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拉科酰胺治疗的疗效和耐受性:中东地区上市后经验

Efficacy and tolerability of treatment with lacosamide: Postmarketing experience from the Middle East region.

作者信息

Arabi Maher, Alsaadi Taoufik, Nasreddine Wassim, Al-Hashel Jasem, Dirani Maya, Beydoun Ahmad

机构信息

Ibn Sina Hospital, Kuwait City, Kuwait.

American Center for Psychiatry & Neurology, Abu Dhabi, United Arab Emirates.

出版信息

Epilepsy Behav. 2018 Jul;84:118-121. doi: 10.1016/j.yebeh.2018.04.020. Epub 2018 May 26.

Abstract

PURPOSE

Lacosamide (LCM) was recently introduced in the Middle East. The aim of this study was to evaluate the safety, tolerability, and efficacy of LCM in patients with focal onset seizures and determine if our results are comparable with those derived from Western countries.

METHODS

This is a retrospective analysis from two medical centers on consecutive patients diagnosed as having focal onset seizures and treated with add-on LCM. The primary efficacy variables were the 50% responder and seizure-free rates, and the secondary outcome variables included the percentages of patients who achieved seizure remission during the last 6-month follow-up period and the percentages of discontinuation due to lack of efficacy or tolerability.

RESULTS

One hundred four patients with a mean age of 30.9 years and experiencing a mean of 9.4 seizures per month during baseline were included. The 50% responder rates were 69% and 70% at 6- and 24-month follow-ups, respectively. Patients concomitantly treated with a sodium channel blocker were less likely to achieve seizure remission during the last 6-month follow-up period while the early introduction of LCM resulted in a significantly higher likelihood of achieving such a remission. Eighty-eight percent of patients were still maintained on LCM at the last follow-up, and the most common adverse events consisted of dizziness and somnolence, double vision, and nausea/vomiting.

CONCLUSIONS

Our data show similar efficacy and tolerability to those reported from Western countries. Our results also substantiate the early introduction of LCM and support the dose reduction of baseline AED especially that of sodium channel blockers to minimize adverse events.

摘要

目的

拉考酰胺(LCM)最近在中东地区开始应用。本研究旨在评估LCM治疗局灶性发作癫痫患者的安全性、耐受性和疗效,并确定我们的结果是否与西方国家的结果可比。

方法

这是一项来自两个医学中心的回顾性分析,研究对象为连续诊断为局灶性发作癫痫并接受LCM添加治疗的患者。主要疗效变量为50%缓解率和无发作率,次要结局变量包括在最后6个月随访期内实现癫痫缓解的患者百分比以及因疗效不佳或耐受性差而停药的百分比。

结果

纳入104例患者,平均年龄30.9岁,基线期平均每月发作9.4次。在6个月和24个月随访时,50%缓解率分别为69%和70%。在最后6个月随访期内,同时接受钠通道阻滞剂治疗的患者癫痫缓解的可能性较小,而早期引入LCM则显著提高了实现缓解的可能性。在最后一次随访时,88%的患者仍在服用LCM,最常见的不良事件包括头晕、嗜睡、复视和恶心/呕吐。

结论

我们的数据显示出与西方国家报告的相似的疗效和耐受性。我们的结果还证实了早期引入LCM,并支持降低基线抗癫痫药物(AED)尤其是钠通道阻滞剂的剂量,以尽量减少不良事件。

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