In COPD, some clinical trials have reported an increased incidence of pneumonia for patients receiving inhaled corticosteroids (ICS).1 This pooled analysis study determined the risk of pneumonia for budesonide (alone or combined with formoterol) compared with non-ICS-treated patients in COPD, and determined whether COPD patients have increased risk of pneumonia compared with patients with asthma.
Individualized data from 7 placebo-controlled trials of budesonide/formoterol or budesonide alone (≥6 months duration) were pooled and the time to the first pneumonia adverse event (AE) or serious AE (SAE) was compared for ICS-containing and non-ICS treatments. The pneumonia rates in these COPD trials were contrasted with those from START2 where budesonide was compared with placebo in 7221 patients with mild, persistent asthma.
In the 7 trials (n=7042, 3801 on ICS), the incidence of pneumonia AE was similar in ICS- and non-ICS-treated patients (3.2% vs. 3.2%, hazard ratio 1.05; 95% CI 0.81, 1.37) over one year, as was the incidence and risk of pneumonia SAE (1.4% vs. 1.5%; hazard ratio 0.92; 95% CI 0.62, 1.35). Two risk factors were significantly related to the occurrence of pneumonia as an AE or SAE: increasing age and decreasing FEV1 as percent predicted. In START,2 over 3 years, pneumonia was reported in 2.4% (0.8% during year 1) of the budesonide-treated and in 3.1% (1.4% during year 1) of the placebo-treated patients.
Budesonide is not associated with an increased risk of pneumonia in COPD or asthma. The incidence of pneumonia is three times higher in COPD than in asthma, possibly because the patients are older and have lower lung function.
These results support the safety of budesonide in COPD patients and suggest that COPD patients are at increased risk of pneumonias.
Data sets were provided by AstraZeneca. Data analysis was performed independently at UBC.
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Don Sin, Shareholder FR, US and TA hold shares in AstraZeneca.; Employee FR, US and TA are full time employees of AstraZeneca.; Consultant fee, speaker bureau, advisory committee, etc. DDS and DPT have received honoraria for speaking engagements and research funding from AstraZeneca and GlaxoSmithKline. PMAC has received honoraria and research funding from AstraZeneca, GlaxoSmithKline, Nycomed, and Boehringer Ingelheim. SIR has received honoraria for speaking, consulting, or research funding from AstraZeneca, GlaxoSmithKline, Schering Plough, Aradigm, Boehringer Ingelheim, Novartis, Pfizer, Mpex, Pulmatrix, Theradvance, Uptake Medical, Wyeth, Nycomed, Almirall, Forest, Dey, Biomark, and Centocor.; No Product/Research Disclosure Information