The purpose of this study is to understand factors that affect the effectiveness of medications to lower cholesterol. This is a study of people who are starting to take cholesterol-lowering medication because of existing cardiovascular disease or because of risk factors for cardiovascular disease. The study will explain variation in the effectiveness of cholesterol-lowering medications in the real world that are caused by two factors. First, people may not always take their medicine as it is supposed to be taken. We will use prescription records to assess how regularly people take their medication, as a proxy for “adherence.” Second, there are many different drugs used by physicians, and these drugs vary in their ability to lower cholesterol. Hence, the other factor is the amount of expected reduction in cholesterol from the prescribed medication, which is referred to as “treatment intensity”. The study will examine the effects of these two factors on cardiovascular events which include things like heart attacks, strokes, and procedures to open up clogged arteries in the heart. The information from this study can be used by primary care physicians to provide better care to patients at risk of cardiovascular events.
Patients may not benefit fully from the use of lipid-lowering agents for at least 2 reasons. First, they may not receive a sufficiently intensive regimen which is directly related to the degree of cholesterol reduction. Second, they may not adhere to their medication properly, either by not taking medication consistently, or by discontinuing their medication altogether. Studies have shown that adherence with lipid-lowering therapy is associated with improved cardiovascular outcomes. Therefore, this retrospective cohort study of new users of statins and/or ezetimibe will address the contributions of both factors by characterizing adherence and treatment intensity for each patient over time. Adherence will be assessed using prescription records to estimate the proportion of days covered by lipid-lowering therapy. These characteristics will then be used to understand the effects of adherence and intensity on CV outcomes in patients initiating statin and/or ezetimibe therapy who have cardiovascular disease, familial hypercholesterolemia, stage 4 chronic kidney disease, or type 2 diabetes. The primary outcome measure is a composite endpoint of CV death or hospitalization for one the following CV events: myocardial infarction, unstable angina, ischemic stroke, heart failure, or surgical or percutaneous revascularization. Analyses will be conducted using Cox proportional hazards time to event analyses.
The primary outcome measure will be a composite endpoint of CV death or hospitalization for one the following CV events:
myocardial infarction (MI)
unstable angina (UA)
ischemic stroke (IS)
heart failure (HF)
surgical or percutaneous revascularization (revascularization)
Mark Danese - Chief Investigator - Outcomes Insights ( Outins )
Mark Danese - Corresponding Applicant - Outcomes Insights ( Outins )
David Catterick - Collaborator - Amgen Ltd
Francisco Sorio-Vilela - Collaborator - Amgen Ltd
Kamlesh Khunti - Collaborator - University of Leicester
Kausik Ray - Collaborator - Imperial College London
Lucie Kutikova - Collaborator - Amgen Ltd
Michelle Gleeson - Collaborator - Outcomes Insights ( Outins )
Sreenivasa Rao Kondapally Seshasai - Collaborator - St George's University Hospitals NHS Foundation Trust
HES Admitted Patient Care;ONS Death Registration Data;Patient Level Townsend Score