Sakai F, Diener H-C, Ryan R, Poole P
Department of Medicine, Kitasato University Hospital, Sagamihara City, Kanagawa Prefecture, Japan.
Curr Med Res Opin. 2004 Mar;20(3):269-77. doi: 10.1185/030079903125002973.
To compare the efficacy, safety and tolerability of eletriptan (20, 40 and 80 mg) to placebo when given to Japanese and Western patients for the acute treatment of migraine.
A double-blind, randomized, parallel-group trial with the aforementioned therapeutic objectives was conducted in Japan (N = 321). By bridging analysis, data from this study were compared to two migraine trials previously conducted in the US (N = 1190) and Europe (N = 563).
The 2-h post-dose headache response rates (i.e., the primary efficacy endpoint) of Japanese migraineurs to eletriptan 20, 40 and 80 mg were 64, 67 and 76%, respectively; European and American migraineurs showed similar trends and, in these studies, eletriptan was significantly superior to placebo (p < 0.05). Japanese patients did demonstrate a higher placebo response than Westerners, possibly due to differences in previous triptan exposure or expectation. Adverse events were generally mild to moderate, were comparable in all three studies, and showed a modest dose-response effect.
The efficacy and tolerability of eletriptan for the acute treatment of migraine is comparable in Japan, Europe and the US.
比较依立曲坦（20毫克、40毫克和80毫克）与安慰剂用于日本和西方患者急性治疗偏头痛时的疗效、安全性和耐受性。
在日本开展了一项具有上述治疗目的的双盲、随机、平行组试验（N = 321）。通过桥接分析，将本研究的数据与先前在美国开展的两项偏头痛试验（N = 1190）和欧洲开展的一项偏头痛试验（N = 563）的数据进行比较。
日本偏头痛患者服用20毫克、40毫克和80毫克依立曲坦后2小时的头痛缓解率（即主要疗效终点）分别为64%、67%和76%；欧洲和美国偏头痛患者呈现出相似趋势，并且在这些研究中，依立曲坦显著优于安慰剂（p < 0.05）。日本患者的安慰剂反应确实高于西方人，这可能是由于先前使用曲坦类药物的经历或期望不同所致。不良事件一般为轻至中度，在所有三项研究中相当，并且呈现出适度的剂量反应效应。
依立曲坦用于急性治疗偏头痛的疗效和耐受性在日本、欧洲和美国相当。
