Burden of disease in high-risk patients without prior myocardial infarction or stroke in the UK

Study type
Protocol
Date of Approval
Study reference ID
23_002982
Lay Summary

Heart disease is the leading cause of death and disability the UK and globally. High blood cholesterol is a significant risk factor for developing heart diseases and high LDL (“bad”) cholesterol is associated with increased risk of stroke and heart attack. In the UK, around 7.6 million people are living with heart disease each year - with an ageing and growing population, we could see these numbers rise still further. Recent advances in medicine, there are treatments now available to substantially lower levels of bad cholesterol in patients with heart disease and preventing them to have stroke and heart attack in the future. These medical treatments also provide an opportunity to help patients to control their bad cholesterol levels and preventing them to have heart disease. The aim of the study is to look at how many patients have these risk factors for heart disease and bad cholesterol, find out more about them, their characteristics, their levels of bad cholesterol, how they are treated and how many develop heart disease. We will use the CPRD database linked to Hospital Episode Statistics Admitted Patient Care (HES APC) data to look at how many patients may develop heart disease, and the impact of this problem to patients and the healthcare system. Our findings will help the government to decide about research priorities and may inform policies to reduce this public health problem.

Technical Summary

Cardiovascular disease (CVD) is the leading cause of death and disability in the UK, it has significant adverse effects on patients and puts substantial strain on our healthcare system. High levels of low-density lipoprotein cholesterol (LDL-C) are associated with increased risk of major adverse cardiovascular events (MACE). There are lipid lowering therapies (LLT) now available to substantially lower LDL-C levels in patients with CVD and reduce risk of MACE. Patients without prior cardiovascular events, having established risk factors and elevated LDL-C may also benefit from intensive LLT. The aim of the study is to estimate the prevalence of high-risk pre-cardiovascular-event population in the real world, characterize the high-risk population, and examine the incidence of MACE using the CPRD databases with HES APC data.

High-risk patients (those with coronary artery disease, cerebrovascular disease, peripheral arterial disease, diabetes mellitus with microvascular complications or chronic insulin use), elevated LDL-C and other risk factors (e.g., chronic kidney disease, cigarette smoking) will be selected for the prevalence calculation. Prevalence for each calendar year will be estimated by counting the number of high-risk patients divided by the population in CPRD database. Descriptive statistics will be used to study characteristics of patients and their LLT patterns.

HES APC data will be used to determine hospitalisations and the MACE outcomes and Office of National Statistics (ONS) Death Registration data will be used for the cause of death (cardiovascular death, coronary heart disease death). Incidence of each individual cardiovascular event, mortality event and the defined composite endpoints will be calculated by counting the number of incident cases of each event/composite across the study period divided by the population at risk.

Evidence generated from this study will provide valuable information on the burden of CVD for the National Health Service (NHS) and other policymakers on research priorities and policy initiatives.

Health Outcomes to be Measured

Myocardial infarction following index date; Stroke following index date; Ischemia-driven arterial revascularisation following index date; Cardiovascular death; Coronary heart disease death; Death from all causes; Composite of myocardial infarction, stroke, ischemia-driven arterial revascularisation, all-cause death following index date; Composite of myocardial infarction, stroke, ischemia-driven arterial revascularisation, cardiovascular or coronary heart disease death following index date; Lipid measurements following index date; Prescribing records of lipid-lowering-therapies, including statins, ezetimibe, proprotein convertase subtilisin/kexin type 9 inhibitors, bempedoic acid

Collaborators

Queenie Chan - Chief Investigator - Amgen Ltd
Queenie Chan - Corresponding Applicant - Amgen Ltd
David Neasham - Collaborator - Amgen Ltd
Francesco Giorgianni - Collaborator - Amgen Ltd
Ian Wong - Collaborator - University College London ( UCL )
Isobel Piper - Collaborator - Amgen Ltd
Joe Maskell - Collaborator - Amgen Ltd
Meda Sandu - Collaborator - Amgen Ltd
Michael Duxbury - Collaborator - Amgen Ltd

Linkages

HES Admitted Patient Care;ONS Death Registration Data