Abstract
BackgroundUse of inhaled corticosteroids (ICS) increases the risk of pneumonia in chronic obstructive pulmonary disease (COPD), but the magnitude of risk with different ICS remains unclear.MethodsA post hoc analysis of the 4-year UPLIFT® trial to assess whether pneumonia risk differed by type of ICS (fluticasone propionate [FP], other ICS, or no ICS) in permanent users (defined by use until end of study) or in users at baseline (sensitivity analysis).ResultsFor the permanent-users analysis, 825 patients receiving FP throughout the trial, 825 patients receiving other ICS and 825 patients not receiving ICS were matched on relevant baseline features 1:1:1. A significantly greater risk of pneumonia was observed for FP versus no ICS: the hazard ratio (HR) for risk of pneumonia was 1.33 (95% confidence interval [CI] 1.00, 1.75; p = 0.046) and the rate ratio (RR) was 1.58 (95% CI 1.05, 2.37; p = 0.028). A greater risk was also found for FP versus other ICS: HR 1.28 (95% CI 0.97, 1.68; p = 0.078) and RR 1.48 (95% CI 1.00, 2.19; p = 0.049). A higher proportion of patients on FP were hospitalized with pneumonia (7.9%) versus other ICS (6.7%) or no ICS (5.9%). Whilst other ICS use was associated with the highest number of fatal pneumonia events, the total number of fatal pneumonia incidents was low. A similar pattern was observed in the sensitivity analyses, which included 4002 patients on different treatments at baseline (FP, other ICS, and no ICS) and considered potential switches during the study.ConclusionThe results support existing evidence of an increased pneumonia risk with FP use compared with other ICS and no ICS use in patients with COPD. Healthcare professionals should evaluate the risk–benefit ratio of using ICS when making treatment decisions with their patients.Trial registrationPost hoc analysis of UPLIFT®. ClinicalTrials.gov number: NCT00144339. Retrospectively registered September 2, 2005.
Highlights
Use of inhaled corticosteroids (ICS) increases the risk of pneumonia in chronic obstructive pulmonary disease (COPD), but the magnitude of risk with different ICS remains unclear
Recent randomized controlled trials suggest that ICS can be discontinued in some patients with stable COPD for whom ICS treatment may not be indicated without compromising safety and efficacy [4]
In this post hoc analysis of the 4-year UPLIFT® trial, we assessed whether ICS use, and fluticasone propionate (FP), when taken long-term in the treatment of COPD was associated with a higher risk of pneumonia
Summary
Use of inhaled corticosteroids (ICS) increases the risk of pneumonia in chronic obstructive pulmonary disease (COPD), but the magnitude of risk with different ICS remains unclear. Inhaled corticosteroids (ICS) are widely used for the treatment of chronic obstructive pulmonary disease (COPD) [1]. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) report currently positions ICS in combination with bronchodilators as a second-line option to reduce exacerbation rates in patients in GOLD groups C and D who have experienced frequent exacerbations [2]. It has been estimated that more than 70% of patients with COPD are treated with high doses of ICS, including those at low risk of exacerbations [3]. Recent randomized controlled trials suggest that ICS can be discontinued in some patients with stable COPD for whom ICS treatment may not be indicated without compromising safety and efficacy [4]. High doses potentially result in systemic effects that could lead to glaucoma, cataracts, adrenal suppression, osteoporosis, bone fractures, skin bruising, and diabetes mellitus [4, 7, 8, 12,13,14,15,16]
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