{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T17:43:36Z","timestamp":1790963016424,"version":"4.1.0"},"reference-count":27,"publisher":"MDPI AG","issue":"8","license":[{"start":{"date-parts":[[2025,4,9]],"date-time":"2025-04-09T00:00:00Z","timestamp":1744156800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001203","name":"GSK","doi-asserted-by":"publisher","award":["study 217515"],"award-info":[{"award-number":["study 217515"]}],"id":[{"id":"10.13039\/501100001203","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background: Japanese guidelines recommend the addition of a long-acting muscarinic antagonist for patients with asthma uncontrolled on inhaled corticosteroid\/long-acting \u03b22-agonist (ICS\/LABA) therapy, the effectiveness of which is evaluated here. Methods: Retrospective, observational, single-arm cohort study in patients with asthma initiating fluticasone furoate\/umeclidinium\/vilanterol (FF\/UMEC\/VI) following ICS\/LABA, using independently analyzed data from Japanese claims databases: JMDC and Medical Data Vision (MDV). The index date was that of the first FF\/UMEC\/VI prescription. Outcomes were assessed during a 12-month follow-up versus a 12-month pre-index period (baseline) and included asthma exacerbations, oral corticosteroid (OCS) use, and short-acting \u03b22-agonist (SABA) use. P-values associated with rate ratios (RRs) were estimated using Conditional Poisson regression. Results: Overall, 3229 patients in the JMDC database and 1135 in the MDV database were included. Following FF\/UMEC\/VI initiation, the total annualized moderate\u2013severe asthma exacerbation rate in the JMDC database reduced from 0.50 to 0.40 per-person-per-year (PPPY) (RR [95% confidence interval]: 0.78 [0.73, 0.84]; p &lt; 0.001), with similar reductions in the MDV database: 0.53 to 0.42 PPPY (0.79 [0.70, 0.89]; p &lt; 0.001). In both databases, there was a 20% reduction (JMDC: 0.80 [0.73, 0.88]; p &lt; 0.001; MDV: 0.80 [0.68, 0.94]; p = 0.005) in patients with \u22651 OCS prescription after FF\/UMEC\/VI initiation. The proportion of patients with \u22651 SABA canister prescription dropped by 31% 0.69 [0.57, 0.84]; p &lt; 0.001) in the JMDC database and 23% (0.77 [0.66, 0.90]; p &lt; 0.001) in the MDV database. Conclusions: This suggests FF\/UMEC\/VI is effective in improving asthma exacerbations and reducing OCS and SABA use in Japanese patients previously using ICS\/LABA in real-world clinical practice.<\/jats:p>","DOI":"10.3390\/jcm14082566","type":"journal-article","created":{"date-parts":[[2025,4,9]],"date-time":"2025-04-09T03:32:53Z","timestamp":1744169573000},"page":"2566","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Real-World Effectiveness of Fluticasone Furoate\/Umeclidinium\/Vilanterol Initiation in Japanese Patients with Asthma Previously on Inhaled Corticosteroid\/Long-Acting \u03b22-Agonist Therapy: A Retrospective Cohort Study"],"prefix":"10.3390","volume":"14","author":[{"given":"Toru","family":"Oga","sequence":"first","affiliation":[{"name":"Department of Respiratory Medicine, Kawasaki Medical School, Kurashiki 701-0192, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0514-3054","authenticated-orcid":false,"given":"Yasuhiro","family":"Gon","sequence":"additional","affiliation":[{"name":"Division of Respiratory Medicine, Department of Internal Medicine, Nihon University School of Medicine, Toyko 173-8610, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4625-3762","authenticated-orcid":false,"given":"Masashi","family":"Takano","sequence":"additional","affiliation":[{"name":"Real World Data Analytics, Japan Development, GSK, Tokyo 107-0052, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-6820-0561","authenticated-orcid":false,"given":"Risako","family":"Ito","sequence":"additional","affiliation":[{"name":"Value Evidence and Outcomes, Chief Patient Officer Organization, GSK, Tokyo 107-0052, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-0510-8641","authenticated-orcid":false,"given":"Chifuku","family":"Mita","sequence":"additional","affiliation":[{"name":"Real World Data Analytics, Japan Development, GSK, Tokyo 107-0052, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isao","family":"Mukai","sequence":"additional","affiliation":[{"name":"Respiratory Medical Affairs, Japan Medical Affairs, GSK, Tokyo 107-0052, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5936-5579","authenticated-orcid":false,"given":"Stephen G.","family":"Noorduyn","sequence":"additional","affiliation":[{"name":"Real World Evidence and Health Outcomes, Global Medical, GSK, Mississauga, ON L5R 4H1, Canada"},{"name":"Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON L8S 4L8, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gema","family":"Requena","sequence":"additional","affiliation":[{"name":"Global Value Evidence and Outcomes, Epidemiology, GSK, London WC1A 1DG, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5770-4496","authenticated-orcid":false,"given":"Masao","family":"Yarita","sequence":"additional","affiliation":[{"name":"Real World Data Analytics, Japan Development, GSK, Tokyo 107-0052, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,4,9]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"169","DOI":"10.1186\/s12931-023-02475-6","article-title":"Global, regional, and national burden of asthma and its attributable risk factors from 1990 to 2019: A systematic analysis for the global burden of disease study 2019","volume":"24","author":"Wang","year":"2023","journal-title":"Respir. 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