Safety and efficacy of budesonide/glycopyrrolate/formoterol fumarate compared with glycopyrrolate/formoterol fumarate for the treatment of COPD: A systematic review and meta-analysis.

BACKGROUND

Chronic obstructive pulmonary disease (COPD) is a progressive illness characterized by persistent respiratory symptoms and restricted airflow, often owing to smoking and prolonged exposure to environmental irritants. COPD affects the pulmonary vasculature, lung parenchyma, and airways, leading to structural abnormalities such as emphysema. This study compares the safety and effectiveness of budesonide/glycopyrrolate/formoterol fumarate (BGF) metered-dose inhaler (MDI) with glycopyrrolate/formoterol fumarate (GFF) MDI in patients with moderate to severe COPD, focusing on adverse events and forced expiratory volume in 1 second (FEV1).

METHODS

A comprehensive literature search was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The search encompassed databases such as PubMed, MEDLINE, ClinicalTrials.gov, Cochrane Library, ScienceDirect, Web of Science, and Google Scholar up to April 2024. Search terms included "COPD," "dual therapies," "triple therapies," "LABA," "LAMA," "BGF MDI," "FEV," and "COPD exacerbation." Only English-language randomized controlled trials involving patients aged 40-80 years who were current or former smokers with confirmed COPD were included. In addition, reference lists of included studies were screened. Study quality was assessed using the Cochrane Risk of Bias 2.0 tool.

RESULTS

Through an initial literature review, we obtained 4022 articles, 4 of which were included in the current study. Results showed a statistically significant rise in FEV1 with BGF MDI compared with GFF MDI at 4, 24, and 52 weeks. At 52 weeks, the pooled mean difference in FEV1 was 46.48 mL (95% CI 25.26-67.71). Safety profiles were similar, with adverse events such as nasopharyngitis and upper respiratory tract infections observed in both treatments.

CONCLUSION

BGF MDI significantly improves lung function compared with GFF MDI in moderate to severe COPD and has a comparable safety profile. Further large-scale studies are needed to confirm long-term safety.