Bousquet Jean, Barnes Neil, Gibbs Michael, Gul Nadeem, Tomkins Susan A, Zhou Xin, Cho Young-Joo, Park Hae-Sim, Busse William, Zhong Nanshan
Fondation MACVIA-LR, Contre les Maladies Chroniques pour un Vieillissement Actif en Languedoc-Roussillon, European Innovation Partnership on Active and Healthy Ageing Reference Site, University of Montpellier, Montpellier, France.
INSERM, VIMA: Ageing and Chronic Diseases, Epidemiological and Public Health Approaches, U1168, Paris, France.
BMC Pulm Med. 2017 Apr 28;17(1):75. doi: 10.1186/s12890-017-0410-x.
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.
分析丙酸氟替卡松（FP）单药治疗及联合沙美特罗（SAL）治疗对亚洲患者实现指南定义的哮喘控制的疗效。
对GOAL研究进行事后分析，根据既往用药情况将患者分为未使用吸入性糖皮质激素（ICS）组（第1层[S1]）、低剂量ICS组（S2）和中等剂量ICS组（S3），并随机接受FP/SAL或FP治疗。每12周增加一次剂量，直至哮喘完全控制或达到最大剂量（第1阶段[PhI]），然后维持至研究结束（第2阶段[PhII]）。主要终点是在PhI期间实现哮喘良好控制的患者比例。其他终点包括完全控制和不良事件。分别对亚洲和非亚洲患者进行分析。
在PhI期的亚洲患者中，S1组中74%（n = 87/118）使用FP/SAL的患者实现了哮喘良好控制，而单独使用FP的患者为74%（n = 89/121）（p = 0.839）；S2组相应数值分别为76%（n = 81/107）和60%（n = 62/104；p = 0.005），S3组分别为58%（n = 59/102）和43%（n = 41/95；p = 0.015）。与单独使用FP相比，所有三层中更多患者使用FP/SAL实现了哮喘完全控制。与单独使用FP相比，使用FP/SAL能更快实现控制且所需ICS剂量更低。在PhI期实现控制的患者中，很大一部分在PhII期维持了控制。在非亚洲患者中也发现了类似趋势。未发现新的安全问题。
与单独使用FP相比，更大比例的亚洲患者（S2和S3组为良好控制；所有层为完全控制）使用FP/SAL实现了指南定义的哮喘控制。S1组中高比例的亚洲患者在两个治疗组中均实现了哮喘良好控制。
