根据基线患者特征和治疗亚组，糠酸氟替卡松/维兰特罗在 Salford 肺研究（SLS COPD）中的获益和安全性。
Benefit and safety of fluticasone furoate/vilanterol in the Salford Lung Study in chronic obstructive pulmonary disease (SLS COPD) according to baseline patient characteristics and treatment subgroups.
机构信息
Salford Royal NHS Foundation Trust, Stott Lane, Salford, M6 8HD, UK; Division of Infection, Immunity and Respiratory Medicine, Manchester Academic Health Sciences Centre, The University of Manchester, Oxford Rd, Manchester, M13 9PL, UK.
Division of Infection, Immunity and Respiratory Medicine, Manchester Academic Health Sciences Centre, The University of Manchester, Oxford Rd, Manchester, M13 9PL, UK; Manchester University NHS Foundation Trust, Manchester, UK.
出版信息
Respir Med. 2019 Feb;147:58-65. doi: 10.1016/j.rmed.2018.12.016. Epub 2019 Jan 10.
BACKGROUND
SLS COPD was the first open-label randomised controlled trial demonstrating a reduction in moderate/severe COPD exacerbations with once-daily inhaled fluticasone furoate/vilanterol (FF/VI) in everyday clinical practice. Here we report FF/VI effectiveness and safety in predefined patient subgroups.
METHODS
Patients with COPD, exacerbation history, and receiving maintenance inhaler therapy, were randomised to initiate FF/VI 100/25 μg or continue usual care (UC) with 12 months' follow-up. Annual rates of moderate/severe exacerbations (primary outcome), selected secondary outcomes, and incidence of pneumonia serious adverse events of special interest (SAESI) were compared between randomisation groups across various patient subgroups/baseline treatment strata. SAESI rates by actual treatment were also assessed.
RESULTS
Lower exacerbation rates were observed for FF/VI versus UC across all subgroups/strata, including ICS + LABA therapy subset (8.0% [0.1, 15.4]), except in patients without baseline airflow limitation (-0.5% [-29.8, 22.1]). Larger reductions compared to the overall analysis were observed for patients on ICS-containing regimens (excluding LAMA) before the study (15.6% [3.4, 26.3]), and with baseline CAT score <10 (25.3% [-0.4, 44.4]). Pneumonia SAESI rates were similar for FF/VI versus UC across all subgroups/strata, except the LABA, LAMA or LABA + LAMA stratum (incidence ratio 2.8 [0.9, 8.5]). SAESI rates were not increased for FF/VI versus other ICS + LABA.
CONCLUSIONS
Initiating FF/VI versus continuing UC reduced exacerbation rates without increased pneumonia SAESI risk compared to other ICS-containing regimens and in various patient subgroups, consistent with primary study findings. FF/VI may be a therapeutic option for a broad population of COPD patients, including those with more severe disease.
背景
SLS COPD 是首个在日常临床实践中证明每日一次吸入糠酸氟替卡松/维兰特罗（FF/VI）可减少中重度 COPD 加重的开放性标签随机对照试验。在此，我们报告了 FF/VI 在预设患者亚组中的疗效和安全性。
方法
具有 COPD 加重史、正在接受维持性吸入治疗的患者被随机分配接受 FF/VI 100/25μg 治疗或继续接受常规护理（UC），随访 12 个月。主要结局（每年中重度加重率）和其他次要结局、以及特别关注的严重不良事件（SAESI）发生率在两组间的各个患者亚组/基线治疗分层中进行比较。还评估了实际治疗的 SAESI 发生率。
结果
在所有亚组/分层中，与 UC 相比，FF/VI 治疗组的加重率均较低，包括 ICS+LABA 治疗亚组（8.0%[0.1，15.4]），但在基线无气流受限的患者中除外（-0.5%[-29.8，22.1]）。与总体分析相比，在研究前正在使用 ICS 方案（不包括 LAMA）的患者中观察到更大的降低（15.6%[3.4，26.3]），且基线 CAT 评分<10 分的患者中观察到更大的降低（25.3%[-0.4，44.4]）。除 LABA、LAMA 或 LABA+LAMA 分层外（发生率比 2.8[0.9，8.5]），FF/VI 与 UC 治疗的患者中肺炎 SAESI 发生率相似。与其他 ICS+LABA 治疗相比，FF/VI 并未增加 SAESI 风险。
结论
与其他 ICS 方案相比，与继续 UC 相比，起始 FF/VI 治疗可降低加重率，且不增加肺炎 SAESI 风险，这在各种患者亚组中是一致的。FF/VI 可能是 COPD 患者的一种治疗选择，包括病情更严重的患者。
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