CHEST 2019 — Aclidinium bromide reduces COPD exacerbation rates in broad range of patients


  • Keren Landman, MD
  • Conference Reports
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Takeaway

  • Aclidinium bromide (AB) reduced exacerbation rates in patients with COPD regardless of their exacerbation history.

Why this matters

  • Few COPD exacerbation studies include patients with no history of exacerbations.

Study design

  • Post hoc analysis of data from ASCENT-COPD, a phase 4, double-blind, parallel-group study of AB effects in patients with moderate-to-very-severe COPD and high cardiovascular risk.
    • 3244 subjects had >1 exacerbation in previous year.
    • 1433 had no history of exacerbations.
  • Patients were randomly assigned 1:1 to AB or placebo for up to 3 years.
  • Analysis assessed AB effect on:
    • Moderate/severe exacerbations (during first year).
    • MACE (a cardiovascular death composite) and nonfatal myocardial infarction and stroke (over 3 years).
  • Funding: AstraZeneca.

Key results

  • Patients with ≥1 and 0 exacerbations in past year receiving AB vs placebo had:
    • Similar reductions in exacerbation rates:
      • 0: rate ratio (RR), 0.69 (95% CI, 0.54-0.89).
      • ≥1: RR, 0.80 (95% CI, 0.68-0.94).
      • P=.34.
    • No significant increase in MACE risk:
      • 0: HR, 1.27 (95% CI, 0.65-2.47).
      • ≥1: HR, 0.79 (95% CI, 0.54-1.16).
      • P=.233.
    • No increase in all-cause mortality risk:
      • 0: HR, 0.66 (95% CI, 0.36-1.22).
      • ≥1: HR, 1.08 (95% CI, 0.81-1.43).
      • P=.154.

Limitations

  • Retrospective study design.
  • Post hoc analysis.
  • Because ASCENT-COPD's inclusion criteria changed midstudy, there is a possibility of undetected differences between the pre- and postchange cohorts.

Expert commentary

  • Victor Test, MD, Co-Chair of the CHEST Scientific Program Committee and Professor of Texas Tech University Health Sciences Center, commented: “This study addresses two very important issues in therapy for COPD—the effect of a long-acting anticholinergic agent on exacerbations and risk of cardiovascular events. In the highest risk patients, aclidinium bromide was superior to placebo in reducing exacerbations but did not increase cardiovascular events in high-risk patients. This study may provide reassurance regarding the efficacy and safety for the long-acting anticholinergic therapy.” Dr. Test was not involved in the study.