Abstract
BACKGROUND: Double-blind randomized controlled trials have compared patients with chronic obstructive pulmonary disease (COPD) taking triple therapy, which can improve lung function, dyspnea, and quality of life and reduce acute exacerbation and mortality, with those taking long-acting muscarinic antagonist/long-acting β2-agonist; however, the real-word treatment scenario may be different from that of a strict and well-designed study. The aim of our study was to assess long-term outcomes among patients with COPD who received triple therapy in real-world practice. METHODS: Data from Taiwan's National Health Insurance Research Database (NHIRD) from 2005 and 2016 were used to identify COPD patients who were over 40 years of age with diagnosis codes 490-492, 496 (ICD-9-CM) or J41-44 (ICD-10-CM). After matching for age, sex, and COPD exacerbations, COPD patients who did and did not receive triple therapy were enrolled in this study. Cox proportional regression was used to estimate the mortality risk between smoking status and COPD patients with and without triple therapy. RESULTS: A total of 19,358 patients with COPD who did or did not receive triple therapy were enrolled in this study. The prevalence rates of some comorbidities were higher among patients with COPD who received triple therapy than among those who did not receive triple therapy. These comorbidities included lung cancer, thoracic malignancies, bronchiectasis, and heart failure. The risk of mortality was higher among patients who received triple therapy than among those who did not receive triple therapy after matching for age, sex, and COPD exacerbations, with a crude hazard ratio, fully adjusted model hazard ratio and stepwise approach reduced hazard ratio of 1.568 (95% CI, 1.500-1.639), 1.675 (95% CI, 1.596-1.757), and 1.677 (95% CI, 1.599-1.76), respectively. CONCLUSION: Over 5 years of observation, patients with COPD who received triple therapy did not show a survival benefit compared with those who did not receive triple therapy in a real-world scenario.