Analysis of data from a German registry study shows that patients with chronic obstructive pulmonary disease (COPD) who shifted from three-drug treatment consisting of inhaled corticosteroid (ICS), long-acting muscarinic antagonist (LAMA), and long-acting β₂-agonists (LABA) to a two-drug LABA/LAMA combination showed symptomatic improvement with fewer adverse effects. These findings were presented at the ATS 2022, the annual conference of the American Thoracic Society held in San Francisco.¹

Researchers analyzed data from the third cohort of the DACCORD non-interventional study, which included patients with COPD on inhaled triple therapy for at least 6 months prior to their enrollment in the present study. The aim was to evaluate the efficacy and safety of a LABA/LAMA FDC in COPD patients following withdrawal of ICS as decided by the treating physician. Time to the first episode of COPD exacerbation was the primary endpoint of the study. The duration of the study was from 2017 to 2021. Out of the 967 patients, 340 shifted to a fixed-dose LABA/LAMA combination and 784 were continued on triple therapy.

Participants who stuck with triple therapy tended to be male, have longer disease duration; they also had compromised pulmonary function with FEV1 of 58% vs 67%. Maintaining symptom control was the most common reason (35%) for continuing with triple therapy; among those who moved to dual therapy, “patient’s wish” was the most common reason (25.6%). Very few changed over to dual therapy owing to distressing adverse effects or lack of improvement.

After one year of follow-up, the overall outcomes were better in patients on LABA/LAMA FDC compared to those on triple therapy. They had significantly less COPD worsening (32.5% vs 55.7%). They not only had fewer exacerbations; 18.5% vs. 28.7%, respectively but also took longer to develop an exacerbation; 14 months vs 9.5 months. About 60% of patients on triple therapy experienced an exacerbation compared to 35% who shifted to dual therapy with a hazard ratio of 2.00. Fifty-eight percent of patients on dual therapy showed clinically relevant improvement in median COPD Assessment Test (CAT) scores (17.0) vs 49% on triple therapy (19.0). Compared to the triple therapy group, dual therapy was also safer with fewer patients reporting non-serious (15.1% vs 12.9%) and serious adverse events (13.8% vs 7.9%).

Patients with COPD, who remain symptomatic despite treatment with LABA/LAMA, are candidates for “step-up” treatment with triple therapy with addition of inhaled steroids. Analysis of data from the first and second cohorts of the DACCORD study indicated that patients could be safely and effectively switched from triple therapy to dual therapy. This premise has been verified in the third DACCORD cohort, which provides “real world evidence” that “stepping-down” from triple therapy to dual therapy with a FDC of LABA/LAMA is safe and also resulted in fewer COPD exacerbations with better health-related quality of life.

Reference

1. Vogelmeier C, et al. Stepping down from triple inhaled therapy to a LABA/LAMA fixed-dose combination: data from the German real-life DACCORD COPD cohort. May 17, 2022. ATS 2022. https://www.abstractsonline.com/pp8/#!/10476/presentation/4616.