Initiating or changing to a fixed-dose combination of Fluticasone propionate/Formoterol over Fluticasone propionate/Salmeterol: A real-life effectiveness and cost impact evaluation

Abstract

Changing to, or initiating FP/FOR combination therapy, is associated with a non-inferior proportion of patients who are severe exacerbation-free at a lower average annual cost compared with continuing or initiating treatment with FP/SAL.

Real‐life effectiveness of inhaler device switch from dry powder inhalers to pressurized metred‐dose inhalers in patients with asthma treated with ICS/LABA

“…This was defined as the percentage of patients who, at 6 months post‐index date, received ≥1 prescriptions of ICS/LABA pMDI (in addition to that issued at their index date prescription) and no prescription for an ICS/LABA DPI over the same period. Persistence of change was claimed if the proportion of patients who persisted with the change was ≥70% which was considered a clinically significant limit …”

“…For the primary outcome, a sample size of 163 has 90% power to detect a non‐inferior difference in proportions of patients with no exacerbations of −0.125 using a paired McNemar's chi‐square test with a 0.025 one‐sided significance level, assuming the proportion of discordant pairs was 0.242 …”

“…Persistence of change was claimed if the proportion of patients who persisted with the change was ≥70% which was considered a clinically significant limit. 16 Exploratory subgroup analysis for primary and secondary outcomes was performed, stratified by the type of FDC ICS/LABA pMDI prescribed: FP/formoterol (FP/FORM; Flutiform, Recipharm, Crewe, UK) or beclomethasone dipropionate/FORM (BDP/FORM; Foster, Chiesi Pharmaceuticals Parma, Italy).…”

“…For the primary outcome, a sample size of 163 has 90% power to detect a non-inferior difference in proportions of patients with no exacerbations of −0.125 using a paired McNemar's chi-square test with a 0.025 onesided significance level, assuming the proportion of discordant pairs was 0.242. 16 For the secondary outcome of persistence, a sample size of 100 per change cohort would be sufficient to construct a 95% one-sided CI with an upper bound of less than 30% to power the evaluation of ICS/LABA pMDI persistence of change based on an expected change-back probability of approximately 20%. 16…”

“…16 For the secondary outcome of persistence, a sample size of 100 per change cohort would be sufficient to construct a 95% one-sided CI with an upper bound of less than 30% to power the evaluation of ICS/LABA pMDI persistence of change based on an expected change-back probability of approximately 20%. 16…”