This study is a longitudinal retrospective observational cohort study based on a population with high and very high-risk of atherosclerotic cardiovascular disease (ASCVD) events (per the 2019 European Society of Cardiology and European Atherosclerosis Society dyslipidaemia guidelines), determined from Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES) databases in the United Kingdom. In addition to information on patient demographics and clinical characteristics, CPRD database will be utilized for treatment patterns and laboratory measures including low-density lipoprotein cholesterol (LDL-C), and HES and Office for National Statistics (ONS) databases to follow-up the study outcomes. Primary and first secondary objectives will describe event rates over time via Kaplan-Meier analyses for the primary outcome (a composite of nonfatal myocardial infarction (MI), nonfatal ischemic stroke, and cardiovascular (CV) death) and for the secondary outcomes (nonfatal MI, nonfatal ischemic stroke, CV death, unstable angina hospitalization, and elective coronary revascularization as a composite outcome and separately, and all-cause mortality), respectively. Possible risk factors for the primary and secondary outcomes will be assessed via Cox proportional hazards models and will include patient demographics, clinical characteristics, laboratory measures, lifestyle, and medication characteristics. Summary statistics of these variables will be provided as part of the second secondary objective. To address the last secondary objective, proportion of patients on various therapies, proportion of patients within categories of achieved LDL-C, rates of treatment-related events including treatment initiation, intensification, discontinuation, and re-start, and LDL-C levels will be described. Analyses will be provided separately for 1) high-risk primary prevention population without ASCVD and 2) population with ASCVD, and further stratified by index event. The knowledge generated by this study will help informing indirectly clinical practices guidelines (whether treatments are appropriately prescribed in these populations) and public health policy (whether some clinical conditions should be emphasized for the prevention of CV events).
Primary outcomes will be defined as the composite of nonfatal myocardial infarction (MI), nonfatal ischemic stroke, and cardiovascular (CV) death.
Secondary outcomes will be defined as nonfatal MI, nonfatal ischemic stroke, CV death, unstable angina hospitalization, and elective coronary revascularization as a composite outcome and separately, and all-cause mortality.
Descriptive variables during the follow-up will be lipid lowering therapies (LLT) (including statins, ezetimibe, and PCSK9 inhibitors) and achieved low-density lipoprotein cholesterol (LDL-C) levels.
Pia Horvat - Chief Investigator - IQVIA Ltd
Nelly Ly - Corresponding Applicant - IQVIA Ltd
Alexandra Koumas - Collaborator - Axtria Inc. USA
Ankita Chauhan - Collaborator - Axtria Inc. USA
Anna Castelo Branco - Collaborator - IMS Health Sweden AB
Aurore Tricotel - Collaborator - IQVIA Operations France SAS
Christian Siegfried - Collaborator - Axtria Inc. USA
Christopher Lee - Collaborator - IQVIA Ltd
Emil Vatov - Collaborator - IQVIA Solution Bulgaria EOOD
Gianluca Lucrezi - Collaborator - IQVIA AG (Switzerland)
Jessica Lundbom - Collaborator - IQVIA Ltd
Louise Raiteri - Collaborator - IQVIA Ltd
Nelly Ly - Collaborator - IQVIA Ltd
Nicole Rutishauser - Collaborator - IQVIA II Technology Solutions Portugal, Unipessoal LDA
Oriane BRETIN - Collaborator - IQVIA Operations France SAS
Quratul Ann - Collaborator - IQVIA Ltd
Sophia Rodopoulou - Collaborator - IQVIA Hellas Technology Solutions S.A.
Stavros Oikonomou - Collaborator - IQVIA Solution Bulgaria EOOD
Sushant Pal - Collaborator - Axtria India Pvt. Ltd.
Tarana Mehdikhanova - Collaborator - IQVIA Ltd
Vanessa Marzola - Collaborator - IMS Health Sweden AB