Department of Medicine, Pulmonary and Critical Care Medicine, University Medical Centre Giessen and Marburg, Philipps-University Marburg, Member of the German Centre for Lung Research (DZL), 35043, Marburg, Germany.
Facharztforum Fürth, 90762, Fürth, Germany.
Respir Res. 2022 May 2;23(1):109. doi: 10.1186/s12931-022-02037-2.
Chronic obstructive pulmonary disease (COPD) guidelines recommend reserving triple therapy of inhaled corticosteroid (ICS), long-acting β-agonist (LABA) and long-acting muscarinic antagonist (LAMA) for patients with exacerbations despite dual therapy. However, many patients receive triple therapy without a clear indication. For these patients, it would be useful to know whether ICS can be withdrawn.
DACCORD was a longitudinal, non-interventional 'real-world' study in three cohorts. This manuscript describes the results of Cohort 3, which recruited patients with COPD who had received triple therapy for ≥ 6 months. Prior to entry, each patient's physician decided to continue triple therapy, or switch to a LABA/LAMA; patients were then followed for 12 months, with exacerbations and COPD Assessment Test (CAT) data recorded every 3 months. The primary endpoint was the time until COPD worsening, defined as the occurrence of a moderate/severe exacerbation or clinically relevant CAT worsening.
Of the 1192 patients recruited into the study, 967 completed the end-of-study visit and ≥ 2 of the three interim visits, 292 and 675 receiving LABA/LAMA and triple therapy, respectively. Most baseline demographics were similar between the two groups. A lower proportion of patients in the LABA/LAMA group had COPD worsening than with triple therapy (32.5% vs 55.7% at 12 months), with the time to worsening extended in the LABA/LAMA group (hazard ratio 2.004, p < 0.001). In addition, a significantly lower proportion of patients in the LABA/LAMA group exacerbated (18.5% vs 28.7%; p < 0.001), accompanied by a greater improvement from baseline in CAT total score. Overall, fewer patients in the LABA/LAMA group reported adverse events than in the triple therapy group (12.9% vs 15.1%).
These results suggest that in a real world setting physicians are able to identify patients who can be 'stepped down' from triple therapy to LABA/LAMA. Following step down, there was no overall decline in COPD-indeed, some patients had better outcomes.
慢性阻塞性肺疾病（COPD）指南建议，对于因双药治疗仍出现加重而需要接受三联治疗（吸入皮质激素（ICS）、长效β激动剂（LABA）和长效抗胆碱能药物（LAMA））的患者，保留三联治疗。然而，许多患者并未明确适应证便接受了三联治疗。对于这些患者，了解是否可以停用 ICS 将很有帮助。
DACCORD 是一项在三个队列中进行的纵向、非干预性“真实世界”研究。本文描述了队列 3 的结果，该队列纳入了接受三联治疗≥6 个月的 COPD 患者。入组前，每位患者的医生决定继续三联治疗或转换为 LABA/LAMA；然后对患者进行 12 个月的随访，每 3 个月记录一次加重事件和 COPD 评估测试（CAT）数据。主要终点是 COPD 恶化的时间，定义为发生中重度加重或 CAT 有临床意义的恶化。
在这项研究中，共纳入了 1192 例患者，其中 967 例完成了研究结束访视和≥3 次中期访视，分别有 292 例和 675 例患者接受了 LABA/LAMA 和三联治疗。两组患者的大多数基线特征相似。与三联治疗相比，LABA/LAMA 组的患者 COPD 恶化比例较低（12 个月时分别为 32.5%和 55.7%），LABA/LAMA 组的恶化时间延长（风险比 2.004，p<0.001）。此外，LABA/LAMA 组的患者恶化比例显著降低（18.5% vs 28.7%；p<0.001），同时 CAT 总分也有更大程度的改善。总体而言，LABA/LAMA 组报告不良事件的患者少于三联治疗组（12.9% vs 15.1%）。
这些结果表明，在真实环境中，医生能够识别出可以从三联治疗转为 LABA/LAMA 的患者。在降级后，COPD 并没有总体恶化——实际上，一些患者的情况有所改善。
