Clinical and Economic Burden of Adults at risk for atherosclerotic cardiovascular disease in England

Study type
Protocol
Date of Approval
Study reference ID
24_004523
Lay Summary

Cardiovascular disease (CVD) is a leading cause of death, sickness and reduced quality of life in Europe, including the UK, and is associated with significant clinical and cost burden. With more patients surviving their first cardiovascular (CV) event, CVD is also a major cause of disability, reduced quality of life, and poor clinical outcomes.
Increased level of lipids is recognized as a causal risk factor of disease in which plaque builds up on the insides of arteries and its associated complications. Research has shown that the risk of occurrence of major clinical events such as heart attack, death due to heart disease, stroke or procedures to restore blood flow in blocked arteries can be reduced with a reduction in lipid levels.
Despite this, the British Heart Foundation estimated that about half of adults in the UK are living with lipid levels higher than the national recommendations for total cholesterol.
National guidance for the UK advocates primary prevention among adults with risk factors for CVDs, including lifestyle and dietary changes followed by medication that can reduce lipid levels, such as statin initiation. Despite effective options, many adults at risk go untreated or undertreated causing more than 160,000 deaths each year in the UK, accounting for 27% of all deaths.
This study will provide a more comprehensive understanding of the occurrence of major clinical events associated with high lipid levels, among adults at risk of these events. This information will support the development of interventions for the prevention and management of CVDs.

Technical Summary

Cardiovascular disease (CVD) is a leading cause of mortality, morbidity, and reduced quality of life in Europe, including the UK, and is associated with significant clinical and economic burden. It is the cause of about 4 million deaths every year in Europe, accounting for 45% of all deaths, and including more than 160,000 deaths each year in the UK, accounting for 27% of all deaths. With more patients surviving their first cardiovascular (CV) event, CVD is also a major cause of disability, reduced quality of life, and poor clinical outcomes.
Increased low-density lipoprotein cholesterol (LDL-C) is recognized as a direct cause of atherosclerotic CVD (ASCVD) and its major clinical sequelae. Research has shown that major vascular events were reduced by 21% over 5 years per 1 mmol/L of LDL-C reduction.
The British Heart Foundation estimated that about half of adults in the UK are living with cholesterol levels higher than the national recommendations for total cholesterol of <5 mmol/L. National guidance for the UK advocates primary prevention in adults with CV risk factors, recommending that people at high risk of CVD (>10% chance of a heart attack or stroke) are first offered lifestyle advice including dietary changes to lower cholesterol and, if that is not effective, are then offered lipid-lowering treatments, starting with statins.
Despite effective treatment options, a large proportion of adults with and at risk for ASCVD with elevated LDL-C remain un or undertreated.
This retrospective observational cohort study will describe demographics and clinical characteristics of adults, and frequency of and time to occurrence of subsequent ASCVD events including non-fatal stroke, non-fatal MI, Acute Limb Ischemia or amputation, urgent revascularization, cardiovascular death with the aim of providing a more comprehensive understanding of the occurrence of ASCVD events, among adults with and at risk for ASCVD events in England.

Health Outcomes to be Measured

Number and timing of ASCVD events (non-fatal stroke (IS), non-fatal MI (MI), Peripheral Ischemic Events (including Acute Limb Ischemia (ALI), urgent revascularization (R) or major amputation due to vascular etiology), cardiovascular and non-cardiovascular death; risk of ASCVD event (intermediate, high, very high risk); inpatient admissions (inpatient length of stay by type of admission); mortality (number and cause); Demographic profiles for each cohort and sub-cohort (Age at event, gender, ethnicity, BMI, total time in cohort, mean and median follow-up time, Charlson Co-morbidity Score, selected comorbidities, Geographic region) by Risk group (low, intermediate and high risk); and treatment patterns (prescription of lipid-lowering-therapies).

Collaborators

Arielle Marks-Anglin - Chief Investigator - Merck & Co. Inc - Pennsylvania, USA
Jay Were - Corresponding Applicant - Parexel International Limited (UK)
Boshu Ru - Collaborator - Merck Sharp & Dohme LLC
Kausik Ray - Collaborator - Imperial College London
Lori Bash - Collaborator - Merck & Co., Inc.
Min Zhuo - Collaborator - Merck & Co., Inc.
Tanvee Thakur - Collaborator - Merck and Company, Incorporated

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;CPRD Aurum Ethnicity Record