OBJECTIVES: Patients with COPD increasingly receive combination bronchodilator therapies. Real-world evidence for the benefits of combination therapy compared to monotherapy is lacking.

METHODS: COPD patients aged ≥40 years initiating monotherapy (MT) with either a LAMA or LABA, or LAMA/LABA FDC dual therapy (DT) between January 1, 2016 and December 31, 2016 were identified from a large US administrative claims database. Patients who were diagnosed with cystic fibrosis, idiopathic pulmonary fibrosis, or asthma were excluded. Cohorts were propensity score matched (PSM) 1:1 using baseline claims measures (e.g., exacerbations, hospitalizations) as proxies for COPD severity to create balanced cohorts; spirometry results were not available. Outcomes were evaluated over approximately 12 months. Multivariate adjustment was performed for significant baseline differences after PSM.

RESULTS: Following PSM, 1286 patients remained in each cohort for analysis (MT: 1238 LAMA; 48 LABA). The only baseline differences that remained after PSM included more all-cause and COPD-related office visits, more COPD-related tests and procedures, and greater use of SAMA/SABAs, for the DT versus MT cohort. Patients in the DT versus MT cohort had lower rates of exacerbation leading to hospitalization (incidence rate ratio: 0.7886; P=0.019), and lower mean COPD-related pharmacy costs PPPM ($300 vs. $379, respectively; P<0.001) and total costs PPPM ($990 vs. $1203, respectively; P=0.003), despite lower mean COPD-related pharmacy fills per patient per month (PPPM) (1.41 vs. 1.51, respectively; P=0.038). A Kaplan-Meier analysis showed that the distribution of switching (P<0.001) and augmentation (P<0.001) over the follow-up period was lower in the DT versus MT cohort. The distribution of non-persistence was higher in the DT versus MT cohort (P<0.001) suggesting lesser symptom burden in the DT cohort.

CONCLUSIONS: Patients in the DT cohort had fewer exacerbations leading to hospitalizations, lower COPD-related pharmacy and total costs, and less switching and augmentation compared with patients in the MT cohort.