Preliminary results from REALITY: a nation-wide study of a database with 1.8 million real-life patients to study atherosclerotic cardiovascular disease and familial hypercholesterolemia in Spain
Authors: Campuzano R , Barrios V , Mostaza J M , Egocheaga I , Perez Roman I , Martinez Lopez A , Sicras-Mainar A , Morant Talamante N , Parrondo J , Gomez Cerezo J F , Pallares V , Martinez Lopez I , Castellanos M , Gamez J M 
Published: October 2022

Abstract

Introduction
Ischemic heart disease and stroke are the leading causes of premature death worldwide. Atherosclerotic cardiovascular disease (ASCVD) is the main determining factor for these and other life-threatening pathologies, such as peripheral artery disease (PAD). LDL-lowering therapies are the gold standard to prevent ASCVD. These treatments are also used for familial hypercholesterolemia (FH), a genetic disorder manifesting with high LDL levels. It is crucial to evaluate the management and level of LDL control in “real-life” patients with ASCVD and FH, but so far very few large-scale studies have focussed on these issues. REALITY is an observational retrospective study of ASCVD and FH in Spain.

Purpose
The goals of REALITY included the analysis of the demographic and clinical characteristics, comorbidities, and concomitant medication of patients with ASCVD and/or FH by a multidisciplinary group of experts. The lipid-lowering therapies used in Spain were assessed, and patient LDL levels were evaluated according to treatment intensity during the two-year follow-up period.

Methods
Electronic medical records were retrieved from the BIG-PAC® database that includes anonymized data of patients from seven health areas in Spain. The study population included patients presenting a new or recurrent episode of ASCVD (n=26,976) or a new diagnosis of FH (n=572) during the recruitment period (from 01/01/2017 to 31/12/2018). The index date was defined as the date of the event/diagnosis, and a 2-year follow-up was established.

Results
The average age was 69.9±11.5 for ASCVD patients and 60.1±12 for FH patients (59.4% and 48.6% males, respectively). The average Charlson index was 2.2±1.6 in ASCVD and 1.2±1.4 in FH. The comorbidities most frequently observed in ASCVD vs. FH were hypercholesterolaemia (55% vs. 100%), arterial hypertension (65% vs. 54%), diabetes mellitus (31% vs. 29%) and obesity (31% vs. 21%). Around 25% and 6% of patients with ASCVD and FH, respectively, presented CV events in the follow-up. During the 24-month period, the highest rate of ischemic heart disease was observed in patients with LDL levels of 55–69 mg/dL, whereas LDL levels below 55 mg/dL were associated with the highest incidence of PAD. The highest lipid biochemical reductions in ASCVD vs. FH were observed in total cholesterol (−52±17.4 vs. −53.5±21.3 mg/dL), triglycerides (−53±7.9 vs. −54.2±8.8 mg/dL) and LDL (−27.4±10.4 vs. −29±12.3 mg/dL). HDL levels showed an average increase of 8.5±2 vs. 9.3±2.5 mg/dL. Treatment intensity correlated with reduction of LDL levels in all ASCVD disease subgroups and FH patients (Table 1).

Conclusions
The results of REALITY provide an estimated clinical picture of ASCVD and FH in Spain. The impact of therapeutical approaches on LDL levels and the prevention of CV events were evaluated by a multidisciplinary group of experts. The findings of the study will help lower the burden of ASCVD and FH in Spain.

Funding Acknowledgement
Type of funding sources: Private company. Main funding source(s): REALITY study was 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.