Real-world efficacy and problems of once-daily use of inhaled steroid (fluticasone furoate) combined with long-acting beta-2 agonist (vilanterol) in Japanese patients with asthma

Umeda, Akira; Yamane, Tateki; Mochizuki, Taichi; Inoue, Yasushi; Tsushima, Kenji; Miyagawa, Kazuya; Mochida, Atsumi; Takeda, Hiroshi; Okada, Yasumasa; Fukunaga, Kouichi

doi:10.1080/2331205x.2019.1600632

Cited by 1 publication

(14 citation statements)

References 26 publications

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“…The p-value before (1st line) and after (2nd line) the omission was consistently almost the same. Most of the statistical results (p-value) were similar between this study and our previous study using FF/VI 200/ 25 μg, except for V25, V50/V25, and V25/HT (Umeda et al, 2019).…”

Section: Change In Various Airflow Datasupporting

confidence: 88%

“…The p-values on VC, percent predicted VC, FVC, %FVC, and ERV after the omission were a little larger than the p-values before the omission. Most of the statistical results (p-value) were similar between this study and our previous study using FF/VI 200/25 μg, except for FVC, %FVC, ERV, and IRV (Umeda et al, 2019).…”

Section: Other Associated Parameter Changessupporting

confidence: 88%

“…Finally, we showed that most of the adverse events observed during FF/ UMEC/VI 200/62.5/25 μg treatment were local side effects, and therefore this combined drug was thought to be safe. The interval between the day of initiating the new inhalation drug and the day of obtaining the after data was shortened from 2-3 months to 1-2 months compared with our previous study on FF/VI 200/25 μg (Umeda et al, 2019). The number of patients "lost to follow-up" was reduced from 5/128 enrollments to 0/ 114 enrollments (Umeda et al, 2019).…”

Section: Discussionmentioning

confidence: 99%

“…We report interesting data on the instantaneous flow at 25% of the forced vital capacity (V25). This effect of additional UMEC 62.5 μg is compared with our previous study that investigated FF/VI 200/25 μg ( Umeda et al, 2019 ). Based on the effects of these drugs, we detected important findings in the field of pulmonary physiology and the pathophysiology of asthma.…”

Section: Introductionmentioning

confidence: 85%

“…The combination of a long-acting β 2 -agonist (LABA) and ICS was recommended for patients at high risk of asthma exacerbations ( Global Initiative for Asthma, 2022 ), and the first combined ICS/LABA, fluticasone propionate/salmeterol xinafoate (FP/S), was approved for use in Japan in 2007. In 2013, the first “once-daily use” of combined ICS/LABA, fluticasone furoate (FF) and vilanterol (VI), was allowed and we demonstrated the real-world efficacy and safety of this FF/VI 200/25 μg in Japanese patients with asthma ( Umeda et al, 2019 ; Allen et al, 2013 ; Slack et al, 2013 ). We concluded that FF/VI appeared to be effective on larger airways and yielded a greater satisfaction despite a higher incidence of local effects compared to previous ICS/LABA.…”

Section: Introductionmentioning

confidence: 99%

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Real-world effects of once-daily inhaled steroid (fluticasone furoate) combined with long-acting beta-2 agonist (vilanterol) and long-acting muscarinic antagonist (umeclidinium) on lung function tests of asthma patients in Japan

Umeda

Shimada²,

Yamane³

et al. 2023

Front. Physiol.

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Background: The Japanese drug use system allowed the once-daily use of inhaled corticosteroid fluticasone furoate (FF) combined with a long-acting beta-2 agonist vilanterol (VI) and a long-acting muscarinic antagonist umeclidinium (UMEC) against asthma on 18 February 2021. We investigated the real-world effects of these drugs (FF/UMEC/VI) mainly on lung function tests.Methods: This was an open-label, uncontrolled, within-group time-series (before-after) study. Prior asthma treatment (inhaled corticosteroid with/without a long-acting beta-2 agonist with/without a long-acting muscarinic antagonist) was switched to FF/UMEC/VI 200/62.5/25 μg. Subjects were evaluated by lung function tests prior to, and 1–2 months after, initiation of FF/UMEC/VI 200/62.5/25 μg. Patients were asked questions regarding the asthma control test and preference for drugs.Results: Overall, 114 asthma outpatients (97% Japanese) were enrolled from February 2021 to April 2022: 104 subjects completed the study. Forced expiratory volume in 1 s, peak flow, and asthma control test score of FF/UMEC/VI 200/62.5/25 μg-treated subjects were significantly increased (p < 0.001, p < 0.001, and p < 0.01, respectively). In contrast with FF/VI 200/25 μg, instantaneous flow at 25% of the forced vital capacity and expiratory reserve volume were significantly increased by FF/UMEC/VI 200/62.5/25 μg (p < 0.01, p < 0.05, respectively). Sixty-six percent of subjects declared they wanted to continue FF/UMEC/VI 200/62.5/25 μg in the future. Adverse effects, mainly local, were seen in 30% of patients, but no serious adverse effects were seen.Conclusion: Once-daily FF/UMEC/VI 200/62.5/25 μg was effective against asthma without serious adverse events. This is the first report that demonstrated FF/UMEC/VI dilated peripheral airways using lung function tests. This evidence on drug effects may improve our understanding of pulmonary physiology and the pathophysiology of asthma.

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Section: Change In Various Airflow Datasupporting

confidence: 88%

Section: Other Associated Parameter Changessupporting

confidence: 88%