TY - JOUR
T1 - Practice guideline update summary
T2 - Efficacy and tolerability of the new antiepileptic drugs II: Treatment-resistant epilepsy: Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy
AU - Kanner, Andres M.
AU - Ashman, Eric
AU - Gloss, David
AU - Harden, Cynthia
AU - Bourgeois, Blaise
AU - Bautista, Jocelyn F.
AU - Abou-Khalil, Bassel
AU - Burakgazi-Dalkilic, Evren
AU - Park, Esmeralda Llanas
AU - Stern, John
AU - Hirtz, Deborah
AU - Nespeca, Mark
AU - Gidal, Barry
AU - Faught, Edward
AU - French, Jacqueline
N1 - Funding Information:
A. Kanner has served on a scientific advisory board for UCB but the honorarium was transferred to the Department of Neurology at the University of Miami, Miller School of Medicine; receives royalties from Psychiatric Aspects of Epilepsy, Treatment of Depression in Neurologic Disorders, and Psychiatric Controversies in Epilepsy; and received honoraria from Medscape and as a consultant for Neuropace. E. Ashman receives funding from the American Academy of Neurology (AAN) for travel; has served as associate editor, level of evi-dence,forNeurology®; has performed imaging studies that include MRI, electrophysiology, and EEG in patients who are comatose; and has provided medical reviews and consultations for lawsuits and medical claims as part of his role in the US Air Force. D. Gloss serves as an evidence-based medicine consultant for the AAN. C. Harden receives royalties from UpToDate and Wiley; serves on the speakers’ bureau for UBC; and has received research support from the National Institute of Neurologic Disorders and Stroke (NINDS) of the NIH and the Epilepsy Therapy Project. B. Bourgeois serves on the data and safety monitoring board for a clinical trial conducted by Pfizer Pharmaceuticals, for which he receives honoraria; and receives royalties for The Epilepsy Prescriber’s Guide to Antiepileptic Drugs. J. Bautista serves on the National Quality Forum Neurology Steering Committee and the Neurology Endorsement Maintenance Committee and has received research funding from the NIH and NINDS. B. Abou-Khalil has served on but declined honoraria from scientific advisory boards for Sunovion and GlaxoSmithKline; served on the editorial board for Epilepsy Research and Clinical Neurophysiology; and received royalties for Atlas of EEG & Seizure Semiology. His institution received research support from UCB, GlaxoSmithKline, Valeant, Sunovion, Upsher-Smith, Pfizer, Cyberonics, and SK Life Science, from the NIH for the Epilepsy Phenome/Genome Project, and from the Human Epilepsy Project. E. Burakgazi-Dalkilic serves on a speakers’ bureau for Eisai Pharmaceuticals. E. Llanas Park reports no disclosures relevant to the manuscript. J. Stern serves on the scientific advisory board for Sunovion and Lundbeck; serves as an editor for MedLink Neurology; receives royalties for Atlas of EEG Patterns and Atlas of Video-EEG Monitoring; receives honoraria from and serves on the speakers’ bureaus of UCB, Lundbeck, Eisai, Cyberonics, and Sunovion; and performs clinical practice in epilepsy (50% of his time). D. Hirtz reports no disclosures relevant to the manuscript. M. Nespeca serves on the Scientific Advisory Committee of the Angelman Syndrome Foundation; is a coinvestigator for a US Food and Drug Administration–funded trial on levetiracetam vs phenobarbital in neonatal seizures and for industry-sponsored trials on everolimus (Novartis) for epilepsy in persons with tuberous sclerosis and on fenfluramine (Zogenix) in Dravet syndrome. B. Gidal serves on science advisory boards and speakers bureaus for UCB, Eisai, and Sunovion, for which he receives honoraria; performs clinical practice in epilepsy (20% of his time); and has provided expert testimony, prepared an affidavit, and acted as a witness in the legal proceeding of Activis v Depomed. E. Faught serves on the scientific advisory boards of Eisai, Lundbeck, SK Life Science, Supernus, Sunovion, and UCB; has received research support from Brain Sentinel, UCB, the Centers for Disease Control and Prevention, University of Alabama at Birmingham, and the Epilepsy Consortium; and has acted as a witness in legal proceedings for Rushton Stakley. J. French serves on the scientific advisory board of Anavex Life Science Corp.; receives travel funding from Upsher-Smith, Marinus Pharmaceuticals, Pfizer, SK Life Science, Biotie, GW Pharmaceuticals, UCB, and Takeda; serves as an editor for Epilepsia; and receives research support from Acorda, Biotie, Eisai, GlaxoSmithKline, Impax, Johnson & Johnson, Marinus Pharmaceuticals, Novartis, Pfizer, Sunovion, SK Life Science, Supernus, and the NINDS of the NIH. Go to Neurology.org/N for full disclosures.
