Characterization of ezetimibe use in the United Kingdom: a retrospective database study

Date of Approval
Application Number
21_000564
Technical Summary

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.

Health Outcomes to be Measured

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

Collaborators

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 UK
Melissa Perry - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Steven Tinsley - Collaborator - NOVARTIS

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation