Background: Inhaled corticosteroid/long-acting ?2-agonist combinations (ICS/LABA) have emerged as first line\ntherapies for chronic obstructive pulmonary disease (COPD) patients with exacerbation history. No randomized clinical\ntrial has compared exacerbation rates among COPD patients receiving budesonide/formoterol combination (BFC) and\nfluticasone/salmeterol combination (FSC) to date, and only limited comparative data are available. This study compared\nthe real-world effectiveness of approved BFC and FSC treatments among matched cohorts of COPD patients in a large\nUS managed care setting.\nMethods: COPD patients (?40 years) naive to ICS/LABA who initiated BFC or FSC treatments between 03/01/2009-03/31/2012\nwere identified in a geographically diverse US managed care database and followed for 12 months; index date\nwas defined as first prescription fill date. Patients with a cancer diagnosis or chronic (?180 days) oral corticosteroid (OCS)\nuse within 12 months prior to index were excluded. Patients were matched 1-to-1 on demographic and pre-initiation\nclinical characteristics using propensity scores from a random forest model. The primary efficacy outcome was COPD\nexacerbation rate, and secondary efficacy outcomes included exacerbation rates by event type and healthcare resource\nutilization. Pneumonia objectives included rates of any diagnosis of pneumonia and pneumonia-related healthcare\nresource utilization.\nResults: Matching of the identified 3,788 BFC and 6,439 FSC patients resulted in 3,697 patients in each group. Matched\npatients were well balanced on age (mean = 64 years), gender (BFC: 52% female; FSC: 54%), prior COPD-related medication\nuse, healthcare utilization, and comorbid conditions. During follow-up, no significant difference was seen between BFC and\nFSC patients for number of COPD-related exacerbations overall (rate ratio [RR] = 1.02, 95% CI = [0.96,1.09], p = 0.56) or by\nevent type: COPD-related hospitalizations (RR = 0.96), COPD-related ED visits (RR = 1.11), and COPD-related office/outpatient\nvisits with OCS and/or antibiotic use (RR = 1.01). The proportion of patients diagnosed with pneumonia during the\npost-index period was similar for patients in each group (BFC = 17.3%, FSC = 19.0%, odds ratio = 0.92 [0.81,1.04],\np = 0.19), and no difference was detected for pneumonia-related healthcare utilization by place of service.
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