The efficacy of perampanel as adjunctive therapy in drug-resistant focal epilepsy in a "real world" context: focus on temporal lobe epilepsy.


Journal

Journal of the neurological sciences
ISSN: 1878-5883
Titre abrégé: J Neurol Sci
Pays: Netherlands
ID NLM: 0375403

Informations de publication

Date de publication:
15 Aug 2020
Historique:
received: 07 04 2020
revised: 06 05 2020
accepted: 11 05 2020
pubmed: 25 5 2020
medline: 15 5 2021
entrez: 25 5 2020
Statut: ppublish

Résumé

Perampanel (PER) is a novel antiepileptic drug approved as an add-on therapy for focal onset seizures with or without generalization and primary generalized tonic-clonic seizures. Aim of this study was to evaluate PER efficacy and tolerability as add-on therapy in patients with drug-resistant focal onset seizures and especially temporal lobe epilepsy (TLE). An observational, prospective, multicentre study on adult with drug-resistant focal epilepsy consecutively recruited from six Italian tertiary epilepsy centres. All patients received add-on PER according to indication and clinical judgement. Seizure frequency and adverse events (AEs) were recorded at 6 and 12 months after PER introduction. Study sample comprised 246 patients, 77 of which with TLE. Seventy-five (35.9%) out of 209 and 66 (38.8%) out of 170 patients still taking PER resulted to be responders (i.e. ≥50% of seizure frequency or seizure free) after six and 12 months, respectively. In the TLE group, 39 (57.3%) out of 68 subjects on PER after 6 months and 32 (60.4%) out of 53 subjects taking PER after 12 months were responders. Overall reported incidence of AEs was 26.1%. In 28 cases (11.3%) AEs lead/contributed to PER discontinuation. The most frequently reported AE were dizziness (14/84) and somnolence (14/84). Regarding TLE patients, 25.9% of them experienced at least one AE and discontinuation for AEs occurred in eight (10.4%). This study confirmed the good efficacy and safety of PER for drug-resistant focal epilepsy in real-life conditions and, above all, for the first time provide its effectiveness in patients with TLE.

Sections du résumé

BACKGROUND BACKGROUND
Perampanel (PER) is a novel antiepileptic drug approved as an add-on therapy for focal onset seizures with or without generalization and primary generalized tonic-clonic seizures. Aim of this study was to evaluate PER efficacy and tolerability as add-on therapy in patients with drug-resistant focal onset seizures and especially temporal lobe epilepsy (TLE).
METHODS METHODS
An observational, prospective, multicentre study on adult with drug-resistant focal epilepsy consecutively recruited from six Italian tertiary epilepsy centres. All patients received add-on PER according to indication and clinical judgement. Seizure frequency and adverse events (AEs) were recorded at 6 and 12 months after PER introduction.
RESULTS RESULTS
Study sample comprised 246 patients, 77 of which with TLE. Seventy-five (35.9%) out of 209 and 66 (38.8%) out of 170 patients still taking PER resulted to be responders (i.e. ≥50% of seizure frequency or seizure free) after six and 12 months, respectively. In the TLE group, 39 (57.3%) out of 68 subjects on PER after 6 months and 32 (60.4%) out of 53 subjects taking PER after 12 months were responders. Overall reported incidence of AEs was 26.1%. In 28 cases (11.3%) AEs lead/contributed to PER discontinuation. The most frequently reported AE were dizziness (14/84) and somnolence (14/84). Regarding TLE patients, 25.9% of them experienced at least one AE and discontinuation for AEs occurred in eight (10.4%).
CONCLUSIONS CONCLUSIONS
This study confirmed the good efficacy and safety of PER for drug-resistant focal epilepsy in real-life conditions and, above all, for the first time provide its effectiveness in patients with TLE.

Identifiants

pubmed: 32447055
pii: S0022-510X(20)30240-9
doi: 10.1016/j.jns.2020.116903
pii:
doi:

Substances chimiques

Anticonvulsants 0
Nitriles 0
Pharmaceutical Preparations 0
Pyridones 0
perampanel H821664NPK

Types de publication

Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

116903

Informations de copyright

Copyright © 2020 Elsevier B.V. All rights reserved.

Auteurs

Angelo Pascarella (A)

Institute of Neurology, University "Magna Graecia", Catanzaro, Italy.

Luigi Francesco Iannone (LF)

Dept of Health Science, School of Medicine, University of Catanzaro, Catanzaro, Italy.

Giancarlo Di Gennaro (G)

Department of Neurology, Mediterranean Neurological Institute, Pozzilli, Italy.

Alfredo D'Aniello (A)

Department of Neurology, Mediterranean Neurological Institute, Pozzilli, Italy.

Edoardo Ferlazzo (E)

Institute of Neurology, University "Magna Graecia", Catanzaro, Italy; Regional Epilepsy Centre, Great Metropolitan Hospital, Via Melacrino, Reggio Calabria, Italy.

Nazareno Gagliostro (N)

Dept of Health Science, School of Medicine, University of Catanzaro, Catanzaro, Italy.

Francesco Ursini (F)

Department of Biomedical Science and Neuromotor Sciences DIBINEM, Bologna, Italy.

Paolo Bonanni (P)

Scientific Institute, IRCCS E. Medea, Epilepsy and Clinical Neurophysiology Unit, Conegliano, Treviso, Italy.

Nicola Paciello (N)

Department of Neurology, San Carlo Regional Hospital, Potenza, Italy.

Andrea Romigi (A)

Department of Neurology, Mediterranean Neurological Institute, Pozzilli, Italy.

Umberto Aguglia (U)

Institute of Neurology, University "Magna Graecia", Catanzaro, Italy; Regional Epilepsy Centre, Great Metropolitan Hospital, Via Melacrino, Reggio Calabria, Italy.

Giovambattista De Sarro (G)

Dept of Health Science, School of Medicine, University of Catanzaro, Catanzaro, Italy.

Emilio Russo (E)

Dept of Health Science, School of Medicine, University of Catanzaro, Catanzaro, Italy.

Antonio Gambardella (A)

Institute of Neurology, University "Magna Graecia", Catanzaro, Italy.

Angelo Labate (A)

Institute of Neurology, University "Magna Graecia", Catanzaro, Italy. Electronic address: labate@unicz.it.

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Classifications MeSH