PMID- 37114853 OWN - NLM STAT- MEDLINE DCOM- 20230817 LR - 20230817 IS - 1528-1167 (Electronic) IS - 0013-9580 (Linking) VI - 64 IP - 8 DP - 2023 Aug TI - Perampanel for the treatment of people with idiopathic generalized epilepsy in clinical practice. PG - 2094-2107 LID - 10.1111/epi.17631 [doi] AB - OBJECTIVE: This study was undertaken to evaluate perampanel (PER) when used under real-world conditions to treat people with idiopathic generalized epilepsy (IGE) included in the PERaMpanel pooled analysIs of effecTiveness and tolerability (PERMIT) study. METHODS: The multinational, retrospective, pooled analysis PERMIT explored the use of PER in people with focal and generalized epilepsy treated in clinical practice across 17 countries. This subgroup analysis included PERMIT participants with IGE. Time points for retention and effectiveness measurements were 3, 6, and 12 months (last observation carried forward, defined as "last visit," was also applied to effectiveness). Effectiveness was evaluated by seizure type (total seizures, generalized tonic-clonic seizures [GTCS], myoclonic seizures, absence seizures) and included >/=50% responder rate and seizure freedom rate (defined as no seizures since at least the previous visit). Safety/tolerability was monitored throughout PER treatment and evaluated by documenting the incidence of adverse events (AEs), including psychiatric AEs and those leading to treatment discontinuation. RESULTS: The Full Analysis Set included 544 people with IGE (51.9% women, mean age = 33.3 years, mean epilepsy duration = 18.1 years). At 3, 6, and 12 months, 92.4%, 85.5%, and 77.3% of participants were retained on PER treatment, respectively (Retention Population, n = 497). At the last visit, responder and seizure freedom rates were, respectively, 74.2% and 54.6% (total seizures), 81.2% and 61.5% (GTCS), 85.7% and 66.0% (myoclonic seizures), and 90.5% and 81.0% (absence seizures) (Effectiveness Population, n = 467). AEs occurred in 42.9% of patients and included irritability (9.6%), dizziness/vertigo (9.2%), and somnolence (6.3%) (Tolerability Population, n = 520). Treatment discontinuation due to AEs was 12.4% over 12 months. SIGNIFICANCE: This subgroup analysis of the PERMIT study demonstrated the effectiveness and good tolerability of PER in people with IGE when administered under everyday clinical practice conditions. These findings are in line with clinical trial evidence, supporting PER's use as broad-spectrum antiseizure medication for the treatment of IGE. CI - (c) 2023 The Authors. Epilepsia published by Wiley Periodicals LLC on behalf of International League Against Epilepsy. FAU - Trinka, Eugen AU - Trinka E AUID- ORCID: 0000-0002-5950-2692 AD - Department of Neurology, Christian-Doppler University Hospital, Paracelsus Medical University, Center for Cognitive Neuroscience, Member of EpiCARE, Salzburg, Austria. AD - Neuroscience Institute, Christian-Doppler University Hospital, Paracelsus Medical University, Center for Cognitive Neuroscience, Salzburg, Austria. AD - Institute of Public Health, Medical Decision-Making, and HTA, UMIT-Private University for Health Sciences, Medical Informatics, and Technology, Hall in Tyrol, Austria. FAU - Alsaadi, Taoufik AU - Alsaadi T AUID- ORCID: 0000-0002-7513-5706 AD - Department of Neurology, American Center for Psychiatry and Neurology, Abu Dhabi, United Arab Emirates. FAU - Goji, Hiroko AU - Goji H AD - Neuropsychiatric Department, Aichi Medical University, Nagakute, Japan. FAU - Maehara, Taketoshi AU - Maehara T AD - Department of Neurosurgery, Tokyo Medical and Dental University, Tokyo, Japan. AD - Department of Neurosurgery, Tsuchiura Kyodo General Hospital, Ibaraki, Japan. FAU - Takahashi, Satoru AU - Takahashi S AD - Department of Neurosurgery, Tokyo Medical and Dental University, Tokyo, Japan. FAU - Jacobs, Julia AU - Jacobs J AD - Alberta Children's Hospital, Calgary, Alberta, Canada. AD - University Medical Center Freiburg, Member of EpiCARE, Freiburg, Germany. FAU - Renna, Rosaria AU - Renna R AD - Neurological Clinic and Stroke Unit, "A. Cardarelli" Hospital, Naples, Italy. FAU - Gil-Lopez, Francisco Jose AU - Gil-Lopez FJ AD - Epilepsy Unit, Department of Neurology, Hospital Universitari Sagrat Cor, Barcelona, Spain. FAU - McMurray, Rob AU - McMurray R AD - Eisai Europe, Hatfield, UK. FAU - Sainz-Fuertes, Ricardo AU - Sainz-Fuertes R AD - Eisai Europe, Hatfield, UK. FAU - Villanueva, Vicente AU - Villanueva V AUID- ORCID: 0000-0003-2080-8042 AD - Refractory Epilepsy Unit, Hospital Universitario y Politecnico La Fe, member of EpiCARE, Valencia, Spain. LA - eng PT - Clinical Trial PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20230604 PL - United States TA - Epilepsia JT - Epilepsia JID - 2983306R RN - 0 (Anticonvulsants) RN - 37341-29-0 (Immunoglobulin E) RN - H821664NPK (perampanel) RN - 0 (Pyridones) RN - Epilepsy, Idiopathic Generalized SB - IM MH - Adult MH - Female MH - Humans MH - Male MH - Anticonvulsants/therapeutic use MH - Drug Therapy, Combination MH - *Epilepsies, Myoclonic/drug therapy MH - *Epilepsy, Absence/drug therapy MH - *Epilepsy, Generalized/drug therapy MH - Immunoglobulin E/therapeutic use MH - Pyridones/therapeutic use MH - Retrospective Studies MH - Seizures/drug therapy/chemically induced MH - Treatment Outcome OTO - NOTNLM OT - absence seizures OT - antiseizure medication OT - epilepsy OT - generalized tonic-clonic seizures OT - myoclonic seizures OT - real world EDAT- 2023/04/28 12:43 MHDA- 2023/08/09 06:43 CRDT- 2023/04/28 08:23 PHST- 2023/04/25 00:00 [revised] PHST- 2023/01/24 00:00 [received] PHST- 2023/04/25 00:00 [accepted] PHST- 2023/08/09 06:43 [medline] PHST- 2023/04/28 12:43 [pubmed] PHST- 2023/04/28 08:23 [entrez] AID - 10.1111/epi.17631 [doi] PST - ppublish SO - Epilepsia. 2023 Aug;64(8):2094-2107. doi: 10.1111/epi.17631. Epub 2023 Jun 4.