Elevated levels low-density lipoprotein cholesterol (LDL-C) are associated with an increased risk of cardiovascular events such as heart attacks and strokes. It has been demonstrated that certain treatments can reduce LDL-C and that this can reduce the risk of such events. However, not all patients are able to tolerate existing treatments; or the treatments may fail to reduce LDL-C to sufficiently low levels. A new drug called inclisiran (Leqvio®) has been shown in clinical trials to reduce LDL-C levels in patients whose LDL-C was high despite being treated with other therapies. In this study, we wish to use the Clinical Practice Research Datalink to select a group of patients who have familial hypercholesterolaemia, a history of cardiovascular disease or have other characteristics which may make them at increased risk of cardiovascular events combined with high levels of LDL-C. We will use these selected patients to estimate how many people have these conditions within the four nations of the United Kingdom and how many of them are using medications to lower LDL-C levels. This study will be important in helping to identify how many people could potentially benefit from treatment with inclisiran (Leqvio®).
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.
Prevalence; therapy use
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 Pharmaceuticals UK Limited
HES Admitted Patient Care