| アブストラクト | Background: Japanese guidelines recommend the addition of a long-acting muscarinic antagonist for patients with asthma uncontrolled on inhaled corticosteroid/long-acting beta(2)-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 beta(2)-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-severe 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 < 0.001), with similar reductions in the MDV database: 0.53 to 0.42 PPPY (0.79 [0.70, 0.89]; p < 0.001). In both databases, there was a 20% reduction (JMDC: 0.80 [0.73, 0.88]; p < 0.001; MDV: 0.80 [0.68, 0.94]; p = 0.005) in patients with >/=1 OCS prescription after FF/UMEC/VI initiation. The proportion of patients with >/=1 SABA canister prescription dropped by 31% 0.69 [0.57, 0.84]; p < 0.001) in the JMDC database and 23% (0.77 [0.66, 0.90]; p < 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. |
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| 投稿者 | Oga, Toru; Gon, Yasuhiro; Takano, Masashi; Ito, Risako; Mita, Chifuku; Mukai, Isao; Noorduyn, Stephen G; Requena, Gema; Yarita, Masao |
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| 組織名 | Department of Respiratory Medicine, Kawasaki Medical School, Kurashiki 701-0192,;Japan.;Division of Respiratory Medicine, Department of Internal Medicine, Nihon;University School of Medicine, Toyko 173-8610, Japan.;Real World Data Analytics, Japan Development, GSK, Tokyo 107-0052, Japan.;Value Evidence and Outcomes, Chief Patient Officer Organization, GSK, Tokyo;107-0052, Japan.;Respiratory Medical Affairs, Japan Medical Affairs, GSK, Tokyo 107-0052, Japan.;Real World Evidence and Health Outcomes, Global Medical, GSK, Mississauga, ON L5R;4H1, Canada.;Department of Health Research Methods, Evidence and Impact, McMaster University,;Hamilton, ON L8S 4L8, Canada.;Global Value Evidence and Outcomes, Epidemiology, GSK, London WC1A 1DG, UK. |
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