The REALITY project: analysis of a national database with 1.8 million real-life patients to study atherosclerotic cardiovascular disease and familial hypercholesterolemia in Spain

Abstract

Abstract Introduction Atherosclerotic cardiovascular disease (ASCVD), hypercholesterolaemia, and familial hypercholesterolaemia (FH) are associated with high mortality, morbidity and direct/indirect economic costs worldwide. However, information about patient characteristics, clinical practice, treatment effectiveness, and economic costs is limited in Spain. To address this issue, a multidisciplinary working group of cardiologists, hospital pharmacists, family physicians, internal medicine specialists, and neurologists took part in the nationwide, observational, retrospective REALITY study. Using information from the Spanish National Health System (SNHS), the group will describe the treatment patterns and clinical profiles of patients with ASCVD and/or FH in Spain. Methods and results REALITY will access 1.8 million electronic medical records in the BIG-PAC® database, which collects anonymised data (in compliance with Organic Law 3/2018 of 5 December) from SNHS primary care centres and hospitals across seven regional health areas in Spain. REALITY was approved by the Hospital of Terrassa Ethics Committee on 17/11/2020. Patients presenting a new/recurrent episode of ASCVD or diagnosed with FH from 01/01/2017 to 31/12/2018 were recruited. The index date was the date of the event/diagnosis, and a two-year follow-up was established. Patients were classified as FH or ASCVD on the basis of their primary diagnosis (five subgroups: stable/unstable angina, acute myocardial infarction, ischemic stroke, transient ischemic attack, and peripheral arterial disease). Primary objectives were to determine demographic and clinical characteristics, comorbidities, and concomitant medication. Secondary objectives were to determine the lipid-lowering therapy applied, persistence of medication and modifications, the rationale for switching therapy, and treatment adherence (including data from non-adherent patients). Endpoints were low-density lipoprotein (LDL) levels, prevalence and incidence of new events, use of healthcare resources (e.g., medical visits or tests, coronary artery bypass surgery, hospitalizations, etc.), and healthcare costs. Using the aforementioned variables, these endpoints were analysed globally according to disease classification. Exploratory objectives included estimation of the percentage of statin-intolerant patients, and a subanalysis of costs according to the intensity of the lipid-lowering treatment and LDL levels. Conclusions The power of the “real-life” data from the BIG-PAC® database and the multidisciplinary approach used in this study will facilitate a wide range of analyses/subanalyses of various clinical issues, including treatment, disease burden, and economic costs. This study will give healthcare practitioners and policy makers valuable data for cardiovascular secondary prevention, control, and strategies to improve management. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): The REALITY study is sponsored by Novartis. Statistical analysis of the BIG-PAC® database was performed by Atrys Health. Medical writing and editing were provided by Medical Science Consulting. All funded by Novartis.