Risks of Pneumonia in Patients with Asthma Taking Inhaled Corticosteroids

• Published in: American journal of respiratory and critical care medicine Vol. 183; no. 5; pp. 589 - 595
• Main Authors: O'BYRNE, Paul M, PEDERSEN, Soren, CARLSSON, Lars-Göran, RADNER, Finn, THOREN, Anders, PETERSON, Stefan, ERNST, Pierre, SUISSA, Samy
• Format: Journal Article
• Language: English
• Published: New York, NY American Thoracic Society 01.03.2011
• Subjects: Administration, Inhalation; Adolescent; Adrenal Cortex Hormones - administration & dosage; Adrenal Cortex Hormones - adverse effects; Adult; Aged; Androstadienes - administration & dosage; Androstadienes - adverse effects; Androstadienes - therapeutic use; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Asthma; Asthma - drug therapy; Asthma - epidemiology; Biological and medical sciences; Bronchodilator Agents - administration & dosage; Bronchodilator Agents - adverse effects; Bronchodilator Agents - therapeutic use; Budesonide - administration & dosage; Budesonide - adverse effects; Budesonide - therapeutic use; Causality; Child; Child, Preschool; Chronic obstructive pulmonary disease; Clinical death. Palliative care. Organ gift and preservation; Clinical trials; Comorbidity; Confidence intervals; Datasets; Double-Blind Method; Female; Fluticasone; Humans; Incidence; Inhalers; Intensive care medicine; Male; Medical sciences; Middle Aged; Patients; Pneumonia; Pneumonia - chemically induced; Pneumonia - epidemiology; Proportional Hazards Models; Randomized Controlled Trials as Topic; Retrospective Studies; Risk Factors; Steroids; Young Adult; Human; Lung disease; Corticosteroid; Pneumonia; Intensive care; Respiratory disease; Asthma; Inhalation; Risk factor; adverse effects; Bronchus disease; Obstructive pulmonary disease; Resuscitation; inhaled corticosteroids
• DOI: 10.1164/rccm.201005-0694OC
• ISSN: 1073-449X

Inhaled corticosteroids (ICS) are the mainstay of asthma treatment. Studies in chronic obstructive pulmonary disease reported increased rates of pneumonia with ICS. Concerns exist about an increased pneumonia risk in patients with asthma taking ICS. To evaluate the risks of pneumonia in patients with asthma taking ICS. A retrospective analysis evaluated studies of the ICS budesonide in asthma. The primary data set were all double-blind, placebo-controlled trials lasting at least 3 months, involving budesonide (26 trials, n = 9,067 for budesonide; n = 5,926 for the comparator) sponsored by AstraZeneca. A secondary data set evaluated all double-blind trials lasting at least 3 months but without placebo control (60 trials, n = 33,496 for budesonide, n = 2,773 for fluticasone propionate). Cox proportional hazards regression modeling was used to estimate the relative effect of ICS on pneumonia adverse events (AEs) or serious adverse events (SAEs). In the primary data set, the occurrence of pneumonia AEs was 0.5% (rate 10.0 events/1,000 patient-years [TPY]) for budesonide and 1.2% (19.3 per TPY) for placebo (hazard ratio, 0.52; 95% confidence interval, 0.36-0.76; P < 0.001); the occurrence of pneumonia SAEs was 0.15% (2.9 per TPY) for budesonide and 0.13% (2.1 per TPY) for placebo (hazard ratio, 1.29; 95% confidence interval, 0.53-3.12; P = 0.58). In the secondary data set, the percentage of patients reporting pneumonia AEs was 0.70% (12.7 per TPY), whereas the percentage of patients reporting pneumonia SAEs was 0.17% (3.1 per TPY). There was no increased risk with higher budesonide doses or any difference between budesonide and fluticasone. There is no increased risk of pneumonia in patients with asthma, identified as an AE or SAE, in clinical trials using budesonide.