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Real-World Safety and Effectiveness of Fluticasone Furoate/Vilanterol in Patients with Asthma and/or Chronic Obstructive Pulmonary Disease: A Post-Marketing Study in Korea

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  • Eun-Yeong Cho

    (Sinchon Yonsei Hospital)

  • Jung-Eun Cho

    (GSK Korea)

  • Seung Hun Jang

    (Hallym University College of Medicine)

  • Ki-Eun Hwang

    (Wonkwang University School of Medicine)

Abstract

Background and Objective Fluticasone furoate/vilanterol (FF/VI; RELVAR ELLIPTA) is approved in Korea for patients with asthma or chronic obstructive pulmonary disease (COPD). This study evaluated the effectiveness and safety of FF/VI in Korean patients with asthma and/or COPD over a 6-year period. Methods This was an open-label, multicentre, observational, post-marketing surveillance study in patients newly treated with FF/VI (100 or 200 μg/25 μg once daily). Safety endpoints were the incidence of adverse events (AEs), including unexpected AEs/adverse drug reactions (ADRs) and serious AEs/ADRs. Effectiveness was assessed after 24 weeks by Global Physician Assessment (logistic regression) and forced expiratory volume in 1 s (FEV1; paired t-tests). Results Of the 3426 patients enrolled across 45 hospitals between July 2014 and June 2020, 3216 were included in the safety analysis (50.5% female; mean age ± standard deviation [SD]: 58.6 ± 16.3 years). Overall incidence of AEs was 30.9% (n = 992); 4.1% (n = 132) were ADRs. Serious AEs were reported in 4.1% (n = 132) of patients; 0.1% (n = 4) were ADRs. Of 1543 patients analysed for symptomatic improvement, 89.2% (n = 1377) improved, 9.4% (n = 145) were unchanged, and 1.4% (n = 21) worsened. Mean FEV1 (difference ± SD) increased significantly in patients with asthma (0.09 ± 0.29 L; p

Suggested Citation

  • Eun-Yeong Cho & Jung-Eun Cho & Seung Hun Jang & Ki-Eun Hwang, 2023. "Real-World Safety and Effectiveness of Fluticasone Furoate/Vilanterol in Patients with Asthma and/or Chronic Obstructive Pulmonary Disease: A Post-Marketing Study in Korea," Drug Safety, Springer, vol. 46(10), pages 951-960, October.
    • Handle: RePEc:spr:drugsa:v:46:y:2023:i:10:d:10.1007_s40264-023-01337-w
    DOI: 10.1007/s40264-023-01337-w
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