Department of Clinical Cardiology, Heart Center, Amsterdam UMC-University of Amsterdam, Cardiovascular Sciences, Meibergdreef 9, Amsterdam, The Netherlands.
Department of Endocrinology and Metabolism, Amsterdam UMC-University of Amsterdam, Meibergdreef 15, 1105 AZ Amsterdam, The Netherlands.
Europace. 2022 Nov 22;24(11):1809-1823. doi: 10.1093/europace/euac087.
While mexiletine has been used for over 40 years for prevention of (recurrent) ventricular arrhythmias and for myotonia, patient access has recently been critically endangered. Here we aim to demonstrate the effectiveness and safety of mexiletine in the treatment of patients with (recurrent) ventricular arrhythmias, emphasizing the absolute necessity of its accessibility.
Studies were included in this systematic review (PROSPERO, CRD42020213434) if the efficacy or safety of mexiletine in any dose was evaluated in patients at risk for (recurrent) ventricular arrhythmias with or without comparison with alternative treatments (e.g. placebo). A systematic search was performed in Ovid MEDLINE, Embase, and in the clinical trial registry databases ClinicalTrials.gov and ICTRP. Risk of bias were assessed and tailored to the different study designs. Large heterogeneity in study designs and outcome measures prompted a narrative synthesis approach. In total, 221 studies were included reporting on 8970 patients treated with mexiletine. Age ranged from 0 to 88 years. A decrease in ventricular arrhythmias of >50% was observed in 72% of the studies for pre-mature ventricular complexes, 64% for ventricular tachycardia, and 33% for ventricular fibrillation. Electrocardiographic effects of mexiletine were small; only in a subset of patients with primary arrhythmia syndromes, a relative (desired) QTc decrease was reproducibly observed. As for adverse events, gastrointestinal complaints were most frequently observed (33% of the patients).
In this systematic review, we present all the currently available knowledge of mexiletine in patients at risk for (recurrent) ventricular arrhythmias and show that mexiletine is both effective and safe.
米贝地尔已被用于预防（复发性）室性心律失常和肌强直超过 40 年，但最近患者的用药途径受到了严重威胁。本研究旨在证明米贝地尔治疗（复发性）室性心律失常患者的有效性和安全性，强调其可及性的绝对必要性。
如果在伴有或不伴有替代治疗（如安慰剂）的情况下，任何剂量的米贝地尔对有（复发性）室性心律失常风险的患者的疗效或安全性进行了评估，本系统评价（PROSPERO，CRD42020213434）将纳入相关研究。在 Ovid MEDLINE、Embase 和临床试验注册数据库 ClinicalTrials.gov 和 ICTRP 中进行了系统检索。评估了偏倚风险，并针对不同的研究设计进行了调整。由于研究设计和结局指标的高度异质性，采用了叙述性综合方法。共纳入 221 项研究，报道了 8970 例接受米贝地尔治疗的患者。患者年龄从 0 岁至 88 岁。72%的研究观察到室性早搏减少>50%，64%的研究观察到室性心动过速减少>50%，33%的研究观察到心室颤动减少>50%。米贝地尔的心电图效应较小；仅在一部分有原发性心律失常综合征的患者中，观察到相对（所需）QTc 下降具有可重复性。至于不良事件，最常见的是胃肠道投诉（33%的患者）。
在本系统评价中，我们呈现了目前所有关于米贝地尔在有（复发性）室性心律失常风险的患者中的知识，并表明米贝地尔既有效又安全。
