{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T22:41:00Z","timestamp":1793400060363,"version":"4.5.0"},"reference-count":20,"publisher":"Wiley","issue":"S1","license":[{"start":{"date-parts":[[2019,3,14]],"date-time":"2019-03-14T00:00:00Z","timestamp":1552521600000},"content-version":"vor","delay-in-days":13,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Eisai Co., Ltd."}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Epilepsia"],"published-print":{"date-parts":[[2019,3]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>This post hoc analysis assessed the long\u2010term 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 (<jats:styled-content style=\"fixed-case\">FIAS<\/jats:styled-content>) with focal to bilateral tonic\u2010clonic (<jats:styled-content style=\"fixed-case\">FBTC<\/jats:styled-content>) seizures. In this subanalysis, data from Asian patients \u226512\u00a0years of age who had focal seizures with <jats:styled-content style=\"fixed-case\">FBTC<\/jats:styled-content> seizures despite taking one to 3 concomitant antiepileptic drugs at baseline, and who had entered either the long\u2010term extension phase of 3 phase\u20103 perampanel trials (study 307) or the 10\u2010week 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\u2010blind phase\u20103 trials and 669 had previously received perampanel 2\u201012\u00a0mg\/day; 313 had <jats:styled-content style=\"fixed-case\">FIAS<\/jats:styled-content> with <jats:styled-content style=\"fixed-case\">FBTC<\/jats:styled-content> seizures at core study baseline. The median duration of exposure to perampanel was 385.0\u00a0days, and the retention rate at one\u00a0year was 62.6%. Overall, during the first 52\u00a0weeks of perampanel treatment, 777 patients (88.9%) had treatment\u2010emergent adverse events (<jats:styled-content style=\"fixed-case\">TEAE<\/jats:styled-content>s), most of which were mild to moderate in severity. The most frequent <jats:styled-content style=\"fixed-case\">TEAE<\/jats:styled-content>s were dizziness (47.1%), somnolence (22.3%), and nasopharyngitis (17.4%). During the first 52\u00a0weeks of perampanel treatment, median percent change in seizure frequency per 28\u00a0days from pre\u2010perampanel baseline for all focal seizures was \u221228.1%, and \u221251.7% for <jats:styled-content style=\"fixed-case\">FIAS<\/jats:styled-content> with <jats:styled-content style=\"fixed-case\">FBTC<\/jats:styled-content> seizures. The 50% responder rate relative to pre\u2010perampanel baseline for all focal seizures was 33.8%, and 51.1% for <jats:styled-content style=\"fixed-case\">FIAS<\/jats:styled-content> with <jats:styled-content style=\"fixed-case\">FBTC<\/jats:styled-content> seizures. Long\u2010term treatment with perampanel in Asian patients had safety, tolerability, and efficacy similar to that of the global population in the phase\u20103 trials and extension study 307. The safety profile and response rate suggest benefit for an Asian population of patients with refractory epilepsy.<\/jats:p>","DOI":"10.1111\/epi.14645","type":"journal-article","created":{"date-parts":[[2019,3,14]],"date-time":"2019-03-14T10:00:13Z","timestamp":1552557613000},"page":"60-67","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["A post hoc analysis of the long\u2010term safety and efficacy of perampanel in Asian patients with epilepsy"],"prefix":"10.1111","volume":"60","author":[{"given":"Yushi","family":"Inoue","sequence":"first","affiliation":[{"name":"National Epilepsy Center NHO Shizuoka Institute of Epilepsy and Neurological Disorders Shizuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sunao","family":"Kaneko","sequence":"additional","affiliation":[{"name":"North Tohoku Epilepsy Center Minato Hospital Hachinohe Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peiyuan F.","family":"Hsieh","sequence":"additional","affiliation":[{"name":"Taichung Veterans General Hospital Taichung City Taiwan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chandrashekhar","family":"Meshram","sequence":"additional","affiliation":[{"name":"Brain and Mind Institute Nagpur India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sang\u2010Ahm","family":"Lee","sequence":"additional","affiliation":[{"name":"Asan Medical Center Seoul South Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zariah Abdul","family":"Aziz","sequence":"additional","affiliation":[{"name":"Hospital Sultanah Nur Zahirah Terengganu Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charcrin","family":"Nabangchang","sequence":"additional","affiliation":[{"name":"Comprehensive Epilepsy Center Phramongkutklao College of Medicine Bangkok Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9351-4021","authenticated-orcid":false,"given":"Amitabh","family":"Dash","sequence":"additional","affiliation":[{"name":"Eisai Singapore Pte. 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