哮喘联盟

   摘要
   研究背景：糠酸氟替卡松(FF)/维兰特罗(VI)是在日本和欧洲获批治疗哮喘的每日一次吸入性糖皮质激素/长效β2受体激动剂 (OD)组合。采用东亚哮喘研究中关于FF/VI的功效和安全性的数据来评估种族敏感性。
   方法：本研究为一项随机、双盲、多中心的IIb/III期研究。比较日本病人(N = 148)和非日本病人(N = 3,066; 三项研究)使用安慰剂或每天两次500ug氟替卡松的谷FEV1自基线的变化。对日本+韩国病人(N = 188)和非日本+韩国病人(N = 3,840；五项研究)的不良反应(AEs)、实验室结果和心电图进行比较。
   结果：在12周时对FF/VI 100/25 μg OD vs.安慰剂的谷FEV1和基线改善情况进行报告(日本: 0.323 L [0.104-0.542]; 非日本: 0.168 L [0.095-0.241])。24周时报告FF/VI 200/25 μg OD自基线（最小平方均值改变[标准误]）有改善情况(日本: 0.355 L [0.1152]; 非日本: 0.396 L [0.0313])。来自更大数量的日本+韩国vs.非日本+韩国病人报告了包括安慰剂组在内的所有治疗组的AEs(FF/VI 100/25 μg: 79 % vs. 57 %; FF/VI 200/25 μg: 64 % vs. 45 %; 安慰剂: 41 % vs. 23 %)。治疗相关或分组相关的AEs无显著差异。日本+韩国和非日本+韩国组在心电图评估或24h尿糖皮质激素排泄方面均无临床差异或统计学区别。
   结论：在东亚哮喘病人中FF/VI 100/25 μg 和200/25 μg OD取得很好的疗效和可接受的安全性；这些全球推荐剂量适用于日本的哮喘病人。
 

（杨冬 审校）
BMC Pulm Med. 2015 Dec 24;15(1):165. doi: 10.1186/s12890-015-0159-z.

 

Ethnic sensitivity assessment of fluticasone furoate/vilanterol in East Asian asthma patients from randomized double-blind multicentre Phase IIb/III trials.
 

Gross AS1, Goldfrad C2, Hozawa S3, James MH4, Clifton CS5, Sugiyama Y6, Jacques L7.
 

Abstract
BACKGROUND:Fluticasone furoate (FF)/vilanterol (VI) is a once daily (OD) inhaled corticosteroid/long-acting β2-agonist combination asthma therapy approved in Japan and the EU. FF/VI efficacy and safety data from asthma studies including patients in East Asia were evaluated to assess ethnic sensitivity.
METHODS:Randomized, double-blind, multicenter Phase IIb/III trials were assessed. Change from baseline relative to placebo or twice-daily fluticasone propionate 500 μg in trough FEV1 was compared between patients from Japan (N = 148) and Not-Japan (N = 3,066; three studies). Adverse events (AEs), laboratory results, and electrocardiograms were compared between patients from Japan + Korea (N = 188) and Not-Japan + Korea (N = 3,840; five studies).
RESULTS:For trough FEV1, improvements from baseline (least-squares mean difference [95 % confidence interval]) were reported for FF/VI 100/25 μg OD versus placebo at Week 12 (Japan: 0.323 L [0.104-0.542]; Not-Japan: 0.168 L [0.095-0.241]). Improvements from baseline (least-squares mean change [standard error]) were reported with FF/VI 200/25 μg OD at Week 24 (Japan: 0.355 L [0.1152]; Not-Japan: 0.396 L [0.0313]). A greater proportion of patients from Japan + Korea versus Not-Japan + Korea reported AEs in all treatment arms including placebo (FF/VI 100/25 μg: 79 % versus 57 %; FF/VI 200/25 μg: 64 % versus 45 %; placebo: 41 % versus 23 %). There were no notable differences in treatment-related or class-related AEs. No clinically significant changes in electrocardiogram assessments or statistically significant differences in 24 h urinary cortisol excretion were observed between the Japan + Korea and Not-Japan + Korea cohorts.
CONCLUSIONS:Good efficacy and an acceptable safety profile were observed for FF/VI 100/25 μg and 200/25 μg OD in East Asian asthma patients; these globally recommended doses are appropriate for asthma patients in Japan.
 

BMC Pulm Med. 2015 Dec 24;15(1):165. doi: 10.1186/s12890-015-0159-z.