Aclidinium Delays COPD Event Onset, Does Not Increase MACE Risk

This article is part of Pulmonology Advisor‘s coverage of the American Thoracic Society International Conference, taking place in Dallas, Texas. Our staff will report on medical research related to asthma and other respiratory conditions, conducted by experts in the field. Check back regularly for more news from ATS 2019.

DALLAS — Individuals with moderate to very severe chronic obstructive pulmonary disease (COPD) and cardiovascular risk factors did not have an increased risk for all-cause mortality or major adverse cardiovascular event (MACE) occurrence with the use of aclidinium, which improved lung function, lowered the exacerbation rates, and delayed the onset of first COPD exacerbation. This research was presented at the American Thoracic Society’s International Conference, held May 17-22, 2019, in Dallas, Texas.

This post hoc analysis of the ASCENT-COPD study (ClinicalTrials.gov Identifier: NCT01966107) included 3589 participants, 35.4% (n=1269) of whom used beta-blockers at baseline and 64.6% (n=2320) of whom did not. Participants were randomly assigned 1:1 to twice daily aclidinium or placebo, both of which were administered by a dry powder inhaler for ≤3 years. Among beta-blocker users, 627 used aclidinium and 642 used a placebo, whereas among beta-blocker nonusers, 1164 used aclidinium and 1156 used a placebo. Outcomes included time to first MACE and all-cause mortality within the 3-year period, rate of moderate to severe COPD exacerbation, time to first moderate to severe COPD exacerbation within the first year, and change in morning trough forced expiratory volume in 1 second (FEV₁) from baseline between weeks 4 and 52.

More men than women (64.4% vs 55.5%) used beta-blockers and had ≥1 previous cardiovascular event (67.9% vs 36.7%); otherwise, characteristics at baseline did not differ significantly. Beta-blocker users and nonusers did not experience significantly different treatment effects on MACE or all-cause mortality, nor did those receiving aclidinium vs placebo. However, aclidinium was associated with longer time to first moderate or severe COPD exacerbation in both beta-blocker users and nonusers and a reduction in exacerbation rate (25% and 21% reduction, respectively). Patients who used beta-blockers and aclidinium also showed more improvement in morning trough FEV₁ than nonusers using aclidinium (99 mL; 95% CI, 76-122 vs 69 mL; 95% CI, 52-86, respectively; P =.041).

The study researchers concluded that “aclidinium treatment did not increase risk of MACE or all-cause mortality [vs] placebo in patients with moderate-to-very severe COPD and [cardiovascular] risk factors, regardless of baseline beta-blocker use. Aclidinium reduced the rate of moderate/severe COPD exacerbations, prolonged the time to first COPD exacerbation, and improved lung function [vs] placebo irrespective of beta-blocker use.”

Disclosures: Certain authors report associations with AstraZeneca.

Visit Pulmonology Advisor‘s conference section for continuous coverage from ATS 2019.

Reference

Chapman KR, Wise RA, Scirica BM, et al. Aclidinium bromide treatment in patients receiving beta-blockers: effects on MACE, moderate/severe COPD exacerbations, and lung function in patients with moderate-to-very severe COPD and cardiovascular risk factors (ASCENT-COPD). Presented at: the American Thoracic Society International Conference; May 19, 2019; Dallas, TX. Abstract A2443/209.

This article originally appeared on Pulmonology Advisor