Benefits of Early Roflumilast Treatment After Hospital or Emergency Department Discharge for a COPD Exacerbation.

BACKGROUND: Chronic lower respiratory disease, which includes chronic obstructive pulmonary disease (COPD), is the third leading cause of death in the United States. Roflumilast is an oral, once-daily, selective phosphodiesterase-4 inhibitor approved for reducing the risk for COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

OBJECTIVES: To evaluate the effects of roflumilast treatment timing on COPD exacerbation rates (primary objective) and on resource utilization and healthcare costs (secondary objective) after hospital or emergency department discharge associated with a COPD exacerbation.

METHODS: In this retrospective cohort study, claims data from March 2011 to March 2013 were extracted from Truven Health MarketScan combined commercial healthcare claims and Medicare supplemental claims databases and were analyzed to compare the exacerbation rates and the healthcare resource utilization and costs between the early roflumilast treatment (treatment initiation ≤30 days after hospital or emergency department discharge) and the delayed roflumilast treatment (treatment initiation 31-180 days after discharge) cohorts. Multivariate logistic regression and generalized linear models with log-link function and gamma distribution were adjusted for age, sex, insurance plan type, COPD disease complexity, and comorbidities.

RESULTS: A total of 995 patients (N = 280 early roflumilast treatment, N = 715 delayed roflumilast treatment) were included. Compared with the delayed roflumilast treatment group, patients in the early roflumilast treatment group were 39% less likely to have an exacerbation after hospital discharge (P = .004). The patients receiving early roflumilast treatment also had 42% (P = .003) and 37% (P = .005) lower risks for COPD-related and all-cause rehospitalizations, respectively, than patients in the delayed roflumilast treatment group. Significantly fewer patients receiving early roflumilast treatment had moderate (P = .013) or severe (P = .002) exacerbations. Early roflumilast treatment also was associated with reduced annualized COPD-related (P = .012) and all-cause (P = .009) rehospitalizations, outpatient visits per patient (P <.001 for COPD-related and all-cause), and procedures or therapies (COPD-related, P = .016; all-cause, P = .009). The early treatment group had fewer COPD-related emergency department visits per patient than the delayed roflumilast treatment group (P = .035), and the total mean annualized COPD-related and all-cause costs were reduced by $7273 (P = .014) and $14,111 (P = .002), respectively. Multivariate analyses showed that early treatment was associated with lower COPD-related and all-cause annualized health services costs per patient annually (P <.001 for both).

CONCLUSION: In this real-world study, the patients with COPD who initiated roflumilast treatment ≤30 days after a hospital or emergency department discharge for a COPD-related exacerbation experienced fewer subsequent exacerbations and rehospitalizations, reduced healthcare utilizations, and lower healthcare costs than the patients who delayed their roflumilast treatment.