National Center for Register-Based Research, Department of Economics and Business Economics, Aarhus University, Aarhus, Denmark.
Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.
Epilepsia. 2022 Sep;63(9):2371-2380. doi: 10.1111/epi.17339. Epub 2022 Jul 5.
The US Food and Drug Administration recently issued a warning against the use of the antiseizure medication lamotrigine in people at risk of cardiac rhythm and conduction abnormalities. This study assessed the risk of cardiac morbidity and mortality in new users of lamotrigine.
In a Danish population-based cohort study, we followed cohort members aged ≥15 years for the first 2 years after they initiated lamotrigine therapy. The main outcomes were cardiac conduction disorders in people without pre-existing cardiac morbidity and all-cause mortality in people with pre-existing cardiac morbidity. Cox proportional hazards models provided hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) for comparison of the risk in current versus past users of lamotrigine.
There were 91 949 (36 618 males [39.8%]) new users of lamotrigine (median age = 45.7 years, interquartile range = 32.0-60.2 years). Among users without pre-existing cardiac disease (n = 86 769), 194 (.23%) developed a cardiac conduction disorder. Comparison of the risk in current and past lamotrigine treatment periods yielded an adjusted HR of new onset cardiac conduction disorder of 1.03 (95% CI = .76-1.40). Among users with pre-existing cardiac disease (n = 5180), 1150 (22.2%) died. Comparison of the risk in current and past lamotrigine treatment periods yielded an adjusted HR for all cause-mortality of 1.05 (95% CI = .93-1.19).
In this large population-based study, lamotrigine use was associated neither with a risk of cardiac conduction disorders in people without pre-existing cardiac morbidity nor with all-cause mortality in people with pre-existing cardiac morbidity.
美国食品和药物管理局最近发布警告称，抗癫痫药物拉莫三嗪可能导致心律失常和传导异常。本研究评估了新使用拉莫三嗪的患者的心脏发病率和死亡率风险。
在一项丹麦基于人群的队列研究中，我们对年龄≥ 15 岁的队列成员在开始拉莫三嗪治疗后的头 2 年内进行了随访。主要结局为无既往心脏疾病的患者中的心脏传导障碍，以及有既往心脏疾病的患者中的全因死亡率。Cox 比例风险模型提供了风险比（HR）和相应的 95%置信区间（CI），用于比较当前与过去使用拉莫三嗪的患者的风险。
共有 91949 名（36618 名男性[39.8%]）新使用拉莫三嗪的患者（中位年龄 45.7 岁，四分位距 32.0-60.2 岁）。在无既往心脏疾病的患者中（n = 86769），有 194 例（0.23%）发生了心脏传导障碍。当前和过去拉莫三嗪治疗期间的风险比较得出新发心脏传导障碍的调整 HR 为 1.03（95%CI = 0.76-1.40）。在有既往心脏疾病的患者中（n = 5180），有 1150 例（22.2%）死亡。当前和过去拉莫三嗪治疗期间的风险比较得出全因死亡率的调整 HR 为 1.05（95%CI = 0.93-1.19）。
在这项大型基于人群的研究中，拉莫三嗪的使用与无既往心脏疾病的患者的心脏传导障碍风险或有既往心脏疾病的患者的全因死亡率均无相关性。
