Contrary to other research findings, patients using the inhaled corticosteroid budesonide to treat Chronic Obstructive Pulmonary Disease (COPD) are not at increased risk of pneumonia, and the drug is safe to use in these patients, concludes an Article in this week's COPD special issue of the Lancet.
Inhaled corticosteroids are prescribed with and without beta-antagonists to relieve the symptoms and improve the quality of life for patients with COPD. However, recent studies have suggested that inhaled corticosteroids increase the risk of pneumonia, particularly in patients receiving high doses. Yet, these studies have been criticised for limitations including their inability to adjust for potential confounders such as age and lung function because of lack of access to patient-level data, and their focus on just one inhaled corticosteroid, fluticasone—which may not have accounted for possible differences between steroid compounds and their different clinical effects.
To address some of these limitations, Don Sin from St Paul's Hospital and the University of British Columbia, Vancouver, Canada and colleagues reviewed seven large clinical trials of inhaled budesonide with or without the long-acting beta antagonist formoterol compared with a control (placebo or formoterol alone), to examine the effects of budesonide on the risk of pneumonia as an adverse event in patients with stable COPD. In total, data from 7042 patients from 30 countries was analysed—3801 given inhaled budesonide and 3241 on control treatment.
Overall, findings showed that the 1-year risk of pneumonia was low and not significantly different in the treatment groups. The occurrence of pneumonia as an adverse event was 3% in the budesonide treated group vs 3% in the control group and, as a serious adverse event,1% vs 2% respectively. Increasing age and reduced lung function were the two most important predictors of pneumonia as an adverse or serious adverse event. But sex, current smoking status, and body-mass index were not significantly associated with an increased risk of pneumonia.
The authors conclude: "Future research should clarify the mechanisms by which inhaled corticosteroids contribute to pneumonia, and how the risk is modified by differences in dosage and pharmacokinetics."
In an accompanying Comment, Tobias Welte from Medizinische Hochschule in Germany says that improving the quality of clinical data is the only way to resolve whether inhaled corticosteroids increase the risk of pneumonia. He suggests that all COPD studies should have 'a definition of community-acquired pneumonia that meets the international guidelines…and all cases with suspicion of pneumonia should have a chest radiograph."
Dr Don Sin, St Paul's Hospital, University of British Columbia, Vancouver, Canada. T) +1 604 806 8395 E) dsin@hli.ubc.ca
Dr Tobias Welte, Medizinische Hochschule, Hanover, Germany. T) +49 511 532 3530 E) welte.tobias@mh-hanover.de
For full Article and Comment, see: http://press.thelancet.com/copdpneum.pdf
Journal
The Lancet