Angelo Pascarella1, Luigi Francesco Iannone2, Giancarlo Di Gennaro3, Alfredo D'Aniello3, Edoardo Ferlazzo4, Nazareno Gagliostro2, Francesco Ursini5, Paolo Bonanni6, Nicola Paciello7, Andrea Romigi3, Umberto Aguglia4, Giovambattista De Sarro2, Emilio Russo2, Antonio Gambardella1, Angelo Labate8. 1. Institute of Neurology, University "Magna Graecia", Catanzaro, Italy. 2. Dept of Health Science, School of Medicine, University of Catanzaro, Catanzaro, Italy. 3. Department of Neurology, Mediterranean Neurological Institute, Pozzilli, Italy. 4. Institute of Neurology, University "Magna Graecia", Catanzaro, Italy; Regional Epilepsy Centre, Great Metropolitan Hospital, Via Melacrino, Reggio Calabria, Italy. 5. Department of Biomedical Science and Neuromotor Sciences DIBINEM, Bologna, Italy. 6. Scientific Institute, IRCCS E. Medea, Epilepsy and Clinical Neurophysiology Unit, Conegliano, Treviso, Italy. 7. Department of Neurology, San Carlo Regional Hospital, Potenza, Italy. 8. Institute of Neurology, University "Magna Graecia", Catanzaro, Italy. Electronic address: labate@unicz.it.
Abstract
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.
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 TLEpatients, 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.
Authors: Anderson Brito da Silva; Jane Pennifold; Ben Henley; Koustav Chatterjee; David Bateman; Roger W Whittaker; Abhijit Joshi; Hrishikesh Kumar; Claire Nicholson; Mark R Baker; Stuart D Greenhill; Richard Walsh; Stefano Seri; Roland S G Jones; Gavin L Woodhall; Mark O Cunningham Journal: Epilepsia Open Date: 2022-05-11
Authors: Anna Mammì; Edoardo Ferlazzo; Sara Gasparini; Valentina Bova; Sabrina Neri; Angelo Labate; Giovanni Mastroianni; Concetta Lo Bianco; Vittoria Cianci; Umberto Aguglia Journal: Front Neurol Date: 2022-03-07 Impact factor: 4.003