Weill Cornell Medical College in Qatar, Qatar Foundation Education City, Doha, Qatar.
Curr Med Res Opin. 2011 Jul;27(7):1285-93. doi: 10.1185/03007995.2011.573778. Epub 2011 May 12.
Some patients with epilepsy require treatment with >1 adjunctive antiepileptic drug (AED) to achieve adequate seizure remission. The purpose of this analysis was to evaluate the efficacy and safety of adding adjunctive pregabalin to an AED regimen that included levetiracetam in patients with refractory partial-onset epilepsy.
Data from the pregabalin and placebo arms of two placebo-controlled, double-blind, randomized studies of pregabalin in patients who received adjunctive treatment with levetiracetam in addition to ≥1 other AEDs were pooled for this post hoc analysis. Patients (aged ≥18 years) had ≥4 partial-onset seizures and no 28-day period free of seizures during baseline. Efficacy outcomes included Response Ratio (RRatio), change from baseline in seizure frequency, proportion of patients with ≥50% reduction in seizure frequency, and 28-day seizure-freedom rate. Safety was evaluated using adverse events (AEs).
In total, 138 patients were included in the analysis (placebo, n = 47; pregabalin, n = 91). Pregabalin was significantly better than placebo for difference in least squares mean of the RRatio (-16.4; 95% confidence interval [CI]: -28.5, -4.5; p = 0.0085), median of the difference in percentage change from baseline in seizure frequency (-22.3; 95% CI: -40.1, -7.2; p = 0.0095), and proportion of 50% responders (36.3 vs. 17.0; odds ratio, 3.2; 95% CI: 1.3, 8.3; p = 0.018), but not 28-day seizure-freedom rate (7 [7.7%] vs. 2 [4.3%]; p = 0.353). The most common AEs when adding pregabalin were dizziness/vertigo, fatigue, somnolence, blurred vision, and increased weight that were not proportional to the number of concomitant AEDs.
In this population of patients with refractory partial-onset seizures, adding pregabalin to an AED regimen with levetiracetam produced further seizure reductions. The safety profile of pregabalin in patients receiving levetiracetam and ≥1 other AEDs did not appear to be compromised by the number of concomitant AEDs.
有些癫痫患者需要使用>1 种辅助抗癫痫药物（AED）才能达到充分的癫痫缓解。本分析的目的是评估在接受左乙拉西坦辅助治疗的基础上，添加辅助性普瑞巴林治疗难治性部分性发作癫痫患者的疗效和安全性。
对接受左乙拉西坦辅助治疗的患者，将普瑞巴林和安慰剂组的两项安慰剂对照、双盲、随机研究的数据进行了汇总，这些患者在基线期至少有 4 次部分性发作，且没有 28 天无发作期。疗效指标包括反应比（RRatio）、发作频率的基线变化、发作频率降低≥50%的患者比例以及 28 天无发作率。采用不良反应（AE）评估安全性。
共纳入 138 例患者进行分析（安慰剂组 47 例，普瑞巴林组 91 例）。与安慰剂相比，普瑞巴林在反应比的最小二乘均数差异（-16.4；95%置信区间[CI]：-28.5，-4.5；p = 0.0085）、发作频率百分比变化中位数差异（-22.3；95%CI：-40.1，-7.2；p = 0.0095）和 50%应答者比例（36.3%比 17.0%；比值比，3.2；95%CI：1.3，8.3；p = 0.018）方面均显著优于安慰剂，但 28 天无发作率无显著差异（7[7.7%]比 2[4.3%]；p = 0.353）。添加普瑞巴林时最常见的不良反应是头晕/眩晕、疲劳、嗜睡、视物模糊和体重增加，但与同时使用的 AED 数量不成比例。
在难治性部分性发作的患者人群中，在左乙拉西坦治疗方案中添加普瑞巴林可进一步减少癫痫发作。在接受左乙拉西坦和≥1 种其他 AED 治疗的患者中，普瑞巴林的安全性似乎不受同时使用的 AED 数量的影响。
