preventing mortality in COPD: the value of Inhaled budesonide added to bronchodilators
Peter Calverley1, Paul Jones2, Thomas Larsson3 and Stefan Peterson3
1Aintree Chest Centre, University of Liverpool, Liverpool, UK; 2St George's Hospital Medical School, London, UK; 3AstraZeneca, Lund, Sweden.
Background: Meta-analysis has demonstrated that inhaled corticosteroids (ICS) reduce mortality in COPD, and retrospective data suggest an added benefit when ICS are combined with a long-acting beta-2 agonist. The potential survival benefits of adding the ICS budesonide to long- and/or short-acting bronchodilators in COPD have not previously been addressed specifically.
Methods: A meta-analysis was performed on mortality and baseline data obtained from two well-controlled 1-year studies (Szafranski, et al. ERJ 2003;21:74–81; Calverley, et al. ERJ 2003;22:912–919) of patients treated with budesonide/formoterol (Symbicort®) or budesonide (pooled data; n=917) compared with patients treated with formoterol or placebo (pooled data; n=917). All were given terbutaline prn; 77% were male; mean age was 64 years, with mean pack-years 41 and mean FEV1 36% predicted normal. Survival times were compared with a log-rank test stratified by study and further descriptions were obtained by Cox regression, with treatment as a factor and stratification by study.
Results: There were 22 deaths in the budesonide/formoterol or budesonide group vs 34 in the formoterol or placebo group (p=0.036), hazard ratio 0.564 (p=0.039).
Conclusions: Budesonide added to formoterol (Symbicort®) and/or terbutaline prn significantly reduced mortality over 1 year in severe COPD compared with formoterol and/or terbutaline prn.
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