Exacerbation heterogeneity in COPD: Subgroup analyses from the FLAME study

Claus F. Vogelmeier, Kenneth R. Chapman, Marc Miravitlles, Nicolas Roche, Jørgen Vestbo, Chau Thach, Donald Banerji, Robert Fogel, Francesco Patalano, Petter Olsson, Konstantinos Kostikas, Jadwiga A. Wedzicha

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The FLAME study compared once-daily indacaterol/glycopyrronium (IND/GLY) 110/50 μg with twice-daily salmeterol/fluticasone (SFC) 50/500 μg in symptomatic patients with moderate to very severe COPD and a history of exacerbations in the previous year. Methods: This prespecified and post hoc subgroup analysis evaluated treatment efficacy on 1) moderate/severe exacerbations according to prior exacerbation history and treatment, and 2) types of exacerbations according to health care resource utilization (HCRU) during 1-year follow-up. Results: IND/GLY reduced the rate of moderate/severe exacerbations versus SFC in patients with a history of 1 exacerbation (rate ratio [RR]: 0.83, 95% CI: 0.75–0.93), ≥2 exacerbations (RR: 0.85, 95% CI: 0.70–1.03) and ≥2 exacerbations or ≥1 hospitalization in the previous year (RR: 0.86, 95% CI: 0.74–1.00). Prolonged time-to-first exacerbation was observed in all the groups according to exacerbation history. Moderate/severe exacerbations decreased with IND/GLY versus SFC, independent of previous treatment. IND/GLY significantly reduced rates of moderate/severe exacerbations treated with antibiotics (RR: 0.79, 95% CI: 0.67–0.93) and systemic corticosteroids and antibiotics (RR: 0.80, 95% CI: 0.70–0.91); rates of exacerbations treated with systemic corticosteroids alone were comparable (RR: 0.99, 95% CI: 0.80–1.22). Conclusion: Overall, IND/GLY demonstrated consistent beneficial effects versus SFC on moderate/severe exacerbations, independent of prior exacerbation history or treatment. The efficacy of IND/GLY on exacerbation prevention was superior to SFC for exacerbations treated with antibiotics with/without systemic corticosteroids and was similar for exacerbations treated with systemic corticosteroids alone.

Original languageEnglish
Pages (from-to)1125-1134
Number of pages10
JournalInternational Journal of COPD
Volume13
Early online date10 Apr 2018
DOIs
Publication statusPublished - 2018

Keywords

  • Indacaterol/glycopyrronium
  • LABA/ICS
  • LABA/LAMA
  • Salmeterol/fluticasone

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