Influence of clinical characteristics and bronchodilator treatment on COPD exacerbations: BIFAP registry

COPD is characterized by exacerbations that increase morbi-mortality. Maintenance pharmacological treatment is based on long-acting bronchodilators. This study assessed the effectiveness of different therapeutic strategies under real-world conditions.

Observational, longitudinal, retrospective cohort study using data from the Spanish BIFAP database (2010-2020) including patients with incident COPD. Patients were stratified by therapy: monotherapy, dual therapy (with/without inhaled glucocorticoids), and triple therapy. Multivariable mixed-effects Cox models adjusted for clinical factors and comorbidities were applied to estimate the risk of moderate-to-severe exacerbations.

A total of 69.565 patients were included (mean age 63 years; 71% men). Age, female sex and diabetes were associated with a higher risk of moderate-to-severe exacerbations. Risk increased with treatment escalation: monotherapy (HR=4.14), dual therapy without inhaled glucocorticoids (HR=2.45), dual therapy with inhaled glucocorticoids (HR=7.11), and triple therapy (HR=5.31), reflecting indication bias. A higher risk was also observed with lack of treatment optimization, either by therapeutic regimen (HR=3.75) or number of devices (HR=1.31). Differences in risk were identified among specific active agents within the same therapeutic class.

In real-world practice, the risk of moderate-to-severe exacerbations is influenced by baseline disease severity, particularly prior exacerbations, and by the therapeutic pattern. LAMA/LABA appears as the preferred option over dual therapy with inhaled glucocorticoids. Optimizing therapy and simplifying inhaler devices are associated with lower risk and should be prioritized in COPD management.