Effect of Triple Therapy on Cardiovascular and Severe Cardiopulmonary Events in Chronic Obstructive Pulmonary Disease: A Post Hoc Analysis of a Randomized, Double-Blind, Phase 3 Clinical Trial (ETHOS).

In the phase III, 52-week ETHOS trial (NCT02465567), triple therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF) reduced rates of moderate/severe exacerbations and all-cause mortality compared with dual therapy with glycopyrrolate/formoterol fumarate (GFF) or budesonide/formoterol fumarate (BFF).

在第三阶段、为期52周的ETHOS试验（NCT02465567）中，布地奈德/甘珀酸/富马酸福莫特罗（BGF）三联疗法与甘珀酸/富马酸福莫特罗（GFF）或布地奈德/富马酸福莫特罗（BFF）的双联疗法相比，降低了中度/重度急性加重率和全因死亡率。

However, the effect of BGF on cardiovascular events versus GFF remains unevaluated.

然而，BGF对心血管事件的影响与GFF相比尚未得到评估。

Furthermore, the effect of BGF on time to first severe exacerbation has not been reported.

此外，BGF对首次严重加重时间的影响尚未被报道。

Objectives: To assess the effects of BGF 320/18/9.6 μg (BGF 320) and other inhaled corticosteroid-containing arms on cardiovascular and severe cardiopulmonary endpoints versus GFF in patients with COPD from the ETHOS trial. Methods: Patients with moderate to very severe COPD and a history of exacerbations were randomized to twice-daily BGF 320, BGF 160/18/9.6 μg, BFF 320/9.6 μg, or GFF 18/9.6 μg (GFF).

目的：评估BGF 320/18/9.6 μg（BGF 320）和其他含有吸入性皮质类固醇的治疗组对心血管和严重心肺终点事件的影响，与GFF在ETHOS试验中的慢性阻塞性肺疾病（COPD）患者进行比较。

Time to first severe COPD exacerbation was a prespecified endpoint; post hoc cardiovascular and severe cardiopulmonary endpoints included time to first major adverse cardiac event, time to first cardiovascular adverse event(AE) of special interest, time to first cardiac AE, and time to the composite endpoint of first severe cardiopulmonary event.

首次严重COPD加重的时间是一个预先设定的终点；事后心血管和严重心肺终点包括首次主要不良心脏事件的时间、首次特别关注的心血管不良事件（AE）的时间、首次心脏不良事件的时间，以及首次严重心肺事件复合终点的时间。

Measurements and Main Results: BGF 320 reduced the rate of first occurrence (hazard ratio[95% confidence interval]) of cardiovascular and severe cardiopulmonary events versus GFF, including for time to first cardiovascular adverse eventof special interest (0.63 [0.48, 0.82]), cardiac AE (0.60 [0.48, 0.76]), and severe cardiopulmonary event (0.80 [0.67, 0.95]).

测量和主要结果：与GFF相比，BGF 320降低了心血管和严重心肺事件首次发生率（风险比[95%置信区间]），包括首次特殊关注的心血管不良事件发生时间（0.63 [0.48, 0.82]）、心脏不良事件（0.60 [0.48, 0.76]）和严重心肺事件（0.80 [0.67, 0.95]）。

Conclusions: BGF had a benefit on cardiovascular endpoints and severe cardiopulmonary events versus GFF in patients with moderate to very severe COPD.

结论：在中度至极重度COPD患者中，与GFF相比，BGF对心血管终点和严重心肺事件有好处。