Aclidinium Bromide May Increase MACE Risk in Those With CV Risk Factors
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SAN ANTONIO — A history of cardiovascular events is associated with a higher risk for major adverse cardiovascular events (MACE) in individuals with chronic obstructive pulmonary disease (COPD) who receive aclidinium 400µg, according to a post hoc analysis of the ASCENT COPD trial (ClinicalTrials.gov Identifier NCT01966107) presented at the CHEST Annual Meeting, held October 6-10, 2018, in San Antonio, Texas.
The study included 3630 individuals with COPD, 1712 of whom had a prior cardiovascular (CV) event (previous event subgroup) and 1865 of whom met ≥2 criteria for atherothrombotic risk (risk factor subgroup). These individuals were randomly assigned 1:1 to either aclidinium 400 µg or placebo twice per day for up to 1.5 years. Participants with a previous event were more likely than those with multiple atherothrombotic risk factors to have had ≥1 exacerbation within the last year (63.9% vs 56.5%), to be older (68.0 years vs 66.4 years), to be male (66.5% vs 51.7%), and to have more severe or very severe COPD (55.8% vs 51.4%). Aclidinium was efficacious in decreasing the number of exacerbations vs placebo in both subgroups (rate ratio=0.76 [95% CI, 0.63-0.92; P=.004] for the previous event subgroup vs rate ratio=0.80 [95% CI, 0.66-0.97; P =.02] for the risk factor subgroup).
MACE were more common in the previous event subgroup, with 5.5% occurring in the aclidinium group and 6.2% occurring in the placebo group, compared with participants with multiple atherothrombotic risk factors (2.4% for both aclidinium and placebo). The previous event subgroup had a MACE hazard ratio of 0.86 (95% CI, 0.58-1.27), compared with 0.99 (95% CI, 0.55-1.78) in the risk factor subgroup. Treatment was not significantly associated with CV risk for exacerbations (P=.67) or MACE (P=.69).
The rate of moderate to acute COPD exacerbations as well as the time to first MACE were examined. Individuals categorized as having multiple atherothrombotic risk factors did not have a history of prior CV events.
The study researchers concluded that “[i]n patients with moderate to very severe COPD receiving aclidinium 400 µg or placebo [twice daily], patients with higher CV risk (prior CV events) had slightly higher COPD exacerbation rates and were more likely to experience a MACE vs patients with lower CV risk (≥2 atherothrombotic risk factors).”
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Chapman K, Wise R, Scirica B, et al. Effect of aclidinium bromide on major adverse cardiovascular events and exacerbations in patients with COPD and different cardiovascular risk factor levels. Presented at: CHEST Annual Meeting 2018; October 6-10, 2018; San Antonio, TX.