Investigation of Influencing Factors on Higher Placebo Response in East Asian Versus Western Clinical Trials for Partial Epilepsy: A Meta-Analysis
Investigation of Influencing Factors on Higher Placebo Response in East Asian Versus Western Clinical Trials for Partial Epilepsy: A Meta-Analysis
复制标题
东亚与西方部分性癫痫临床试验中较高安慰剂反应的影响因素调查：荟萃分析
DOI：
10.1007/s40261-013-0077-x
复制
发表时间：
2013
影响因子：
3.2
通讯作者：
M. Narukawa
中科院分区：
文献类型：
--
作者：
Y. Tachibana;M. Narukawa
背景抗癫痫药物（AEDs）临床试验中的安慰剂反应已被研究，最近的一项荟萃分析显示，东亚试验显示出出乎意料的更高的安慰剂反应。由于跨国试验已变得普遍，因此了解不同环境下的安慰剂反应非常重要，包括未来临床试验的地区/国家。目前的荟萃分析旨在研究在临床试验中导致更高安慰剂应答的潜在因素，对东亚和西方人群中成人难治性部分性癫痫患者的治疗进行了研究。在东亚和西方国家进行的临床试验。安慰剂的反应和潜在的影响因素之间的关系进行了检查，通过Logistic回归analysis.ResultsThe数据库包括33个试验从5个抗癫痫药物：加巴喷丁，托吡酯，左乙拉西坦，普瑞巴林，唑尼沙胺。安慰剂反应与患者特征相关，如疾病持续时间、基线时复杂部分性癫痫发作（CPS）患者百分比、接受两种AED治疗的患者百分比、基线时方案要求的癫痫发作频率和发表年份。Logistic回归分析表明，在东亚试验的安慰剂反应在统计学上高于西方trials.ConclusionPatient的特点，如较长的疾病持续时间和CPS在基线有助于减少安慰剂反应的AED部分癫痫的临床试验。虽然安慰剂反应存在地域差异的原因尚不清楚，但在设计未来的AED治疗部分性癫痫的临床试验时，应仔细考虑这些和其他有助于安慰剂反应的患者特征。
BackgroundPlacebo response in clinical trials for anti-epileptic drugs (AEDs) has been examined and a recent meta-analysis revealed that East Asian trials showed unexpectedly higher placebo response. As multi-national trials have become common, it is important to understand placebo response in different settings, including regions/countries for future clinical trials.ObjectiveThe present meta-analysis aims to investigate the potential factors that contribute to higher placebo response in clinical trials for add-on therapy to adult patients with refractory partial epilepsy in East Asian and Western populations.MethodsA database was established based on published clinical trials conducted in East Asian and Western countries. The relationship between the degree of placebo response and potential influencing factors was examined by logistic regression analyses.ResultsThe database included 33 trials from five AEDs: gabapentin, topiramate, levetiracetam, pregabalin, and zonisamide. Placebo response was associated with patient characteristics such as disease duration, percentage of patients with complex partial seizure (CPS) at baseline, percentage of patients treated with two AEDs, protocol-required seizure frequency at baseline, and year of publication. Logistic regression analysis demonstrated that the placebo response in East Asian trials was statistically higher than that in Western trials.ConclusionPatient characteristics such as longer disease duration and CPS at baseline contribute to a reduction in placebo response in clinical trials of AEDs for partial epilepsy. While the reasons for the geographical difference in placebo response are not clear, these and other patient characteristics contributing to placebo response should be carefully considered in the design of future clinical trials of AEDs for partial epilepsy.