Safety and efficacy of perampanel in children and adults with various epilepsy syndromes: A single-center postmarketing study.
Perampanel is an AMPA receptor antagonist recently approved for the treatment of partial and generalized epilepsies with tonic-clonic seizures as an add-on therapy.



This single-center postmarketing study retrospectively evaluated the efficacy of perampanel in patients with partial onset and other seizure types, with a special emphasis on its efficacy, safety, and tolerability.



Review of medical records revealed that adequate data were available on 101 patients taking perampanel. Fifty-seven patients were female. Sixteen patients were of pediatric age range. The average dose of perampanel was 6.5mg, and average treatment duration was 8.2months. After treatment, median seizure frequency reduction was 50% overall, 50% in children, and 33% in adults; 44% in primary generalized, 38% in secondarily generalized, and 33% in partial seizures. Responder rate (50% seizure frequency reduction) was 51% overall, 63% in children, and 49% in adults; 60% in partial seizures, 43% in secondarily generalized tonic-clonic seizures, 53% in primary generalized tonic-clonic seizures, and 56% in other seizure types. Seizure freedom was attained in 6% of cases. Most common adverse events were sleepiness/fatigue (35%), behavioral problems (30%), and dizziness (22%). Adverse events were correlated with dosage. Average dose was 7.3mg in patients with adverse events vs. 5.5mg in those without adverse events. Patients who developed fatigue, cognitive decline, headaches, and weight gain were more likely to discontinue perampanel than those patients who experienced coordination issues and behavioral problems.



These findings suggest that perampanel is safe, well-tolerated, and effective in treatment of various types of adult and pediatric epilepsy syndromes. Fatigue, cognitive decline, headache and weight gain were the main causes of perampanel discontinuation.
Division of Pediatric Neurology, University of Massachusetts Medical School, USA.
Kanwaljit
K
Singh
Comprehensive Epilepsy Center, Department of Neurology, NYU Langone Medical Center, USA.
Yash D
YD
Shah
Comprehensive Epilepsy Center, Department of Neurology, NYU Langone Medical Center, USA.
Daniel
D
Luciano
Comprehensive Epilepsy Center, Department of Neurology, NYU Langone Medical Center, USA.
Daniel
D
Friedman
Comprehensive Epilepsy Center, Department of Neurology, NYU Langone Medical Center, USA.
Orrin
O
Devinsky
Comprehensive Epilepsy Center, Department of Neurology, NYU Langone Medical Center, USA. Electronic address: sanjeev.kothare@nyumc.org.
Sanjeev V
SV
Kothare
D000293:Adolescent; D000328:Adult; D000368:Aged; D000927:Anticonvulsants / Q000009:adverse effects* / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004828:Epilepsies, Partial / Q000188:drug therapy; D004830:Epilepsy, Tonic-Clonic / Q000188:drug therapy*; D005221:Fatigue / Q000139:chemically induced / Q000523:psychology; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D009570:Nitriles; D011358:Product Surveillance, Postmarketing; D011728:Pyridones / Q000009:adverse effects* / Q000627:therapeutic use*; D018091:Receptors, AMPA / Q000037:antagonists & inhibitors*; D012189:Retrospective Studies; D012449:Safety; D012640:Seizures / Q000517:prevention & control; D016896:Treatment Outcome; D055815:Young Adult
D000927:Anticonvulsants; D009570:Nitriles; D011728:Pyridones; D018091:Receptors, AMPA; C551441:perampanel
Adverse events; Efficacy; Perampanel; Postmarketing; Safety