布地奈德/格隆溴铵/富马酸福莫特罗与糠酸氟替卡松/乌美溴铵/维兰特罗相比在慢性阻塞性肺疾病中降低死亡风险：基于ETHOS和IMPACT的匹配调整间接比较
Mortality risk reduction with budesonide/glycopyrrolate/formoterol fumarate versus fluticasone furoate/umeclidinium/vilanterol in COPD: a matching-adjusted indirect comparison based on ETHOS and IMPACT.
作者信息
Stolz Daiana, Hermansson Erik, Ouwens Mario, Singh Barinder, Sharma Akanksha, Jackson Dan, Darken Patrick, Marshall Jonathan, Bowen Karin, Müllerová Hana, Alcázar Navarrete Bernardino, Russell Richard, Han MeiLan K, Tansey-Dwyer Deniz
机构信息
Clinic of Respiratory Medicine, Medical Center and Faculty of Medicine, University of Freiburg, Freiburg, Germany.
AstraZeneca, Gothenburg, Sweden.
出版信息
Curr Med Res Opin. 2023 Oct;39(10):1395-1405. doi: 10.1080/03007995.2023.2247969. Epub 2023 Aug 29.
OBJECTIVE
Chronic obstructive pulmonary disease (COPD) is a leading cause of death worldwide. While two approved fixed-dose inhaled corticosteroid/long-acting muscarinic antagonist (LAMA)/long-acting β-agonist (LABA) triple therapies reduce all-cause mortality (ACM) versus dual LAMA/LABA therapy in patients with COPD, head-to-head studies have not compared the effects of these therapies on ACM. We compared ACM in adults with moderate-to-very severe COPD receiving budesonide/glycopyrrolate/formoterol fumarate (BGF) in ETHOS versus fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) in IMPACT using a matching-adjusted indirect comparison (MAIC).
METHODS
A systematic literature review identified two studies (ETHOS [NCT02465567]; IMPACT [NCT02164513]) of ≥52 weeks reporting ACM as an efficacy endpoint in patients receiving triple therapy. As ETHOS and IMPACT lack a common comparator, an unanchored MAIC compared ACM between licensed doses of BGF (320/18/9.6 μg) from ETHOS and FF/UMEC/VI (100/62.5/25 μg) from IMPACT in patients with moderate-to-very severe COPD. Using on- and off-treatment data from the final retrieved datasets of the intention-to-treat populations, BGF data were adjusted according to aggregate FF/UMEC/VI data using 11 baseline covariates; a supplementary unadjusted indirect treatment comparison was also conducted. -values for these post-hoc analyses are not adjusted for Type I error.
RESULTS
ACM over 52 weeks was statistically significantly reduced by 39% for BGF versus FF/UMEC/VI in the MAIC (hazard ratio [HR] [95% CI]: 0.61 [0.38, 0.95], = 0.030) and unadjusted analysis (HR [95% CI]: 0.61 [0.41, 0.92], = 0.019).
CONCLUSION
In this MAIC, which adjusted for population heterogeneity between ETHOS and IMPACT, ACM was significantly reduced with BGF versus FF/UMEC/VI in patients with moderate-to-very severe COPD.
目的
慢性阻塞性肺疾病（COPD）是全球主要的死亡原因之一。虽然两种已获批的吸入性糖皮质激素/长效毒蕈碱拮抗剂（LAMA）/长效β受体激动剂（LABA）固定剂量三联疗法相较于COPD患者的LAMA/LABA双联疗法可降低全因死亡率（ACM），但头对头研究尚未比较这些疗法对ACM的影响。我们采用匹配调整间接比较（MAIC）方法，比较了中度至重度COPD成人患者在ETHOS研究中接受布地奈德/格隆溴铵/富马酸福莫特罗（BGF）与在IMPACT研究中接受糠酸氟替卡松/乌美溴铵/维兰特罗（FF/UMEC/VI）后的ACM情况。
方法
一项系统文献综述确定了两项≥52周的研究（ETHOS [NCT02465567]；IMPACT [NCT02164513]），这些研究将ACM作为接受三联疗法患者的疗效终点进行报告。由于ETHOS和IMPACT缺乏共同对照，一项非锚定MAIC比较了中度至重度COPD患者中ETHOS研究的BGF许可剂量（320/18/9.6μg）与IMPACT研究的FF/UMEC/VI许可剂量（100/62.5/25μg）之间的ACM情况。利用意向性治疗人群最终检索数据集的治疗期和非治疗期数据，根据汇总的FF/UMEC/VI数据，使用11个基线协变量对BGF数据进行调整；还进行了一项补充性的未调整间接治疗比较。这些事后分析的P值未针对I型错误进行调整。
结果
在MAIC分析中，BGF组52周的ACM相较于FF/UMEC/VI组在统计学上显著降低了39%（风险比[HR][95%CI]：0.61[0.38, 0.95]，P = 0.030），未调整分析结果为（HR[95%CI]：0.61[0.41, 0.92]，P = 0.019）。
结论
在这项针对ETHOS和IMPACT之间人群异质性进行调整的MAIC中，中度至重度COPD患者使用BGF相较于FF/UMEC/VI可显著降低ACM。
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