title: Initiation of triple therapy maintenance treatment among patients with COPD in the US.
abstract: BACKGROUND
  The Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommends triple therapy (long-acting muscarinic receptor antagonists, long-acting beta-2 agonists, and inhaled corticosteroids) for patients with only the most severe COPD. Data on the proportion of COPD patients on triple therapy and their characteristics are sparse and dated. Objective 1 of this study was to estimate the proportion of all, and all treated, COPD patients receiving triple therapy. Objective 2 was to characterize those on triple therapy and assess the concordance of triple therapy use with GOLD guidelines.
  
  
  METHODS
  This retrospective study used claims from the IMS PharMetrics Plus database from 2009 to 2013. Cohort 1 was selected to assess Objective 1 only; descriptive analyses were conducted in Cohort 2 to answer Objective 2. A validated claims-based algorithm and severity and frequency of exacerbations were used as proxies for COPD severity.
  
  
  RESULTS
  Of all 199,678 patients with COPD in Cohort 1, 7.5% received triple therapy after diagnosis, and 25.5% of all treated patients received triple therapy. In Cohort 2, 30,493 COPD patients (mean age =64.7 years) who initiated triple therapy were identified. Using the claims-based algorithm, 34.5% of Cohort 2 patients were classified as having mild disease (GOLD 1), 40.8% moderate (GOLD 2), 22.5% severe (GOLD 3), and 2.3% very severe (GOLD 4). Using exacerbation severity and frequency, 60.6% of patients were classified as GOLD 1/2 and 39.4% as GOLD 3/4.
  
  
  CONCLUSIONS
  In this large US claims database study, one-quarter of all treated COPD patients received triple therapy. Although triple therapy is recommended for the most severe COPD patients, spirometry is infrequently assessed, and a majority of the patients who receive triple therapy may have only mild/moderate disease. Any potential overprescribing of triple therapy may lead to unnecessary costs to the patient and health care system.
authors.affiliation: Real-World Evidence, Evidera, Waltham, MA.
authors.forename: Jason C
authors.initials: JC
authors.lastname: Simeone
authors.affiliation: HEOR Value Demonstration Team, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
authors.forename: Rakesh
authors.initials: R
authors.lastname: Luthra
authors.affiliation: HEOR Value Demonstration Team, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
authors.forename: Shuchita
authors.initials: S
authors.lastname: Kaila
authors.affiliation: Real-World Evidence, Evidera, Waltham, MA.
authors.forename: Xiaoyun
authors.initials: X
authors.lastname: Pan
authors.affiliation: Real-World Evidence, Evidera, Waltham, MA.
authors.forename: Tarun D
authors.initials: TD
authors.lastname: Bhagnani
authors.affiliation: Real-World Evidence, Evidera, Waltham, MA.
authors.forename: Jieruo
authors.initials: J
authors.lastname: Liu
authors.affiliation: Real-World Evidence, Evidera, Waltham, MA.
authors.forename: Teresa K
authors.initials: TK
authors.lastname: Wilcox
mesh_terms: D000280:Administration, Inhalation; D000067575:Administrative Claims, Healthcare; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage* / Q000009:adverse effects; D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000368:Aged; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D016208:Databases, Factual; D018450:Disease Progression; D011307:Drug Prescriptions; D004359:Drug Therapy, Combination; D005260:Female; D019983:Guideline Adherence / Q000639:trends; D006801:Humans; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians' / Q000639:trends; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D012189:Retrospective Studies; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D000305:Adrenal Cortex Hormones; D058666:Adrenergic beta-2 Receptor Agonists; D001993:Bronchodilator Agents; D018727:Muscarinic Antagonists
keywords: COPD; epidemiology; retrospective study; severity; triple therapy