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Treatment failure and hospital readmissions in severe COPD exacerbations treated with azithromycin versus placebo - A post-hoc analysis of the BACE randomized controlled trial
Authors
Joseph Aumann
Joseph Aumann
+34 more
Ann Belmans
Kris Bogaerts
Guy G. Brusselle
Guy G. Brusselle
Nina Cardinaels
Jean Louis Corhay
Jean Louis Corhay
Alix Debrock
Alain Delobbe
Ingel K. Demedts
Ingel K. Demedts
Antoine Fremault
Maria Gabrovska
Iwein Gyselinck
Christel Haenebalcke
Christel Haenebalcke
Michiel Haerens
Wim Janssens
Paul Jordens
Jan Lamont
Tine Lauwerier
Eric Marchand
Jean Benoît Martinot
Vincent Ninane
Vincent Ninane
Rudi Peché
Hans Slabbynck
Hans Slabbynck
Geert Tits
Thierry Troosters
Geert M. Verleden
Kristina Vermeersch
Stefanie Vermeersch
Walter Vincken
Publication date
1 January 2019
Publisher
'Springer Science and Business Media LLC'
Doi
Cite
Abstract
Background: 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. 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. Methods: Enrolment 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. Results: Azithromycin 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. Conclusions: 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 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 registration: ClinicalTrials.gov number. NCT02135354. © 2019 The Author(s)
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