Böttcher Stefan, Lutz Martin T, Mayer Thomas
Saxonian Epilepsy Center at Radeberg, Radeberg, Germany.
Epilepsia. 2017 Oct;58(10):1749-1754. doi: 10.1111/epi.13869. Epub 2017 Aug 14.
This study aimed to analyze the retention rate of lacosamide (LCM) in patients with epilepsy and intellectual disabilities (IDs), to identify factors influencing retention rate, and to investigate the LCM retention rate with and without concomitant sodium channel blocker (SCB). We hypothesized that the retention rate of LCM with concomitant SCB would be lower than without SCB.
Using the Kaplan-Meier estimator, we conducted a monocentric, retrospective, observational, open-label study to evaluate LCM retention rates in patients with IDs and drug-resistant epilepsy. In addition, the impact of therapy-related variables on the long-term retention of LCM was evaluated.
One hundred thirty-six subjects with IDs and drug-resistant epilepsy were included (age 2-66 years); most patients had focal epilepsy. Long-term retention rates were 62.0% at 1 year, 43.7% at 2 years, and 29.1% at 3 and 4 years. Reasons for LCM discontinuation included insufficient therapeutic benefits (69%), adverse events (11%), or a combination of both factors (8%). The LCM retention rate was influenced by the number of background antiepileptic drugs (AEDs). An additional and independent influence of concomitant therapy with SCB on retention rate could not be confirmed.
One of the major challenges in medically caring for patients with epilepsy and IDs is the high rate of drug resistance. However, there is a lack of evidence-based information about the efficacy and tolerability of AEDs in this population. It has been shown that concomitant SCB use is a key factor in increasing the risk of LCM failure in children with epilepsy. This finding has not been replicated in our predominantly adult sample of patients with IDs.
本研究旨在分析拉科酰胺(LCM)在癫痫合并智力障碍(ID)患者中的留存率,确定影响留存率的因素,并研究联合使用与未联合使用钠通道阻滞剂(SCB)时LCM的留存率。我们假设联合使用SCB时LCM的留存率低于未使用SCB时。
我们使用Kaplan-Meier估计量进行了一项单中心、回顾性、观察性、开放标签研究,以评估ID和耐药性癫痫患者中LCM的留存率。此外,还评估了治疗相关变量对LCM长期留存的影响。
纳入了136例患有ID和耐药性癫痫的受试者(年龄2至66岁);大多数患者患有局灶性癫痫。1年时的长期留存率为62.0%,2年时为43.7%,3年和4年时为29.1%。停用LCM的原因包括治疗效果不佳(69%)、不良事件(11%)或两者兼而有之(8%)。LCM的留存率受背景抗癫痫药物(AED)数量的影响。无法证实联合使用SCB对留存率有额外的独立影响。
癫痫合并ID患者医疗护理的主要挑战之一是耐药率高。然而,缺乏关于该人群中AED疗效和耐受性的循证信息。已表明联合使用SCB是癫痫儿童LCM治疗失败风险增加的关键因素。这一发现尚未在我们以成年患者为主的ID样本中得到验证。