EVELUT®: A Real-World, Observational Study Assessing Dyspnoea and Symptom Burden in COPD Patients Switched from LABA/ICS to LAMA/LABA or LAMA/LABA/ICS

Abstract

Introduction The Global Initiative for Chronic Obstructive Lung Disease (GOLD 2023) no longer recommends a long-acting β 2 -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. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-023-02524-y.