Discontinuation of Inhaled Corticosteroids in COPD and the Risk Reduction of Pneumonia

Suissa, Samy; Coulombe, Janie; Ernst, Pierre

doi:10.1378/chest.15-0627

Cited by 69 publications

(53 citation statements)

References 18 publications

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“…ICS has been used widely to treat patients with COPD, and recent trials have shown that ICS use is associated with increasing occurrence of pneumonia, and discontinuation of ICS use reduces the elevated risk of serious pneumonia (33)(34)(35). In the present study, prior use of ICS in patients with COPD was a risk factor of ICU transfer.…”

Section: Discussionmentioning

confidence: 57%

Different characteristics associated with intensive care unit transfer from the medical ward between patients with acute exacerbations of chronic obstructive pulmonary disease with and without pneumonia

et al. 2016

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Section: Discussionmentioning

confidence: 57%

Different characteristics associated with intensive care unit transfer from the medical ward between patients with acute exacerbations of chronic obstructive pulmonary disease with and without pneumonia

et al. 2016

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“…In this nested case–control analysis of 163,514 COPD patients, ICS use (either alone or in a combination inhaler) was associated with a 69% increase in the risk of serious pneumonia (either requiring hospitalization or fatal), and this was higher with fluticasone (122% increase at 1,000 μg/d) than with budesonide (17% increase) 6. This finding was supported by a later study from the same group indicating a decrease in risk after discontinuation of ICS, including after discontinuation of budesonide 7. Recently, a comprehensive study-level meta-analysis from Kew and Seniukovich8 estimated the odds ratio for nonfatal pneumonia serious adverse events (SAEs) to be 1.62 for budesonide-containing compared to non-budesonide-containing treatment (95% confidence interval [CI]: 1.00–2.62).…”

Section: Introductionmentioning

confidence: 68%

Risk of pneumonia with budesonide-containing treatments in COPD: an individual patient-level pooled analysis of interventional studies

Hollis

Jorup

Lythgoe³

et al. 2017

COPD

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BackgroundConcerns have been raised that treatment of COPD with inhaled corticosteroids may increase pneumonia risk. Responding to a request from the European Medicines Agency Pharmacovigilance Risk Assessment Committee, a pooled analysis of interventional studies compared pneumonia risk with inhaled budesonide-containing versus non-budesonide-containing treatments and the impact of other clinically relevant factors.MethodsAstraZeneca-sponsored, parallel-group, double-blind, randomized controlled trials meeting the following criteria were included: >8 weeks’ duration; ≥60 patients with COPD; inhaled budesonide treatment arm (budesonide/formoterol or budesonide); and non-budesonide-containing comparator arm (formoterol or placebo). Primary and secondary outcomes were time to first pneumonia treatment-emergent serious adverse event (TESAE) and treatment-emergent adverse event (TEAEs), respectively, analyzed using Cox regression models stratified by study.ResultsEleven studies were identified; 10,570 out of 10,574 randomized patients receiving ≥1 dose of study treatment were included for safety analysis (budesonide-containing, n=5,750; non-budesonide-containing, n=4,820). Maximum exposure to treatment was 48 months. The overall pooled hazard ratio (HR), comparing budesonide versus non-budesonide-containing treatments, was 1.15 for pneumonia TESAEs (95% confidence interval [CI]: 0.83, 1.57) and 1.13 for pneumonia TEAEs (95% CI: 0.94, 1.36). The annual incidence of pneumonia TESAEs was 1.9% and 1.5% for budesonide-containing and non-budesonide-containing treatments, respectively. Comparing budesonide/formoterol with non-budesonide-containing treatment, the HRs for pneumonia TESAEs and TEAEs were 1.00 (95% CI: 0.69, 1.44) and 1.21 (95% CI: 0.93, 1.57), respectively. For budesonide versus placebo, HRs were 1.57 for pneumonia TESAEs (95% CI: 0.90, 2.74) and 1.07 for pneumonia TEAEs (95% CI: 0.83, 1.38).ConclusionThis pooled analysis found no statistically significant increase in overall risk for pneumonia TESAEs or TEAEs with budesonide-containing versus non-budesonide-containing treatments. However, a small increase in risk with budesonide-containing treatment cannot be ruled out; there is considerable heterogeneity in study designs and patient characteristics, particularly in the early budesonide studies, and each study contributes <40 pneumonia TESAEs.

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“…17 A database study with 4.9 years follow up found similar reductions in pneumonia, primarily with fluticasone discontinuation. 18 …”

Section: Ics Withdrawal Studiesmentioning

confidence: 99%

Nuggets of Knowledge: COPD – targeting the use of inhaled corticosteroids

Bryant¹

2016

J Prim Health Care

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Discontinuation of Inhaled Corticosteroids in COPD and the Risk Reduction of Pneumonia

Cited by 69 publications

References 18 publications

Different characteristics associated with intensive care unit transfer from the medical ward between patients with acute exacerbations of chronic obstructive pulmonary disease with and without pneumonia

Different characteristics associated with intensive care unit transfer from the medical ward between patients with acute exacerbations of chronic obstructive pulmonary disease with and without pneumonia

Risk of pneumonia with budesonide-containing treatments in COPD: an individual patient-level pooled analysis of interventional studies

Nuggets of Knowledge: COPD – targeting the use of inhaled corticosteroids

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