{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T22:33:24Z","timestamp":1788993204748,"version":"build-2803163510"},"reference-count":4,"publisher":"Wiley","issue":"s1","license":[{"start":{"date-parts":[[2014,1,8]],"date-time":"2014-01-08T00:00:00Z","timestamp":1389139200000},"content-version":"vor","delay-in-days":7,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Epilepsia"],"published-print":{"date-parts":[[2014,1]]},"abstract":"<jats:title>Summary<\/jats:title><jats:p>Quality of life is directly related to the number and severity of adverse effects, and a successful antiepileptic medication must demonstrate a good balance between efficacy and tolerability. Perampanel is a newly licensed antiepileptic medication for the adjunctive treatment of patients (age 12 and older) with partial epilepsy with or without secondary generalization. Safety endpoints in the three phase <jats:styled-content style=\"fixed-case\">III<\/jats:styled-content> trials (304, 305, and 306) included treatment\u2010emergent adverse events (<jats:styled-content style=\"fixed-case\">TEAE<\/jats:styled-content>s), vital signs, clinical laboratory parameters, and electrocardiography studies (<jats:styled-content style=\"fixed-case\">ECG<\/jats:styled-content>s). The most common adverse drug reactions in patients receiving perampanel were dizziness, somnolence, fatigue, irritability, nausea, and falls. Of particular concern to patients are cognitive and psychiatric side effects. Overall, depression and aggression were reported more frequently in patients taking perampanel, particularly at higher doses, than in patients taking placebo. <jats:styled-content style=\"fixed-case\">TEAE<\/jats:styled-content>s necessitated the withdrawal of perampanel in 99 patients (9.5%) and placebo in 21 patients (4.8%). Typically this was due to dizziness, convulsion, and somnolence. There were no clinically important changes or treatment group differences in vital signs, <jats:styled-content style=\"fixed-case\">ECG<\/jats:styled-content> measures, or biochemical or hematologic parameters. Weight increase of greater than 7% was seen in 14.6% of perampanel\u2010treated patients versus 7.1% of placebo\u2010treated patients. Overall, perampanel appears to be associated with a relatively low incidence of serious adverse effects, particularly at low doses, and the majority of <jats:styled-content style=\"fixed-case\">TEAE<\/jats:styled-content>s were mild or moderate in intensity. The incidence of predictable side effects, such as somnolence and dizziness, is seen more frequently at higher doses. Of importance is the greater rate of psychiatric side effects in patients treated with perampanel, principally, irritability and aggression, than with placebo. However, the rate of serious psychiatric <jats:styled-content style=\"fixed-case\">TEAE<\/jats:styled-content>s was low.<\/jats:p>","DOI":"10.1111\/epi.12504","type":"journal-article","created":{"date-parts":[[2014,1,8]],"date-time":"2014-01-08T19:58:02Z","timestamp":1389211082000},"page":"13-15","source":"Crossref","is-referenced-by-count":117,"title":["Adverse effects and safety profile of perampanel: A review of pooled data"],"prefix":"10.1111","volume":"55","author":[{"given":"Fergus","family":"Rugg\u2010Gunn","sequence":"first","affiliation":[{"name":"Department of Clinical and Experimental Epilepsy The National Hospital for Neurology and Neurosurgery London United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2014,1,8]]},"reference":[{"key":"e_1_2_5_2_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e3182635735"},{"key":"e_1_2_5_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1167.2012.03638.x"},{"key":"e_1_2_5_4_1","doi-asserted-by":"publisher","DOI":"10.1212\/WNL.0b013e318254473a"},{"key":"e_1_2_5_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1528-1167.2012.03648.x"}],"container-title":["Epilepsia"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fepi.12504","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/epi.12504","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,14]],"date-time":"2023-09-14T00:38:54Z","timestamp":1694651934000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/epi.12504"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2014,1]]},"references-count":4,"journal-issue":{"issue":"s1","published-print":{"date-parts":[[2014,1]]}},"alternative-id":["10.1111\/epi.12504"],"URL":"https:\/\/doi.org\/10.1111\/epi.12504","archive":["Portico"],"relation":{},"ISSN":["0013-9580","1528-1167"],"issn-type":[{"value":"0013-9580","type":"print"},{"value":"1528-1167","type":"electronic"}],"subject":[],"published":{"date-parts":[[2014,1]]}}}