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