Corticosteroids (CS) are common treatments for managing inflammation, but there are limitations to its use. Even though they are commonly used, we don’t really have a clear understanding about the association of use of the drug with the risks of major adverse cardiovascular events (MACE), solid-tumours or mortality.
The study will determine if oral or injected corticosteroid use in adults is a risk factor for: 1) MACE; 2) solid-tumours; and 3) mortality.
The number of people that are first identified with MACE and/or solid-tumours will be compared between those who take the drug and those who do not. The study will provide estimates of the difference (if any) of the risks associated with being treated with CS and the likelihood of MACE, solid-tumours and mortality.
Systemic corticosteroids (CS) are important for managing inflammation, but there are limitations to its use. Few consistent data exist describing the association of CS and risks of major adverse cardiovascular events (MACE), solid-tumours or mortality.
The study will determine if oral or intravenous CS (OIVCS) exposure in adults is a risk factor for: 1) MACE; 2) solid-tumours; and 3) mortality; testing the hypothesis that disturbance in glucose metabolism is driven by OIVCS in a dose-dependent manner with both acute and chronic cumulative effects.
A ‘new-user’ matched cohort design comparing OIVCS-exposed versus non-exposed patients is drawn from CPRD GOLD with linked hospital data. Cases have a MACE, incident solid-tumours or mortality. It is a matched cohort study so exposed will compared and matched to non-exposed patients similar in baseline characteristics from the same GP practice.
OIVCS exposure will be measured by intended time exposed for ‘on’ episodes, and dose intensity. Concomitant prescribed CS either inhaled, topically applied, or otherwise administered will also be assessed as covariates.
The primary analyses will be time-to-event, namely cardiovascular outcomes, solid-tumours and mortality, respectively using Cox regression modelling with mixed effects, the principal output will be the hazard ratios (and their 95% confidence intervals) for the exposures and covariates on the outcomes of interest.
This study will include applying for permission to carry out the study, data cleaning and statistical analysis. The aim will be to publish this research in a peer-reviewed journal. The study will provide population-wide estimates of the excess cardiovascular risks associated with CS prescribing adding to the current body of knowledge which hitherto has comprised smaller studies of specific clinical subgroups with limited generalisability.
Major adverse cardiovascular events (MACE); incident solid-tumours; mortality.
- Chief Investigator -
Benjamin Heywood - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
- Collaborator -
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Sara Jenkins-Jones - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Thomas Berni - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation