{"title":"Cenobamate在临床实践中的长期疗效和耐受性：一项回顾性观察研究。","authors":"Shubhi Agrawal, Batool A Hussain, Kiran M Kanth","doi":"10.4103/aian.aian_441_25","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and objectives: </strong>Cenobamate (CNB) was approved in the US in 2020 and showed 12% seizure freedom in drug-resistant epilepsy (DRE) in pivotal trials. The open-label extension (OLE) study reported 13%-16% seizure freedom and sustained responder rates over 4 years. It is unclear how much of the treatment benefit during OLE was attributable to CNB, as people could have received other treatments. This study aimed to assess CNB efficacy and safety over an extended follow-up.</p><p><strong>Methods: </strong>This retrospective study was conducted among adults with DRE, treated with CNB between May 2020 and Dec 2023, at the University of California, Davis. Data on demographics, epilepsy history, CNB dose, seizure frequencies, adverse events, and treatment changes were collected. Treatment failure was considered if CNB was withdrawn for any reason or if another epilepsy treatment was needed after starting CNB.</p><p><strong>Results: </strong>Sixty people with epilepsy (PWE) were included, with 78% having focal epilepsy and 11.3% generalized epilepsy. Over the mean follow-up period of 20.5 months, 56.7% had treatment failure, with a median survival time of 17.2 months. Seizure freedom was seen in 15% of participants, and 90% or more seizure reduction in 21% of participants. Of the failures, 44% were due to incomplete efficacy, 38% were due to adverse effects, and the rest due to a combination of both. Seventy-eight percent of PWE who started CNB were taking it at last follow-up.</p><p><strong>Conclusions: </strong>CNB shows clinically meaningful efficacy for at least 1.5 years in people with DRE.</p>","PeriodicalId":8036,"journal":{"name":"Annals of Indian Academy of Neurology","volume":" ","pages":""},"PeriodicalIF":1.8000,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Long-Term Efficacy and Tolerability of Cenobamate in Clinical Practice: A Retrospective Observational Study.\",\"authors\":\"Shubhi Agrawal, Batool A Hussain, Kiran M Kanth\",\"doi\":\"10.4103/aian.aian_441_25\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background and objectives: </strong>Cenobamate (CNB) was approved in the US in 2020 and showed 12% seizure freedom in drug-resistant epilepsy (DRE) in pivotal trials. The open-label extension (OLE) study reported 13%-16% seizure freedom and sustained responder rates over 4 years. It is unclear how much of the treatment benefit during OLE was attributable to CNB, as people could have received other treatments. This study aimed to assess CNB efficacy and safety over an extended follow-up.</p><p><strong>Methods: </strong>This retrospective study was conducted among adults with DRE, treated with CNB between May 2020 and Dec 2023, at the University of California, Davis. Data on demographics, epilepsy history, CNB dose, seizure frequencies, adverse events, and treatment changes were collected. Treatment failure was considered if CNB was withdrawn for any reason or if another epilepsy treatment was needed after starting CNB.</p><p><strong>Results: </strong>Sixty people with epilepsy (PWE) were included, with 78% having focal epilepsy and 11.3% generalized epilepsy. Over the mean follow-up period of 20.5 months, 56.7% had treatment failure, with a median survival time of 17.2 months. Seizure freedom was seen in 15% of participants, and 90% or more seizure reduction in 21% of participants. Of the failures, 44% were due to incomplete efficacy, 38% were due to adverse effects, and the rest due to a combination of both. Seventy-eight percent of PWE who started CNB were taking it at last follow-up.</p><p><strong>Conclusions: </strong>CNB shows clinically meaningful efficacy for at least 1.5 years in people with DRE.</p>\",\"PeriodicalId\":8036,\"journal\":{\"name\":\"Annals of Indian Academy of Neurology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2025-09-26\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annals of Indian Academy of Neurology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.4103/aian.aian_441_25\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of Indian Academy of Neurology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.4103/aian.aian_441_25","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
Long-Term Efficacy and Tolerability of Cenobamate in Clinical Practice: A Retrospective Observational Study.
Background and objectives: Cenobamate (CNB) was approved in the US in 2020 and showed 12% seizure freedom in drug-resistant epilepsy (DRE) in pivotal trials. The open-label extension (OLE) study reported 13%-16% seizure freedom and sustained responder rates over 4 years. It is unclear how much of the treatment benefit during OLE was attributable to CNB, as people could have received other treatments. This study aimed to assess CNB efficacy and safety over an extended follow-up.
Methods: This retrospective study was conducted among adults with DRE, treated with CNB between May 2020 and Dec 2023, at the University of California, Davis. Data on demographics, epilepsy history, CNB dose, seizure frequencies, adverse events, and treatment changes were collected. Treatment failure was considered if CNB was withdrawn for any reason or if another epilepsy treatment was needed after starting CNB.
Results: Sixty people with epilepsy (PWE) were included, with 78% having focal epilepsy and 11.3% generalized epilepsy. Over the mean follow-up period of 20.5 months, 56.7% had treatment failure, with a median survival time of 17.2 months. Seizure freedom was seen in 15% of participants, and 90% or more seizure reduction in 21% of participants. Of the failures, 44% were due to incomplete efficacy, 38% were due to adverse effects, and the rest due to a combination of both. Seventy-eight percent of PWE who started CNB were taking it at last follow-up.
Conclusions: CNB shows clinically meaningful efficacy for at least 1.5 years in people with DRE.
期刊介绍：
The journal has a clinical foundation and has been utilized most by clinical neurologists for improving the practice of neurology. While the focus is on neurology in India, the journal publishes manuscripts of high value from all parts of the world. Journal publishes reviews of various types, original articles, short communications, interesting images and case reports. The journal respects the scientific submission of its authors and believes in following an expeditious double-blind peer review process and endeavors to complete the review process within scheduled time frame. A significant effort from the author and the journal perhaps enables to strike an equilibrium to meet the professional expectations of the peers in the world of scientific publication. AIAN believes in safeguarding the privacy rights of human subjects. In order to comply with it, the journal instructs all authors when uploading the manuscript to also add the ethical clearance (human/animals)/ informed consent of subject in the manuscript. This applies to the study/case report that involves animal/human subjects/human specimens e.g. extracted tooth part/soft tissue for biopsy/in vitro analysis.
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