Fluticasone furoate/Vilanterol 92/22 μg once-a-day vs Beclomethasone dipropionate/Formoterol 100/6 μg b.I.D.: a 12-month comparison of outcomes in mild-to-moderate asthma

BACKGROUND: Bronchial asthma is an inflammatory disease of the airways. Beclomethasone dipropionate/Formoterol (BDP/F) and Fluticasone furoate/Vilanterol (FF/V) are two of the most effective LABA/ICS combinations for managing persistent bronchial asthma. Aim of the study was to compare the outcomes achieved in mild-to-moderate asthma patients assuming BDP/F 100/6 μg b.i.d. (Group A) or FF/V 92/22 μg once-daily (Group B) for 12-months. No head-to-head long-term comparison is available at present. METHODS: Data were automatically and anonymously obtained from the institutional database: FEV(1)% predicted values; the exacerbation and hospitalization rates; days of hospitalization; GP and/or specialist visits; days of inactivity; courses of systemic steroids and/or antibiotics were recorded at baseline and after 3, 6 and 12 months of both treatments. The overall adherence to treatments was also calculated. The propensity score method was used for matching and comparing the two cohorts of patients; Anova and Wilcoxon tests were used for checking the trends and time-to-time comparisons over the period; statistical significance was accepted for p < 0.05. RESULTS: The PS-matching process returned a cohort of 40 group A patients matched with 40 patients of group B, fully comparable for demographics, clinical characteristics, and comorbidities. The improvement in lung function was significant in both groups (p < 0.001), even if it was significantly higher and time-dependent in group B. The mean (±SE) exacerbation rate/patient changed from 0.63 (±0.13) at baseline to 0.53 (±0.12) after three; to 0.58 (±0.13) after six, and to 0.60 (±0.18) after twelve months in group A (p = ns), while from of 1.05 (±0.16) at baseline, to 0.28 (±0.07) after three; to 0.33 (±0.08) after six, and to 0.18 (±0.08) after twelve months in group B (p < 0.001), respectively. The mean hospitalization rate/patient changed from 0.25 ± 0.07 at baseline to 0.15 (±0.06) after three; to 0.08 (±0.04) after six, and to 0.13 (±0.05) after twelve months in group A (p = ns), while from 0.30 (±0.07) at baseline to 0.08 (±0.04) after three; to 0.10 (±0.05) after six, and to 0.03 (±0.03) after twelve months in group B (p < 0.001), respectively. Also mean duration of hospitalization and days of inactivity were in favour of FF/V treatment over time (in both cases p < 0.001). GP’s visits were reduced by both treatments (p < 0.007 in group A and p < 0.001 in group B, respectively, while Specialist’s visits only dropped during FF/V (p < 0.001). Steroid and antibiotic courses were significantly reduced by both treatments, even if more systematically in group B (p < 0.001 vs p < 0.007, and p < 0.001 vs p < 0.044, respectively). Moreover, changes in all outcomes considered proved time-dependent during the FF/V treatment only, particularly over the second semester. Finally, the overtime adherence to treatment was higher by 22 days during FF/V . CONCLUSIONS: Both the ICS/LABA combinations proved effective, even if characterized by different patterns of effectiveness either in terms of lung function and of long-term clinical outcomes. Only the once-daily inhalation of combined FF/V 92/22 μg once-daily optimized systematically the exacerbation and hospitalization rates in mild-to-moderate asthma, together with all other outcomes over time. The effectiveness of FF/V 92/22 once-daily μg proved progressive and time-dependent over the twelve-month period of the study, and associated to a higher adherence to treatment.