PMID- 32447055 OWN - NLM STAT- MEDLINE DCOM- 20210514 LR - 20211204 IS - 1878-5883 (Electronic) IS - 0022-510X (Linking) VI - 415 DP - 2020 Aug 15 TI - The efficacy of perampanel as adjunctive therapy in drug-resistant focal epilepsy in a "real world" context: focus on temporal lobe epilepsy. PG - 116903 LID - S0022-510X(20)30240-9 [pii] LID - 10.1016/j.jns.2020.116903 [doi] AB - 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: 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: 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: 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. CI - Copyright (c) 2020 Elsevier B.V. All rights reserved. FAU - Pascarella, Angelo AU - Pascarella A AD - Institute of Neurology, University "Magna Graecia", Catanzaro, Italy. FAU - Iannone, Luigi Francesco AU - Iannone LF AD - Dept of Health Science, School of Medicine, University of Catanzaro, Catanzaro, Italy. FAU - Di Gennaro, Giancarlo AU - Di Gennaro G AD - Department of Neurology, Mediterranean Neurological Institute, Pozzilli, Italy. FAU - D'Aniello, Alfredo AU - D'Aniello A AD - Department of Neurology, Mediterranean Neurological Institute, Pozzilli, Italy. FAU - Ferlazzo, Edoardo AU - Ferlazzo E AD - Institute of Neurology, University "Magna Graecia", Catanzaro, Italy; Regional Epilepsy Centre, Great Metropolitan Hospital, Via Melacrino, Reggio Calabria, Italy. FAU - Gagliostro, Nazareno AU - Gagliostro N AD - Dept of Health Science, School of Medicine, University of Catanzaro, Catanzaro, Italy. FAU - Ursini, Francesco AU - Ursini F AD - Department of Biomedical Science and Neuromotor Sciences DIBINEM, Bologna, Italy. FAU - Bonanni, Paolo AU - Bonanni P AD - Scientific Institute, IRCCS E. Medea, Epilepsy and Clinical Neurophysiology Unit, Conegliano, Treviso, Italy. FAU - Paciello, Nicola AU - Paciello N AD - Department of Neurology, San Carlo Regional Hospital, Potenza, Italy. FAU - Romigi, Andrea AU - Romigi A AD - Department of Neurology, Mediterranean Neurological Institute, Pozzilli, Italy. FAU - Aguglia, Umberto AU - Aguglia U AD - Institute of Neurology, University "Magna Graecia", Catanzaro, Italy; Regional Epilepsy Centre, Great Metropolitan Hospital, Via Melacrino, Reggio Calabria, Italy. FAU - De Sarro, Giovambattista AU - De Sarro G AD - Dept of Health Science, School of Medicine, University of Catanzaro, Catanzaro, Italy. FAU - Russo, Emilio AU - Russo E AD - Dept of Health Science, School of Medicine, University of Catanzaro, Catanzaro, Italy. FAU - Gambardella, Antonio AU - Gambardella A AD - Institute of Neurology, University "Magna Graecia", Catanzaro, Italy. FAU - Labate, Angelo AU - Labate A AD - Institute of Neurology, University "Magna Graecia", Catanzaro, Italy. Electronic address: labate@unicz.it. LA - eng PT - Journal Article PT - Multicenter Study DEP - 20200515 PL - Netherlands TA - J Neurol Sci JT - Journal of the neurological sciences JID - 0375403 RN - 0 (Anticonvulsants) RN - 0 (Nitriles) RN - 0 (Pharmaceutical Preparations) RN - 0 (Pyridones) RN - H821664NPK (perampanel) SB - IM MH - Adult MH - Anticonvulsants/therapeutic use MH - Drug Therapy, Combination MH - *Epilepsy, Temporal Lobe/drug therapy MH - Humans MH - Italy MH - Nitriles MH - *Pharmaceutical Preparations MH - Prospective Studies MH - Pyridones MH - Treatment Outcome OTO - NOTNLM OT - Antiepileptic drugs OT - Drug-resistant epilepsy OT - Focal seizures OT - Perampanel OT - Temporal lobe epilepsy EDAT- 2020/05/25 06:00 MHDA- 2021/05/15 06:00 CRDT- 2020/05/25 06:00 PHST- 2020/04/07 00:00 [received] PHST- 2020/05/06 00:00 [revised] PHST- 2020/05/11 00:00 [accepted] PHST- 2020/05/25 06:00 [pubmed] PHST- 2021/05/15 06:00 [medline] PHST- 2020/05/25 06:00 [entrez] AID - S0022-510X(20)30240-9 [pii] AID - 10.1016/j.jns.2020.116903 [doi] PST - ppublish SO - J Neurol Sci. 2020 Aug 15;415:116903. doi: 10.1016/j.jns.2020.116903. Epub 2020 May 15.