Real-World Effectiveness of Triple Extrafine Fixed-Dose Combination with Beclomethasone/Formoterol/Glycopyrronium on Symptoms and Lung Function in COPD: A Systematic Review and Meta-Analysis.

INTRODUCTION

Chronic obstructive pulmonary disease (COPD) is a significant global health issue characterized by persistent airflow limitation and inflammation. Triple fixed-dose combinations (FDCs) of inhaled corticosteroids (ICS), long-acting β2-agonists (LABA), and long-acting muscarinic antagonists (LAMA) show promise by potentially enhancing bronchodilation and anti-inflammatory effects. Although randomized controlled trials (RCTs) provide efficacy data, they may not fully represent real-world clinical practice, highlighting the value of real-world evidence (RWE).

METHODS

This study conducted a systematic review and meta-analysis of prospective observational multicenter studies to evaluate the real-world effectiveness of a triple extrafine FDC containing beclomethasone dipropionate (BDP), formoterol fumarate (FF), and glycopyrronium (G) in moderate-to-severe COPD patients. Databases MEDLINE and SCOPUS were searched for relevant studies reporting on the COPD Assessment Test (CAT) score and forced expiratory volume in one second (FEV1).

RESULTS

The meta-analysis included seven studies with 5952 patients, indicating high methodological quality with Newcastle-Ottawa Scale scores ≥7. Results showed significant improvement in CAT scores (-5.82 95% CI -7.61 - -4.03; P < 0.001) and FEV1 (127 mL 95% CI 42-212; P < 0.001) for extrafine BDP/FF/G FDC compared to any prior treatments (ICS/LABA, ICS+LABA, LABA/LAMA, LABA+LAMA, multiple-inhaler triple therapy, single-inhaler triple therapy), exceeding minimal clinically important differences. Heterogeneity was significant, but Egger's test suggested no significant publication bias.

CONCLUSION

The triple extrafine BDP/FF/G FDC effectively improves health status and lung function in real-world COPD patients, supporting its use as a viable therapeutic strategy. Further research should explore long-term outcomes and investigate specific patient subgroups to optimize individualized treatment approaches.