Comparison of Risk of Pneumonia Caused by Fluticasone Propionate versus Budesonide in Chronic Obstructive Pulmonary Disease: A Nationwide Retrospective Cohort Study

Abstract

Introduction: Inhaled corticosteroids (ICSs) play an important role in lowering the risk of acute exacerbation of chronic obstructive pulmonary disease (COPD). However, ICSs are known to increase the risk of pneumonia. Moreover, previous studies have shown that the incidence rate of pneumonia varies depending on the type of ICS. In this study, the risk of pneumonia according to the type of ICS was investigated in a population-based cohort.

Methods: A retrospective cohort study was conducted using claims data of the entire population from the Korean National Health Insurance Service. Patients who were newly diagnosed with COPD and prescribed fluticasone propionate or budesonide were enrolled as study subjects. Cumulative doses of ICSs were classified into categorical variables to analyze the risk of pneumonia within identical ICS doses.

Results: A total of 47,473 subjects were identified and allocated as 14,518 fluticasone propionate and 14,518 budesonide users through 1:1 propensity score matching. Fluticasone propionate users were more likely to develop pneumonia than budesonide users (14.22% vs 10.66%, p<0.0001). The incidence rate per 100,000 person-years was 2,914.77 for fluticasone propionate users and 2,102.90 for budesonide users. The hazard ratio (HR) of pneumonia in fluticasone propionate compared to budesonide was 1.34 (95% CI 1.26-1.43, p<0.0001). The risk of pneumonia for fluticasone propionate compared to budesonide increased with higher ICS cumulative doses: 1.06 (0.93-1.21), 1.41 (1.19-1.66), 1.41 (1.23-1.63), and 1.49 (1.33-1.66) from the lowest to highest quartiles, respectively.

Conclusion: ICS types and doses need to be carefully considered during treatment with ICSs in patients with COPD.

Keywords: budesonide; chronic obstructive pulmonary disease; fluticasone propionate; inhaled corticosteroid; pneumonia.

Figure 1

Flowchart of patient selection.

Figure 2

The probability free of pneumonia over time in patients treated with different types of ICSs.

Figure 3

Risk of pneumonia in fluticasone propionate users compared with budesonide users. Hazard ratios were calculated as the ratio of the risk of pneumonia in fluticasone propionate compared to budesonide (reference) within identical doses and presented with 95% CIs and p value.