title: Comparative analysis of budesonide/formoterol and fluticasone/salmeterol combinations in COPD patients: findings from a real-world analysis in an Italian setting.
abstract: OBJECTIVE
  The objective of this study was to evaluate the different outcomes associated with the use of budesonide/formoterol compared to fluticasone/salmeterol in fixed combinations in patients with COPD in a "real-world" setting. The outcomes included exacerbation rates and health care costs.
  
  
  METHODS
  An observational retrospective cohort analysis, based on administrative databases of three local health units, was conducted. Patients with at least one prescription of fixed-dose combination of inhaled corticosteroids and long-acting β2-agonists (budesonide/formoterol or fluticasone/salmeterol), at dosages and formulations approved for COPD in Italy, between January 1, 2009 and December 31, 2011 (inclusion period), were included. Patients were followed until December 2012, death or end of treatment (follow-up period), whichever occurred first. Patients were included if they were aged ≥40 years and had at least 6 months of follow-up. Propensity score matching was performed to check for confounding effects. Number of hospitalizations for COPD and number of oral corticosteroid and antibiotic prescriptions during follow-up were analyzed using Poisson regression models. The cost analysis was conducted from the perspective of the National Health System.
  
  
  RESULTS
  After matching, 4,680 patients were analyzed, of which 50% were males with a mean age of 64±13 years. In the Poisson regression models, the incidence rate ratio for budesonide/formoterol as compared to fluticasone/salmeterol was 0.84 (95% confidence interval [CI]: 0.74-0.96,P=0.010) for number of hospitalizations, 0.89 (95% CI: 0.87-0.92,P<0.001) for number of oral corticosteroid prescriptions and 0.88 (95% CI: 0.86-0.89,P<0.001) for number of antibiotic prescriptions. The mean annual expenditure for COPD management was €2,436 for patients treated with budesonide/formoterol and €2,784 for patients treated with fluticasone/salmeterol.
  
  
  CONCLUSIONS
  Among patients with COPD, treatment with a fixed combination of budesonide/formoterol was associated with fewer exacerbations and a lower, but not significant, cost of illness than the treatment with fluticasone/salmeterol. Real-world analyses are requested to ameliorate interventions to address unmet needs, optimizing treatment pathways to improve COPD-related burden and outcomes.
authors.affiliation: CliCon S.r.l. Health, Economics and Outcomes Research, Ravenna, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Perrone
authors.affiliation: CliCon S.r.l. Health, Economics and Outcomes Research, Ravenna, Italy.
authors.forename: Diego
authors.initials: D
authors.lastname: Sangiorgi
authors.affiliation: CliCon S.r.l. Health, Economics and Outcomes Research, Ravenna, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Buda
authors.affiliation: CliCon S.r.l. Health, Economics and Outcomes Research, Ravenna, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Degli Esposti
mesh_terms: D000067575:Administrative Claims, Healthcare; D058666:Adrenergic beta-2 Receptor Agonists / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D000368:Aged; D001993:Bronchodilator Agents / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D000069502:Budesonide, Formoterol Fumarate Drug Combination / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D016208:Databases, Factual; D018450:Disease Progression; D016527:Drug Costs; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D005938:Glucocorticoids / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D006801:Humans; D007558:Italy; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D057216:Propensity Score; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics / Q000503:physiopathology; D020127:Recovery of Function; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D001993:Bronchodilator Agents; D000069502:Budesonide, Formoterol Fumarate Drug Combination; D000068297:Fluticasone-Salmeterol Drug Combination; D005938:Glucocorticoids
keywords: COPD; budesonide/formoterol; exacerbations; fluticasone/salmeterol; inhaled corticosteroids; long-acting β2-agonist