PMID- 34075567 OWN - NLM STAT- MEDLINE DCOM- 20211021 LR - 20220531 IS - 1179-1969 (Electronic) IS - 1170-229X (Print) IS - 1170-229X (Linking) VI - 38 IP - 7 DP - 2021 Jul TI - Adjunctive Perampanel in Older Patients With Epilepsy: A Multicenter Study of Clinical Practice. PG - 603-610 LID - 10.1007/s40266-021-00865-3 [doi] AB - BACKGROUND: Clinical data regarding use of newer antiseizure medications (ASMs) in an older population are limited. In randomized-controlled, placebo-controlled trials, older patients are under-represented, and protocols deviate markedly from routine clinical practice, limiting the external validity of results. Studies performed in a naturalistic setting are a useful complement to characterize the drug profile. Perampanel is a third-generation ASM and the first and only non-competitive alfa-amino-3-hydroxyl-5-methyl-4-isoxazole-propionate receptor antagonist. OBJECTIVE: The aim of this study was to assess the effectiveness and tolerability of adjunctive perampanel over a 1-year period in a population of older patients with epilepsy treated in a real-world setting. METHODS: Older (>/= 65 years of age) patients prescribed add-on perampanel at 12 Italian epilepsy centers were retrospectively identified. Seizure occurrence, adverse events (AEs), and drug withdrawal were analyzed. Effectiveness outcomes included the rates of seizure response (>/= 50% reduction in baseline monthly seizure frequency), seizure freedom, and treatment discontinuation. Safety and tolerability outcomes were the rate of treatment discontinuation due to AEs and the incidence of AEs. RESULTS: A total of 92 patients with a median age of 69 (range 65-88) years were included. The median daily dose of perampanel at 12 months was 6 mg (interquartile range 4-6 mg). At 12 months, 53 (57.6%) patients were seizure responders, and 22 (23.9%) patients were seizure free. Twenty (21.7%) patients discontinued perampanel; the reasons for treatment withdrawal were insufficient efficacy (n = 6/20; 30.0%), AEs (n = 12/20; 60.0%), and a combination of both (n = 2/20; 10%). The most common AEs included irritability (8.7%), somnolence (4.3%), and dizziness/vertigo (4.3%). The rate of behavioral and psychiatric AEs was higher in patients with history of psychiatric comorbidities (p = 0.044). There were no differences in the occurrence of behavioral and psychiatric AEs according to the concomitant use of levetiracetam (p = 0.776) and history of cognitive decline (p = 0.332). CONCLUSIONS: Adjunctive perampanel was associated with improvement in seizure control and good tolerability in a real-life setting and can represent a viable therapeutic option in older patients with epilepsy. FAU - Lattanzi, Simona AU - Lattanzi S AUID- ORCID: 0000-0001-8748-0083 AD - Department of Experimental and Clinical Medicine, Neurological Clinic, Marche Polytechnic University, Via Conca 71, 60020, Ancona, Italy. alfierelattanzisimona@gmail.com. FAU - Cagnetti, Claudia AU - Cagnetti C AD - Department of Experimental and Clinical Medicine, Neurological Clinic, Marche Polytechnic University, Via Conca 71, 60020, Ancona, Italy. FAU - Foschi, Nicoletta AU - Foschi N AD - Department of Experimental and Clinical Medicine, Neurological Clinic, Marche Polytechnic University, Via Conca 71, 60020, Ancona, Italy. FAU - Ciuffini, Roberta AU - Ciuffini R AD - Department of Life, Health and Environmental Sciences, University of