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Meta-Analysis
. 2019 Apr 1:14:757-766.
doi: 10.2147/COPD.S192166. eCollection 2019.

Risks of budesonide/formoterol for the treatment of stable COPD: a meta-analysis

Bin Tang  1 , Jun Wang  1 , Lin-Lin Luo  1 , Qiu-Gen Li  1 , Dan Huang  2
Affiliations
Meta-Analysis

Risks of budesonide/formoterol for the treatment of stable COPD: a meta-analysis

Bin Tang et al. Int J Chron Obstruct Pulmon Dis. .

Abstract

Purpose: The aim of this study was to investigate the comparative risks of budesonide/formoterol, versus placebo or monotherapies, for the treatment of patients with stable COPD.

Materials and methods: We undertook a systematic search of the literature in PubMed, Embase, and the Cochrane Central Register of Controlled Trials, for randomized controlled trials (RCTs) comparing budesonide/formoterol with control regimens for the treatment of patients with stable COPD and at least 12 weeks of follow-up, meeting the inclusion criteria. Studies were reviewed, and OR with corresponding 95% CI was used to pool the results.

Results: A total of eight studies involving 9,254 patients met the inclusion criteria of this meta-analysis. Compared with placebo, combination therapy with budesonide/formoterol was associated with a significantly higher risk of adverse effects including oral candidiasis (OR: 3.09, 95% CI: 1.95-4.91) and dysphonia (OR: 2.76, 95% CI: 1.40-5.44), but not pneumonia (OR: 0.94, 95% CI: 0.64-1.37) or bronchitis (OR: 1.36, 95% CI: 0.95-1.95). A similar pattern was also evident for the comparison of formoterol with budesonide/formoterol, with increased occurrence of oral candidiasis (OR: 2.72, 95% CI: 1.33-5.58) and dysphonia (OR: 4.13, 95% CI: 1.95-8.76); however, there were no significant differences in pneumonia (OR: 1.31, 95% CI: 0.98-1.74) or bronchitis (OR: 1.05, 95% CI: 0.83-1.31). In contrast, compared with budesonide, combined budesonide/formoterol was associated with similar risks of adverse effects, including pneumonia (OR: 1.20, 95% CI: 0.60-2.39), bronchitis (OR: 0.95, 95% CI: 0.41-2.20), oral candidiasis (OR: 0.79, 95% CI: 0.41-1.53), and dysphonia (OR: 1.00, 95% CI: 0.40-2.47).

Conclusion: Combination therapy does not cause more adverse events, including pneumonia and bronchitis, than control (placebo, formoterol, or budesonide) treatment in patients with stable COPD, while there were higher risks of oral candidiasis and dysphonia compared with the non-inhaled corticosteroid group (placebo, formoterol).

Keywords: COPD; budesonide/formoterol; meta-analysis; randomized controlled trial; risk.

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Conflict of interest statement

Disclosure The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Flowchart of the study selection procedure. Abbreviation: RCT, randomized controlled trial.
Figure 2
Figure 2
Forest plot of pneumonia, bronchitis, oral candidiasis, and dysphonia comparison. (A) Pneumonia in BUD/FM versus placebo. (B) Bronchitis in BUD/FM versus placebo. (C) Oral candidiasis in BUD/FM versus placebo. (D) Dysphonia in BUD/FM versus placebo. Abbreviations: BUD, budesonide; FM, formoterol; PL, placebo.
Figure 3
Figure 3
Forest plot of pneumonia, bronchitis, oral candidiasis, and dysphonia comparison. (A) Pneumonia in BUD/FM versus FM. (B) Bronchitis in BUD/FM versus FM. (C) Oral candidiasis versus FM. (D) Dysphonia in BUD/FM versus FM. Note: Weights are from random-effects analysis. Abbreviations: BUD, budesonide; FM, formoterol.
Figure 4
Figure 4
Forest plot of pneumonia, bronchitis, oral candidiasis, and dysphonia comparison. (A) Pneumonia in BUD/FM versus BUD. (B) Bronchitis in BUD/FM versus BUD. (C) Oral candidiasis in BUD/FM versus BUD. (D) Dysphonia in BUD/FM versus BUD. Note: Weights are from random-effects analysis. Abbreviations: BUD, budesonide; FM, formoterol.
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