David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, CA, USA.
Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.
Respir Med. 2019 Aug;155:113-120. doi: 10.1016/j.rmed.2019.07.019. Epub 2019 Jul 19.
Smoking continues to be a major risk factor for COPD and may impact the efficacy of COPD treatments, with guidelines supporting the crucial importance for current smokers of smoking cessation. A post-hoc analysis of the FLIGHT1 and FLIGHT2 studies assessed the impact of smoking status on the efficacy and safety of indacaterol/glycopyrrolate (IND/GLY) 27.5/15.6 μg twice daily versus its monocomponents or placebo in patients with COPD.
This post-hoc analysis of pooled data from the replicate, 12-week, placebo-controlled FLIGHT1 and FLIGHT2 studies compared the efficacy and safety of IND/GLY with that of IND, GLY, and placebo in patients with moderate-to-severe COPD. Baseline data from 2038 patients were pooled and grouped by smoking status (52% were current smokers and 48% were ex-smokers). The effects of treatment on lung function, patient-reported outcomes (PROs), and safety were evaluated by baseline smoking status.
Treatment with IND/GLY resulted in significant improvements in lung function measurements compared with placebo, irrespective of smoking status. Improvements in St George's Respiratory Questionnaire and transition dyspnea index were significantly greater than placebo in both current and ex-smokers, whereas changes in COPD assessment test were significant only among current smokers. Improvements in lung function and PROs were greater with IND/GLY compared with its monocomponents in current and ex-smokers. The incidences of AEs and SAEs were similar between current and ex-smokers.
IND/GLY demonstrated significant improvements in lung function and PROs, independent of baseline smoking status. The safety profile of IND/GLY did not differ between current and ex-smokers.
吸烟仍是 COPD 的主要危险因素，可能影响 COPD 治疗的效果，指南支持目前吸烟者戒烟的重要性。FLIGHT1 和 FLIGHT2 研究的事后分析评估了吸烟状况对 COPD 患者中每日两次使用茚达特罗/格隆溴铵（IND/GLY）27.5/15.6μg 与单药成分或安慰剂疗效和安全性的影响。
对重复的、为期 12 周、安慰剂对照的 FLIGHT1 和 FLIGHT2 研究的汇总数据进行事后分析，比较了 IND/GLY 与 IND、GLY 和安慰剂在中重度 COPD 患者中的疗效和安全性。汇总了 2038 例患者的基线数据，并根据吸烟状况分组（52%为当前吸烟者，48%为前吸烟者）。根据基线吸烟状况评估治疗对肺功能、患者报告的结局（PROs）和安全性的影响。
与安慰剂相比，无论吸烟状况如何，使用 IND/GLY 治疗均可显著改善肺功能测量值。与安慰剂相比，当前吸烟者和前吸烟者的圣乔治呼吸问卷和呼吸困难转移指数均显著改善，而 COPD 评估测试的变化仅在当前吸烟者中具有统计学意义。与单药成分相比，当前吸烟者和前吸烟者使用 IND/GLY 治疗时肺功能和 PROs 的改善更大。当前吸烟者和前吸烟者的 AE 和 SAE 发生率相似。
无论基线吸烟状况如何，IND/GLY 均能显著改善肺功能和 PROs。IND/GLY 的安全性特征在当前吸烟者和前吸烟者之间没有差异。
