Treatment patterns in patients with stable COPD in China: analysis of a prospective, 52-week, nationwide, observational cohort study (REAL)

Abstract

Background: Underdiagnosis and undertreatment pose major barriers to optimal management of chronic obstructive pulmonary disease (COPD) in China. Objective: The REAL trial was performed to generate reliable information on real-world COPD management, outcomes and risk factors among Chinese patients. Here, we present study outcomes related to COPD management. Design: It is a 52-week, prospective, observational, multicentre study. Methods: Outpatients (aged ⩾40 years) enrolled from 50 secondary and tertiary hospitals across six geographic regions of China were followed up for 12 months, with two onsite visits and by telephone every 3 months following baseline. Results: Between June 2017 and January 2019, 5013 patients were enrolled and 4978 included in the analysis. Mean [standard deviation (SD)] age was 66.2 (8.9) years, the majority of patients were male (79.5%) and mean (SD) time since COPD diagnosis was 3.8 (6.2) years. The most common treatments at each study visit were inhaled corticosteroids/long-acting beta-agonists (ICSs/LABAs; 28.3–36.0%), long-acting muscarinic antagonists (LAMAs; 13.0–16.2%) and ICS/LABA + LAMA (17.5–18.7%), but up to 15.8% of patients at each visit received neither ICS nor long-acting bronchodilators. The use of ICS/LABA, LAMA and ICS/LABA + LAMA differed across regions and hospital tiers; up to fivefold, more patients received neither ICS nor long-acting bronchodilators in secondary (17.3–25.4%) versus tertiary hospitals (5.0–5.3%). Overall, rates of nonpharmacological management were low. Direct treatment costs increased with disease severity, but the proportion of direct treatment costs incurred due to maintenance treatment decreased with disease severity. Conclusion: ICS/LABA, LAMA and ICS/LABA + LAMA were the most frequently prescribed maintenance treatments for patients with stable COPD in China, although their use differed between region and hospital tier. There is a clear need for improved COPD management across China, particularly in secondary hospitals. Registration: The trial was registered on 20 March 2017 (ClinicalTrials.gov identifier: NCT03131362; https://clinicaltrials.gov/ct2/show/NCT03131362 ). Plain language summary Treatment patterns in patients with COPD in China Background: Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory lung disease characterized by progressive and irreversible airflow limitation. In China, many patients with this disease do not receive a diagnosis or appropriate treatment. Objective: This study aimed to generate reliable information on the treatment patterns among patients with COPD in China to help inform future management strategies. Study design and methods: Patients (aged ⩾40 years) were enrolled from 50 hospitals across 6 regions of China and physicians collected data over the course of 1 year during routine outpatient visits. Results: The majority of patients were receiving long-acting inhaled treatments, which are recommended to prevent worsening of the disease. Up to 16% of patients in this study, however, did not receive any of these recommended treatments. The proportion of patients who received long-acting inhaled treatments differed across regions and hospital tiers; there were about five times more patients in secondary hospitals (about 25%) who did not receive these treatments compared with those in tertiary hospitals (about 5%). Guidelines recommend that pharmacological treatment should be complemented by nondrug treatment, but this was only received by a minority of patients in this study. Patients with higher disease severity incurred greater direct treatment costs compared with those with milder disease. Maintenance treatment costs made up a smaller proportion of overall direct costs for patients with higher disease severity (60–76%) compared with patients with milder disease (81–94%). Conclusion: Long-acting inhaled treatments were the most frequently prescribed maintenance treatments among patients with COPD in China, but their use differed between region and hospital tier. There is a clear need to improve disease management across China, especially in secondary hospitals.

Exacerbation in patients with stable COPD in China: analysis of a prospective, 52-week, nationwide, observational cohort study (REAL)

“…Given the potential impact of residence area (rural versus urban) on disease burden, this may also partly explain the difference in exacerbation rates observed across geographic regions in China. In the REAL study, the northwest region had the highest proportion of rural residents (64.6%) 14 and also the highest rate of exacerbation that resulted in hospitalisation, while the north and east were among regions with the highest proportion of urban residents (59.9–62.0%) 14 and with the lowest rate of exacerbation that resulted in hospitalisation. The lack of high-level medical institutions in rural areas may limit access to specialist medical services and optimal COPD management.…”

“…requiring hospitalisation) as the severity of COPD increased. 20 We have previously reported that secondary hospitals had a greater proportion of patients with very severe COPD compared with tertiary hospitals, 14 which may have contributed to the differences in exacerbation rates across hospital tiers.…”

“…We have reported that the majority of patients at secondary hospitals in the REAL study were from rural areas, whereas patients at tertiary hospitals were more frequently from urban areas. 14 Patients from rural areas have limited disease awareness, reported lower medication use and are less likely to seek medical advice despite a higher proportion of them reporting more severe conditions compared with patients from urban areas. 24 Other studies have shown that patients from rural areas experience greater COPD burden (including hospitalisation, disability and worsened health).…”

“… 30 The lower rate of exacerbation that resulted in hospitalisation in the north could also be a reflection of the fewer patients in that region having severe/very severe COPD at baseline. 14 Across different regions, patients with severe/very severe COPD had higher exacerbation rates than those with mild/moderate COPD. Notably, the south-central region had one of the highest rates of severe and overall exacerbations, despite having a similar proportion of patients with severe/very severe disease compared with other regions.…”

“…Notably, the south-central region had one of the highest rates of severe and overall exacerbations, despite having a similar proportion of patients with severe/very severe disease compared with other regions. 14 This may be due to the higher proportion of patients who did not receive inhaled corticosteroids or long-acting bronchodilator therapy in the south-central region compared with most other regions. 14 However, due to limited patient numbers across geographic regions in this study, these findings should be interpreted with caution.…”