PMID- 34427754 OWN - NLM STAT- MEDLINE DCOM- 20220324 LR - 20220408 IS - 1432-1459 (Electronic) IS - 0340-5354 (Print) IS - 0340-5354 (Linking) VI - 269 IP - 4 DP - 2022 Apr TI - PERMIT study: a global pooled analysis study of the effectiveness and tolerability of perampanel in routine clinical practice. PG - 1957-1977 LID - 10.1007/s00415-021-10751-y [doi] AB - The PERaMpanel pooled analysIs of effecTiveness and tolerability (PERMIT) study was a pooled analysis of data from 44 real-world studies from 17 countries, in which people with epilepsy (PWE; focal and generalized) were treated with perampanel (PER). Retention and effectiveness were assessed after 3, 6, and 12 months, and at the last visit (last observation carried forward). Effectiveness assessments included 50% responder rate (>/= 50% reduction in seizure frequency from baseline) and seizure freedom rate (no seizures since at least the prior visit); in PWE with status epilepticus, response was defined as seizures under control. Safety and tolerability were assessed by evaluating adverse events (AEs) and discontinuation due to AEs. The Full Analysis Set included 5193 PWE. Retention, effectiveness and safety/tolerability were assessed in 4721, 4392 and 4617, respectively. Retention on PER treatment at 3, 6, and 12 months was 90.5%, 79.8%, and 64.2%, respectively. Mean retention time on PER treatment was 10.8 months. The 50% responder rate was 58.3% at 12 months and 50.0% at the last visit, and the corresponding seizure freedom rates were 23.2% and 20.5%, respectively; 52.7% of PWE with status epilepticus responded to PER treatment. Overall, 49.9% of PWE reported AEs and the most frequently reported AEs (>/= 5% of PWE) were dizziness/vertigo (15.2%), somnolence (10.6%), irritability (8.4%), and behavioral disorders (5.4%). At 12 months, 17.6% of PWEs had discontinued due to AEs. PERMIT demonstrated that PER is effective and generally well tolerated when used to treat people with focal and/or generalized epilepsy in everyday clinical practice. CI - (c) 2021. The Author(s). FAU - Villanueva, Vicente AU - Villanueva V AD - Refractory Epilepsy Unit, Hospital Universitario y Politecnico La Fe, Valencia, Spain. villanueva_vichab@gva.es. FAU - D'Souza, Wendyl AU - D'Souza W AUID- ORCID: 0000-0002-1750-5131 AD - Department of Medicine, St Vincent's Hospital Melbourne, The University of Melbourne, Victoria, Australia. FAU - Goji, Hiroko AU - Goji H AD - Neuropsychiatric Department, Aichi Medical University, Aichi, Japan. FAU - Kim, Dong Wook AU - Kim DW AD - Department of Neurology, Konkuk University School of Medicine, Seoul, Korea. FAU - Liguori, Claudio AU - Liguori C AUID- ORCID: 0000-0003-2845-1332 AD - Epilepsy Centre, Neurology Unit, University Hospital "Tor Vergata", Rome, Italy. AD - Department of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy. FAU - McMurray, Rob AU - McMurray R AD - European Knowledge Centre, Eisai Europe Ltd, Hatfield, Hertfordshire, UK. FAU - Najm, Imad AU - Najm I AD - Cleveland Clinic Epilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA. FAU - Santamarina, Estevo AU - Santamarina E AUID- ORCID: 0000-0003-1915-0335 AD - Epilepsy Unit, Hospital Universitari Vall D'Hebron, Barcelona, Spain. FAU - Steinhoff, Bernhard J AU - Steinhoff BJ AD - Kork Epilepsy Center, Kehl-Kork, Germany. AD - Department of Neurology and Neurophysiology, Albert-Ludwigs University of Freiburg, Freiburg, Germany. FAU - Vlasov, Pavel AU - Vlasov P AUID- ORCID: 0000-0001-8321-5864 AD - Department of Neurology, General Medical Faculty of Moscow State University of Dentistry named after A.I. Evdokimov, Moscow, Russian