title: Comparative effectiveness of budesonide/formoterol combination and tiotropium bromide among COPD patients new to these controller treatments.
abstract: BACKGROUND
  Inhaled corticosteroid/long-acting β2-agonist combinations and/or long-acting muscarinic antagonists are recommended first-line therapies for preventing chronic obstructive pulmonary disease (COPD) exacerbation. Comparative effectiveness of budesonide/formoterol combination (BFC, an inhaled corticosteroid/long-acting β2-agonist combination) vs tiotropium (long-acting muscarinic antagonist) in the US has not yet been studied.
  
  
  METHODS
  Using US claims data from the HealthCore Integrated Research Environment, COPD patients (with or without comorbid asthma) ≥40 years old initiating BFC or tiotropium between March 1, 2009 and February 28, 2012 and at risk for exacerbation were identified and followed for 12 months. Patients were propensity score matched on demographics and COPD disease severity indicators. The primary outcome was time to first COPD exacerbation. Secondary outcomes included COPD exacerbation rate, health care resource utilization, and costs.
  
  
  RESULTS
  The Cox proportional hazards model for time to first exacerbation yielded a hazard ratio (HR) of 0.78 (95% CI =[0.70, 0.87], P<0.001), indicating a 22% reduction in risk of COPD exacerbation associated with initiation of BFC versus tiotropium. A post hoc sensitivity analysis found similar effects in those who had a prior asthma diagnosis (HR =0.72 [0.61, 0.86]) and those who did not (HR =0.83 [0.72, 0.96]). BFC initiation was associated with lower COPD-related health care resource utilization and costs ($4,084 per patient-year compared with $5,656 for tiotropium patients, P<0.001).
  
  
  CONCLUSIONS
  In COPD patients new to controller therapies, initiating treatment with BFC was associated with improvements in health and economic outcomes compared with tiotropium.
authors.affiliation: AstraZeneca Pharmaceuticals LP, Wilmington, DE, USA.
authors.forename: Frank
authors.initials: F
authors.lastname: Trudo
authors.affiliation: HealthCore, Inc., Wilmington, DE, USA.
authors.forename: David M
authors.initials: DM
authors.lastname: Kern
authors.affiliation: AstraZeneca Pharmaceuticals LP, Wilmington, DE, USA.
authors.forename: Jill R
authors.initials: JR
authors.lastname: Davis
authors.affiliation: HealthCore, Inc., Wilmington, DE, USA.
authors.forename: Ozgur
authors.initials: O
authors.lastname: Tunceli
authors.affiliation: HealthCore, Inc., Wilmington, DE, USA.
authors.forename: Siting
authors.initials: S
authors.lastname: Zhou
authors.affiliation: AstraZeneca Pharmaceuticals LP, Alderley Park, Cheshire, UK.
authors.forename: Emma L
authors.initials: EL
authors.lastname: Graham
authors.affiliation: Division of Pulmonary and Critical Care Medicine, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: Charlie
authors.initials: C
authors.lastname: Strange
authors.affiliation: AstraZeneca Pharmaceuticals LP, Wilmington, DE, USA.
authors.forename: Setareh A
authors.initials: SA
authors.lastname: Williams
mesh_terms: D000280:Administration, Inhalation; D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage*; D000368:Aged; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000191:economics; D019819:Budesonide / Q000008:administration & dosage* / Q000191:economics; D015897:Comorbidity; D004359:Drug Therapy, Combination; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination / Q000627:therapeutic use; D000068759:Formoterol Fumarate / Q000008:administration & dosage* / Q000191:economics; D017048:Health Care Costs; D006760:Hospitalization; D006801:Humans; D007344:Insurance Claim Reporting; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000627:therapeutic use; D016016:Proportional Hazards Models; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000191:economics*; D012189:Retrospective Studies; D012602:Scopolamine Derivatives / Q000627:therapeutic use; D000069447:Tiotropium Bromide / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D001993:Bronchodilator Agents; D000068297:Fluticasone-Salmeterol Drug Combination; D018727:Muscarinic Antagonists; D012602:Scopolamine Derivatives; D019819:Budesonide; D000068759:Formoterol Fumarate; D000069447:Tiotropium Bromide
keywords: COPD; administrative claims; comparative effectiveness; inhaled corticosteroid/long-acting β2-agonist combinations; long-acting muscarinic antagonist