Efficacy and safety of LABA/LAMA fixed-dose combinations approved in the US for the management of COPD

ABSTRACT

Introduction: Long-acting β₂-agonists [LABAs] and long-acting muscarinic antagonists [LAMAs]) are primary therapies for chronic obstructive pulmonary disease (COPD). Despite improvements in lung function and patient-reported outcomes (PROs) with these therapies, there is room to optimize outcomes further. Combined use of LABAs and LAMAs is recommended when symptoms are not improved with a single agent, and LABA/LAMA fixed-dose combinations (FDCs) are at the forefront of drug development in COPD.

Areas covered: This review focusses on the three LABA/LAMA FDCs (indacaterol/glycopyrrolate¹ [IND/GLY] 27.5/15.6 µg twice daily, umeclidinium/vilanterol [UMEC/VI] 62.5/25 µg once daily and tiotropium/olodaterol [Tio/Olo] 5/5 µg once daily approved in the US. Phase III clinical trials have shown benefits in lung function, dyspnea and health status with FDCs of IND/GLY, UMEC/VI and Tio/Olo versus placebo and monotherapies.

Expert commentary: Data from recent studies of three LABA/LAMA combinations, reviewed here, indicate that dual bronchodilation may be beneficial above and beyond both the monotherapies and LABA/ICS combinations, in providing improvements in lung function and PROs for patients with COPD, which may encourage a shift away from the use of ICS in COPD management, in particular for non-exacerbating patients.

KEYWORDS:

• Dyspnea
• health status
• long-acting β₂-agonist/long-acting muscarinic antagonist
• lung function
• indacaterol/glycopyrrolate
• safety
• St George’s Respiratory Questionnaire
• tiotropium/olodaterol
• Transition Dyspnea Index
• umeclidinium/vilanterol

Declaration of interest

The authors received medical writing assistance from Lietta Nicolaides (CircleScience, an Ashfield Company, part of UDG Healthcare plc), Sharon Smalley (contracted to CircleScience, an Ashfield Company, part of UDG Healthcare plc) and Santanu Sannigrahi (Novartis Healthcare Pvt. Ltd) and this was funded by Novartis Pharmaceuticals Corporation, USA. Donald Banerji is an employee of Novartis Pharmaceuticals Corporation and holds shares in the company. Donald A. Mahler and Nicola A Hanania have received honoraria for serving on advisory boards for Novartis and their institutions have received financial support to conduct clinical trials. Writing assistance was utilized in the production of this manuscript. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Supplementary Material

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