Prompt initiation of single-inhaler budesonide/glycopyrrolate/formoterol fumarate (BGF) following a COPD exacerbation reduces exacerbations and cardiopulmonary risk in patients with COPD: insights from the MITOS EROS+CP study in the United States

To investigate the association between the timing of single-inhaler triple therapy Budesonide/Glycopyrrolate/Formoterol Fumarate (BGF) initiation following a COPD exacerbation and subsequent COPD exacerbations and non-fatal cardiopulmonary events. This was a retrospective analysis of the Inovalon MORE² Registry and Medicare Fee-for-Service claims databases spanning July 1, 2019 to May 31, 2023. Eligible patients with COPD were aged ≥40 years, and initiated BGF treatment within 1-year of a qualifying COPD exacerbation (index event) with 12 months of baseline enrollment. Secondary study populations included patients escalating from dual therapy and patients with comorbid asthma. Negative binomial regressions were used to evaluate the adjusted risks for subsequent annualized exacerbations and cardiopulmonary events based on the timing of BGF initiation: prompt (≤30 days), delayed (31–180 days), and very delayed (181–365 days). Among 25,603 patients included, 14.8% were prompt, 37.7% delayed, and 47.5% very delayed initiators. Mean age was 60.3 years and 64.3% were female. Among the 10,630 cardiopulmonary events observed, 63% were cardiovascular-related. During follow-up, prompt initiators had 25.7% (adjIR_D: 0.74 [0.72-0.77]) and 30.6% (adjIR_VD: 0.69 [0.67-0.72]) lower risk of subsequent annualized exacerbations compared to delayed and very delayed initiators, respectively. Additionally, prompt initiators had 16.3% (adjIR_D: 0.84 [0.77-0.91]) and 17.5% (adjIR_VD: 0.83 [0.77-0.89]) lower risk of cardiopulmonary events, respectively. Similar results were observed for patients escalating from dual therapy and those with asthma. Prompt initiation of BGF following a COPD exacerbation, including among patients previously managed with dual therapy, was associated with lower annualized rates of cardiopulmonary and exacerbation events.