Exacerbation and cardiopulmonary risk after prompt initiation of single-inhaler budesonide /glycopyrrolate/formoterol fumarate following COPD exacerbations: Insights from MITOS EROS (Japan) study

IF 2.1 Q2 RESPIRATORY SYSTEM

Respiratory investigation Pub Date : 2025-11-01 Epub Date: 2025-11-04 DOI:10.1016/j.resinv.2025.10.015

Koichiro Takahashi , Yuri Yoshida , Naoyuki Makita , Kenichiro Nishida , Michihiro Yoshimura , Zhao Cheng , Aaro Salosensaari , Catarina Camarinha , Reiko Yamaura , Marta Cuntin , Michael Pollack

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Abstract

Background

Previous evidence supported prompt initiation of single-inhaler triple therapy in chronic obstructive pulmonary disease (COPD), but data specific to Japan are lacking. This study investigated the association between budesonide/glycopyrrolate/formoterol fumarate (BGF) initiation and subsequent COPD exacerbations or severe cardiopulmonary events in Japanese patients initiating BGF following previous exacerbations.

Methods

This was an observational cohort study among patients with COPD using IQVIA Integrated claims data. Between BGF launch (September 2019) and March 2023, patients aged ≥40 years initiating BGF following COPD exacerbations (index) were included. Patients were categorized into BGF initiation groups by treatment initiation timing following index exacerbations: prompt (≤30 days), delayed (31–180 days), and very delayed (181–365 days). Multivariable negative binomial regression models evaluated the associations between BGF initiation strategies and subsequent exacerbations or severe cardiopulmonary events.

Results

3402 eligible patients were included: 840 prompt, 1143 delayed, and 1419 very delayed BGF initiators. The crude COPD exacerbation event rate (95 % confidence interval [CI]) per person-year was 1.66 (1.58–1.74) for prompt, 2.36 (2.30–2.43) for delayed, and 2.60 (2.54–2.66) for very delayed initiators during follow-up. Compared to prompt initiation, delayed (adjusted rate ratio [RR]: 1.25; 95 % CI: 1.13–1.38) and very delayed (adjusted RR: 1.09; 95 % CI: 0.99–1.20) BGF initiation showed an increased risk of COPD exacerbations. No associations were observed between BGF initiation strategies and severe cardiopulmonary events.

Conclusion

Following COPD exacerbations, initiating BGF promptly was associated with reduction in subsequent exacerbations. Patients should receive prompt and proactive treatment to reduce COPD morbidity.

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慢性阻塞性肺病（COPD）加重后立即开始使用单吸入器布地奈德/甘罗酸酯/富马酸福莫特罗后的加重和心肺风险：来自MITOS EROS（日本）研究的见解

背景：先前的证据支持慢性阻塞性肺疾病（COPD）的单吸入器三联疗法的迅速启动，但缺乏日本特有的数据。本研究调查了布地奈德/甘罗酸酯/富马酸福莫特罗（BGF）启动与随后COPD加重或严重心肺事件的关系，这些患者在既往加重后启动BGF。方法：这是一项使用IQVIA综合索赔数据的COPD患者观察性队列研究。在BGF推出（2019年9月）至2023年3月期间，纳入年龄≥40岁的COPD加重（指数）后开始BGF的患者。根据指标加重后的治疗起始时间将患者分为BGF起始组：提示（≤30天）、延迟（31-180天）和非常延迟（181-365天）。多变量负二项回归模型评估了BGF启动策略与随后的恶化或严重心肺事件之间的关系。结果：纳入3402例符合条件的患者：840例及时启动，1143例延迟启动，1419例非常延迟启动。随访期间，急性COPD患者的年均急性加重发生率（95%可信区间[CI]）为：即刻者1.66(1.58-1.74)，迟发者2.36(2.30-2.43)，迟发者2.60（2.54-2.66）。与立即启动相比，延迟启动（调整后的比率比[RR]: 1.25; 95% CI: 1.13-1.38）和非常延迟启动（调整后的RR: 1.09; 95% CI: 0.99-1.20）的BGF显示COPD加重的风险增加。未观察到BGF起始策略与严重心肺事件之间的关联。结论：COPD加重后，及时启动BGF与随后加重的减少相关。患者应及时接受积极治疗以降低COPD发病率。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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