title: Comparative effectiveness of budesonide/formoterol combination and fluticasone/salmeterol combination among chronic obstructive pulmonary disease patients new to controller treatment: a US administrative claims database study.
abstract: BACKGROUND
  Inhaled corticosteroid/long-acting β2-agonist combinations (ICS/LABA) have emerged as first line therapies for chronic obstructive pulmonary disease (COPD) patients with exacerbation history. No randomized clinical trial has compared exacerbation rates among COPD patients receiving budesonide/formoterol combination (BFC) and fluticasone/salmeterol combination (FSC) to date, and only limited comparative data are available. This study compared the real-world effectiveness of approved BFC and FSC treatments among matched cohorts of COPD patients in a large US managed care setting.
  
  
  METHODS
  COPD patients (≥40 years) naive to ICS/LABA who initiated BFC or FSC treatments between 03/01/2009-03/31/2012 were identified in a geographically diverse US managed care database and followed for 12 months; index date was defined as first prescription fill date. Patients with a cancer diagnosis or chronic (≥180 days) oral corticosteroid (OCS) use within 12 months prior to index were excluded. Patients were matched 1-to-1 on demographic and pre-initiation clinical characteristics using propensity scores from a random forest model. The primary efficacy outcome was COPD exacerbation rate, and secondary efficacy outcomes included exacerbation rates by event type and healthcare resource utilization. Pneumonia objectives included rates of any diagnosis of pneumonia and pneumonia-related healthcare resource utilization.
  
  
  RESULTS
  Matching of the identified 3,788 BFC and 6,439 FSC patients resulted in 3,697 patients in each group. Matched patients were well balanced on age (mean=64 years), gender (BFC: 52% female; FSC: 54%), prior COPD-related medication use, healthcare utilization, and comorbid conditions. During follow-up, no significant difference was seen between BFC and FSC patients for number of COPD-related exacerbations overall (rate ratio [RR]=1.02, 95% CI=[0.96,1.09], p=0.56) or by event type: COPD-related hospitalizations (RR=0.96), COPD-related ED visits (RR=1.11), and COPD-related office/outpatient visits with OCS and/or antibiotic use (RR=1.01). The proportion of patients diagnosed with pneumonia during the post-index period was similar for patients in each group (BFC =17.3%, FSC =19.0%, odds ratio=0.92 [0.81,1.04], p=0.19), and no difference was detected for pneumonia-related healthcare utilization by place of service.
  
  
  CONCLUSIONS
  This study demonstrated no difference in COPD-related exacerbations or pneumonia events between BFC and FSC treatment groups for patients new to ICS/LABA treatment in a real-world setting.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier NCT01921127 .
authors.affiliation: HealthCore, Inc., 123 Justison St, Suite 200, Wilmington, DE, 19801-5134, USA. dkern@healthcore.com.
authors.forename: David M
authors.initials: DM
authors.lastname: Kern
authors.affiliation: AstraZeneca Pharmaceuticals, 1800 Concord Pike, Wilmington, DE, 19850, USA. Jill.Davis@astrazeneca.com.
authors.forename: Jill
authors.initials: J
authors.lastname: Davis
authors.affiliation: AstraZeneca Pharmaceuticals, One MedImmune Way, Gaithersburg, MD, 20878, USA. Setareh.Williams@astrazeneca.com.
authors.forename: Setareh A
authors.initials: SA
authors.lastname: Williams
authors.affiliation: HealthCore, Inc., 123 Justison St, Suite 200, Wilmington, DE, 19801-5134, USA. otunceli@healthcore.com.
authors.forename: Ozgur
authors.initials: O
authors.lastname: Tunceli
authors.affiliation: HealthCore, Inc., 123 Justison St, Suite 200, Wilmington, DE, 19801-5134, USA. bwu@healthcore.com.
authors.forename: Bingcao
authors.initials: B
authors.lastname: Wu
authors.affiliation: AstraZeneca Pharmaceuticals, Alderley Park, Cheshire, UK. Sally.Hollis@astrazeneca.com.
authors.forename: Sally
authors.initials: S
authors.lastname: Hollis
authors.affiliation: Department of Medicine, Division of Pulmonary and Critical Care Medicine, Medical University of South Carolina, Charleston, SC, 29425, USA. strangec@musc.edu.
authors.forename: Charlie
authors.initials: C
authors.lastname: Strange
authors.affiliation: AstraZeneca Pharmaceuticals, 1800 Concord Pike, Wilmington, DE, 19850, USA. Frank.Trudo@astrazeneca.com.
authors.forename: Frank
authors.initials: F
authors.lastname: Trudo
mesh_terms: D000280:Administration, Inhalation; D000067575:Administrative Claims, Healthcare; D000368:Aged; D001993:Bronchodilator Agents / Q000008:administration & dosage; D000069502:Budesonide, Formoterol Fumarate Drug Combination / Q000008:administration & dosage*; D015331:Cohort Studies; D004359:Drug Therapy, Combination; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology*; D012189:Retrospective Studies; D014481:United States / Q000453:epidemiology
chemical_list: D001993:Bronchodilator Agents; D000069502:Budesonide, Formoterol Fumarate Drug Combination; D000068297:Fluticasone-Salmeterol Drug Combination