Patients with chronic obstructive pulmonary disease using budesonide-glycopyrrolate-formoterol had a 29% higher risk of severe exacerbations compared with those using fluticasone-umeclidinium-vilanterol, with no difference in pneumonia hospitalizations, according to a recent study.
In the study, published in The BMJ, investigators compared the safety and efficacy of two single-inhaler triple therapies for chronic obstructive pulmonary disease (COPD): budesonide-glycopyrrolate-formoterol (a twice-daily metered-dose inhaler) and fluticasone-umeclidinium-vilanterol (a once-daily dry powder inhaler). The investigators analyzed U.S. commercial claims data in a cohort study to evaluate outcomes in routine clinical practice.
The study included 20,388 propensity score-matched pairs of new users initiating either therapy between January 2021 and September 2023. The patients were aged 40 years or older, had a diagnosis of COPD, and were followed for up to 1 year. The primary outcomes were the first moderate or severe COPD exacerbation (effectiveness) and the first hospital admission for pneumonia (safety). Hazard ratios (HR) were calculated using a Cox proportional hazards regression model.
Patients receiving budesonide-glycopyrrolate-formoterol had a 9% increased risk of moderate or severe exacerbations compared with those receiving fluticasone-umeclidinium-vilanterol (HR = 1.09, 95% confidence interval [CI] = 1.04–1.14, number needed to harm [NNH] = 38). This was further stratified into a 7% increased risk of moderate exacerbations (HR = 1.07, 95% CI = 1.02–1.12, NNH = 54) and a 29% higher risk of severe exacerbations (HR = 1.29, 95% CI = 1.12–1.48, NNH = 97).
Pneumonia-related hospitalizations were identical between the groups (HR = 1.00, 95% CI = 0.91–1.10), with a crude incidence rate of 104.9 events per 1,000 person-years. All-cause mortality was comparable, with no statistically significant differences (HR = 1.04, 95% CI = 0.93–1.16).
Secondary analyses supported these findings, showing consistent results across subgroups, including patients with severe baseline disease or elevated eosinophil levels. Sensitivity analyses validated the robustness of the results, accounting for variations in treatment discontinuation and follow-up time.
The investigators concluded that fluticasone-umeclidinium-vilanterol demonstrated slightly better clinical outcomes for COPD exacerbation prevention, with a comparable safety profile to budesonide-glycopyrrolate-formoterol. They noted the added environmental burden of metered-dose inhalers and suggested further research exploring the mechanisms underlying these differences.
Full disclosures can be found in the published study.
