Introduction: We compared the real-world effectiveness of initiating beclometasone dipropionate/formoterol fumarate (BDP/FOR) versus fluticasone furoate/vilanterol (FF/VI) in a general practice (GP) asthma cohort in England.
Methods: Patients newly initiating BDP/FOR or FF/VI between 1 December 2015 and 28 February 2019 (index), were selected from anonymised Clinical Practice Research Datalink data. Baseline was < 12 months pre-index with ≤ 12 months follow-up post-index. Eligible patients were aged ≥ 18 years at index, had diagnosed asthma, ≥ 1 FF/VI or BDP/FOR prescription, medical records eligible for linkage to secondary care data and continuous GP-registration ≥ 12 months pre-index. Patients with chronic obstructive pulmonary disease, ≥ 1 fixed-dose inhaled corticosteroid/long-acting β2-agonist, single-inhaler triple or biologic therapy at index were excluded. The primary study outcome was asthma exacerbation rate. Secondary outcomes included medication persistence and oral corticosteroid (OCS) use. Propensity scores were generated for each treatment comparison; inverse probability of treatment weighting adjusted for confounding in baseline characteristics between groups, applied to each outcome separately. Analyses considered intercurrent events (ICEs; treatment switching, discontinuation, loss to follow-up, death, rescue medication use).
Results: Weighted group standard mean differences showed adequate balance for most covariates. Patients initiating BDP/FOR (n = 46,809) and FF/VI (n = 3773) had numerically similar exacerbation rates per person per year (PPPY) while-on index treatment [measuring outcome until ICE; BDP/FOR, 0.1479 (n = 31,715); FF/VI, 0.1338 (n = 2547); rate ratio 0.9048, p = 0.2841]. Patients continuing uninterrupted index treatment for 12 months had a lower exacerbation rate PPPY for FF/VI [0.0681 (n = 384)] than BDP/FOR [0.1104 (n = 3342); rate ratio, 0.6162 (p = 0.0293)]. For patients initiating FF/VI versus BDP/FOR, treatment persistence was greater [hazard ratio, 0.76 (p < 0.0001)].
Conclusion: Overall, patients initiating FF/VI and BDP/FOR had numerically similar exacerbation rates; of the patients continuing 12 months' uninterrupted treatment, the FF/VI group had a lower exacerbation rate versus BDP/FOR. Patients initiating FF/VI were less likely to discontinue treatment than those initiating BDP/FOR.
Keywords: Asthma; Beclometasone dipropionate/formoterol fumarate; Comparative effectiveness; Fluticasone furoate/vilanterol; General practice; Real-world data; United Kingdom.
We compared how well two common, daily, asthma treatments work, by comparing people with asthma in England who started treatment with beclometasone dipropionate/formoterol fumarate (abbreviated to BDP/FOR) with fluticasone furoate/vilanterol (abbreviated to FF/VI). Patients with asthma who started these medications between 1 December 2015 and 28 February 2019, were selected. The database included anonymised information, which meant the researchers could not tell who each patient was. It included information from general practice and hospital appointments. Patients with chronic obstructive pulmonary disease were excluded. The primary study question was whether rates of asthma attacks (or exacerbations) differed between patients starting BDP/FOR compared with FF/VI. We also looked at the proportion of patients who continued with their new treatment and how often, and at what dose, oral corticosteroids were needed. The characteristics of the patients in each treatment group were analysed and balanced to ensure a fair comparison. For every 100 patients in the study, overall there were 14 exacerbations per year with FF/VI (total of 3773 patients) and 15 exacerbations per year with BDP/FOR (total of 46,809 patients). Of the patients who continued uninterrupted treatment for 12 months, there were significantly fewer exacerbations with FF/VI (7 per 100 patients) than BDP/FOR (11 per 100 patients), although group sizes were smaller (384 and 3342 patients, respectively). Patients in the FF/VI group were 24% less likely to discontinue treatment than patients in the BDP/FOR group.
© 2025. The Author(s).