Budesonide Does Not Increase Risk of Pneumonia

Use of Budesonide Does Not Increase Risk of Pneumonia in Patients With COPD

NEW YORK — August 27, 2009 — Contrary to other research findings, a study published in this week’s COPD special issue of[ The Lancet shows that 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.

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 1 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, MD, St Paul’s Hospital and the University of British Columbia, Vancouver, British Columbia, and colleagues reviewed 7 large clinical trials of inhaled budesonide with or without formoterol compared with a 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 7,042 patients from 30 countries was analysed of which 3,801 patients were given inhaled budesonide and 3,241 received 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 versus 3% in the control group and, as a serious adverse event,1% versus 2% respectively.

Increasing age and reduced lung function were the 2 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.

“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,’ the authors concluded.

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