Trial stopped early due to futility with respect to primary end point and safety concerns
MONDAY, Oct. 21, 2019 (HealthDay News) — For patients with chronic obstructive pulmonary disease (COPD), metoprolol does not reduce the time to first exacerbation versus placebo, according to a study published online Oct. 20 in the New England Journal of Medicine. The research was published to coincide with a presentation at CHEST 2019, the annual meeting of the American College of Chest Physicians, held from Oct. 19 to 23 in New Orleans.
Mark T. Dransfield, M.D., from the Lung Health Center at the University of Alabama at Birmingham, and colleagues conducted a prospective randomized trial involving patients aged 40 to 85 years with COPD. A total of 532 patients were randomly assigned to receive either a beta-blocker (extended-release metoprolol) or placebo.
Due to futility with respect to the primary end point and safety concerns, the trial was stopped early. The researchers found that the median time until the first exacerbation did not differ significantly between the groups (202 days in the metoprolol group versus 222 days in the placebo group; hazard ratio for metoprolol versus placebo, 1.05; 95 percent confidence interval, 0.84 to 1.32; P = 0.66). A higher risk for exacerbation leading to hospitalization was seen in association with metoprolol (hazard ratio, 1.91; 95 percent confidence interval, 1.29 to 2.83).
“Although observational studies have suggested that the benefits of beta-blockers in patients with recent myocardial infarction and heart failure extend to those with COPD, this hypothesis has not been prospectively confirmed,” the authors write.
Several authors disclosed financial ties to the pharmaceutical industry.
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