ICSs ‘do not increase pneumonia risk in asthma patients’
MedWire News: Use of the inhaled corticosteroid (ICS) budesonide is not associated with an increased risk for pneumonia in asthma patients, results from a review of published studies indicate.
Paul O'Byrne (McMaster University, Hamilton, Ontario, Canada) and team explain: "Several recent studies in patients with chronic obstructive pulmonary disease (COPD) reported increased rates of pneumonia among patients treated with the ICS fluticasone propionate. In addition, a Canadian nested case-control study in a cohort of patients with COPD suggested that treatment with any ICS may be associated with an increased risk of pneumonia."
They add: "Because ICSs are so widely prescribed in asthma, there is a possibility of an increased risk of pneumonia in patients with asthma who are taking ICSs."
To investigate, the researchers examined data on pneumonia-related adverse events (AEs) or serious adverse events (SAE) from 26 double-blind, placebo-controlled trials of budesonide, involving 14,993 asthma patients, that lasted for at least 3 months.
They also examined a secondary data set from 60 double-blind trials lasting at least 3 months, but without placebo control, that involved 36,269 asthma patients assigned to take budesonide or fluticasone propionate.
Analysis of the primary data set revealed that the pneumonia-related AE rate was 0.5% (10.0 events per 1000 patient-years) in budesonide-treated patients and 1.2% (19.3 events per 1000 patient-years) in those assigned to placebo, at a hazard ratio of 0.52. The SAE rate was a corresponding 0.15% (2.9 events per 1000 patient-years) and 0.13% (2.1 events per 1000 patient-years), at a hazard ratio of 1.29.
Analysis of the secondary data set revealed that the AE and SAEs rates were a respective 0.70% (12.7 events per 1000 patient-years) and 0.17% (3.1 events per 1000 patient-years) in budesonide-treated patients, which did not differ significantly from those in fluticasone-treated patients.
Budesonide dosage did not affect the findings, the researchers note in the American Journal of Respiratory and Critical Care Medicine.
O'Byrne and team conclude: "The results of this retrospective analysis do not support the concern that the use of ICSs increases the risk of pneumonia in patients with asthma, identified as either an AE or SAE in clinical trials using budesonide."
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By Mark Cowen