Background: Two long-acting muscarinic antagonist inhaler fixed dose combinations (olodaterol/tiotropium (OLO/TIO) and vilanterol/umeclidinium (VI/UMEC)) have once-a-day dosing for managing chronic obstructive pulmonary disease (COPD). This study aimed to compare clinical effectiveness of these inhalers in terms of ability to prevent severe COPD exacerbations in a United States Medicare population.
Research design and methods: Using nationally representative Medicare data (2013-2019), we employed a new user, active comparator design among beneficiaries aged 65 years and older with COPD. The outcome of interest was time to first occurrence of a severe COPD exacerbation. To ensure comparability between the groups, we performed 1:3 (OLO/TIO:VI/UMEC) nearest neighbor matching based on their high-dimensional propensity scores.
Results: The study included 2,263 OLO/TIO new initiators matched to 6,789 VI/UMEC new initiators. The incidence rate of the first severe COPD exacerbation was 40.8 per 100 person-years among new initiators (39.9 per 100 person-years for OLO/TIO, 41.1 per 100 person-years for VI/UMEC). The adjusted hazard ratio of the time to first COPD exacerbation was 0.948 (95% Confidence interval: 0.813-1.105) for individuals initiating OLO/TIO versus VI/UMEC.
Conclusion: We did not find a statistically significant difference between the OLO/TIO and VI/UMEC new users in terms of time to first severe exacerbation among Medicare COPD patients aged 65 or older.
Keywords: COPD; COPD exacerbations; chronic conditions warehouse data; inhalers; long acting muscarinic antagonist; olodaterol/tiotropium; real world evidence; vilanterol/umeclidinium.