Abstract
BackgroundIn the BACE trial, a 3-month (3 m) intervention with azithromycin, initiated at the onset of an infectious COPD exacerbation requiring hospitalization, decreased the rate of a first treatment failure (TF); the composite of treatment intensification (TI), step-up in hospital care (SH) and mortality.Objectives(1) To investigate the intervention’s effect on recurrent events, and (2) to identify clinical subgroups most likely to benefit, determined from the incidence rate of TF and hospital readmissions.MethodsEnrolment criteria included the diagnosis of COPD, a smoking history of ≥10 pack-years and ≥ 1 exacerbation in the previous year. Rate ratio (RR) calculations, subgroup analyses and modelling of continuous variables using splines were based on a Poisson regression model, adjusted for exposure time.ResultsAzithromycin significantly reduced TF by 24% within 3 m (RR = 0.76, 95%CI:0.59;0.97, p = 0.031) through a 50% reduction in SH (RR = 0.50, 95%CI:0.30;0.81, p = 0.006), which comprised of a 53% reduction in hospital readmissions (RR = 0.47, 95%CI:0.27;0.80; p = 0.007). A significant interaction between the intervention, CRP and blood eosinophil count at hospital admission was found, with azithromycin significantly reducing hospital readmissions in patients with high CRP (> 50 mg/L, RR = 0.18, 95%CI:0.05;0.60, p = 0.005), or low blood eosinophil count (<300cells/μL, RR = 0.33, 95%CI:0.17;0.64, p = 0.001). No differences were observed in treatment response by age, FEV1, CRP or blood eosinophil count in continuous analyses.ConclusionsThis post-hoc analysis of the BACE trial shows that azithromycin initiated at the onset of an infectious COPD exacerbation requiring hospitalization reduces the incidence rate of TF within 3 m by preventing hospital readmissions. In patients with high CRP or low blood eosinophil count at admission this treatment effect was more pronounced, suggesting a potential role for these biomarkers in guiding azithromycin therapy.Trial registrationClinicalTrials.gov number. NCT02135354.
Highlights
In the field of chronic obstructive pulmonary disease (COPD), acute exacerbations (AECOPD) are considered the most important determinants of a patient’s health status [1,2,3]
Vermeersch et al Respiratory Research (2019) 20:237 (Continued from previous page). This post-hoc analysis of the BACE trial shows that azithromycin initiated at the onset of an infectious COPD exacerbation requiring hospitalization reduces the incidence rate of treatment failure (TF) within 3 m by preventing hospital readmissions
In patients with high C-reactive protein (CRP) or low blood eosinophil count at admission this treatment effect was more pronounced, suggesting a potential role for these biomarkers in guiding azithromycin therapy
Summary
In the field of chronic obstructive pulmonary disease (COPD), acute exacerbations (AECOPD) are considered the most important determinants of a patient’s health status [1,2,3] They are characterized by an acute worsening of respiratory symptoms that necessitate additional therapy, based on which they are classified as mild (treated with short-acting bronchodilators only), moderate (requiring systemic corticosteroids and/or antibiotics) or severe (requiring hospitalization) [4]. Though formally negative on the primary endpoint (p = 0.0526), the applied time-to-first event analyses of its 3 subcomponents revealed that the reduction in TF rate within 3 months of hospital admission was mainly driven by a significant decrease of treatment intensification with systemic corticosteroids and/or antibiotics (TI), as well as step-up in hospital care (SH) for respiratory reasons, while no difference was observed for all-cause mortality. In the BACE trial, a 3-month (3 m) intervention with azithromycin, initiated at the onset of an infectious COPD exacerbation requiring hospitalization, decreased the rate of a first treatment failure (TF); the composite of treatment intensification (TI), step-up in hospital care (SH) and mortality
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