噻托溴铵可减少轻中度慢性阻塞性肺疾病患者的临床重要恶化：Tie-COPD 研究的事后分析。

Tiotropium reduces clinically important deterioration in patients with mild-to-moderate chronic obstructive pulmonary disease: A post hoc analysis of the Tie-COPD study.

机构信息

State Key Laboratory of Respiratory Disease & National Clinical Research Center for Respiratory Disease & National Center for Respiratory Medicine & Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China; Guangzhou National Laboratory, Guangzhou, China.

出版信息

Respir Med. 2024 Feb;222:107527. doi: 10.1016/j.rmed.2024.107527. Epub 2024 Jan 8.

DOI:10.1016/j.rmed.2024.107527

PMID:38199288

Abstract

BACKGROUND

Clinically important deterioration (CID) is a composite endpoint used to holistically assess the complex progression of chronic obstructive pulmonary disease (COPD). Tiotropium improves lung function and reduces the rate of COPD exacerbations in patients with COPD of Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 1 (mild) or 2 (moderate). However, whether tiotropium reduces CID risk in patients with mild-to-moderate COPD remains unclear.

METHODS

This was a post hoc analysis of the 24-month Tie-COPD study comparing 18 μg tiotropium with placebo in patients with mild-to-moderate COPD. CID was defined as a decrease of ≥100 mL in trough forced expiratory volume in 1 s, an increase of ≥2 unit in COPD Assessment Test (CAT) score, or moderate-to-severe exacerbation. The time to the first occurrence of one of these events was recorded as the time to the first CID. Subgroup analyses were conducted among patients stratified by CAT score, modified Medical Research Council (mMRC) dyspnea score, and GOLD stage at baseline.

RESULTS

Of the 841 randomized patients, 771 were included in the full analysis set. Overall, 643 patients (83.4 %) experienced at least one CID event. Tiotropium significantly reduced the CID risk and delayed the time to first CID compared with placebo (adjusted hazard ratio = 0.58, 95 % confidence interval = 0.49-0.68, P < 0.001). Significant reductions in CID risk were also observed in various subgroups, including patients with a CAT score <10, mMRC score <2, and mild COPD.

CONCLUSIONS

Tiotropium reduced CID risk in patients with mild-to-moderate COPD, even in patients with fewer respiratory symptoms or mild disease, which highlights tiotropium's effectiveness in treating COPD patients with mild disease.

TRIAL REGISTRATION

This study is registered at ClinicalTrials.gov (Tie-COPD, NCT01455129).

摘要

背景

临床上重要的恶化（CID）是一个综合终点，用于全面评估慢性阻塞性肺疾病（COPD）的复杂进展。噻托溴铵可改善肺功能并降低 COPD 患者的 COPD 加重率，这些患者为全球倡议慢性阻塞性肺疾病（GOLD）阶段 1（轻度）或 2（中度）。然而，噻托溴铵是否降低轻度至中度 COPD 患者的 CID 风险尚不清楚。

方法

这是 24 个月 Tie-COPD 研究的事后分析，该研究比较了 18μg 噻托溴铵与安慰剂在轻度至中度 COPD 患者中的疗效。CID 定义为：1 秒用力呼气容积（FEV1）的谷值下降≥100ml、COPD 评估测试（CAT）评分增加≥2 分或中度至重度加重。记录首次发生这些事件之一的时间作为首次 CID 的时间。在基线时按 CAT 评分、改良的医学研究委员会（mMRC）呼吸困难评分和 GOLD 分期分层的患者中进行了亚组分析。

结果

在 841 名随机患者中，771 名患者被纳入全分析集。总体而言，643 名患者（83.4%）发生了至少一次 CID 事件。与安慰剂相比，噻托溴铵显著降低了 CID 风险并延迟了首次 CID 的时间（调整后的危险比=0.58，95%置信区间=0.49-0.68，P<0.001）。在各种亚组中也观察到 CID 风险的显著降低，包括 CAT 评分<10、mMRC 评分<2 和轻度 COPD 的患者。