title: The burden of chronic obstructive pulmonary disease associated with maintenance monotherapy in the UK.
abstract: BACKGROUND
  This study characterized a cohort of chronic obstructive pulmonary disease (COPD) patients on maintenance bronchodilator monotherapy for ≥6 months to establish their disease burden, measured by health care utilization.
  
  
  METHODS
  Data were extracted from the UK Clinical Practice Research Datalink and linked to Hospital Episode Statistics. The monotherapy period spanned the first prescription of a long-acting β2-adrenergic agonist or a long-acting muscarinic antagonist until the end of the study (December 31, 2013) or until step up to dual/triple therapy, for example, addition of another long-acting bronchodilator, an inhaled corticosteroid, or both. A minimum of four consecutive prescriptions and 6 months on continuous monotherapy were required. Patients <50 years old at first COPD diagnosis or with another significant respiratory disease before starting monotherapy were excluded. Disease burden was evaluated by measuring patients' rate of face-to-face interactions with a health care professional (HCP), COPD-related exacerbations, hospitalizations, and referrals.
  
  
  RESULTS
  A cohort of 8,811 COPD patients (95% Global initiative for chronic Obstructive Lung Disease stage A/B) on maintenance monotherapy was identified between 2002 and 2013; 45% of these patients were still on monotherapy by the end of the study. Median time from first COPD diagnosis to first monotherapy prescription was 56 days, while the median time on maintenance bronchodilator monotherapy was 2 years. The median number of prescriptions was 14. On average, patients had 15 HCP interactions per year, and one in ten patients experienced a COPD exacerbation (N=8,811). One in 50 patients were hospitalized for COPD per year (n=4,848).
  
  
  CONCLUSIONS
  The average monotherapy-treated patient had a higher than average HCP interaction rate. We also identified a large cohort of patients who were stepped up to triple therapy despite a low rate of exacerbations. The use of the new class of long-acting muscarinic antagonist/long-acting β2-adrenergic agonist fixed-dose combinations may provide a useful step-up treatment option in such monotherapy patients, before the use of inhaled corticosteroids.
authors.affiliation: Department of Market Access Pricing & Outcomes Research.
authors.forename: Susan C
authors.initials: SC
authors.lastname: Edwards
authors.affiliation: Department of Medical Affairs -Respiratory.
authors.forename: Sian E
authors.initials: SE
authors.lastname: Fairbrother
authors.affiliation: Department of Market Access.
authors.forename: Anna
authors.initials: A
authors.lastname: Scowcroft
authors.affiliation: Department of Prescription Medicine - Respiratory, Boehringer Ingelheim, Bracknell, UK.
authors.forename: Gavin
authors.initials: G
authors.lastname: Chiu
authors.affiliation: Department of Market Access.
authors.forename: Andrew
authors.initials: A
authors.lastname: Ternouth
authors.affiliation: Asthma and Allergy Research Group, Division of Cardiovascular and Diabetes Medicine, Scottish Centre for Respiratory Research, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK.
authors.forename: Brian J
authors.initials: BJ
authors.lastname: Lipworth
mesh_terms: D000280:Administration, Inhalation; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage; D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage*; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D016208:Databases, Factual; D018450:Disease Progression; D011307:Drug Prescriptions; D004359:Drug Therapy, Combination; D017723:Drug Utilization Review; D005260:Female; D006295:Health Resources / Q000706:statistics & numerical data*; D006760:Hospitalization; D006801:Humans; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage*; D009819:Office Visits / Q000706:statistics & numerical data; D010818:Practice Patterns, Physicians'; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D012017:Referral and Consultation / Q000706:statistics & numerical data; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D000305:Adrenal Cortex Hormones; D058666:Adrenergic beta-2 Receptor Agonists; D001993:Bronchodilator Agents; D018727:Muscarinic Antagonists
keywords: COPD; UK primary care setting; bronchodilators; monotherapy; prescribing patterns