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The Safety of Lacosamlde for Treatment of Seizures and Seizure Prophylaxis in Adult Hospitalized Patients

机译:Lacosamlde治疗成人住院癫痫发作和预防癫痫发作的安全性

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Background: Lacosamide (LCM) is a newer antiepileptic drug (AED) with favorable properties for hospitalized patients including intravenous formulation, minimal hepatic metabolism, and no adverse respiratory effects. We sought to determine the safety profile of LCM in hospitalized patients. Methods: We performed a retrospective medical record review of patients who received LCM between July 1, 2009, and January 31, 2010, at Mayo Clinic Hospital. Data included demographics, LCM dosing, concomitant AED therapy, documented seizure activity, hemodynamic variables, electrocardiogram (ECG), and laboratory data. Adverse drug reaction and drug-drug interactions were reviewed. Results: Thirty-two patients were identified. No major hypotension or serious cardiac arrhythmias occurred. Heart rate increased, however, in seizure group compared with the prophylaxis group 2 hours postdrug infusion (median heart rate = 86 vs 164). The ECGs demonstrated a mean PR interval prolongation of about 6 milliseconds (ms) after LCM initiation (mean PR 185.5 ms, compared with baseline ECG mean of 179.3 ms). Laboratory data revealed no clinically significant changes 24 hours after LCM initiation. Three patients developed adverse events (9.4%): One with altered mental state and exceptionally prolonged ECG PR interval (212 vs 178 ms baseline); One with unexplained thrombocytopenia; and a third patient with dizziness, all of which resolved after drug discontinuation. Conclusion: The LCM demonstrated ECG PR prolongation as previously reported without systemic hypotension, with no discernable drug-drug interactions in hospitalized patients. About 9% of patients had transient adverse drug reactions after LCM, namely alteration in mental state, unexplained thrombocytopenia, and dizziness, which stopped after discontinuation of the drug.
机译:背景:拉考酰胺(LCM)是一种较新的抗癫痫药(AED),对住院患者具有有利的特性,包括静脉内调配,最小的肝代谢和无不良呼吸作用。我们试图确定住院患者中LCM的安全性。方法:我们对2009年7月1日至2010年1月31日期间在梅奥诊所医院接受LCM的患者进行了回顾性医疗记录审查。数据包括人口统计学,LCM剂量,伴随的AED治疗,记录的癫痫发作活动,血液动力学变量,心电图(ECG)和实验室数据。审查了药物不良反应和药物相互作用。结果:确定了32例患者。没有发生严重的低血压或严重的心律不齐。然而,与预防组相比,癫痫发作组在药物输注后2小时的心率增加(中位心率= 86 vs 164)。心电图显示LCM启动后平均PR间隔延长约6毫秒(ms)(平均PR为185.5 ms,而基线ECG平均值为179.3 ms)。实验室数据显示LCM启动后24小时无临床显着变化。 3例患者发生了不良事件(9.4%):1例患者精神状态改变,ECG PR间隔异常延长(基线为212 ms对178 ms);一种原因不明的血小板减少症;第三名头晕患者,停药后全部消退。结论:LCM表现出ECG PR延长,如先前报道的那样,没有系统性低血压,住院患者中没有可辨别的药物相互作用。 LCM后约9%的患者出现短暂的药物不良反应,即精神状态改变,无法解释的血小板减少和头晕,在停药后停止。

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