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

• Published in: International journal of chronic obstructive pulmonary disease 2019-01, Vol.14, p.757-766
• Main Authors: Tang, Bin, Wang, Jun, Luo, Lin-Lin, Li, Qiu-Gen, Huang, Dan
• Format: Article
• Language: English
• Subjects: Adrenergic beta-2 Receptor Agonists - adverse effects; Adrenergic beta-2 Receptor Agonists - therapeutic use; Adrenergic receptors; Bronchitis; Bronchodilator Agents - adverse effects; Bronchodilator Agents - therapeutic use; Budesonide, Formoterol Fumarate Drug Combination - adverse effects; Budesonide, Formoterol Fumarate Drug Combination - therapeutic use; budesonide/formoterol; Candidiasis; Chronic obstructive lung disease; Chronic obstructive pulmonary disease; Clinical trials; Corticosteroid drugs; Drug therapy; Glucocorticoids; Glucocorticoids - adverse effects; Glucocorticoids - therapeutic use; Humans; Lung - drug effects; Lung - physiopathology; Medical research; Meta-analysis; Mycoses; Oral candidiasis; Original Research; Pneumonia; Pulmonary Disease, Chronic Obstructive - diagnosis; Pulmonary Disease, Chronic Obstructive - drug therapy; Pulmonary Disease, Chronic Obstructive - physiopathology; Quality of life; randomized controlled trial; Recovery of Function; risk; Risk Factors; Steroids; Treatment Outcome
• ISSN: 1178-2005; 1176-9106; 1178-2005
• DOI: 10.2147/COPD.S192166

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. 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. 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). 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).