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The Utilization and Safety of Umeclidinium and Umeclidinium/Vilanterol in UK Primary Care: A Retrospective Cohort Study

Authors Requena G, Dedman D, Quint JK, Ghosh RE, Williams R, Pimenta JM

Received 13 November 2020

Accepted for publication 22 February 2021

Published 10 March 2021 Volume 2021:16 Pages 629—642


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 5

Editor who approved publication: Dr Richard Russell

Gema Requena,1 Daniel Dedman,2 Jennifer K Quint,3 Rebecca E Ghosh,2 Rachael Williams,2 Jeanne M Pimenta1

1Respiratory Epidemiology, GSK, Brentford, Middlesex, UK; 2Clinical Practice Research Datalink, MHRA, London, UK; 3National Heart and Lung Institute, Imperial College London, London, UK

Correspondence: Gema Requena
Respiratory Epidemiology, GSK, 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK
Tel +44 2080 476893
Email [email protected]

Background: Umeclidinium bromide (UMEC) and umeclidinium/vilanterol (UMEC/VI) received European approval for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) in 2014. This study examined prescribing patterns, possible off-label prescribing, potential safety-related outcomes and adherence of these medications in routine clinical practice post-approval.
Methods: This retrospective, multi-database, longitudinal observational study of new users of UMEC, UMEC/VI, or other long-acting bronchodilators (LABD) analyzed data from UK electronic health record databases (primary care cohort), linked to hospital data (linked cohort). Off-label prescribing, safety outcomes (cardiovascular, respiratory, and mortality), treatment patterns, and medication adherence were assessed.
Results: In the primary care cohort (new users of UMEC n=3875; UMEC/VI n=2224; other LABD n=32,809), two-thirds of UMEC users were prescribed concomitant inhaled corticosteroids/long-acting β2-agonists. Possible off-label prescribing, defined as use in patients without COPD, was similar for UMEC (7.0%) and UMEC/VI (8.8%), but higher for new users of other LABD (18.0%). There were 547 UMEC users and 512 UMEC/VI users in the linked cohort. In both cohorts, incidence rates (IRs) of cardiovascular outcomes were similar for UMEC and UMEC/VI users (myocardial infarction IR per 1000 person-years [95% CIs]: UMEC 6.9 [4.4, 10.2]; UMEC/VI 6.8 [3.5, 11.9]). IRs of pneumonia and acute COPD exacerbations (AECOPD) were slightly higher among UMEC users compared with UMEC/VI users (AECOPD IR per 1000 person-years [95% CIs]: UMEC 979 [931, 1030]; UMEC/VI 746 [687, 811]). Adherence (medication possession ratio ≥ 80%) was 64% for UMEC and UMEC/VI.
Conclusion: Most new users of UMEC were receiving multiple-inhaler triple therapy. Off-label prescribing was uncommon for new users of UMEC and UMEC/VI. Incidence of cardiovascular and respiratory outcomes was as expected for these drug classes. This study provides evidence that UMEC and UMEC/VI are being prescribed appropriately and their safety profile remains unchanged.

Keywords: chronic obstructive pulmonary disease, electronic medical records, long-acting β2-agonist, long-acting muscarinic antagonist, umeclidinium, umeclidinium/vilanterol

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