Université Victor Segalen CIC0005, INSERM - CHU de Bordeaux INSERM U657 CHU de Bordeaux, Bordeaux Cedex CHU de Nancy, Nancy, France.
Br J Clin Pharmacol. 2011 Jan;71(1):121-7. doi: 10.1111/j.1365-2125.2010.03805.x.
Levetiracetam has shown good safety/tolerability and efficacy in regulatory trials. This was confirmed in observational investigations performed soon after marketing by using continuation or retention rates as a composite measure. When an anti-epileptic drug first becomes available; however, there is evidence of channelling to more severe patients than thereafter.
This study was performed several years after marketing of levetiracetam and found high rates of continuation. It also further explores this measure by determining the continuation in the absence of initiation of additional anti-epileptic drugs.
To investigate real-life effectiveness of levetiracetam in patients initiating treatment in a stable market situation.
Epileptic adults who had initiated levetiracetam between 1 January and 31 August in 2005 or 2006 were included and followed for 1 year by hospital or nonhospital neurologists practising in France. One-year continuation rates were estimated using Kaplan-Meier analysis. Among those still treated at end of study, treatment goals were investigated. Factors associated with discontinuation were investigated using Cox proportional hazards regression.
A total of 794 subjects were included in the cohort, and 753 subjects were followed up and included in the analysis. Among these, mean (SD) age was 42.6 (±17.0) years, 51.1% were female, 76.6% had partial epilepsy, 93.5% had seizures in the 6 months preceding levetiracetam initiation and 82.9% had at least one concomitant anti-epileptic drug when starting levetiracetam. One-year levetiracetam continuation rate was 83.5% (95% confidence interval, 80.5-86.0%). Of the 579 patients still using levetiracetam at end of study, 46.8% were seizure free during the last 6 months, and 24% were on levetiracetam monotherapy. Reasons for discontinuation (n= 122) were adverse events (45%), lack of efficacy (38%) or both (9%). Levetiracetam discontinuation was most strongly associated with previous exposure to more than four anti-epileptic drugs, whereas continuation was most strongly associated with presence of seizure-related falls in the 6 months preceding levetiracetam initiation.
This population-based cohort study in a stable market situation found a high 1 year levetiracetam continuation rate compared with previous studies done sooner after market introduction.
在监管试验中，左乙拉西坦已显示出良好的安全性/耐受性和疗效。在上市后不久，使用继续或保留率作为综合指标进行观察性研究，对此进行了证实。然而，当一种抗癫痫药物首次上市时，有证据表明其流向比此后更严重的患者。
本研究在左乙拉西坦上市几年后进行，发现继续治疗的比例很高。它还通过确定在没有开始使用其他抗癫痫药物的情况下的继续治疗来进一步探讨这一措施。
在稳定的市场情况下，调查开始治疗的患者中左乙拉西坦的真实疗效。
2005 年 1 月 1 日至 8 月 31 日期间在法国稳定市场中开始使用左乙拉西坦的成年癫痫患者，由医院或非医院的神经科医生进行随访 1 年。使用 Kaplan-Meier 分析估计 1 年的继续治疗率。在研究结束时仍接受治疗的患者中，调查了治疗目标。使用 Cox 比例风险回归分析了与停药相关的因素。
共纳入 794 例患者，753 例患者接受随访并纳入分析。其中，平均（SD）年龄为 42.6（±17.0）岁，51.1%为女性，76.6%为部分性癫痫，93.5%在开始左乙拉西坦前 6 个月有癫痫发作，82.9%在开始左乙拉西坦时至少有 1 种合用的抗癫痫药物。1 年左乙拉西坦继续治疗率为 83.5%（95%置信区间，80.5-86.0%）。在研究结束时仍使用左乙拉西坦的 579 例患者中，46.8%在最后 6 个月无癫痫发作，24%接受左乙拉西坦单药治疗。停药原因（n=122）为不良事件（45%）、疗效不佳（38%）或两者兼有（9%）。左乙拉西坦停药与以前暴露于超过 4 种抗癫痫药物关系最密切，而继续治疗与左乙拉西坦开始前 6 个月与癫痫相关的跌倒有关。
与上市后不久进行的早期研究相比，本项在稳定市场情况下的基于人群的队列研究发现，1 年左乙拉西坦继续治疗率较高。
