Treatment persistence and exacerbations in patients with asthma initiating treatment with inhaled corticosteroids and beta-adrenergic agonists: retrospective cohort study

Abstract

ObjectiveTo determine treatment persistence and exacerbations in patients initiating inhaler treatment with fixed-dose combinations of inhaled corticosteroids/long-acting beta-2-adrenergic agonists (ICS/LABA) for the treatment of asthma.DesignRetrospective observational study conducted by review of electronic medical records (database: Fundación RediSS).SettingRetrospective cohort study. The follow-up period was 1 year.ParticipantsThe study included patients aged ≥18 years who started treatment with ICS/LABA and met the inclusion/exclusion criteria.Main outcomes and measuresThe study groups were fluticasone propionate/salmeterol (FP/SAL), beclomethasone/formoterol (BDP/FORM), budesonide/formoterol (BUD/FORM), fluticasone furoate/vilanterol (FF/VI) and fluticasone propionate/formoterol (FP/FORM). The main measurements were persistence, medication possession ratio (MPR) and exacerbations. Statistical significance was established as p<0.05.ResultsIn total, 3203 patients were recruited for the study. By groups, 31.1% FP/SAL, 28.6% BDP/FORM, 25.0% BUD/FORM, 8.2% FF/VI and 7.0% FP/FORM. The mean age was 52.2 years, 60.8% were female and 44.9% had persistent-moderate asthma. Treatment persistence was 61.7% (95% CI 60.0% to 63.4%) and by study group it was FP/SAL: 60.7%, BDP/FORM: 61.2%, BUD/FORM: 60.3%, FF/VI: 66.7% and FP/FORM: 67.6% (p=0.046). MPR by study group was FP/SAL: 74.3%, BDP/FORM: 73.8%, BUD/FORM: 74.6%, FF/VI: 79.4% and FP/FORM: 80.6% (p=0.028). The mortality rate was 2.9%. By treatment group, exacerbations were FP/SAL: 21.9% (95% CI 19.3% to 24.5%), BDP/FORM: 22.2% (95% CI 19.5% to 24.9%), BUD/FORM: 22.8% (95% CI 19.9% to 25.7%), FF/VI: 17.9% (95% CI 14.9% to 20.7%) and FP/FORM: 16.0% (95% CI 12.2% to 19.3%), p=0.036.ConclusionsPatients undergoing treatment with FP/FORM and FF/VI versus FP/SAL, BDP/FORM and BUD/FORM were associated with greater treatment adherence (persistence, MPR) and lower rates of exacerbations. However, further studies will be needed to strengthen the consistency of the results.

Assessing the Effects of Changing Patterns of Inhaled Corticosteroid Dosing and Adherence with Fluticasone Furoate and Budesonide on Asthma Management

“…Primary variable, PDC Patients receiving FF/VI OD demonstrated higher PDC and probability of achieving a clinically significant level of adherence, as well as lower risk of discontinuation compared with those receiving BUD/FOR BID Parimi et al, 2020 [ 28 ] Retrospective new-user, active comparator database FF/VI 100/25 µg OD FF/VI 200/25 µg OD BUD/FOR 100/6 µg (MART/BID) a BUD/FOR 200/6 µg (MART/BID) a BUD/FOR 400/12 µg (MART/BID) Comparison of treatment persistence. Primary variable, time to discontinuation Patients who initiated FF/VI OD were less likely to discontinue treatment and showed greater treatment adherence (higher mean PDC) than patients who initiated BUD/FOR BID Sicras-Mainar et al, 2022 [ 29 ] Observational, retrospective FF/VI 100/25 µg OD FF/VI 200/25 µg OD BUD/FOR 200/6 µg BID BUD/FOR 200/6 µg BID × 2 BUD/FOR 400/12 μg BID × 2 Main endpoints (not stated as primary): comparison of treatment persistence (6- and 12-month rate), % MPR (number of days of medication dispensed by number of days on treatment), and exacerbations (mean no., no. per year, % patients with event) Compared with BUD/FOR BID, FF/VI OD was associated with significantly increased treatment persistence and MPR, resulting in a lower percentage of patients reporting exacerbations (mean number of exacerbations was similar between groups) Stanford et al, 2019 [ 31 ] Retrospective cohort FF/VI 100/25 μg OD BUD/FOR 160/4.5 µg BID Adherence, measured by PDC; persistence, measured by time to index treatment discontinuation; and AMR Patients initiating once-daily FF/VI were more likely to be adherent and have an AMR ≥ 0.5, and were less likely to discontinue therapy compared with patients initiating twice-daily BUD/FOR Dal Negro et al, 2018 [ 27 ] Observational, retrospective FF/VI 100/25 μg OD b Efficacy of FF/VI OD over 12 months.…”

“…These findings are supported by an analysis of data from phase 2/3 trials of FF in asthma, which demonstrated significant increases in FEV 1 compared with placebo, without any evidence of cortisol suppression at 100 µg and 200 µg OD [ 57 ]. Four RWD studies demonstrated that the initiation of regular FF/VI OD dosing led to generally better treatment persistence or adherence than regular ICS/FOR dosing [ 26 , 28 , 29 , 31 ]. Consequently, real-world evidence to date has shown that FF/VI provided benefits for lung function, asthma control, and reduced reliever use and risk of exacerbations compared with regular ICS/FOR [ 27 , 29 , 30 ].…”

“…Four RWD studies demonstrated that the initiation of regular FF/VI OD dosing led to generally better treatment persistence or adherence than regular ICS/FOR dosing [ 26 , 28 , 29 , 31 ]. Consequently, real-world evidence to date has shown that FF/VI provided benefits for lung function, asthma control, and reduced reliever use and risk of exacerbations compared with regular ICS/FOR [ 27 , 29 , 30 ]. This is an important finding as it is well recognized that poor adherence to ICS therapy can have a negative impact on asthma outcomes [ 12 , 29 , 31 , 58 , 59 ].…”

“…Consequently, real-world evidence to date has shown that FF/VI provided benefits for lung function, asthma control, and reduced reliever use and risk of exacerbations compared with regular ICS/FOR [ 27 , 29 , 30 ]. This is an important finding as it is well recognized that poor adherence to ICS therapy can have a negative impact on asthma outcomes [ 12 , 29 , 31 , 58 , 59 ].…”