NEW ORLEANS — Treatment with aclidinium bromide reduced the rate of exacerbations in patients with moderate to severe chronic obstructive pulmonary disease (COPD) and high cardiovascular (CV) risk compared with placebo, according to research presented at the CHEST 2019 annual meeting held October 19 to 23, in New Orleans, Louisiana.
Researchers conducted a phase 4, double-blind, parallel-group study to assess the effects of aclidinium bromide on COPD exacerbations and CV safety (ASCENT-COPD; ClinicalTrials.gov Identifier: NCT01966107). A total of 3589 patients were randomly assigned to receive either twice-daily aclidinium bromide or placebo for up to 3 years. Exacerbation rates and the percentage of patients with major adverse cardiovascular events (MACE) and all-cause mortality were numerically higher in patients with prior COPD exacerbations vs those without.
Aclidinium bromide reduced the exacerbation rate compared with placebo for both groups, with similar relative benefit (≥1 exacerbation: aclidinium bromide, 0.65 vs placebo, 0.82; rate ratio [RR], 0.80; 95% CI, 0.68-0.94 and no exacerbations: aclidinium bromide, 0.27 vs placebo, 0.38; RR, 0.69; 95% CI, 0.54-0.89; P for interaction =.0340).
However, there was no statistically significant increase in the risk for MACE in either the aclidinium bromide or placebo group (≥1 exacerbation: aclidinium bromide, 49 patients with events vs placebo, 61 patients; hazard ratio [HR], 0.79; 95% CI, 0.54-1.16 and no exacerbations: aclidinium bromide, 20 patients vs 15 patients; HR, 1.27; 95% CI, 0.65-2.47; P for interaction =.233).
Regardless of exacerbation history, aclidinium bromide did not increase the all-cause mortality risk (≥1 exacerbation: aclidinium bromide, 99 patients vs placebo, 93 patients; HR, 1.08; 95% CI, 0.81-1.43 and no exacerbations: aclidinium bromide, 17 patients vs placebo, 25 patients; HR, 0.66; 95% CI, 0.36-1.22; P for interaction =.154).
The researchers concluded that aclidinium bromide reduced the exacerbation rate in patients with moderate to severe COPD and high CV risk, and did not increase the risk for MACE in patients with or without prior exacerbations.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Wise R, Chapman K, Scirica B, Daoud S, Lythgoe D, Gil EG. Aclidinium bromide treatment stratified by exacerbation history: effects on exacerbations and major cardiovascular events in patients with COPD and high cardiovascular risk (ASCENT-COPD). Presented at: CHEST 2019 Annual Meeting; October 19-23, 2019; New Orleans, LA. Abstract 154.