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

Abstract

PurposeTo 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 methodsHistorical, 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.ResultsNon-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).ConclusionTypical asthma patients may be switched from other ICS devices to the Easyhaler® with no reduction in clinical effectiveness or increase in cost.

Real-world effectiveness evaluation of budesonide/formoterol Spiromax for the management of asthma and chronic obstructive pulmonary disease in the UK

“…Although a higher proportion of patients achieved RDC in the group that switched to BF Spiromax compared with patients who stayed on BF Turbuhaler, the difference was not statistically significant, and the mean between-group difference was less than the 10% considered to be clinically relevant. 22 23 30 31 In the sensitivity analysis where only BF Spiromax switchers that had three matched controls were used, a significant difference was shown in the combined patients group (adjusted % difference 8.3; 95% CI 1.0% to 15.6%; p=0.025) (data not shown). In the sensitivity analysis, the adjusted percentage difference was nearly 10% in the COPD group but there was a wide CI (adjusted % difference 9.9; 95% CI −2.4% to 22.2%; p=0.114).…”

“…Adequate treatment stability was defined as achieving RDC and no increase in dose, change in delivery device, and change in type of ICS and/or use of LABAs, theophylline, long-acting muscarinic antagonists, or leukotriene receptor antagonists. 22 Additional outcomes were SABA usage, which was expressed as average daily SABA dosage during the outcome year and calculated from prescriptions as (( Count of inhalers × doses in pack × µg strength )/365), and a pneumonia event which was defined as having a Read coded diagnosis (probable pneumonia), or a Read coded diagnosis with a hospital admission or chest X-ray within 1 month (definite pneumonia).…”

“…Non-inferiority was claimed if the lower bound of the 95% CI for the primary end point (RDC) was above −10%, a difference widely regarded as clinically important for many outcomes in respiratory studies, 30 31 and used previously in similar real-life studies of patients in primary care settings. 22 23 If non-inferiority was achieved, superiority was tested.…”

Does co-payment for inhaler devices affect therapy adherence and disease outcomes? A historical, matched cohort study

“…For this analysis, the average daily dose of SABA was categorized as 0, >0–200, >200–400, >400–600, and >600 μg/day (salbutamol equivalent). These categories have been used in previous studies 38,39…”

Performance of database-derived severe exacerbations and asthma control measures in asthma: responsiveness and predictive utility in a UK primary care database with linked questionnaire data

“… 8 There are no standardized tools for asthma risk stratification in clinical practice or RCTs, but some models have been described. 9 , 10 One of the strongest predictors of future exacerbations, independent of recent symptom control, is the occurrence of one or more exacerbations in the previous 12 months. 11 …”