Consultant and Yale University, 2207 Bancroft St., Houston, TX 77027, United States of America.
Sunovion Pharmaceuticals Inc., 84 Waterford Drive, Marlborough, MA 01752, United States of America.
Epilepsy Behav. 2019 Mar;92:31-35. doi: 10.1016/j.yebeh.2018.12.003. Epub 2019 Jan 2.
While antiepileptic drug (AED) treatment effectiveness is traditionally assessed based on seizure frequency reduction (SFR), the overall value of AEDs in managing epilepsy and associated sequelae may be best assessed by how patients feel and function in terms of overall health-related quality of life (HRQoL). We conducted a pooled analysis of the Quality of Life in Epilepsy-31 (QOLIE-31) questionnaire from two phase 3 trials to explore the effect of response to conversion to eslicarbazepine acetate (ESL) monotherapy on HRQoL.
Data were pooled from two multicenter, randomized, double-blind, historical control phase 3 trials examining conversion to ESL monotherapy in adults with inadequately controlled partial-onset seizures (POS). The relationship between HRQoL and ESL treatment response was examined through the analysis of week 18 QOLIE-31 scores between patients who met the SFR ≥50% threshold (responders) and patients with SFR <50% (nonresponders). The analysis was conducted in the efficacy population (intent-to-treat (ITT) patients who entered the AED taper/conversion period) and completer population (efficacy patients who completed the ESL monotherapy period) and was repeated using an SFR ≥75% threshold.
In the efficacy population, week 18 QOLIE-31 total score least squares mean (LSM) was significantly higher for responders with ≥50% SFR (LSM difference: 3.0; 95% confidence interval (CI): 0.2-5.8; p = 0.037) and with ≥75% SFR (LSM difference: 7.0; 95% CI: 3.6-10.3; p < 0.001) than nonresponders. In the completer population, overall quality of life (QoL) (LSM difference: 5.1; 95% CI: 1.5-8.6; p = 0.006) and social functioning (LSM difference: 5.4; 95% CI: 0.1-10.7; p = 0.046) were significantly higher for responders with ≥50% SFR than nonresponders, and all domain LSMs were higher for responders with ≥75% SFR (all p < 0.05) than nonresponders.
This analysis of data from the phase 3 trials demonstrated significantly higher HRQoL among ESL responders with SFR of ≥75% and also at the lower SFR threshold of ≥50% compared with nonresponders.
传统上，抗癫痫药物 (AED) 治疗效果是基于癫痫发作频率降低 (SFR) 来评估的，但 AED 在管理癫痫及其相关后遗症方面的总体价值，可能最好通过患者在整体健康相关生活质量 (HRQoL) 方面的感觉和功能来评估。我们对两项 3 期临床试验的癫痫生活质量 31 项问卷 (QOLIE-31) 进行了汇总分析，以探讨对转换为依佐加滨乙酯 (ESL) 单药治疗的反应与 HRQoL 的关系。
数据来自两项多中心、随机、双盲、历史对照的 3 期临床试验，研究了在部分性发作控制不佳的成人中转换为 ESL 单药治疗的情况。通过分析满足 SFR ≥50%阈值（应答者）和 SFR <50%（无应答者）的患者在第 18 周 QOLIE-31 评分之间的关系，探讨了 HRQoL 与 ESL 治疗反应之间的关系。分析在疗效人群（意向治疗（ITT）患者进入 AED 减量/转换期）和完成者人群（完成 ESL 单药治疗期的疗效患者）中进行，并使用 SFR ≥75%阈值重复进行。
在疗效人群中，SFR ≥50%的应答者的第 18 周 QOLIE-31 总分最小二乘均值 (LSM) 显著高于无应答者（LSM 差值：3.0；95%置信区间 [CI]：0.2-5.8；p=0.037），SFR ≥75%的应答者也显著高于无应答者（LSM 差值：7.0；95%CI：3.6-10.3；p<0.001）。在完成者人群中，总体生活质量（LSM 差值：5.1；95%CI：1.5-8.6；p=0.006）和社会功能（LSM 差值：5.4；95%CI：0.1-10.7；p=0.046）应答者的 LSM 显著高于无应答者，所有领域的 LSM 也均高于 SFR ≥75%的应答者（所有 p<0.05）。
本项对 3 期临床试验数据的分析表明，与无应答者相比，SFR≥75%的 ESL 应答者的 HRQoL 更高，而 SFR 较低的应答者（≥50%）的 HRQoL 也更高。
