{"title":"Single-Inhaler Triple vs LABA-ICS Therapy for COPD: Comparative Safety in Real-World Clinical Practice.","authors":"Samy Suissa, Sophie Dell'Aniello, Pierre Ernst","doi":"10.1016/j.chest.2024.10.025","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Recent treatment guidelines for COPD have replaced the long-acting beta<sub>2</sub>-agonist (LABA) and inhaled corticosteroid (ICS) combination with single-inhaler triple therapy that adds a long-acting muscarinic antagonist (LAMA) (LAMA-LABA-ICS). However, the corresponding trials reported numerically higher incidences of cardiovascular adverse events with triple therapy compared with LABA-ICS.</p><p><strong>Research question: </strong>Does single-inhaler triple therapy increase the incidence of major adverse cardiovascular events, compared with LABA-ICS, in a real-world clinical practice setting?</p><p><strong>Study design and methods: </strong>We identified a cohort of patients with COPD, ≥ 40 years of age, treated during 2017-2021, from the UK'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 (MACEs), defined as hospitalization for myocardial infarction or stroke, or all-cause-mortality, over 1 year.</p><p><strong>Results: </strong>The cohort included 10,255 initiators of triple therapy and 10,255 matched users of LABA-ICS. The incidence rate of MACEs 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 MACEs with triple therapy was 1.28 (95% CI, 1.05-1.55), relative to LABA-ICS; however, the increase was mainly in the first 4 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), whereas 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.</p><p><strong>Interpretation: </strong>In a real-world setting of COPD treatment, patients who initiated single-inhaler triple therapy had an increased incidence of MACEs compared with similar patients treated with an LABA-ICS inhaler. This small increase was due to the all-cause mortality component, occurring mainly in the first 4 months after treatment initiation.</p>","PeriodicalId":9782,"journal":{"name":"Chest","volume":" ","pages":""},"PeriodicalIF":9.5000,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Chest","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.chest.2024.10.025","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CRITICAL CARE MEDICINE","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Recent treatment guidelines for COPD have replaced the long-acting beta2-agonist (LABA) and inhaled corticosteroid (ICS) combination with single-inhaler triple therapy that adds a long-acting muscarinic antagonist (LAMA) (LAMA-LABA-ICS). However, 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 patients with COPD, ≥ 40 years of age, treated during 2017-2021, from the UK'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 (MACEs), defined as hospitalization for myocardial infarction or stroke, or all-cause-mortality, over 1 year.
Results: The cohort included 10,255 initiators of triple therapy and 10,255 matched users of LABA-ICS. The incidence rate of MACEs 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 MACEs with triple therapy was 1.28 (95% CI, 1.05-1.55), relative to LABA-ICS; however, the increase was mainly in the first 4 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), whereas 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 MACEs compared with similar patients treated with an LABA-ICS inhaler. This small increase was due to the all-cause mortality component, occurring mainly in the first 4 months after treatment initiation.
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.