Previous research has reported an increased risk of pneumonia in patients with COPD who are on inhaled corticosteroids (ICS). This finding was associated with use of fluticasone, but not with budesonide-treated COPD. O’Byrne et al. (Am J Respir Crit Care Med 2010, doi:10.1164/rccm.201005-0694OC) present results from their analyses on pneumonia adverse events [AEs] and serious adverse events [SAE] from budesonide and budesonide/formoterol clinical trials involving asthma subjects. AstraZeneca collected and analyzed the data, which was reviewed by an independent statistician for the purposes of this research.
O’Byrne and co-authors evaluate two datasets, one from studies in subjects 4 years of age and older comparing placebo to Pulmicort® or Symbicort®, and a second dataset from studies of similar design that also include comparative data on fluticasone and high- and low-dosing effects. Pneumonia AEs from the first dataset were 0.5% in the budesonide group and 1.2% in the placebo group. Pneumonia SAEs were lower in the budesonide and placebo groups.
Analyses of the second dataset show pneumonia AEs in the budesonide group were slightly higher, but still lower than in the placebo group from the first dataset. Pneumonia SAEs were similar between the two datasets. The authors note that the risk of pneumonia between high-dose subjects and low-dose subjects was nearly equivalent. In contrast to the findings in COPD, pneumonia risk was similar, low, and not significant between budesonide and fluticasone.
Wrapping up, O’Byrne et al. point out that subjects in the second dataset with the lowest FEV1 values had higher risk of pneumonia. They comment that, in general, COPD subjects have lower baseline FEV1 than asthma subjects, which could account for greater risk of pneumonia in COPD.
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