Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-Universität Marburg, Member of the German Center for Lung Research (DZL), Marburg, Germany.
Global Specialty & Primary Care, GSK, Brentford, Middlesex, UK.
Int J Chron Obstruct Pulmon Dis. 2021 May 3;16:1215-1226. doi: 10.2147/COPD.S295835. eCollection 2021.
This post hoc analysis of the "Early MAXimization of bronchodilation for improving COPD stability" (EMAX) trial investigated whether patients achieving early clinically important improvement (CII) sustained longer-term improvements and lower risk of clinically important deterioration (CID).
Patients were randomized to umeclidinium/vilanterol, umeclidinium, or salmeterol for 24 weeks. The patient-reported outcomes (PROs) Transition Dyspnea Index (TDI), Evaluating Respiratory Symptoms, St George's Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT) were assessed. CII, defined as attaining minimum clinically important differences (MCID) in ≥2 PROs, was assessed at Weeks 4, 12 and 24. CID was defined as a deterioration in CAT, SGRQ, TDI by the MCID and/or a moderate/severe exacerbation from Day 30.
Of 2425 patients, 50%, 53% and 51% achieved a CII at Weeks 4, 12 and 24, respectively. Patients with a CII at Week 4 versus those without had significantly greater odds of achieving a CII at Weeks 12 and 24 (odds ratio: 5.57 [95% CI: 4.66, 6.66]; 4.09 [95% CI: 3.44, 4.86]). The risk of a CID was higher in patients who did not achieve a CII at Week 4 compared with patients who did (hazard ratio [95% CI]: 2.09 [1.86, 2.34]). Patients treated with umeclidinium/vilanterol versus either monotherapy had significantly greater odds of achieving CII at Weeks 4, 12 and 24.
Achieving a CII at Week 4 was associated with longer-term improvement in PROs and a reduced risk of deterioration. Further research is required to investigate the importance of an early response to treatment on the long-term disease course.
本研究是 EMAX 试验的事后分析，旨在探讨早期临床重要改善（CII）的患者是否能持续获得长期改善和降低临床重要恶化（CID）的风险。
患者随机接受乌美溴铵/维兰特罗、乌美溴铵或沙美特罗治疗 24 周。采用患者报告的结局（PROs）过渡呼吸困难指数（TDI）、呼吸症状评估、圣乔治呼吸问卷（SGRQ）和 COPD 评估测试（CAT）进行评估。CII 定义为≥2 项 PRO 达到最小临床重要差异（MCID），在第 4、12 和 24 周进行评估。CID 定义为 CAT、SGRQ、TDI 按 MCID 恶化和/或从第 30 天起发生中度/重度加重。
在 2425 例患者中，分别有 50%、53%和 51%在第 4、12 和 24 周达到 CII。与未达到 CII 的患者相比，第 4 周达到 CII 的患者在第 12 和 24 周达到 CII 的可能性显著更高（优势比：5.57 [95%CI：4.66，6.66]；4.09 [95%CI：3.44，4.86]）。与达到 CII 的患者相比，第 4 周未达到 CII 的患者发生 CID 的风险更高（风险比[95%CI]：2.09 [1.86，2.34]）。与两种单药治疗相比，乌美溴铵/维兰特罗治疗的患者在第 4、12 和 24 周达到 CII 的可能性显著更高。
第 4 周达到 CII 与 PRO 长期改善和降低恶化风险相关。需要进一步研究以探讨早期治疗反应对疾病长期病程的重要性。