L'Aquila, L'Aquila, Italy. FAU - Osanni, Elisa AU - Osanni E AD - Epilepsy and Psychopathology Unit, IRCCS Medea, Conegliano, Treviso, Italy. FAU - Chiesa, Valentina AU - Chiesa V AD - Epilepsy Center, San Paolo Hospital, Milan, Italy. FAU - Dainese, Filippo AU - Dainese F AD - Epilepsy Center, Neurology Unit, Venice, Italy. FAU - Dono, Fedele AU - Dono F AD - Department of Neuroscience, Imaging and Clinical Science, "G. D'Annunzio" University of Chieti-Pescara, Chieti, Italy. FAU - Canevini, Maria Paola AU - Canevini MP AD - Epilepsy Center, San Paolo Hospital, Milan, Italy. AD - Department of Health Sciences, Universita degli Studi, Milan, Italy. FAU - Evangelista, Giacomo AU - Evangelista G AD - Department of Neuroscience, Imaging and Clinical Science, "G. D'Annunzio" University of Chieti-Pescara, Chieti, Italy. FAU - Paladin, Francesco AU - Paladin F AD - Epilepsy Center, Neurology Unit, Venice, Italy. FAU - Bartolini, Emanuele AU - Bartolini E AD - Neurology Unit, USL Centro Toscana, Prato, Italy. FAU - Ranzato, Federica AU - Ranzato F AD - Neurology Unit, Epilepsy Center, Vicenza, Italy. FAU - Nilo, Annacarmen AU - Nilo A AD - Clinical Neurology Unit, Department of Neurosciences, S. Maria della Misericordia University Hospital, ASUFC, Udine, Italy. FAU - Pauletto, Giada AU - Pauletto G AD - Neurology Unit, Department of Neurosciences, S. Maria della Misericordia University Hospital, ASUFC, Udine, Italy. FAU - Marino, Daniela AU - Marino D AD - Neurology Unit, Department of Cardiac, Thoracic, Neurological and Vascular Sciences, San Donato Hospital, Arezzo, Italy. FAU - Rosati, Eleonora AU - Rosati E AD - Neurology Unit 2, Neuromuscular and Sense Organs Department, Careggi University Hospital, Florence, Italy. FAU - Bonanni, Paolo AU - Bonanni P AD - Epilepsy and Psychopathology Unit, IRCCS Medea, Conegliano, Treviso, Italy. FAU - Marrelli, Alfonso AU - Marrelli A AD - Neurophysiopathology Unit, Epilepsy Center, San Salvatore Hospital, L'Aquila, Italy. LA - eng PT - Journal Article PT - Multicenter Study DEP - 20210602 PL - New Zealand TA - Drugs Aging JT - Drugs & aging JID - 9102074 RN - 0 (Anticonvulsants) RN - 0 (Nitriles) RN - 0 (Pyridones) RN - H821664NPK (perampanel) SB - IM MH - Aged MH - Aged, 80 and over MH - Anticonvulsants/adverse effects/*therapeutic use MH - *Epilepsy/drug therapy MH - Humans MH - Nitriles/*therapeutic use MH - Pyridones/*therapeutic use MH - Retrospective Studies MH - Treatment Outcome PMC - PMC8266697 COIS- Simona Lattanzi has received speaker's or consultancy fees from Eisai, GW Pharmaceuticals, and UCB Pharma and has served on advisory boards for Angelini, Arvelle Therapeutics, BIAL, and GW Pharmaceuticals. Valentina Chiesa has received speaker's or consultancy fees from Eisai, UCB Pharma, and Livanova. Fedele Dono has received speaker's fees from Eisai. Maria Paola Canevini has received speaker's or consultancy fees from Bial, EISAI, Italfarmaco, Sanofi, and UCB. All other authors have nothing to disclose. EDAT- 2021/06/03 06:00 MHDA- 2021/10/26 06:00 PMCR- 2021/06/02 CRDT- 2021/06/02 06:52 PHST- 2021/05/16 00:00 [accepted] PHST- 2021/06/03 06:00 [pubmed] PHST- 2021/10/26 06:00 [medline] PHST- 2021/06/02 06:52 [entrez] PHST- 2021/06/02 00:00 [pmc-release] AID - 10.1007/s40266-021-00865-3 [pii] AID - 865 [pii] AID - 10.1007/s40266-021-00865-3 [doi] PST - ppublish SO - Drugs Aging. 2021 Jul;38(7):603-610. doi: 10.1007/s40266-021-00865-3. Epub 2021 Jun 2.