Disease Burden and Healthcare Utilization Among Patients with Chronic Obstructive Pulmonary Disease (COPD) in England

Abstract

Purpose

Clinical guidelines for COPD management suggest pharmacologic treatment algorithms based on symptoms and exacerbation history. As previous research has suggested that prescribing patterns are not always aligned with these recommendations, this study investigated the burden of disease in patients with COPD receiving, and persisting on, new inhaled maintenance therapy.

Patients and Methods

This was a retrospective observational study using two linked electronic databases containing health records of patients in England. Patients aged ≥35 years with a confirmed diagnosis of COPD, and who initiated a new inhaled respiratory pharmacologic maintenance regimen between January 1, 2014 and December 31, 2016 (index date) were eligible for inclusion. New treatments could be long-acting muscarinic antagonist (LAMA) or long-acting β₂-agonist (LABA) monotherapy, inhaled corticosteroid (ICS)/LABA or LAMA/LABA dual therapy, or a multiple-inhaler triple therapy (MITT; LAMA/LABA/ICS). Patients were required to have 12 months of available medical history prior to, and after, the index date.

Results

In total, 25,350 eligible patients were identified, of these 8282 (mean age: 70.9 years; 51.5% male) persisted with their newly prescribed inhaled therapy for ≥12 months and were included in the analysis. In the 12 months prior to index, 54% of patients had moderate or severe dyspnea (Medical Research Council score ≥3). The most common therapy initiated at index was MITT (42%), followed by ICS/LABA dual therapy (31.2%). The proportion of patients with moderate or severe dyspnea in the post-index period ranged from 29.0% of patients receiving ICS to 64.2% of patients receiving MITT. In the post-index period, 48.1% of patients experienced ≥1 exacerbation and 54.9% had ≥5 general practitioner visits.

Conclusion

Many of the patients with COPD in our study continued to experience symptoms and exacerbations, despite persisting on the same treatment for ≥12 months. This suggests that some patients may benefit from treatment modification in accordance with guideline recommendations.

Keywords:

• chronic obstructive pulmonary disease
• exacerbations
• healthcare utilization
• maintenance therapy
• general practice

Abbreviations

BMI, body mass index; CI, confidence interval; COPD, chronic obstructive pulmonary disease; CPRD-GOLD, Clinical Practice Research Database – GP OnLine Data; FEV₁, forced expiratory volume in 1 second; FF, fluticasone furoate; FVC, forced vital capacity; GOLD, Global Initiative for Chronic Obstructive Lung Disease; GP, general practitioner; HES, Hospital Episode Statistics; HES-APC, Hospital Episode Statistics Admitted Patient Care; HR, hazard ratio; ICD, International Classification of Diseases; ICS, inhaled corticosteroid; LABA, long-acting β₂-agonist; LAMA, long-acting muscarinic antagonist; MITT, multiple-inhaler triple therapy; mMRC, (modified) Medical Research Council; NHS, National Health Service; NICE, National Institute for Health and Care Excellence; RR, rate ratio; SITT, single-inhaler triple therapy; TORCH, Towards a Revolution in COPD Health; UMEC, umeclidinium; VI, vilanterol.

Data Sharing Statement

The data analyzed in this publication are derived from the Clinical Practice Research Datalink (www.cprd.com) and Hospital Episode Statistics database (https://digital.nhs.uk/data-and-information/data-tools-and-services/data-services/hospital-episode-statistics). Authors had access to the study data for the purposes of this work only. Data were accessed through an existing GSK license to address the prespecified research questions only. Therefore, the data cannot be broadly disclosed or made publicly available at this time. Access to each database can be requested via the respective websites.

Ethics Approval and Informed Consent

Approval of this study was provided by the GlaxoSmithKline Protocol Review Committee and by the Independent Scientific Advisory Committee (ISAC), which reviewed the protocol and approved access to Clinical Practice Research Datalink data (ISAC study no. 18_094). Patient consent was not required as anonymized patient-level data were used in this analysis.

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, of Aura, a division of Spirit Medical Communications Group Limited (Manchester, UK), and was funded by GlaxoSmithKline. Trademarks are the property of their respective owners.

These data have previously been presented in abstract/poster form at the American Thoracic Society International Conference, Dallas, TX, USA, May 17–22, 2019: Sansbury L, Bains C, Ho S, Ismaila A, Anley G. Disease burden, health care utilization, and unmet need among chronic obstructive pulmonary disease (COPD) patients in United Kingdom (UK) general practice. D23. COPD: DIAGNOSIS AND EPIDEMIOLOGY. Am J Respir Crit Care Med. 2019; 199: A5944.

This study is based, in part, on data from the Clinical Practice Research Datalink obtained under license from the UK Medicines and Healthcare products Regulatory Agency. The data is provided by patients and collected by the NHS as part of their care and support. The interpretation and conclusions contained in this study are those of the authors alone.

Copyright © (2020), re-used with the permission of The Health & Social Care Information Centre. All rights reserved.

Author Contributions

All authors made a significant contribution to the work reported, whether that was 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 manuscript; 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

The authors declare the following conflicts of interest during the last three years in relation to this manuscript: DAL, GAA, KJR, and ASI are employees of and/or hold stocks/shares in GlaxoSmithKline. Current affiliation details for GAA and KJR: Speciality & Primary Care, GlaxoSmithKline, Brentford, UK. LBS was an employee of and/or held stocks/shares in GlaxoSmithKline at the time the study was conducted. LBS is currently affiliated with Global Epidemiology, Medical Affairs, Ultragenyx Pharmaceutical Inc., Novato, CA, USA. CB was a contingent worker at Value Evidence and Outcomes, R&d Global Medical, GlaxoSmithKline, Uxbridge, UK, at the time of the study/analysis. ASI is also an unpaid part-time professor at McMaster University, Hamilton, ON, Canada. The authors report no other conflicts of interest in this work.

Additional information

Funding

This study was funded by GlaxoSmithKline (study number 208757/PRJ3187). 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.