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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

Summary
Lancet 2009; 374: 712–19 See Comment page 668 Providence Heart and Lung Institute, St Paul’s Hospital (iCAPTURE Centre), and Department of Medicine (Division ofRespirology), University of British Columbia, Vancouver, BC, Canada (D D Sin MD, X Zhang MSc); Division of Pulmonary and Critical Care Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, USA (Prof D Tashkin MD); AstraZeneca R&D, Lund, Sweden (F Radner PhD, U Sjöbring MD, A Thorén MD); School of Clinical Sciences, University of Liverpool, Liverpool, UK (Prof P M A CalverleyMD); and Internal Medicine Section of Pulmonary and Critical Care, Nebraska Medical Center, Omaha, NE, USA (Prof S I Rennard MD) Correspondence to: Dr Don D Sin, St Paul’s Hospital, 1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada dsin@mrl.ubc.ca

Background Concern is continuing about increased risk of pneumonia in patients with chronic obstructive pulmonary disease (COPD) who use inhaledcorticosteroids. We aimed to establish the effects of inhaled budesonide on the risk of pneumonia in such patients. Methods We pooled patient data from seven large clinical trials of inhaled budesonide (320–1280 μg/day), with or without formoterol, versus control regimen (placebo or formoterol alone) in patients with stable COPD and at least 6 months of follow-up. The primary analysis comparedtreatment groups for the risk of pneumonia as an adverse event or serious adverse event during the trial or within 15 days of the trial end. Cox proportional hazards regression was used to analyse the data on an intention-to-treat basis. Data were adjusted for patients’ age, sex, smoking status, body-mass index, and postbronchodilator percent of predicted forced expiratory volume in 1 s (FEV1). FindingsWe analysed data from 7042 patients, of whom 3801 were on inhaled budesonide and 3241 were on control treatment, with 5212 patient-years of exposure to treatment. We recorded no significant difference between treatment groups for the occurrence of pneumonia as an adverse event (3% [n=122 patients] vs 3% [n=103]; adjusted hazard ratio 1·05, 95% CI 0·81–1·37) or a serious adverse event (1% [n=53] vs 2%[n=50]; 0·92, 0·62–1·35), or for time to pneumonia as an adverse event (log-rank test 0·94) or a serious adverse event (0·61). Increasing age and decreasing percent of predicted FEV1 were the only two variables that were significantly associated with occurrence of pneumonia as an adverse event or a serious adverse event. Interpretation Budesonide treatment for 12 months does not increase the riskof pneumonia in patients with COPD during that time and therefore is safe for clinical use in such patients. Funding Michael Smith Foundation for Health Research.

Introduction
Inhaled corticosteroids, given with and without longacting β2 agonists, reduce the occurrence of disease exacerbation and improve quality of life for patients with chronic obstructive pulmonary disease (COPD), but theyhave also been associated with increased risk of pneumonia.1 Results from the largest clinical trial so far showed that inhaled corticosteroids increase the risk of pneumonia by nearly 50%.1 In an observational study of a large health database, Ernst and colleagues2 reported a 70% increase in the risk of hospital admission for pneumonia in patients who used inhaled corticosteroids. Findings from ameta-analysis indicated that on average, inhaled corticosteroids raised the risk of pneumonia by 34%;3 however, results differed widely between studies with some trials reporting increased risk,1,4 whereas others reported reduced risk.5,6 The excess risk seemed to be mainly restricted to patients who received doses of inhaled corticosteroids exceeding 1000 μg/day beclometasone or equivalent.3...
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