Abstract：
BACKGROUND: Patients with chronic obstructive pulmonary disease (COPD) frequently have cardiovascular comorbidities, increasing the risk of hospitalised COPD exacerbations (H-ECOPDs) or death. This pragmatic study examined the effects of adding an inhaled corticosteroid (ICS) to long-acting bronchodilator(s) (LABDs) in patients with COPD and cardiac comorbidities who had a recent H-ECOPD.
METHODS: Patients >60 years of age with COPD and ≥1 cardiac comorbidity, within 6 months after discharge following an H-ECOPD, were randomised to receive LABD(s) with or without ICS, and were followed for 1 year. The primary outcome was the time to first rehospitalisation and/or all-cause death.
RESULTS: The planned number of patients was not recruited (803/1032), limiting the strength of the conclusions. In the intention-to-treat population, 89/403 patients (22.1 %) were rehospitalised or died in the LABD group (probability 0.257 [95 % confidence interval 0.206, 0.318]), vs 85/400 (21.3 %) in the LABD+ICS group (0.249 [0.198, 0.310]), with no difference between groups in time-to-event (hazard ratio 1.116 [0.827, 1.504]; p = 0.473). All-cause and cardiovascular mortality were lower in patients receiving LABD(s)+ICS, with relative reductions of 19.7 % and 27.4 %, respectively (9.8 % vs 12.2 % and 4.5 % vs 6.2 %), although the groups were not formally statistically compared for these endpoints. Fewer patients had adverse events in the LABD+ICS group (43.0 % vs 50.4 %; p = 0.013), with 4.9 % vs 5.4 % reporting pneumonia adverse events.
CONCLUSIONS: Results suggest addition of ICS to LABDs did not reduce the time-to-combined rehospitalisation/death, although it decreased all-cause and cardiovascular mortality. ICS use was not associated with an increased risk of adverse events, particularly pneumonia.
METHODS: Patients >60 years of age with COPD and ≥1 cardiac comorbidity, within 6 months after discharge following an H-ECOPD, were randomised to receive LABD(s) with or without ICS, and were followed for 1 year. The primary outcome was the time to first rehospitalisation and/or all-cause death.
RESULTS: The planned number of patients was not recruited (803/1032), limiting the strength of the conclusions. In the intention-to-treat population, 89/403 patients (22.1 %) were rehospitalised or died in the LABD group (probability 0.257 [95 % confidence interval 0.206, 0.318]), vs 85/400 (21.3 %) in the LABD+ICS group (0.249 [0.198, 0.310]), with no difference between groups in time-to-event (hazard ratio 1.116 [0.827, 1.504]; p = 0.473). All-cause and cardiovascular mortality were lower in patients receiving LABD(s)+ICS, with relative reductions of 19.7 % and 27.4 %, respectively (9.8 % vs 12.2 % and 4.5 % vs 6.2 %), although the groups were not formally statistically compared for these endpoints. Fewer patients had adverse events in the LABD+ICS group (43.0 % vs 50.4 %; p = 0.013), with 4.9 % vs 5.4 % reporting pneumonia adverse events.
CONCLUSIONS: Results suggest addition of ICS to LABDs did not reduce the time-to-combined rehospitalisation/death, although it decreased all-cause and cardiovascular mortality. ICS use was not associated with an increased risk of adverse events, particularly pneumonia.
摘要：
背景：慢性阻塞性肺疾病（COPD）患者经常有心血管合并症，增加住院COPD急性加重（H-ECOPDs）或死亡的风险。这项实用研究检查了在近期患有H-ECOPD的COPD和心脏合并症患者中添加吸入皮质类固醇（ICS）到长效支气管扩张剂（LABDs）的效果。
方法：患者>60岁患有COPD且心脏合并症≥1，H-ECOPD出院后6个月内，随机接受有或没有ICS的LABD，并随访了1年。主要结果是首次住院和/或全因死亡的时间。
结果：未招募计划患者人数（803/1032），限制了结论的强度。在意向治疗人群中，LABD组89/403患者（22.1%）再次住院或死亡（概率0.257[95%置信区间0.206,0.318]），LABD+ICS组的85/400（21.3%）（0.249[0.198,0.310]），事件发生时间组间无差异(风险比1.116[0.827,1.504];p=0.473).接受LABD（s）+ICS的患者的全因死亡率和心血管死亡率较低，相对减少19.7%和27.4%，分别(9.8%对12.2%和4.5%对6.2%)，尽管没有对这些终点进行正式的统计学比较.LABD+ICS组出现不良事件的患者较少（43.0%vs50.4%；p=0.013），报告肺炎不良事件的比例分别为4.9%和5.4%。
结论：结果表明，在LABD中增加ICS并不能减少合并再住院/死亡的时间，尽管它降低了全因死亡率和心血管死亡率。ICS使用与不良事件风险增加无关，尤其是肺炎。
方法：患者>60岁患有COPD且心脏合并症≥1，H-ECOPD出院后6个月内，随机接受有或没有ICS的LABD，并随访了1年。主要结果是首次住院和/或全因死亡的时间。
结果：未招募计划患者人数（803/1032），限制了结论的强度。在意向治疗人群中，LABD组89/403患者（22.1%）再次住院或死亡（概率0.257[95%置信区间0.206,0.318]），LABD+ICS组的85/400（21.3%）（0.249[0.198,0.310]），事件发生时间组间无差异(风险比1.116[0.827,1.504];p=0.473).接受LABD（s）+ICS的患者的全因死亡率和心血管死亡率较低，相对减少19.7%和27.4%，分别(9.8%对12.2%和4.5%对6.2%)，尽管没有对这些终点进行正式的统计学比较.LABD+ICS组出现不良事件的患者较少（43.0%vs50.4%；p=0.013），报告肺炎不良事件的比例分别为4.9%和5.4%。
结论：结果表明，在LABD中增加ICS并不能减少合并再住院/死亡的时间，尽管它降低了全因死亡率和心血管死亡率。ICS使用与不良事件风险增加无关，尤其是肺炎。
