Are Lung Disease Patients Using Inhaled Corticosteroid Budesonide At Increased Risk Of Pneumonia?

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Main Category: COPD
Also Included In: Clinical Trials / Drug Trials
Article Date: 28 Aug 2009 - 0:00 PDT

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An article in this week's COPD special issue of The Lancet reports that patients using the inhaled corticosteroid budesonide to treat Chronic Obstructive Pulmonary Disease (COPD) are not at increased risk of pneumonia. In addition, the drug is safe to use in these patients. Those conclusions are contrary to other research findings.

Inhaled corticosteroids are prescribed with and without beta-antagonists. They ease the symptoms and improve the quality of life for patients with COPD. But the latest studies have suggested that inhaled corticosteroids increase the risk of pneumonia, mostly in patients receiving high doses. However, these studies have been criticized for their limitations as well as their incapacity to adjust for potential factors such as age and lung function. This is due to a lack in patient data. Furthermore, they focused on just one inhaled corticosteroid, fluticasone. These studies may not have accounted for possible differences between steroid compounds and their different clinical effects.

In order 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. They analysed the use of inhaled budesonide with or without the long-acting beta antagonist formoterol compared with a control (placebo or formoterol alone). The researchers examined the effects of budesonide on the risk of pneumonia as an adverse event in patients with stable COPD. They analyzed data from 7,042 patients from 30 countries, from which 3,801 were given inhaled budesonide and 3,241 were on control treatment.

In general, results suggested that the one-year risk of pneumonia was low and not noticeably different in the treatment groups. The incidence of pneumonia as an adverse event was 3 percent in the budesonide treated group. In the control group, it was 3 percent. And as a serious adverse event, 1 percent compared to 2 percent, respectively. The two most important predictors of pneumonia as an adverse or serious adverse event were increasing age and reduced lung function. But gender, current smoking status, and body-mass index were not significantly linked with an increased risk of pneumonia.

The authors write in conclusion: "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 associated note, Tobias Welte from Medizinische Hochschule in Germany remarks that the improvement of the quality of clinical data is the best approach in order to determine whether inhaled corticosteroids increase the risk of pneumonia. He advises 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."

"Budesonide and the risk of pneumonia: a meta-analysis of individual patient data"
Don D Sin, Donald Tashkin, Xuekui Zhang, Finn Radner, Ulf Sjöbring, Anders Thorén, Peter M A Calverley, Stephen I Rennard
Lancet 2009; 374: 712-19
The Lancet

Written by Stephanie Brunner (B.A.)
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