Early occurrence of any COPD exacerbation predicts further higher risk of moderate/severe exacerbations regardless of recording tool: the FLAME study
EUROPEAN RESPIRATORY JOURNAL(2017)
摘要
Introduction: FLAME study evaluated COPD exacerbations as primary endpoint. 1 We assessed the annualised rate of moderate/severe exacerbations in patients (pts) with or without mild/moderate/severe or EXACT exacerbations in first 12 weeks (wks) of FLAME study. Methods: FLAME study recorded exacerbations using e-diary in all pts and EXACT-PRO tool (subset; n=453) over 52 wk randomised treatment with indacaterol/glycopyrronium or salmeterol/fluticasone. The annualised rate of moderate/severe exacerbations was compared in pts having 0 or ≥1 exacerbations in first 12 wks. Results: In pts with any exacerbations recorded in e-diary in the first 12 wks, rate of moderate/severe exacerbations was significantly higher in remaining 40 wks. A similar trend was observed in pts with EXACT-PRO exacerbations in first 12 wks, although this was not statistically significant (Table). Responder/E-RS responder (decrease of ≥0.6unit in total and ≥2units in E-RS symptom scores) status in first 12 wks had no significant impact on rate of moderate/severe exacerbations. Conclusion: The rate of moderate/severe exacerbations was higher in pts with any exacerbation during first 12 wks treatment period regardless of recording tool. These data support the fact that any prior exacerbation is a strong predictor for future moderate/severe exacerbation. Reference 1. Wedzicha JA et al.NEJM.2016;374:2222-2234
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