Federation. FAU - Wu, Tony AU - Wu T AD - Chang Gung Memorial Hospital Linkou Medical Center and Chang Gung University College of Medicine, Taoyuan, Taiwan. FAU - Trinka, Eugen AU - Trinka E AUID- ORCID: 0000-0002-5950-2692 AD - Department of Neurology, Christian-Doppler University Hospital, Paracelsus Medical University, Affiliated EpiCARE Partner, Centre for Cognitive Neuroscience, Salzburg, Austria. AD - Department of Public Health, Health Services Research and Health Technology Assessment, UMIT-University for Health Sciences, Medical Informatics and Technology, Hall in Tirol, Austria. AD - Neuroscience Institute, Christian Doppler University Hospital, Paracelsus Medical University, Salzburg, Austria. CN - PERMIT pooled analysis participants LA - eng PT - Journal Article DEP - 20210824 PL - Germany TA - J Neurol JT - Journal of neurology JID - 0423161 RN - 0 (Anticonvulsants) RN - 0 (Nitriles) RN - 0 (Pyridones) RN - H821664NPK (perampanel) SB - IM MH - *Anticonvulsants/adverse effects MH - Drug Therapy, Combination MH - Humans MH - *Nitriles MH - Pyridones/adverse effects MH - Treatment Outcome PMC - PMC8940799 OTO - NOTNLM OT - Antiseizure medication OT - Effectiveness OT - Focal epilepsy OT - Generalized epilepsy OT - Observational study OT - Tolerability COIS- Vicente Villanueva has received honoraria and/or research funds from Angelini, Arvelle, Bial, Eisai, Esteve, GW Pharma, NewBridge, Novartis, UCB Pharma and Zogenix. Wendyl D'Souza's salary is part-funded by The University of Melbourne. He has received travel, investigator-initiated, scientific advisory board and speaker honoraria from UCB Pharma Australia & Global; investigator-initiated, scientific advisory board, travel and speaker honoraria from Eisai Australia & Global; advisory board honoraria from Liva Nova and Tilray; educational grants from Novartis Pharmaceuticals, Pfizer Pharmaceuticals and Sanofi-Synthelabo; educational, travel and fellowship grants from GSK Neurology Australia; and honoraria from SciGen Pharmaceuticals. He has an equity interest in the device company EpiMinder and health software company KeyLead Health. Hiroko Goji has no conflicts of interest. Dong Wook Kim has no conflicts of interest. Claudio Liguori has no conflicts of interest. Rob McMurray is an employee of Eisai Europe Ltd. Imad Najm has received honoraria from Eisai. Estevo Santamarina has received honoraria and/or research funds from Bial, Eisai, Esteve, GW Pharma and UCB Pharma. Bernhard J. Steinhoff has received consultation fees and/or honoraria from Arvelle, B. Braun Melsungen, Desitin, Eisai, GW Pharma, Neuraxpharm, Precisis, UCB Pharma, and Zogenix. Pavel Vlasov has received consultation fees and/or honoraria from Alkaloid, Eisai, Novartis, Sanofi, Teva and UCB Pharma. Tony Wu has no conflicts of interest. Eugen Trinka has received consultation fees and/or speakers honoraria from Angelini, Argenx, Arvelle, Bial, Biogen-Idec, Boehringer Ingelheim, Eisai, Epilog, EVER Pharma, Genzyme, GL Pharma, GW Pharmaceuticals, Hikma, LivaNova, Marinus, Medtronic, NewBridge, Novartis, Sanofi, and UCB Pharma. EDAT- 2021/08/25 06:00 MHDA- 2022/03/25 06:00 PMCR- 2021/08/24 CRDT- 2021/08/24 12:27 PHST- 2021/06/08 00:00 [received] PHST- 2021/08/06 00:00 [accepted] PHST- 2021/08/03 00:00 [revised] PHST- 2021/08/25 06:00 [pubmed] PHST- 2022/03/25 06:00 [medline] PHST- 2021/08/24 12:27 [entrez] PHST- 2021/08/24 00:00 [pmc-release] AID - 10.1007/s00415-021-10751-y [pii] AID - 10751 [pii] AID - 10.1007/s00415-021-10751-y [doi] PST - ppublish SO - J Neurol. 2022 Apr;269(4):1957-1977. doi: 10.1007/s00415-021-10751-y. Epub 2021 Aug 24.