Prevalence estimate of atherosclerotic cardiovascular disease, atherosclerotic cardiovascular disease -risk equivalent and familial hypercholesterolaemia patients with elevated low-density lipoprotein cholesterol.

Date of Approval
Application Number
20_000224
Technical Summary

It has been shown in clinical and real-world studies that elevated levels of low-density lipoprotein cholesterol (LDL-C) are strongly associated with cardiovascular disease and risk of stroke and myocardial infarction. Pharmacological interventions to reduce LDL-C has been shown to be associated with reduced incidence of atherosclerotic cardiovascular disease (ASCVD). However, a large proportion of patients with elevated LDL-C have been shown to be either intolerant or else refractory to conventional cholesterol lowering regimens. In particular, those patients with familial hypercholesterolemia whose LDL-C may be grossly increased are difficult to manage. Inclisiran is a subcutaneously delivered therapy that has been shown in clinical trials to reduce refractory LDL-C in patients with ASCVD and familial hypercholesterolaemia. Novartis are interested in understanding the prevalence of these populations. In this study we wish to conduct a non-comparative, retrospective study using the Clinical Practice Research Datalink (CPRD) GOLD database. Three cohorts of patients with elevated LDL-C will be selected from CPRD GOLD, with either i) familial hypercholesterolemia, ii) history of ASCVD (coronary heart disease, cerebrovascular disease or peripheral arterial disease) or iii) primary prevention with elevated risks (PPER) based on either comorbidity (type II diabetes or familial hypercholesterolemia) or Framingham risk score indicative of >20% risk of a cardiovascular event within 10 years. These cohorts will not be mutually exclusive. We then wish to calculate the point prevalence of each cohort population for 2018 within the four nations of the United Kingdom and the proportions of these patients treated with statins, exenatide or defined as statin intolerant.

Health Outcomes to be Measured

Prevalence; therapy use

Collaborators

Christopher Morgan - Chief Investigator - Pharmatelligence Limited t/a Human Data Sciences
Cerys Jenkins - Corresponding Applicant - Pharmatelligence Limited t/a Human Data Sciences
Adeline Durand - Collaborator - Novartis UK

Linkages

HES Admitted Patient Care