Patients with chronic obstructive pulmonary disease (COPD) and heightened cardiovascular (CV) risk continued to receive respiratory benefit without an increased CV risk from long-acting beta-agonist therapy, irrespective of baseline beta-blocker therapy, according to a study published in the Annals of the American Thoracic Society.
CVD is a common comorbidity in patients with COPD. Mark T. Dransfield, MD, from the University of Alabama at Birmingham and the Birmingham VA Medical Center, and colleagues compared the differential effects of long-acting beta-agonist or inhaled corticosteroid use on clinical outcomes in patients with COPD and heightened CV risk who were treated and not treated with beta blockers.
They examined data from 16,485 participants in the Study to Understand Mortality and Morbidity in COPD (SUMMIT; ClinicalTrials.gov Identifier: NCT01313676) who were randomly assigned to once-daily inhaled fluticasone furoate, the beta-2 agonist vilanterol, the combination of both agents, or placebo and evaluated the associations between the treatment received and lung function, COPD exacerbations, CV events, and all-cause mortality stratified by baseline beta-blocker therapy.
A total of 31% of SUMMIT participants used baseline beta-blocker therapy. However, use or nonuse of baseline beta-blocker therapy was not associated with differences in the association between inhaled treatments compared with placebo and postbronchodilator forced expiratory volume in 1 second (FEV1) at 3 months (interaction P =.27), 6 months (interaction P =.14), or 12 months (interaction P =.33).
The placebo-adjusted mean difference in postbronchodilator FEV1 at 3 months in the vilanterol group was 58 mL in participants taking baseline beta-blocker therapy and 51 mL in those not taking baseline beta-blocker therapy. The placebo-adjusted mean difference in postbronchodilator FEV1 at 3 months in the fluticasone furoate/vilanterol combination group was 85 mL in those taking baseline beta-blocker therapy and 68 mL in those not taking baseline beta-blocker therapy.
In addition, the authors found no evidence of interactions by randomized treatment, including vilanterol monotherapy, or in combination with fluticasone furoate for COPD exacerbations (P =.18), CV composite events (P =.33), and all-cause mortality (P =.41).
The authors noted that these results are supported by previous trials that also found no association between beta-blocker use and change in lung function over time.
Study limitations included the use of observational data within a randomized controlled trial where the use of baseline beta-blocker therapy at study entry was not randomized and changes in beta-blocker use during the trial were not captured precisely. The authors acknowledged that residual bias could have affected the study results.
Disclosures: This study was funded by GlaxoSmithKline.
Dransfield MT, McAllister DA, Anderson JA, et al. Beta-blocker therapy and clinical outcomes in patients with moderate COPD and heightened cardiovascular risk: an observational sub-study of SUMMIT [published online February 6, 2018]. Ann Am Thorac Soc. doi:10.1513/AnnalsATS.201708-626OC