To compare the risk of moderate or severe COPD exacerbations between azithromycin and roflumilast in patients with active COPD.
Approach:
Study Design: A target trial emulation using the Optum Clinformatics Data Mart Database to identify patients aged 40 and older who initiated maintenance azithromycin or roflumilast.
Patient Selection: Included patients had at least 183 days of continuous insurance enrollment and active COPD defined by specific claims criteria.
Outcome Measures: Moderate exacerbations required 5 to 14 days of oral glucocorticoid treatment; severe exacerbations required hospitalization.
Analysis: Primary analysis was as-treated with a median follow-up of 88 days and included 7,550 matched pairs.
Key Findings:
Azithromycin was associated with a 17% lower likelihood of a first moderate or severe exacerbation compared to roflumilast.
Unadjusted incidence rates were 1.1 events per person-year for azithromycin and 1.3 for roflumilast.
Model-based 1-year risks were 60% for azithromycin and 67% for roflumilast.
Azithromycin also showed a 17% lower risk of a first moderate exacerbation and an 11% lower annual rate of moderate or severe exacerbations.
Limitations:
Short follow-up period.
Potential misclassification due to claims data.
Residual confounding possible due to lack of certain clinical measures.