Funding Information:
This guideline was developed with financial support from the American Academy of Neurology (AAN). Authors who serve as AAN subcommittee members or methodologists (E.A., D.G., C.H., and J.F.) were reimbursed by the AAN for expenses related to travel to subcommittee meetings where drafts of manuscripts were reviewed.
Publisher Copyright:
Copyright © 2018 American Academy of Neurology.
PY - 2018
Y1 - 2018
N2 - Objective: To update the 2004 American Academy of Neurology guideline for managing treatmentresistant (TR) epilepsy with second- and third-generation antiepileptic drugs (AEDs). Methods: 2004 criteria were used to systemically review literature (January 2003 to November 2015), classify pertinent studies according to the therapeutic rating scheme, and link recommendations to evidence strength. Results: Forty-two articles were included. Recommendations: The following are established as effective to reduce seizure frequency (Level A): immediate-release pregabalin and perampanel for TR adult focal epilepsy (TRAFE); vigabatrin for TRAFE (not firstline treatment); rufinamide for Lennox-Gastaut syndrome (LGS) (add-on therapy). The following should be considered to decrease seizure frequency (Level B): lacosamide, eslicarbazepine, and extended-release topiramate for TRAFE (ezogabine production discontinued); immediate- and extended-release lamotrigine for generalized epilepsy with TR generalized tonic-clonic (GTC) seizures in adults; levetiracetam (add-on therapy) for TR childhood focal epilepsy (TRCFE) (1 month-16 years), TR GTC seizures, and TR juvenile myoclonic epilepsy; clobazam for LGS (add-on therapy); zonisamide for TRCFE (6-17 years); oxcarbazepine for TRCFE (1 month-4 years). The text presents Level C recommendations. AED selection depends on seizure/syndrome type, patient age, concomitant medications, and AED tolerability, safety, and efficacy. This evidencebased assessment informs AED prescription guidelines for TR epilepsy and indicates seizure types and syndromes needing more evidence. A recent Food and Drug Administration (FDA) strategy allows extrapolation of efficacy across populations; therefore, for focal epilepsy, eslicarbazepine and lacosamide (oral only for pediatric use) as add-on or monotherapy in persons ≥4 years of age and perampanel as monotherapy received FDA approval.
AB - Objective: To update the 2004 American Academy of Neurology guideline for managing treatmentresistant (TR) epilepsy with second- and third-generation antiepileptic drugs (AEDs). Methods: 2004 criteria were used to systemically review literature (January 2003 to November 2015), classify pertinent studies according to the therapeutic rating scheme, and link recommendations to evidence strength. Results: Forty-two articles were included. Recommendations: The following are established as effective to reduce seizure frequency (Level A): immediate-release pregabalin and perampanel for TR adult focal epilepsy (TRAFE); vigabatrin for TRAFE (not firstline treatment); rufinamide for Lennox-Gastaut syndrome (LGS) (add-on therapy). The following should be considered to decrease seizure frequency (Level B): lacosamide, eslicarbazepine, and extended-release topiramate for TRAFE (ezogabine production discontinued); immediate- and extended-release lamotrigine for generalized epilepsy with TR generalized tonic-clonic (GTC) seizures in adults; levetiracetam (add-on therapy) for TR childhood focal epilepsy (TRCFE) (1 month-16 years), TR GTC seizures, and TR juvenile myoclonic epilepsy; clobazam for LGS (add-on therapy); zonisamide for TRCFE (6-17 years); oxcarbazepine for TRCFE (1 month-4 years). The text presents Level C recommendations. AED selection depends on seizure/syndrome type, patient age, concomitant medications, and AED tolerability, safety, and efficacy. This evidencebased assessment informs AED prescription guidelines for TR epilepsy and indicates seizure types and syndromes needing more evidence. A recent Food and Drug Administration (FDA) strategy allows extrapolation of efficacy across populations; therefore, for focal epilepsy, eslicarbazepine and lacosamide (oral only for pediatric use) as add-on or monotherapy in persons ≥4 years of age and perampanel as monotherapy received FDA approval.
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U2 - 10.1212/WNL.0000000000005756
DO - 10.1212/WNL.0000000000005756
M3 - Article
C2 - 29898974
AN - SCOPUS:85055732252
VL - 91
SP - 82
EP - 90
JO - Neurology
JF - Neurology
SN - 0028-3878
IS - 2
ER -