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EVELUT®: A Real-World, Observational Study Assessing Dyspnoea and Symptom Burden in COPD Patients Switched from
Roland Buhl1, Michael Dreher2, Muriel Mattiucci-Guehlke3
1Pulmonary Department, Mainz University Hospital, Langenbeckstrasse 1, 55131, Mainz, Germany. roland.buhl@gmail.com.
Introduction:
The Global Initiative for Chronic Obstructive Lung Disease (GOLD 2023) no longer recommends a long-acting β2-agonist (LABA) plus inhaled corticosteroid (ICS) combination for the treatment of chronic obstructive pulmonary disease (COPD). In patients treated with LABA/ICS, who continue to experience symptoms without frequent or severe exacerbations, GOLD now recommends switching to long-acting muscarinic antagonist (LAMA)/LABA instead of escalating to triple therapy (TT; LAMA/LABA/ICS), which previously was also a recommended option. EVELUT®, a real-life, observational study, compared these two treatment strategies in terms of symptom relief and health status improvement.
Methods:
Patients with symptomatic COPD at low exacerbation risk (GOLD B) were switched, at their physicians' discretion, from LABA/ICS to either fixed-dose LAMA/LABA (tiotropium/olodaterol, Respimat® [Tio/Olo]) or fixed or free TT. Primary endpoints were change in modified Medical Research Council (mMRC) and COPD Assessment Test™ (CAT™) scores after 12 weeks.
Results:
The safety set contained 463 patients (Tio/Olo, n = 329; TT, n = 134). In a propensity score-matched set (Tio/Olo, n = 121; TT, n = 121), improvement in mMRC score was similar in patients on Tio/Olo (-0.23; 95% confidence interval [CI] -0.11, -0.36) and TT (-0.25; 95% CI -0.13, -0.38). Improvement in total CAT score was slightly larger in patients on Tio/Olo (-3.45; 95% CI -2.45, -4.45) versus TT (-2.51; 95% CI -1.62, -3.40). In both groups, Physician's Global Evaluation scores increased, with 69-89% of patients satisfied with their treatment overall. Marginally more patients on Tio/Olo responded to treatment versus TT (Δ mMRC score ≥ 1; 25% vs. 22%; Δ CAT score ≥ 2, 68% vs. 56%).
Conclusion:
In patients with symptomatic COPD at low exacerbation risk, treatment can be switched from LABA/ICS to LAMA/LABA without compromising clinical benefit, compared with escalating to LAMA/LABA/ICS. Switching from LABA/ICS to LAMA/LABA can provide symptom relief and improve health status without exposure to the risks associated with ICS.
Clinical Trial Registration:
ClinicalTrials.gov: NCT03954132.
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