN: 1059-1311            Impact factor:   3.184


  1 in total

Review 1.  Effects of antiepileptic drugs on sleep architecture parameters in adults.

Authors:  Bruno Miguel Santos Carvalho; João Chaves; António Martins da Silva
Journal:  Sleep Sci       Date:  2022 Apr-Jun
  1 in total

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