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首页> 外文期刊>BMC Neurology >Comparative effectiveness of levetiracetam, valproate and carbamazepine among elderly patients with newly diagnosed epilepsy: subgroup analysis of the randomized, unblinded KOMET study
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Comparative effectiveness of levetiracetam, valproate and carbamazepine among elderly patients with newly diagnosed epilepsy: subgroup analysis of the randomized, unblinded KOMET study

机译：左乙拉西坦，丙戊酸盐和卡马西平在老年初诊癫痫患者中的比较有效性：随机，无盲KOMET研究的亚组分析

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Background Few clinical trials have evaluated the efficacy and tolerability of antiepileptic drugs (AEDs) as initial monotherapy for elderly patients. Methods This post-hoc subgroup analysis of data from an unblinded, randomized, 52-week superiority study (KOMET) compared the effectiveness of levetiracetam (LEV) with extended-release sodium valproate (VPA-ER) and controlled-release carbamazepine (CBZ-CR) as monotherapy in patients aged?≥?60?years with newly diagnosed epilepsy. The physician chose VPA or CBZ as preferred standard treatment; patients were randomized to standard AEDs or LEV. The primary endpoint was time to treatment withdrawal. Results are exploratory, since KOMET was not powered for a subgroup analysis by age. Results Patients ( n =?308) were randomized to LEV ( n =?48) or VPA-ER ( n =?53) in the VPE-ER stratum or to LEV ( n =?104) or CBZ-CR ( n =?103) in the CBZ-CR stratum. Mean age was 69.6?years, range 60.2–89.9?years (intention-to-treat population n =?307). Time to treatment withdrawal hazard ratio [HR] (95?% confidence interval [CI]) for LEV vs. standard AEDs was 0.44 (0.28–0.67); LEV vs. VPA-ER: 0.46 (0.16–1.33); LEV vs. CBZ-CR: 0.45 (0.28–0.72). Twelve-month withdrawal rates were: LEV vs. standard AEDs, 20.4 vs. 38.7?%; LEV vs. VPA-ER, 10.4 vs. 23.1?%; LEV vs. CBZ-CR, 25.0 vs. 46.6?%. Time to first seizure was similar between LEV and standard AEDs (HR: 0.92, 95?% CI: 0.63–1.35), LEV and VPA-ER (0.77, 0.38–1.56), and LEV and CBZ-CR (1.02, 0.64–1.63). Adverse events were reported by 76.2, 67.3, and 82.5?% of patients for LEV, VPA-ER, and CBZ-CR, respectively. Discontinuation rates due to AEs were 11.3, 10.2, and 35.0?% for LEV, VPA-ER, and CBZ-CR, respectively. Conclusions Time to treatment withdrawal was longer with LEV compared with standard AEDs. This finding was driven primarly by the result in the CBZ-CR stratum, which in turn was likely due to the more favorable tolerability profile of LEV. Results of this post-hoc analysis suggest that LEV may be a suitable option for initial monotherapy for patients aged?≥?60?years with newly diagnosed epilepsy. Trial registration ClinicalTrials.gov: NCT00175903 ; September 9, 2005.
机译：背景技术很少有临床试验评估抗癫痫药物（AED）作为老年患者最初的单一疗法的疗效和耐受性。方法这项来自52周无盲随机对照研究（KOMET）的事后亚组分析比较了左乙拉西坦（LEV）与缓释丙戊酸钠（VPA-ER）和控释卡马西平（CBZ- CR）作为≥60岁的新诊断癫痫患者的单药治疗。医师选择VPA或CBZ作为首选标准治疗方法;患者被随机分为标准AED或LEV。主要终点是停药时间。由于KOMET未按年龄进行亚组分析，因此结果具有探索性。结果患者（n =？308）被随机分配到VPE-ER层中的LEV（n =？48）或VPA-ER（n =？53）或LEV（n =？104）或CBZ-CR（n = （？103）在CBZ-CR层中。平均年龄为69.6岁，范围为60.2-89.9岁（意向性治疗人群n = 307）。与标准AED相比，LEV的治疗撤回风险比[HR]（95％置信区间[CI]）为0.44（0.28-0.67）; LEV与VPA-ER：0.46（0.16-1.33）; LEV对CBZ-CR：0.45（0.28–0.72）。十二个月的退出率是：LEV vs.标准AED，20.4 vs. 38.7％; LEV vs.VPA-ER，分别为10.4和23.1％。 LEV对CBZ-CR，25.0对46.6％。 LEV和标准AED（HR：0.92，95％CI：0.63–1.35），LEV和VPA-ER（0.77，0.38–1.56）和LEV和CBZ-CR（1.02，0.64–1.0）的首次发作时间相似。 1.63）。 LEV，VPA-ER和CBZ-CR分别报告了76.2％，67.3％和82.5％的不良事件。 LEV，VPA-ER和CBZ-CR的AEs停产率分别为11.3％，10.2％和35.0％。结论与标准AED相比，LEV的停药时间更长。这一发现主要是由CBZ-CR层中的结果驱动的，这又可能是由于LEV的耐受性更有利。事后分析的结果表明，对于初诊为癫痫的≥60岁的患者，LEV可能是初始单药治疗的合适选择。试用注册ClinicalTrials.gov：NCT00175903; 2005年9月9日。

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