High levels of low-density lipoprotein cholesterol (LDL-C), are known to increase the risk of cardiovascular events such as heart attacks and strokes. Reduction of cholesterol by changes in diet and/or initiation of lipid-lowering medication can reduce these risks. The most widely used types of medication for reducing cholesterol are statins but for a proportion of patients these may not be appropriate, reasons include pre-existing health-conditions, patients being unable to tolerate statins due to side-effects or that statins fail to reduce LDL-C to acceptable levels. For these aforementioned patients, the National Institute for Health and Care Excellence recommend ezetimibe as a treatment option either on its own, or in addition to statins. We wish to use both the Clinical Practice Research Datalink GOLD and Aurum databases to select patients who have initiated ezetimibe between 1st January to 2003 to 31st December 2020 and to describe these patients in terms of their age, gender, lipid levels before and after starting ezetimibe, their pre-existing health conditions and which lipid lowering therapies they have previously been prescribed. We then want to see how long these patients are staying on ezetimibe. Finally, we want to know how many patients stop taking ezetimibe; how quickly this happens and what lipid lowering therapies they take next. This will help the future care of patients by providing information about how closely treatment guidelines are followed and provide valuable information on how ezetimibe benefits patients with elevated LDL-C levels.
Elevated LDL-C is a known risk factor for cardiovascular events such as myocardial infarction, stroke and consequent cardiovascular death. The effectiveness of lipid lowering strategies by dietary modification and/or therapeutic intervention has been established. Initial pharmacological treatment for elevated LDL-C is focused on statins. Ezetimibe monotherapy is recommended as an option for those patients who are contraindicated or statin intolerant while ezetimibe in combination with statins is recommended as an option for patients where statins alone fail to achieve sufficient LDL-C reduction. However, it is known that many patients with increased cardiovascular risk factors are not achieving guideline LDL-C target levels and many are untreated after discontinuing statin therapy. In this retrospective database study, we wish to profile ezetimibe use within a United Kingdom population represented in the Clinical Practice Research Datalink (CPRD) Aurum and GOLD databases. The case selection period will be from 1st January to 2003 to 31st December 2020. Incident initiators of ezetimibe will be selected by drug codes in the Therapy (GOLD) and Drug issue (Aurum) tables from patients classified as of acceptable status by CPRD with a minimum of 90 days wash-in prior to first-ever lipid lowering therapy. Ezetimibe initiation by year will be presented and demographic, therapy and clinical characteristics (including duration of prior lipid-lowering therapy, proportion estimated to be statin intolerant and nearest prior lipid test values) will be presented. Change in lipid levels will be compared pre- and post-ezetimibe initiation. Time to discontinuation will be presented in a Cox proportional hazards model. Characteristics of those discontinuing, including subsequent treatment patterns will be presented. Change in lipid levels will also be compared pre- and post-ezetimibe discontinuation. Index of multiple deprivation and HES inpatient data will linked data will be used to provide baseline characteristics. ONS mortality data will be used to censor patients.
Patient demographics; cardiovascular comorbidities; baseline lipid-lowering therapy, baseline biochemistry, therapy change, low-density lipoprotein cholesterol change, high-density lipoprotein cholesterol change, non-high-density lipoprotein cholesterol change, total cholesterol change, triglycerides change
Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Christopher Morgan - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Adeline Durand - Collaborator - Novartis Pharmaceuticals UK Limited
Melissa Perry - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Steven Tinsley - Collaborator - NOVARTIS
Melissa Perry - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation