Single-inhaler triple versus LABA-ICS therapy for COPD: Comparative safety in real-world clinical practice.

IF 9.5 1区 医学 Q1 CRITICAL CARE MEDICINE Chest Pub Date : 2024-10-24 DOI:10.1016/j.chest.2024.10.025
Samy Suissa, Sophie Dell'Aniello, Pierre Ernst
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Abstract

Background: Recent treatment guidelines for chronic obstructive pulmonary disease (COPD) have replaced the long-acting beta2-agonist and inhaled corticosteroid (LABA-ICS) combination with single-inhaler triple therapy that adds a long-acting muscarinic antagonist (LAMA-LABA-ICS). Yet, the corresponding trials reported numerically higher incidences of cardiovascular adverse events with triple therapy compared with LABA-ICS.

Research question: Does single-inhaler triple therapy increase the incidence of major adverse cardiovascular events, compared with LABA-ICS, in a real-world clinical practice setting?

Study design and methods: We identified a cohort of COPD patients, 40 years or older, treated during 2017-2021, from the United Kingdom's Clinical Practice Research Datalink. Among LAMA-naïve patients, initiators of single-inhaler triple therapy were matched 1:1 to LABA-ICS users on time-conditional propensity scores. They were compared on the incidence of major adverse cardiovascular events (MACE), defined as hospitalization for myocardial infarction or stroke, or all-cause-mortality, over one year.

Results: The cohort included 10,255 initiators of triple therapy and 10,255 matched users of LABA-ICS. The incidence rate of MACE was 11.3 per 100 per year with triple therapy compared with 8.7 per 100 per year for LABA-ICS. The corresponding adjusted hazard ratio (HR) of MACE with triple therapy was 1.28 (95% CI: 1.05-1.55), relative to LABA-ICS, though the increase was mainly in the first four months (HR 1.41; 95%CI: 1.14-1.74). The HR of all-cause death was 1.31 (95% CI: 1.06-1.62), while for acute myocardial infarction and stroke hospitalization it was 1.00 (95% CI: 0.56-1.79) and 1.06 (95% CI: 0.48-2.36), respectively, with triple therapy, relative to LABA-ICS.

Interpretation: In a real-world setting of COPD treatment, patients who initiated single-inhaler triple therapy had an increased incidence of MACE compared with similar patients treated with a LABA-ICS inhaler. This small increase was due to the all-cause mortality component, occurring mainly in the first four months after treatment initiation.

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单吸入器三联疗法与 LABA-ICS 治疗慢性阻塞性肺疾病:真实世界临床实践中的安全性比较。
背景:最新的慢性阻塞性肺病(COPD)治疗指南用添加长效毒蕈碱类拮抗剂的单吸入器三联疗法(LAMA-LABA-ICS)取代了长效β2-受体激动剂和吸入性皮质类固醇(LABA-ICS)组合疗法。然而,据相应试验报告,与 LABA-ICS 相比,三联疗法的心血管不良事件发生率更高:研究问题:在实际临床实践中,与 LABA-ICS 相比,单吸入器三联疗法是否会增加主要心血管不良事件的发生率?我们从英国临床实践研究数据链(Clinical Practice Research Datalink)中确定了一组在 2017-2021 年期间接受治疗的 40 岁或以上 COPD 患者。在对 LAMA 不敏感的患者中,单吸入器三联疗法的启动者与 LABA-ICS 使用者根据时间条件倾向评分进行了 1:1 匹配。比较了他们一年内主要不良心血管事件(MACE)的发生率,MACE的定义是心肌梗死或中风住院或全因死亡:队列中包括10255名开始使用三联疗法的患者和10255名匹配的LABA-ICS使用者。三联疗法的MACE发生率为每年11.3/100,而LABA-ICS为每年8.7/100。相对于LABA-ICS,三联疗法发生MACE的相应调整后危险比(HR)为1.28(95% CI:1.05-1.55),但增加主要出现在前四个月(HR 1.41;95% CI:1.14-1.74)。相对于LABA-ICS,三联疗法的全因死亡HR为1.31(95% CI:1.06-1.62),急性心肌梗死和中风住院HR分别为1.00(95% CI:0.56-1.79)和1.06(95% CI:0.48-2.36):在慢性阻塞性肺疾病的真实治疗环境中,与使用LABA-ICS吸入器治疗的类似患者相比,使用单吸入器三联疗法的患者MACE发生率增加。这种小幅增加主要是由于全因死亡率,主要发生在开始治疗后的前四个月。
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来源期刊
Chest
Chest 医学-呼吸系统
CiteScore
13.70
自引率
3.10%
发文量
3369
审稿时长
15 days
期刊介绍: At CHEST, our mission is to revolutionize patient care through the collaboration of multidisciplinary clinicians in the fields of pulmonary, critical care, and sleep medicine. We achieve this by publishing cutting-edge clinical research that addresses current challenges and brings forth future advancements. To enhance understanding in a rapidly evolving field, CHEST also features review articles, commentaries, and facilitates discussions on emerging controversies. We place great emphasis on scientific rigor, employing a rigorous peer review process, and ensuring all accepted content is published online within two weeks.
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