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Introduction <p>There is a paucity of comparative real-world evidence for fluticasone-based and beclometasone-based single-inhaler triple therapies in patients with chronic obstructive pulmonary disease (COPD).</p> Aim <p>To compare clinical outcomes of fluticasone/umeclidinium/vilanterol (a once-daily dry powder inhaler) and beclometasone/glycopyrrolate/formoterol (a twice-daily metered dose inhaler) in patients with COPD.</p> Method <p>This population-based cohort study enrolled patients with COPD who initiated fluticasone/umeclidinium/vilanterol or beclometasone/glycopyrrolate/formoterol from a nationwide Taiwanese database between 2019 and 2022. The effectiveness outcomes included severe and moderate exacerbations and the safety outcomes were pneumonia and composite cardiovascular events. Patients were followed from the first day after cohort entry to the earliest of each outcome occurrence, study treatment discontinuation or change, death, end of data (2022/12/31), or the 365th day after cohort entry. Cox regression models were employed to estimate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) for each outcome comparing fluticasone/umeclidinium/vilanterol versus beclometasone/glycopyrrolate/formoterol after high-dimensional propensity score matching.</p> Results <p>There were 12,971 initiators included in the high-dimensional propensity score matched cohort. The HR suggested a lower risk of severe and moderate exacerbations (0.80 [95% CI 0.69–0.93] and 0.80 [95% CI 0.74–0.87], respectively) and a marginally non-significant decreased risk of pneumonia (0.85 [95% CI 0.70–1.02]) associated with fluticasone/umeclidinium/vilanterol. However, both treatments showed a similar risk of composite cardiovascular events (0.96 [95% CI 0.69–1.35]). The results were generally consistent across several pre-specified sensitivity and subgroup analyses. Of note, among patients treated for ≥ 90&#xa0;days (nearly 73% of the initiators), the differences in clinical outcomes of both treatments tended to be minimal, with an HR of 0.98 (95% CI 0.78–1.23) for severe exacerbations, 0.93 (95% CI 0.72–1.20) for pneumonia, and 1.07 (95% CI 0.64–1.77) for composite cardiovascular events. Nevertheless, fluticasone/umeclidinium/vilanterol remained having a lower risk of moderate exacerbations (0.86 [95% CI 0.74–0.98]).</p> Conclusion <p>This cohort study conducted in an Asian COPD population suggests that fluticasone/umeclidinium/vilanterol may be a preferred initial treatment option over beclometasone/glycopyrrolate/formoterol. While among patients who are able to maintain their therapies for ≥ 90&#xa0;days, both treatments may demonstrate more comparable effectiveness and safety profiles.</p>

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Comparative effectiveness and safety of fluticasone-based versus beclometasone-based single-inhaler triple therapies in patients with chronic obstructive pulmonary disease: a population-based cohort study

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  • 发表日期：

    2025年11月7日

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  • Yaa-Hui Dong,
  • Sheng-Wei Pan,
  • Ming-Ching Chen,
  • Chun-Yu Chen,
  • Ning-Hsin Tsai,
  • Hiraku Kumamaru

摘要

Introduction

There is a paucity of comparative real-world evidence for fluticasone-based and beclometasone-based single-inhaler triple therapies in patients with chronic obstructive pulmonary disease (COPD).

Aim

To compare clinical outcomes of fluticasone/umeclidinium/vilanterol (a once-daily dry powder inhaler) and beclometasone/glycopyrrolate/formoterol (a twice-daily metered dose inhaler) in patients with COPD.

Method

This population-based cohort study enrolled patients with COPD who initiated fluticasone/umeclidinium/vilanterol or beclometasone/glycopyrrolate/formoterol from a nationwide Taiwanese database between 2019 and 2022. The effectiveness outcomes included severe and moderate exacerbations and the safety outcomes were pneumonia and composite cardiovascular events. Patients were followed from the first day after cohort entry to the earliest of each outcome occurrence, study treatment discontinuation or change, death, end of data (2022/12/31), or the 365th day after cohort entry. Cox regression models were employed to estimate hazard ratios (HRs) and corresponding 95% confidence intervals (CIs) for each outcome comparing fluticasone/umeclidinium/vilanterol versus beclometasone/glycopyrrolate/formoterol after high-dimensional propensity score matching.

Results

There were 12,971 initiators included in the high-dimensional propensity score matched cohort. The HR suggested a lower risk of severe and moderate exacerbations (0.80 [95% CI 0.69–0.93] and 0.80 [95% CI 0.74–0.87], respectively) and a marginally non-significant decreased risk of pneumonia (0.85 [95% CI 0.70–1.02]) associated with fluticasone/umeclidinium/vilanterol. However, both treatments showed a similar risk of composite cardiovascular events (0.96 [95% CI 0.69–1.35]). The results were generally consistent across several pre-specified sensitivity and subgroup analyses. Of note, among patients treated for ≥ 90 days (nearly 73% of the initiators), the differences in clinical outcomes of both treatments tended to be minimal, with an HR of 0.98 (95% CI 0.78–1.23) for severe exacerbations, 0.93 (95% CI 0.72–1.20) for pneumonia, and 1.07 (95% CI 0.64–1.77) for composite cardiovascular events. Nevertheless, fluticasone/umeclidinium/vilanterol remained having a lower risk of moderate exacerbations (0.86 [95% CI 0.74–0.98]).

Conclusion

This cohort study conducted in an Asian COPD population suggests that fluticasone/umeclidinium/vilanterol may be a preferred initial treatment option over beclometasone/glycopyrrolate/formoterol. While among patients who are able to maintain their therapies for ≥ 90 days, both treatments may demonstrate more comparable effectiveness and safety profiles.