Low-density lipoprotein cholesterol (LDL-C), often referred to as ‘bad cholesterol’, makes up most our bodies cholesterol. High levels of LDL-C are associated with an increased risk of cardiovascular events such as heart attacks and strokes. Cholesterol-lowering medicine can lower LDL-C but despite taking high-level doses of these therapies, some patients still fail to reduce their LDL-C levels below recommended levels and thus remain at increased risk of cardiovascular events. Familial hypercholesterolemia (FH) is a genetic condition in which people have extremely high levels of LDL-C and, as a result, have difficulty reducing them to a safe level. A new drug called inclisiran has been tested in clinical trials and been shown to reduce LDL-C levels in patients whose LDL-C was high despite being treated with other lipid-lowering drugs. In this study, we wish to use the Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) to find a population of patients who either have had a previous cardiovascular event and have high levels of LDL-C or who have FH. We then wish to link these patients to the Patient Level Index of Multiple Deprivation (IMD). The deprivation score index is a measure of deprivation for small localised geographical areas in England. This will allow us to find the percentage of each patient population in each quintile. We plan to use these results to analyse the impact of inclisiran on socioeconomic health inequalities in England.
Low density lipoprotein cholesterol (LDL-C) has been strongly associated with cardiovascular disease and coronary heart disease risk. Reducing LDL-C with pharmaceutical interventions such as statins has been shown in clinical trials to be associated with reduced incidence of atherosclerotic cardiovascular disease (ASCVD). However, a large proportion of patients with elevated LDL-C have shown to be refractory to conventional cholesterol lowering regimens. Patients with familial hypercholesterolemia (FH) are particularly difficult to manage due to genetically high baseline LDL-C levels. Inclisiran is a subcutaneously delivered therapy that has shown in clinical trials to reduce refractory LDL-C in patients with ASCVD and FH. Given that strong associations have also been observed between cardiovascular events and socioeconomic status, Novartis is interested in understanding the potential impact of inclisiran on socioeconomic health inequalities in England. In this study we wish to conduct a non-interventional, descriptive study with no statistical comparison. We wish to use the Clinical Practice Research Datalink (CPRD) linked to the Hospital Episode Statistics (HES) admitted patient care dataset to obtain patients who would be eligible to receive inclisiran. Patients found in the CRPD and HES dataset will be linked to the Patient Level Index of Multiple Deprivation (IMD) to obtain their deprivation quintile group. We aim to identify three, non-mutually exclusive cohorts of patients with elevated LDL-C: i) history of ASCVD (coronary heart disease, cerebrovascular disease or peripheral arterial disease), ii) ASCVD-risk equivalent (defined as a diagnosis of type II diabetes mellitus or familial hypercholesterolemia without a cardiovascular event) and iii) familial hypercholesterolemia. We will describe these cohorts in terms of demographics and baseline therapy profile. The results for each cohort will be reported separately. These results will be used to analyse the potential impact of inclisiran on socioeconomic health inequalities in England.
Disease prevalence, Index of Multiple Deprivation (IMD) score quintile, patient demographics, and clinical and treatment characteristics
Pascal Lecomte - Chief Investigator - Novartis Pharma AG ( Switzerland )
Hayden Holmes - Corresponding Applicant - York Health Economics Consortium Ltd ( YHEC )
Adeline Durand - Collaborator - Novartis Pharmaceuticals UK Limited
Ana Filipa Fonseca - Collaborator - Novartis Pharma AG ( Switzerland )
Erin Barker - Collaborator - York Health Economics Consortium Ltd ( YHEC )
Hannah Wood - Collaborator - York Health Economics Consortium Ltd ( YHEC )
James Love-Koh - Collaborator - University of York
Joe Moss - Collaborator - York Health Economics Consortium Ltd ( YHEC )
Raquel Lahoz - Collaborator - NOVARTIS
HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation