How the aclidinium bromide trial brings novel perspective to COPD care.
This week at the CHEST 2019 Annual Meeting in New Orleans, Robert Wise, MD, presented data from the ASCENT-COPD trial showing the significantly reduced exacerbation rate among patients with chronic obstructive pulmonary disease (COPD) when treated with aclidinium bromide.
The phase 4 findings—which also showed exacerbation risk reduction regardless of patient exacerbation history, as well as benefit for reduced cardiovascular event risk—are considered novel in their comprehensive exacerbation benefit for COPD.
In an interview with MD Magazine® while at CHEST, Wise, a professor of Medicine at Johns Hopkins University School of Medicine, broke down the clinical meaning of the ASCENT findings.
MD Mag: What are the key takeaways from ASCENT-COPD?
Wise: Well I think the first thing that’s very important to understand is that there's been a controversy over the safety of anti-cholinergic agents over decades, and the ASCENT study provides a great deal of confidence that these agents are safe in patients who even have a high risk of cardiovascular disease.
That is to say, there was no difference between those treated with aclidinium, and those who were not, in terms of cardiac events. In addition, there was a benefit in terms of reducing the prevalence of exacerbations.
MD Mag: Is the overall exacerbation risk reduction benefit a truly novel finding?
Wise: I think this is very important—and somewhat surprising, that the drug was just as effective in patients who were at high risk of exacerbations by way of having had a previous exacerbations as those who had not had an exacerbation within the preceding year.
So the proportional reduction in risk in those low exacerbation patients was actually greater. It was about a 31% reduction compared to a 20% reduction. So even though the number of exacerbations was less, the proportional improvement was greater.
MD Mag: Is this indicative of a capability to treat COPD earlier into its initial diagnosis?
Wise: What this tells us is that there's a broad population of patients with COPD who benefit from long-acting antimuscarinic agents such as aclidinium.
MD Mag: What is the risk of associated cardiovascular event risk in patients with COPD?
Wise: Well, we know that patients with COPD have a lot of comorbidities, and one of them is coronary artery disease. So, they do have a high prevalence of coronary artery disease, and those patients who have exacerbations are thought to be at risk for having more cardiac events.
So aclidinium would be a good drug in those people, insofar as it's safe. There was another study that was done on just those patients who were taking beta blockers. And beta blockers as a background therapy might be considered to a group of patients who would not particularly benefit from aclidinium.
As it turns out, those patients on beta blockers had about the same reduction in exacerbations as those who were not taking beta blockers—but they actually had a better response in terms of spirometry improvement in FEV1.