Aclidinium bromide plus LABA improves lung function in COPD: Cochrane

  • Ni H & al.
  • Cochrane Database Syst Rev
  • 11 Dec 2018

  • curated by Jenny Blair, MD
  • Clinical Essentials
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Takeaway

  • For patients with COPD, a fixed-dose combination (FDC) of aclidinium/formoterol (Duaklir, AstraZeneca, new drug application submitted 2018) appears safe and effective for some outcomes.

Why this matters

  • Most studies on long-acting muscarinic antagonist (LAMA)/long-acting beta2-agonist (LABA) combinations evaluate the LAMA tiotropium.
  • Aclidinium is less well-studied than tiotropium.
  • Safety and efficacy of aclidinium/formoterol FDC have been unclear.

Key results

  • Studies lasted 4-52 weeks.
  • Most had overall low bias risk.
  • FDC vs aclidinium (ORs; 95% CIs):
    • Symptomatic improvement: 1.34 (1.11-1.62);
    • Similar rates of exacerbations, QoL improvement, adverse events (AEs), nonfatal serious AEs, exacerbation-related admissions.
  • FDC vs formoterol:
    • Fewer exacerbations: 0.78 (0.62-0.99);
    • Symptomatic improvement: 1.30 (1.07-1.56);
    • Fewer AEs: 0.78 (0.65-0.93).
  • FDC vs placebo:
    • QoL improvement: 1.72 (1.39-2.13);
    • Symptomatic improvement: 2.51 (2.02-3.11).
  • With all 3 comparisons, FDC resulted in higher change in trough FEV1 vs baseline.
  • All significant findings were high-certainty.

Study design

  • Systematic review of 7 parallel-group randomized controlled trials (6 meta-analyzed).
  • Trials assessed aclidinium/LABA FDCs in adults with stable moderate-to-severe COPD (n=5921).
  • Primary outcomes: exacerbations; QoL; nonfatal serious AEs.
  • Funding: National Institute for Health Research (UK).

Limitations

  • No head-to-head comparisons between aclidinium/formoterol and other LAMA/LABAs.