title: Switching patients from other inhaled corticosteroid devices to the Easyhaler(®): historical, matched-cohort study of real-life asthma patients.
abstract: OBJECTIVE
  To investigate the clinical and cost effectiveness of switching real-life asthma patients from other types of inhalers to the Easyhaler(®) (EH) for the administration of inhaled corticosteroids (ICS).
  
  
  METHODS
  Historical, matched-cohort study of 1,958 asthma patients (children and adults) treated in UK primary-care practices, using data obtained from the Optimum Patient Care Research Database and Clinical Practice Research Datalink. Other inhalers (OH) included pressurized metered-dose inhalers, breath-actuated inhalers, and dry-powder inhalers, delivering beclomethasone, budesonide, fluticasone, or ciclesonide. Patients remaining on OH unchanged (same drug, dosage, and device; n=979) were matched 1:1 with those switched to the EH (beclomethasone or budesonide) at the same or lower ICS dosage (n=979), based on age, sex, year of index patient review/switch, most recent ICS drug, dosage, and device, and the number of severe exacerbations and average daily short-acting β2 agonist (SABA) dosage in the preceding year. Clinical outcomes and health care costs were compared between groups for 12 months before and after the switch. Co-primary clinical outcomes were: 1) risk domain asthma control (RDAC) - no asthma-related hospitalization, acute oral steroid use, or lower respiratory tract infection (LRTI); 2) exacerbation rate (American Thoracic Society [ATS] definition) - where exacerbation is asthma-related hospitalization or acute oral steroid use; 3) exacerbation rate (clinical definition) - where exacerbation is ATS exacerbation or LRTI; and 4) overall asthma control (OAC) - RDAC plus average salbutamol-equivalent SABA dosage ≤200 μg/day. Non-inferiority (at least equivalence) of EH was tested against OH for the four co-primary outcomes in order (hierarchical approach) by comparing the difference in proportions of patients [EH-OH] achieving asthma control or having no exacerbations in the outcome year, using a limit of 10% difference.
  
  
  RESULTS
  Non-inferiority was shown for the EH for all four co-primary outcomes. There were no significant differences between groups for RDAC or exacerbation rates, but EH patients were significantly more likely to achieve OAC (adjusted odds ratio [95% confidence interval]: 1.26 [1.05, 1.52]), as significantly more EH than OH patients had an average SABA dosage of ≤200 μg/day (52% versus 47%, respectively; P<0.001). Mean asthma-related health care costs increased from baseline to outcome years in both groups, but SABA costs increased significantly more in OH than EH patients (mean difference £5.5/patient/year) and consultation costs decreased significantly more in EH than OH patients (mean difference £13.5/patient/year).
  
  
  CONCLUSIONS
  Typical asthma patients may be switched from other ICS devices to the Easyhaler(®) with no reduction in clinical effectiveness or increase in cost.
authors.affiliation: Academic Centre of Primary Care, University of Aberdeen, Aberdeen, UK ; Research in Real Life, Oakington, Cambridge, UK.
authors.forename: David
authors.initials: D
authors.lastname: Price
authors.affiliation: Research in Real Life, Oakington, Cambridge, UK.
authors.forename: Vicky
authors.initials: V
authors.lastname: Thomas
authors.affiliation: Research in Real Life, Oakington, Cambridge, UK.
authors.forename: Julie
authors.initials: J
authors.lastname: von Ziegenweidt
authors.affiliation: Research in Real Life, Oakington, Cambridge, UK.
authors.forename: Shuna
authors.initials: S
authors.lastname: Gould
authors.affiliation: Research in Real Life, Oakington, Cambridge, UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Hutton
authors.affiliation: Research in Real Life, Oakington, Cambridge, UK.
authors.forename: Christine
authors.initials: C
authors.lastname: King
keywords: Easyhaler; ICS; asthma; cost; inhaler
references.citation: Thorax. 1993 Aug;48(8):803-8
references.pmid: 8211869
references.citation: J Asthma. 2008 Mar;45(2):109-13
references.pmid: 18350401
references.citation: Int J Pharm. 2013 Feb 28;444(1-2):169-74
references.pmid: 23333708
references.citation: Pharm Res. 1994 Sep;11(9):1320-4
references.pmid: 7816763
references.citation: Arch Bronconeumol. 2004 Mar;40(3):106-9
references.pmid: 14998473
references.citation: J Asthma. 2005 Apr;42(3):173-8
references.pmid: 15962873
references.citation: J Aerosol Med. 2004 Spring;17(1):15-24
references.pmid: 15120009
references.citation: Respiration. 1994;61(1):37-41
references.pmid: 8177971
references.citation: Respir Med. 2001 Nov;95(11):863-9
references.pmid: 11716199
references.citation: BMC Pulm Med. 2009 Jan 02;9:1
references.pmid: 19121204
references.citation: Clin Drug Investig. 2006;26(4):175-83
references.pmid: 17163249
references.citation: J Aerosol Med. 2003 Fall;16(3):249-54
references.pmid: 14572322
references.citation: Respir Med. 2002 Apr;96(4):221-9
references.pmid: 12000000
references.citation: Respir Med. 2000 May;94(5):501-4
references.pmid: 10868715
references.citation: Thorax. 1991 Sep;46(9):643-50
references.pmid: 1948793
references.citation: Respir Med. 2013 Jan;107(1):37-46
references.pmid: 23098685
references.citation: Respir Med. 2001 Sep;95(9):720-7
references.pmid: 11575892
references.citation: J Aerosol Med Pulm Drug Deliv. 2013 Jun;26(3):138-44
references.pmid: 22947131
references.citation: Curr Opin Allergy Clin Immunol. 2013 Feb;13(1):50-7
references.pmid: 23242115
references.citation: Respiration. 2006;73(4):441-8
references.pmid: 16432294
references.citation: Br J Clin Pharmacol. 2005 Feb;59(2):167-73
references.pmid: 15676038
references.citation: Arch Pediatr. 2007 Oct;14(10):1190-5
references.pmid: 17658246
references.citation: Respir Med. 2002 Aug;96(8):599-606
references.pmid: 12195841
references.citation: Pediatr Allergy Immunol. 1999 Feb;10(1):66-70
references.pmid: 10410920
references.citation: Int J Clin Pract Suppl. 2005 Dec;(149):7-12
references.pmid: 16279997
references.citation: Int J Chron Obstruct Pulmon Dis. 2010 Aug 09;5:257-62
references.pmid: 20714380
references.citation: Asian Pac J Allergy Immunol. 2011 Mar;29(1):25-33
references.pmid: 21560485
references.citation: Respir Med. 2000 Dec;94(12):1229-33
references.pmid: 11192960
references.citation: Ann Allergy. 1994 Feb;72(2):178-82
references.pmid: 8109809
references.citation: J Aerosol Med Pulm Drug Deliv. 2008 Dec;21(4):321-8
references.pmid: 18823257
references.citation: Prim Care Respir J. 2010 Jun;19(2):131-9
references.pmid: 20174771
references.citation: Int J Clin Pract. 2000 Jul-Aug;54(6):368-72
references.pmid: 11092110
references.citation: Clin Drug Investig. 1998;16(2):101-10
references.pmid: 18370527
references.citation: Eur Respir J. 2011 Jun;37(6):1308-31
references.pmid: 21310878
references.citation: Arzneimittelforschung. 1995 Jan;45(1):44-7
references.pmid: 7893268
references.citation: Respiration. 2000;67(1):77-82
references.pmid: 10705267