The combination of umeclidinium bromide and vilanterol in the management of chronic obstructive pulmonary disease: current evidence and future prospects

Abstract

The defining feature of chronic obstructive pulmonary disease (COPD) is progressive airflow limitation that causes air trapping and hyperinflation. The increasing hyperinflation results in dyspnea along with associated inability to engage in the activities of daily living. The American Thoracic Society (ATS), European Respiratory Society (ERS) and Global Initiative for Chronic Obstructive Lung Disease (GOLD) treatment guidelines all place bronchodilators as the foundation of pharmacological management of COPD. In patients with moderate-to-very-severe respiratory impairment, adding regular treatment with one or more long-acting bronchodilators is recommended [long-acting β2-agonists (LABAs) or long-acting muscarinic antagonists (LAMAs)]. A growing body of evidence shows that LAMA and LABA co-administration is more effective than either drug class alone in managing stable COPD to improve lung function, symptoms and health status. Recently, new drug applications (NDAs) for a fixed-dose combination (FDC) of umeclidinium (UMEC), a LAMA, and vilanterol (VI), a LABA, at UMEC/VI doses of 125/25 and 62.5/25 µg have been submitted by sponsors to the US Food and Drug Administration (FDA) and to the European Medicines Agency (EMA). Thus, UMEC/VI has become the first FDC LAMA/LABA product that has reached a regulatory approval stage. Other LAMA/LABA once-daily combinations coming through development include FDCs of tiotropium and olodaterol, glycopyrronium and indacaterol, and twice-daily aclidinium and formoterol. The aim of this review is to explore currently available data for once-daily UMEC/VI in the context of the evolving standards of COPD management.

Discovering the Relative Efficacy of Inhaled Medications for Chronic Obstructive Pulmonary Disease: Multiple Treatment Comparisons

“…As a result, combining LABA with LAMA has been recommended by clinicians [10]. This recommendation has been confirmed in our NMA which revealed that COPD patients with LABA + LAMA exhibited stronger improvements in both tFEV 1 and SGREQ scores compared to those with LABA or LAMA.…”

“…For instance, LABA + LAMA may be more efficacious than single inhaled medication, but such combined medications have not been thoroughly investigated [10,11]. The newly-adopted disease classification approach takes account both symptoms and exacerbation risks.…”

Efficacy and safety of long-acting β-agonist/long-acting muscarinic antagonist combinations in COPD: a network meta-analysis

“…A fixed-dose combination of umeclidinium/vilanterol was approved in the USA and Canada for maintenance treatment of COPD 5. Although LABA/LAMA combination therapies were superior to monotherapies with regards to lung function improvement, it is less clear that the surplus of bronchodilation by combination therapy would translate into better clinical outcomes such as better quality of life and fewer exacerbations 6 7…”

Differential pharmacology and clinical utility of emerging combination treatments in the management of COPD – role of umeclidinium/vilanterol

“…Moreover, new guidelines underline that symptoms and not just airflow limitation now have to be taken into account to guide the management of COPD 48,49. Although the combination of UMEC/VI has demonstrated good efficacy and safety in trials conducted to date, studies assessing the impact of this combination on exacerbations, delay in disease progression, and health status in patients with COPD are still needed.…”