Characteristics of New Users of Single- and Multiple-Inhaler Triple Therapy for COPD in Primary Care in England

Abstract

Purpose

Inhaled triple therapy is recommended for patients with chronic obstructive pulmonary disease (COPD) who have poorly controlled symptoms and to reduce the risk of exacerbations. This study assessed the clinical characteristics of new users of single- and multiple-inhaler triple therapy (SITT and MITT) treated in a primary care setting in England.

Patients and Methods

This cross-sectional, observational study used data from an electronic health record database (CPRD Aurum) of COPD patients registered with a primary care practice in England, with linkage to a secondary care database. Patients were required to have initiated a new triple therapy (index) between November 2017 and November 2018 and have ≥12 months of available medical history prior to the index date.

Results

In total, 3536 patients initiated fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI) SITT for the first time: 65% had a Medical Research Council (MRC) dyspnea score ≥3, 45% had forced expiratory volume in 1 second (FEV₁)% predicted <50%, and 64% had a moderate or severe exacerbation in the previous 12 months. The majority (83%) of new FF/UMEC/VI users had a history of MITT use. Immediately prior to FF/UMEC/VI initiation, 46% received MITT, 25% received an inhaled corticosteroid (ICS)/long-acting β₂-agonist (LABA), 12% received long-acting muscarinic antagonist (LAMA)/LABA, and 14% stepped up directly from LAMA monotherapy. A second cohort of 6540 patients initiated triple therapy (SITT or MITT) for the first time. COPD severity (airflow limitation, exacerbation history) was worse among patients initiating SITT versus MITT. In the 12 months before triple-therapy initiation, ICS/LABA was the most common treatment; a step up from LAMA/LABA was more common among patients initiating FF/UMEC/VI (34%) or beclomethasone/formoterol/glycopyrronium bromide SITT (25%) than MITT (14%).

Conclusion

First-time triple therapy was frequently initiated in patients with COPD inadequately controlled on maintenance therapy. General practitioners in England generally identify appropriate patients who require initiation of triple therapy.

Keywords:

• chronic obstructive pulmonary disease
• multiple-inhaler triple therapy
• patient characteristics
• single-inhaler triple therapy
• triple therapy

Abbreviations

AECOPD, acute exacerbation of COPD; APC, admitted patient care; BEC, beclomethasone; COPD, chronic obstructive pulmonary disease; CPRD, Clinical Practice Research Datalink; EMA, European Medicines Agency; FEV₁, forced expiratory volume in 1 second; FF, fluticasone furoate; FOR, formoterol; FVC, forced vital capacity; GERD, gastroesophageal reflux disease; GOLD, Global Initiative for Chronic Obstructive Lung Disease; GP, general practitioner; GLY, glycopyrronium bromide; HES, hospital episode statistics; ICD, International Classification of Diseases; ICS, inhaled corticosteroid; ISAC, Independent Scientific Advisory Committee; IQR, interquartile range; LABA, long-acting β₂-agonist; LAMA, long-acting muscarinic antagonist; MITT, multiple-inhaler triple therapy; MRC, Medical Research Council; NHS, National Health Service; SABA, short-acting β₂-agonist; SAMA, short-acting muscarinic antagonist; SD, standard deviation; SITT, single-inhaler triple therapy; UMEC, umeclidinium; VI, vilanterol.

Additional Information

The abstract of this paper was presented at the 2020 European Respiratory Society – 30th Annual Congress as a poster presentation. The poster’s abstract was published in the European Respiratory Journal. 2020;56(64):2417. Available from: https://erj.ersjournals.com/content/56/suppl_64/2417 DOI: 10.1183/13993003.congress-2020.2417

Data Sharing Statement

The data underlying this study are owned by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The CPRD is a center of the MHRA, and access to individual-level CPRD data is subject to protocol approval by the Independent Scientific Advisory Committee (ISAC). CPRD anonymized data can only be used by bona fide researchers for research to benefit patient and public health. Researchers and their affiliated organizations seeking access to CPRD data may contact CPRD to discuss access.

Ethics Approval and Informed Consent

This study complied with all applicable laws regarding patient privacy. No direct patient contact or primary collection of individual patient data occurred. The study was approved by the CPRD’s Independent Scientific Advisory Committee (ISAC study number: 19_228). Following the initial approval of the protocol, a minor amendment was made to also describe the characteristics of all new users of FF/UMEC/VI irrespective of prior triple-therapy use. Generic ethical approval for observational research using the CPRD with approval from ISAC was granted by the Health Research Authority Research Ethics Committee (East Midlands-Derby, REC reference number 05/MRE04/87).

Acknowledgments

Editorial support (in the form of writing assistance, including preparation of the draft manuscript under the direction and guidance of the authors, collating and incorporating authors’ comments for each draft, assembling tables and figures, grammatical editing, and referencing) was provided by Fiona Goodwin and Rebecca Cunningham of Aura, a division of Spirit Medical Communications Group Limited, and was funded by GlaxoSmithKline.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis, and interpretation, or in all these areas; took part in drafting, revising, or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

KJR, SJ, CC, VDB, and ASI are employees of and/or hold stocks/shares in GlaxoSmithKline. LBS was an employee of, and held shares in, GlaxoSmithKline, during the time the study was conducted and is currently affiliated with Medical Affairs, Ultragenyx Pharmaceutical Inc., Novato, CA, USA. ASI is also an unpaid part-time professor at McMaster University. The authors report no other conflicts of interest in this work.

Additional information

Funding

This study was funded by GlaxoSmithKline (study number 213325). The sponsor was involved in study conception and design, data interpretation, and the decision to submit the article for publication. The sponsor was also given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.