NEW ORLEANS, Oct. 14, 2019 /PRNewswire/ -- The long-acting bronchodilator aclidinium bromide (AB) is safe for patients at increased risk for heart attack and stroke and reduces the risk of new exacerbations in people with chronic obstructive pulmonary disease (COPD), regardless of whether they have had an exacerbation in the preceding year, according to Robert Wise, MD, FCCP, from Johns Hopkins University, School of Medicine, Baltimore, who will present the study findings at the CHEST Annual Meeting 2019 in New Orleans.
Dr. Wise noted that there are a few implicit issues surrounding the use of AB, "First, there has been some controversy over the cardiovascular safety of aclidinium, which this study shows not to be a problem. Second, although aclidinium has been shown to be a good bronchodilator, the overall study indicates that it is also effective in reducing exacerbations, which is a pivotal finding. Most studies of exacerbations include only patients who have had an exacerbation in the preceding year whereas ASCENT included patients both with and without exacerbations. Therefore, the finding that there was a similar risk reduction in those with and without exacerbations is an important and novel finding and perhaps surprising to some."
The researchers conducted a subgroup analysis of ASCENT-COPD trial to evaluate the effect of AB on COPD exacerbations and cardiovascular events, including death and non-fatal heart attacks and strokes in patients with and without exacerbations in the previous year. ASCENT-COPD is a phase IV, double-blind, parallel-group study of the effects of AB on cardiovascular (CV) safety and COPD exacerbations in patients with moderate to very severe COPD and high CV risk.
The 3,589 patients were randomized 1:1 to AB or placebo for up to three years. Moderate to severe COPD exacerbation rate was assessed during the first year, and cardiovascular events and all-cause mortality were assessed over three years.
The investigators found that in patients with moderate to very severe COPD and high CV risk, AB reduced the moderate/severe exacerbation rate vs. placebo and did not increase the risk of all-cause mortality regardless of prior exacerbations.
"Prevention of exacerbations of COPD should be a treatment goal in COPD patients regardless of whether they have a history of recent exacerbations," concluded Dr. Wise. "Aclidinium is a safe and effective maintenance therapy."
Victor Test, MD, Co-Chair of the CHEST Scientific Program Committee and Professor of Texas Tech University Health Sciences Center, commented: "This study addresses two very important issues in therapy for COPD—the effect of a long-acting anticholinergic agent on exacerbations and risk of cardiovascular events. In the highest risk patients, aclidinium bromide was superior to placebo in reducing exacerbations but did not increase cardiovascular events in high-risk patients. This study may provide reassurance regarding the efficacy and safety for the long-acting anticholinergic therapy."
MEETING Further results from this study will be shared at CHEST Annual Meeting 2019 in New Orleans on Monday, Oct. 21, 1:30 p.m. to 1:45 p.m., at the Ernest N. Morial Convention Center, Room 292. The study abstracts can be viewed on the journal CHEST® website.
ABOUT CHEST 2019 CHEST 2019 is the 85th annual meeting for the American College of Chest Physicians held Oct. 19 to Oct. 23, 2019, in New Orleans. The American College of Chest Physicians, publisher of the journal CHEST®, is the global leader in advancing best patient outcomes through innovative chest medicine education, clinical research and team-based care. Its mission is to champion the prevention, diagnosis and treatment of chest diseases through education, communication and research. It serves as an essential connection to clinical knowledge and resources for its 19,000 members from around the world who provide patient care in pulmonary, critical care and sleep medicine. For more information about CHEST 2019, visit chestmeeting.chestnet.org, or follow CHEST meeting hashtag, #CHEST2019, on social media.