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Original Research

Switching patients from other inhaled corticosteroid devices to the Easyhaler®: historical, matched-cohort study of real-life asthma patients

, , , , &
Pages 31-51 | Published online: 10 Apr 2014
 

Abstract

Purpose

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).

Patients and 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).

Conclusion

Typical asthma patients may be switched from other ICS devices to the Easyhaler® with no reduction in clinical effectiveness or increase in cost.

Supplementary materials

Figure S1 Potential confounders examined in the initial analysis.

Notes: aThe equations of Roberts et alCitation1 were used for patients >18 years of age and the equations of Rosenthal et alCitation2 were used for patients 6–18 years of age; bas described by Aylin et al.Citation3

Figure S1 Potential confounders examined in the initial analysis.Notes: aThe equations of Roberts et alCitation1 were used for patients >18 years of age and the equations of Rosenthal et alCitation2 were used for patients 6–18 years of age; bas described by Aylin et al.Citation3
Figure S1 Potential confounders examined in the initial analysis.Notes: aThe equations of Roberts et alCitation1 were used for patients >18 years of age and the equations of Rosenthal et alCitation2 were used for patients 6–18 years of age; bas described by Aylin et al.Citation3

Table S1 Baseline patient characteristics: demographics and co-morbidities

Table S2 Baseline patient characteristics: disease severity and therapies

Table S3 Baseline patient characteristics: ICS drugs, dosages, and devices

Table S4 Patient characteristics during the outcome year: disease severity and therapies

References

Disclosure

This study was sponsored by Orion Pharma UK Ltd; however, the funders had no role in the conduct of the study, interpretation of study results, nor preparation of the manuscript.

DP has consultant arrangements with Almirall, AstraZeneca (AZ), Boehringer Ingelheim (BI), Chiesi, GlaxoSmithKline (GSK), Merck, Mundipharma, Medapharma, Novartis, Napp, Nycomed, Pfizer, Sandoz, and Teva. He or his research team has received grants and support for research in respiratory disease from the following organizations in the last 5 years: UK National Health Service, Aerocrine, AZ, BI, Chiesi, GSK, Merck, Mundipharma, Novartis, Nycomed, Orion, Pfizer, and Teva. He has spoken for Almirall, AZ, Activaero, BI, Chiesi, Cipla, GSK, Kyorin, Novartis, Merck, Mundipharma, Pfizer, and Teva. He has shares in AKL Ltd, which produces phytopharmaceuticals. He is the sole owner of Research in Real Life (RiRL) and its subsidiary social enterprise, Optimum Patient Care.

VT, JvZ, SG, and CH are employees of RiRL, which has conducted paid research in respiratory disease for the following organizations in the last 5 years: Aerocrine, Almirall, AZ, BI, Chiesi, GSK, Meda, Merck, Mundipharma, Novartis, Nycomed, Orion, Pfizer, Takeda, Teva, and Zentiva. CK declares that she has no conflicts of interest in relation to this article.