Asthma control using fluticasone propionate/salmeterol in Asian and non-Asian populations: a post hoc analysis of the GOAL study.
Asthma control using fluticasone propionate/salmeterol in Asian and non-Asian populations: a post hoc analysis of the GOAL study.
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DOI：
10.1186/s12890-017-0410-x
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发表时间：
2017-04-28
影响因子：
3.1
通讯作者：
Zhong N
中科院分区：
文献类型：
--
作者：
Bousquet J;Barnes N;Gibbs M;Gul N;Tomkins SA;Zhou X;Cho YJ;Park HS;Busse W;Zhong N
分析丙酸氟替卡松（FP）单用和联合沙美特罗（SAL）在亚洲患者中实现指南定义的哮喘控制的疗效。一项对GOAL研究的事后分析，在该研究中，将患者按既往用药分层为吸入性皮质类固醇（ICS）初治（分层[S] 1）、低剂量ICS（S2）和中剂量ICS（S3），并随机接受FP/SAL或FP。每12周递增一次剂量，直至哮喘完全控制或达到最大剂量（PhI），然后维持至研究结束（PhII）。主要终点是PhI期间哮喘控制良好的患者比例。其他终点包括总控制和不良事件。对亚洲和非亚洲患者进行了单独分析。在PhI的亚洲患者中，74%（n = 87/118）在S1中实现了良好控制的哮喘，FP/SAL为74%，（n = 89/121）单独使用FP（p = 0.839）;相应值为76%（n = 81/107）与S2中的60%（n = 62/104; p = 0.005），以及S3中的58%（n = 59/102）与43%（n = 41/95; p = 0.015）。在所有三个分层中，FP/SAL组与FP单药组相比，更多的患者实现了哮喘完全控制。与FP相比，FP/SAL更快地实现了控制，ICS剂量更低。在PhI期间达到控制的患者中，有很高比例在PhII期间保持控制。在非亚裔患者中也发现了类似的趋势。未发现新的安全性问题。与FP单药治疗相比，FP/SAL治疗后达到指南定义的哮喘控制的亚洲患者比例更高（S2和S3，控制良好;所有分层，完全控制）。在两个治疗组中，S1的亚洲患者中哮喘控制良好的比例较高。本文的在线版本（doi：10.1186/s12890-017-0410-x）包含补充材料，可供授权用户使用。
To analyse the efficacy of fluticasone propionate (FP) alone and combined with salmeterol (SAL) in achieving guideline-defined asthma control in Asian patients. A post hoc analysis of the GOAL study in which patients were stratified by prior-medication use into inhaled corticosteroid (ICS)-naïve (Stratum [S] 1), low-dose ICS (S2), and medium-dose ICS (S3), and randomised to receive FP/SAL or FP. Doses were stepped-up every 12 weeks until Totally Controlled asthma or maximum dose was reached (PhI) and then maintained until study end (PhII). The primary endpoint was the proportion of patients achieving Well-Controlled asthma during PhI. Additional endpoints included Total Control and adverse events. Asian and non-Asian patients were analysed separately. In Asian patients in PhI, 74% (n = 87/118) in S1 achieved Well-Controlled asthma with FP/SAL versus 74% (n = 89/121) with FP alone (p = 0.839); corresponding values were 76% (n = 81/107) versus 60% (n = 62/104; p = 0.005) in S2, and 58% (n = 59/102) versus 43% (n = 41/95; p = 0.015) in S3. More patients in all three strata achieved Totally Controlled asthma with FP/SAL versus FP alone. Control was achieved more rapidly and with lower ICS doses with FP/SAL versus FP. A high proportion of patients who achieved control during PhI maintained control during PhII. Similar trends were found in non-Asian patients. No new safety concerns were identified. A greater proportion of Asian patients (S2 and S3, for Well-Controlled; all strata, for Totally Controlled) achieved guideline-defined asthma control with FP/SAL versus FP alone. High proportions of Asian patients in S1 achieved Well-Controlled asthma in both treatment groups. The online version of this article (doi:10.1186/s12890-017-0410-x) contains supplementary material, which is available to authorized users.