Risk of Exacerbation and Pneumonia with Single-Inhaler Triple versus Dual Therapy in IMPACT.
Risk of Exacerbation and Pneumonia with Single-Inhaler Triple versus Dual Therapy in IMPACT.
复制标题
DOI：
10.1513/annalsats.202002-096oc
复制
发表时间：
2021-05
影响因子：
8.3
通讯作者：
Lange P
中科院分区：
文献类型：
--
作者：
Dransfield MT;Crim C;Criner GJ;Day NC;Halpin DMG;Han MK;Jones CE;Kilbride S;LaFon D;Lipson DA;Lomas DA;Martin N;Martinez FJ;Singh D;Wise RA;Lange P
理由：在影响（告知COPD治疗的途径）试验中，单烟氟替卡酮狂热/乌姆克利德岛/vilanterol（ff/umec/vi）三重治疗降低了ff/vi和umec/vi and umec/vi和死亡率的风险，而umec/vi却施加了。关于减少脱颖而出的相对好处，与增加的风险增加肺炎。
目标：通过评估复合执行或肺炎结局的第一时间和率，确定三种治疗的收益 - 三种处理的风险。
方法：我们评估了调查人员报告的肺炎，严重的肺炎，导致住院或死亡的严重肺炎以及1个复合终点（所需的抗生素/严重的（住院）执行次数严重的肺炎和严重的执行）。 ED肺炎（事后）。
结果：中度/严重的加剧发生在47％，49％和50％的患者中，将其随机分为FF/UMEC/VI，FF/VI和UMEC/VI，以及8％，7％和5％的患者，分别减少了ff/umec/umec/umec/umec/umec/umec/umec/umec/umec/umec/umec/umec/umec/umec/umec/umec/umec/umec/umec/umec/umec/umec的综合率均匀/peremec/vi分别降低了。 [95％置信区间（CI），0.82-0.92]）和UMEC/VI（0.87 [0.81-0.94]），以及结合严重的肺炎或UMEC/VI的风险（0.83 [0.72-0.96]）。 76 [0.65–0.89]与UMEC/VI相似。端点。
结论：尽管肺炎在含FF的臂中的越来越多，但这些复合执行/肺炎结局支持了FF/UMEC/VI与FF/VI与FF/VI和UMEC/VI的有利益处 - 对符合对称性的患有符合时间表的时间表梗阻性肺部疾病的患者以及执行史。
Rationale: In the IMPACT (Informing the Pathway of COPD Treatment) trial, single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) triple therapy reduced exacerbation risk versus FF/VI and UMEC/VI and mortality risk versus UMEC/VI. However, pneumonia incidence was higher in the inhaled corticosteroid (FF)–containing arms, raising questions about the relative benefit of exacerbation reduction compared with the increased risk of pneumonia. Objectives: Determine benefit–risk of the three treatments by evaluating time-to-first and rates of composite exacerbation or pneumonia outcomes. Methods: We evaluated time-to-first (prespecified) and rates (post hoc) of investigator-reported pneumonia, serious pneumonia leading to hospitalization or death, and the composite endpoints of 1) moderate (required antibiotics/corticosteroids)/severe (hospitalized) exacerbation or pneumonia and 2) severe exacerbation or serious (hospitalized) pneumonia. Analyses were repeated for radiographically confirmed pneumonia (post hoc). Results: Moderate/severe exacerbations occurred in 47%, 49%, and 50% of patients randomized to FF/UMEC/VI, FF/VI and UMEC/VI, and pneumonias in 8%, 7%, and 5%, respectively. FF/UMEC/VI reduced the risk of combined moderate/severe exacerbation or pneumonia (time-to-first) versus FF/VI (hazard ratio, 0.87 [95% confidence interval (CI), 0.82–0.92]) and UMEC/VI (0.87 [0.81–0.94]), as well as the risk of combined severe exacerbation or serious pneumonia versus UMEC/VI (0.83 [0.72–0.96]). FF/UMEC/VI reduced the rate of combined moderate/severe exacerbation or pneumonia (rate ratio, 0.78 [0.72–0.84]) and combined severe exacerbation or serious pneumonia (rate ratio, 0.76 [0.65–0.89]) versus UMEC/VI. Results were similar for radiographically confirmed pneumonia endpoints. Conclusions: Despite higher incidence of pneumonia in FF-containing arms, these composite exacerbation/pneumonia outcomes support a favorable benefit–risk profile of FF/UMEC/VI versus FF/VI and UMEC/VI in patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations.