An Evaluation of Risk Factors, Treatment Patterns and Outcomes Among Patients Treated with Lipid Lowering Therapy in the United Kingdom from 2008 to 2017

Study type
Protocol
Date of Approval
Study reference ID
20_041
Lay Summary

The term “cardiovascular disease” refers to conditions that involve narrowed or blocked blood vessels that can lead to a heart attack, chest pain (angina), poor circulation in hands or feet, or stroke. Some of the risk factors for heart attack and stroke include high cholesterol, diabetes, and pre-existing cardiovascular disease. This goal of this study is to describe the proportion of the United Kingdom (UK) population that has risk factors for heart attack and stroke, to estimate the rate of heart attack and stroke over time, and to describe the use of treatments to lower cholesterol. We will study people with a very high risk for heart attack and stroke, either because they already have cardiovascular disease or because they have diabetes. This study will collect the data on all such patients for 10 years from 2008 through 2017. Results will be analyzed separately across different calendar years to look for patterns in the proportion of patients with risk factors, the rate of heart attack or stroke, and the proportion using treatments for lowering cholesterol. The study will describe changes over 10 years in how well doctors and patients followed expert recommendations for lowering cholesterol. The study will also try to see whether these changes track with changes in the cholesterol levels and the rate of heart attacks and strokes the same 10-year time period.

Technical Summary

This is a descriptive study whose primary objective is to describe changes over time in cardiovascular disease risk factors, treatment patterns, and cardiovascular events. We will estimate the following annually over a 10-year period (2008 – 2017) in two cohorts of patients receiving lipid-lowering therapy who 1) have documented CVD and 2) have documented CVD or diabetes but no history of myocardial infarction or stroke (i.e., 2 separate but overlapping cohorts):
- Prevalence of cardiovascular (CV) conditions overall as well as by vascular bed (coronary, cerebrovascular, and peripheral) including polyvascular disease
- Serum LDL-C and total cholesterol distribution
- Serum LDL-C and total cholesterol measurement frequency
- Patterns of lipid-lowering treatment utilization
- 1-year incidence rates of CV events (with and without revascularization)
The primary output will be prevalence proportions, mean laboratory values, and event rates over time, along with 95% confidence intervals to show uncertainty. No statistical comparisons will be made across years.

Health Outcomes to be Measured

Myocardial infarction [MI]; ischemic stroke [IS]; revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG])

Collaborators

Mark Danese - Chief Investigator - Outcomes Insights ( Outins )
Mark Danese - Corresponding Applicant - Outcomes Insights ( Outins )
David Catterick - Collaborator - Amgen Ltd
Deborah Lubeck - Collaborator - Outcomes Insights ( Outins )
Eduard Sidelnikov - Collaborator - Amgen Ltd
Guillermo Villa - Collaborator - Amgen Ltd
Jeetesh Patel - Collaborator - NHS England
Mazhar Iqbal - Collaborator - Amgen Ltd
Michelle Gleeson - Collaborator - Outcomes Insights ( Outins )
Youssef Beaini - Collaborator - NHS England