» Articles » PMID: 37256536

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

Overview
Journal Adv Ther
Date 2023 May 31
PMID 37256536
Authors
Affiliations
Soon will be listed here.
Abstract

Introduction: The Global Initiative for Chronic Obstructive Lung Disease (GOLD 2023) no longer recommends a long-acting β-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.

References
1.
Miravitlles M, Auladell-Rispau A, Monteagudo M, Vazquez-Niebla J, Mohammed J, Nunez A . Systematic review on long-term adverse effects of inhaled corticosteroids in the treatment of COPD. Eur Respir Rev. 2021; 30(160). PMC: 9488732. DOI: 10.1183/16000617.0075-2021. View

2.
Vogelmeier C, Worth H, Buhl R, Criee C, Guckel E, Kardos P . Impact of switching from triple therapy to dual bronchodilation in COPD: the DACCORD 'real world' study. Respir Res. 2022; 23(1):109. PMC: 9059416. DOI: 10.1186/s12931-022-02037-2. View

3.
Kardos P, Vogelmeier C, Worth H, Buhl R, Lossi N, Mailander C . A two-year evaluation of the 'real life' impact of COPD on patients in Germany: The DACCORD observational study. Respir Med. 2017; 124:57-64. DOI: 10.1016/j.rmed.2017.02.007. View

4.
Singh D, Ferguson G, Bolitschek J, Gronke L, Hallmann C, Bennett N . Tiotropium + olodaterol shows clinically meaningful improvements in quality of life. Respir Med. 2015; 109(10):1312-9. DOI: 10.1016/j.rmed.2015.08.002. View

5.
Buhl R, Dreher M, Korn S, Taube C, Stock C, Zehendner C . A Non-Interventional Study of Tiotropium/Olodaterol versus Any Triple Combination Therapy for Chronic Obstructive Pulmonary Disease: The EVELUT Study Protocol. Int J Chron Obstruct Pulmon Dis. 2020; 15:2601-2608. PMC: 7591229. DOI: 10.2147/COPD.S262746. View