Subcutaneous Levetiracetam Administration in Latino Patients on Home Care.

Laura Cuellar-Valencia, Angelica Claros-Hulbert, Adriana Ortegon, Juliana Pino, Laura Velandia, Juan Esteban Correa-Morales
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Abstract

Background: Levetiracetam has a favorable pharmacology profile to be used subcutaneously. However, its subcutaneous use is still considered off-label as this is beyond its license. The evidence base for its safety, tolerability, and efficacy is limited to observational studies. Objectives: To report the safety and efficacy of subcutaneous levetiracetam in Latino patients on home care. Design: Observational retrospective case series study. Subjects: Consecutive sample of Latino adults with life-limiting illnesses. Methods: A case series framework with 4 domains (selection, ascertainment, causality, and reporting) to ensure reporting quality was used. Additionally, 8 relevant outcomes established in a previous comprehensive review, were collected and reported. Adverse reactions were documented using the Common Terminology Criteria for Adverse Events. Results: Fifteen Latino patients with oncological and non-oncological diagnoses received subcutaneous levetiracetam for a mean of 21 days on home care. Levetiracetam was most frequently initiated subcutaneously due to loss of the oral route. The average dosage of subcutaneous levetiracetam was 1200 mg. Only 1 patient required a dose adjustment, and only 2 patients experienced a total of 5 seizures during the therapy trial. No adverse reactions were reported. Conclusions: Subcutaneous levetiracetam appears to be effective and safe. This case series of Latino patients in home care expands the evidence of its use in the home care setting. The preliminary data reported by now on multiple case series warrants robust trials.

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拉丁裔家庭护理患者皮下注射左乙拉西坦。
背景:左乙拉西坦具有良好的皮下使用药理学特性。然而,它的皮下使用仍然被认为是标签外的,因为这超出了它的许可范围。其安全性、耐受性和有效性的证据基础仅限于观察性研究。目的:报告皮下左乙拉西坦在拉丁裔家庭护理患者中的安全性和有效性。设计:观察性回顾性病例系列研究。受试者:患有限制生命疾病的拉丁裔成年人的连续样本。方法:采用病例系列框架,包括4个领域(选择、确定、因果关系和报告),以确保报告质量。此外,还收集并报告了先前全面审查中确定的8项相关结果。使用不良事件通用术语标准记录不良反应。结果:15名经肿瘤学和非肿瘤学诊断的拉丁裔患者接受皮下左乙拉西坦治疗,平均21天,接受家庭护理。由于口服途径的丧失,左乙拉西坦最常通过皮下给药。皮下注射左乙拉西坦的平均剂量为1200 mg。只有1名患者需要调整剂量,只有2名患者在治疗试验期间总共经历了5次癫痫发作。无不良反应报告。结论:皮下注射左乙拉西坦是安全有效的。这一系列拉丁裔患者在家庭护理中的案例扩展了其在家庭护理环境中使用的证据。目前报告的关于多个案件系列的初步数据值得进行有力的审判。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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