Low exacerbation rates with triple combination therapy in moderate to very severe COPD
Click Here to Manage Email Alerts
Key takeaways:
- Patients receiving triple combination COPD therapy had fewer exacerbations than patients receiving dual therapy.
- Caution is necessary when interpreting these findings, according to the study author.
WASHINGTON — Compared with dual therapies, a triple fixed-dose combination budesonide/glycopyrrolate/formoterol fumarate metered-dose inhaler showed more reductions in exacerbation rates across different COPD severity levels.
These data were presented at the American Thoracic Society International Conference.
“To some extent these findings are surprising in documenting reduction in exacerbation rates with triple inhaled therapy despite absence of prior year exacerbation history and independent of spirometric airflow obstruction severity,” Fernando J. Martinez, MD, MS, chief of the division of pulmonary and critical care medicine at Weill Cornell Medicine, told Healio. “On the other hand, these are post-hoc analyses and need to be interpreted with caution.”
As Healio previously reported, a subgroup analysis of the multicenter, double-blind, parallel-group KRONOS study found that the reduction in COPD exacerbations seen with the triple fixed-dose combination budesonide/glycopyrrolate/formoterol fumarate (BGF; Breztri Aerosphere, AstraZeneca) metered-dose inhaler was not driven by patients with a prior exacerbation history when compared with a dual bronchodilator.
In a post-hoc analysis of the KRONOS study, Martinez and colleagues evaluated 1,896 patients with moderate, severe or very severe COPD to understand how triple therapy of BGF impacts the rate of moderate or severe exacerbations across different levels of baseline COPD severity compared with various dual therapies.
Reports of COPD exacerbations 1 year before starting treatment were not necessary in this study, but patients did need to have data before their randomized treatment was discontinued, according to the abstract.
Of the total cohort, 637 patients received 320/18/9.6 µg of BGF, 625 received 18/9.6 µg of glycopyrrolate/formoterol fumarate (GFF), 313 received 320/9.6 µg of budesonide/formoterol fumarate (BFF) and 318 received 400/12 g of open-label budesonide/formoterol fumarate (BUD/FORM). According to the abstract, BGF, GFF and BFF were administered through metered-dose inhalers, whereas BUD/FORM was administered through a dry-powder inhaler.
Across all treatment groups, more patients had moderate COPD (FEV1 50% to 80% predicted normal) or severe COPD (FEV1 30% to less than 50% predicted normal) at baseline than very severe COPD.
When comparing moderate or severe exacerbation rates between those administered BGF and those administered GFF, researchers found reduced rates with BGF in the three studied severity levels of moderate COPD (BGF, 0.36 vs. GFF, 0.81), severe COPD (0.59 vs. 1) and very severe COPD (0.32 vs. 1.25).
Compared with BFF, BGF showed a trend toward a decreased exacerbation rate in those with severe COPD (BGF, 0.59 vs. BFF, 0.7) and very severe COPD (0.32 vs. 0.85).
Researchers reported similar findings when comparing exacerbations rates of BGF and BUD/FORM in patients with severe COPD (BGF, 0.59 vs. BUD/FORM, 0.79) and very severe COPD (0.32 vs. 0.62).
“At this point, these post-hoc data should not be used to make clinical decisions,” Martinez told Healio. “Prospective confirmation is required, and prospective study in this population is sorely needed.”