Abstract
Background: Oral corticosteroids (OCS) are often prescribed for chronic obstructive pulmonary disease (COPD) exacerbations.
Methods: This observational, individually-matched historical cohort study used electronic medical records (1987–2019) from the UK Clinical Practice Research Datalink linked to English Hospital Episode Statistics (HES) to evaluate adverse outcomes in patients with COPD who used OCS (OCS cohort) and those not exposed to OCS (non-OCS cohort). Risk of 17 adverse outcomes was estimated using proportional hazard regression.
Results: Of 323,722 patients, 106,775 (33.0%) had COPD-related OCS prescriptions. Of the 106,775 patients in the overall cohort, 58,955 had HES linkage and were eligible for inclusion in the OCS cohort. The individual matching process identified 53,299 pairs of patients to form the OCS and non-OCS cohorts. Median follow-up post-index was 6.9 years (OCS cohort) and 5.4 years (non-OCS cohort). Adjusted risk of multiple adverse outcomes was higher for the OCS cohort versus the non-OCS cohort, including osteoporosis with/without fractures (adjusted hazard ratio [aHR] 1.80; 95% confidence interval [CI] 1.70–1.92), type 2 diabetes mellitus (aHR 1.44; 95% CI 1.37–1.51), cardiovascular/cerebrovascular disease (aHR 1.26; 95% CI 1.21–1.30), and all-cause mortality (aHR 1.04; 95% CI 1.02– 1.07). In the OCS cohort, risk of most adverse outcomes increased with increasing categorized cumulative OCS dose. For example, risk of cardiovascular/cerebrovascular disease was 34% higher in the 1.0–<2.5 g group versus the <0.5 g group (HR 1.34; 95% CI 1.26–1.42).
Conclusion: Any OCS use was associated with higher risk of adverse outcomes in patients with COPD, with risk generally increasing with greater cumulative OCS dose.
Methods: This observational, individually-matched historical cohort study used electronic medical records (1987–2019) from the UK Clinical Practice Research Datalink linked to English Hospital Episode Statistics (HES) to evaluate adverse outcomes in patients with COPD who used OCS (OCS cohort) and those not exposed to OCS (non-OCS cohort). Risk of 17 adverse outcomes was estimated using proportional hazard regression.
Results: Of 323,722 patients, 106,775 (33.0%) had COPD-related OCS prescriptions. Of the 106,775 patients in the overall cohort, 58,955 had HES linkage and were eligible for inclusion in the OCS cohort. The individual matching process identified 53,299 pairs of patients to form the OCS and non-OCS cohorts. Median follow-up post-index was 6.9 years (OCS cohort) and 5.4 years (non-OCS cohort). Adjusted risk of multiple adverse outcomes was higher for the OCS cohort versus the non-OCS cohort, including osteoporosis with/without fractures (adjusted hazard ratio [aHR] 1.80; 95% confidence interval [CI] 1.70–1.92), type 2 diabetes mellitus (aHR 1.44; 95% CI 1.37–1.51), cardiovascular/cerebrovascular disease (aHR 1.26; 95% CI 1.21–1.30), and all-cause mortality (aHR 1.04; 95% CI 1.02– 1.07). In the OCS cohort, risk of most adverse outcomes increased with increasing categorized cumulative OCS dose. For example, risk of cardiovascular/cerebrovascular disease was 34% higher in the 1.0–<2.5 g group versus the <0.5 g group (HR 1.34; 95% CI 1.26–1.42).
Conclusion: Any OCS use was associated with higher risk of adverse outcomes in patients with COPD, with risk generally increasing with greater cumulative OCS dose.
| Original language | English |
|---|---|
| Pages (from-to) | 2565—2580 |
| Number of pages | 16 |
| Journal | International journal of chronic obstructive pulmonary disease |
| Volume | 2023 |
| Issue number | 18 |
| Early online date | 15 Nov 2023 |
| DOIs | |
| Publication status | Published - 15 Nov 2023 |
Bibliographical note
Acknowledgments: The authors thank Hilda de Jong, PhD (the PHARMO Institute, Utrecht, the Netherlands) for her assistance in developing the study protocol. The authors also thank Sharen Lee (Cardiovascular Analytics Group, Hong Kong) for her technical assistance in generating the figures for the dose-dependent relationship between OCS dose and adverse outcomes. The authors also thank Colin Bonner, Linda Stotsky, Mario Marinazzo, and Philomena Britto, for their review of the plain language summary as people living with COPD; these individuals were compensated for their time. Medical writing support, under theguidance of the authors, was provided by Sara Cameron, MPhil, and Sarah Piggott, MChem, CMC Connect, a division of IPG Health Medical Communications, funded by AstraZeneca, in accordance with Good Publication Practice (GPP 2022) guidelines.
Funding: This study was sponsored by AstraZeneca. All authors, including those employed by the funder of the study, were involved in the interpretation of data, and writing or revising the report, had final responsibility for the decision to submit for publication, and take responsibility for the integrity of the data and the accuracy of the data analysis.
Data Availability Statement
Data availability: Per the Clinical Practice Research Datalink Independent ScientificAdvisory Committee guidance, the data will not be made available for sharing
Keywords
- chronic obstructive pulmonary disease
- cohort study
- COPD
- corticosteroids
- observational
- Primary Care
Access to Document
- TSE_etal_IJCOPD_A_Long_Term_VoR
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