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A post hoc analysis of the long-term safety and efficacy of perampanel in Asian patients with epilepsy.
Epilepsia 2019; 60 Suppl 1:60-67E

Abstract

This post hoc analysis assessed the long-term safety, tolerability, and efficacy of perampanel in Asian patients with refractory focal seizures; an additional analysis assessed the effect of perampanel on focal impaired awareness seizures (FIAS) with focal to bilateral tonic-clonic (FBTC) seizures. In this subanalysis, data from Asian patients ≥12 years of age who had focal seizures with FBTC seizures despite taking one to 3 concomitant antiepileptic drugs at baseline, and who had entered either the long-term extension phase of 3 phase-3 perampanel trials (study 307) or the 10-week extension phase of study 335, were analyzed for the effect of perampanel on duration of exposure, safety, and seizure outcomes. Of 874 Asian patients included in the analysis, 205 had previously received placebo during the double-blind phase-3 trials and 669 had previously received perampanel 2-12 mg/day; 313 had FIAS with FBTC seizures at core study baseline. The median duration of exposure to perampanel was 385.0 days, and the retention rate at one year was 62.6%. Overall, during the first 52 weeks of perampanel treatment, 777 patients (88.9%) had treatment-emergent adverse events (TEAEs), most of which were mild to moderate in severity. The most frequent TEAEs were dizziness (47.1%), somnolence (22.3%), and nasopharyngitis (17.4%). During the first 52 weeks of perampanel treatment, median percent change in seizure frequency per 28 days from pre-perampanel baseline for all focal seizures was -28.1%, and -51.7% for FIAS with FBTC seizures. The 50% responder rate relative to pre-perampanel baseline for all focal seizures was 33.8%, and 51.1% for FIAS with FBTC seizures. Long-term treatment with perampanel in Asian patients had safety, tolerability, and efficacy similar to that of the global population in the phase-3 trials and extension study 307. The safety profile and response rate suggest benefit for an Asian population of patients with refractory epilepsy.

Authors+Show Affiliations

National Epilepsy Center, NHO Shizuoka Institute of Epilepsy and Neurological Disorders, Shizuoka, Japan.North Tohoku Epilepsy Center, Minato Hospital, Hachinohe, Japan.Taichung Veterans General Hospital, Taichung City, Taiwan.Brain and Mind Institute, Nagpur, India.Asan Medical Center, Seoul, South Korea.Hospital Sultanah Nur Zahirah, Terengganu, Malaysia.Comprehensive Epilepsy Center, Phramongkutklao College of Medicine, Bangkok, Thailand.Eisai Singapore Pte. Ltd., Singapore.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

30869167

Citation

Inoue, Yushi, et al. "A Post Hoc Analysis of the Long-term Safety and Efficacy of Perampanel in Asian Patients With Epilepsy." Epilepsia, vol. 60 Suppl 1, 2019, pp. 60-67.
Inoue Y, Kaneko S, Hsieh PF, et al. A post hoc analysis of the long-term safety and efficacy of perampanel in Asian patients with epilepsy. Epilepsia. 2019;60 Suppl 1:60-67.
Inoue, Y., Kaneko, S., Hsieh, P. F., Meshram, C., Lee, S. A., Aziz, Z. A., ... Dash, A. (2019). A post hoc analysis of the long-term safety and efficacy of perampanel in Asian patients with epilepsy. Epilepsia, 60 Suppl 1, pp. 60-67. doi:10.1111/epi.14645.
Inoue Y, et al. A Post Hoc Analysis of the Long-term Safety and Efficacy of Perampanel in Asian Patients With Epilepsy. Epilepsia. 2019;60 Suppl 1:60-67. PubMed PMID: 30869167.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A post hoc analysis of the long-term safety and efficacy of perampanel in Asian patients with epilepsy. AU - Inoue,Yushi, AU - Kaneko,Sunao, AU - Hsieh,Peiyuan F, AU - Meshram,Chandrashekhar, AU - Lee,Sang-Ahm, AU - Aziz,Zariah Abdul, AU - Nabangchang,Charcrin, AU - Dash,Amitabh, PY - 2017/05/16/received PY - 2018/12/13/revised PY - 2018/12/18/accepted PY - 2019/3/15/entrez KW - Asian KW - anticonvulsants KW - focal epilepsy KW - long-term therapy KW - perampanel SP - 60 EP - 67 JF - Epilepsia JO - Epilepsia VL - 60 Suppl 1 N2 - This post hoc analysis assessed the long-term safety, tolerability, and efficacy of perampanel in Asian patients with refractory focal seizures; an additional analysis assessed the effect of perampanel on focal impaired awareness seizures (FIAS) with focal to bilateral tonic-clonic (FBTC) seizures. In this subanalysis, data from Asian patients ≥12 years of age who had focal seizures with FBTC seizures despite taking one to 3 concomitant antiepileptic drugs at baseline, and who had entered either the long-term extension phase of 3 phase-3 perampanel trials (study 307) or the 10-week extension phase of study 335, were analyzed for the effect of perampanel on duration of exposure, safety, and seizure outcomes. Of 874 Asian patients included in the analysis, 205 had previously received placebo during the double-blind phase-3 trials and 669 had previously received perampanel 2-12 mg/day; 313 had FIAS with FBTC seizures at core study baseline. The median duration of exposure to perampanel was 385.0 days, and the retention rate at one year was 62.6%. Overall, during the first 52 weeks of perampanel treatment, 777 patients (88.9%) had treatment-emergent adverse events (TEAEs), most of which were mild to moderate in severity. The most frequent TEAEs were dizziness (47.1%), somnolence (22.3%), and nasopharyngitis (17.4%). During the first 52 weeks of perampanel treatment, median percent change in seizure frequency per 28 days from pre-perampanel baseline for all focal seizures was -28.1%, and -51.7% for FIAS with FBTC seizures. The 50% responder rate relative to pre-perampanel baseline for all focal seizures was 33.8%, and 51.1% for FIAS with FBTC seizures. Long-term treatment with perampanel in Asian patients had safety, tolerability, and efficacy similar to that of the global population in the phase-3 trials and extension study 307. The safety profile and response rate suggest benefit for an Asian population of patients with refractory epilepsy. SN - 1528-1167 UR - https://www.unboundmedicine.com/medline/citation/30869167/A_post_hoc_analysis_of_the_long-term_safety_and_efficacy_of_perampanel_in_Asian_patients_with_epilepsy L2 - https://doi.org/10.1111/epi.14645 DB - PRIME DP - Unbound Medicine ER -