Achievement of LDL-C targets in clinical practice in Spain: a comparison between Observatory II and Observatory I

Abstract Purpose Dyslipidemia management Observatory II (2024-2026) was developed following the results of Observatory I (2020–2022), which identified poor lipid control and wide variability in clinical practice across Spain. The aim of this study was to update these findings after the introduction of new lipid-lowering therapies (LLT). Methods Non-interventional study involving physicians with expertise in the management of vascular risk factors (mainly cardiologist, general practitioners and internal medicine). Data collection included: (i) ad hoc questionnaires, requesting aggregated data from the last 15 patients visited (real-world data [RWD]); and (ii) 70 in-person meetings moderated using a standardised guide approved by the Scientific Committee. The study followed a methodology comparable to that used in Observatory I. In this analysis, we report RWD from the questionnaires of Observatory II and compare them with RWD from Observatory I. Results In Observatory II, 210 physicians participated (mean age 50.8 years), representing 70 healthcare areas across Spain and providing data on 3,075 patients. Observatory I included 435 physicians and 4,010 patients. Among patients from the Observatory II, 52% had a previous cardiovascular event, 16% had familial hypercholesterolaemia and 45% had diabetes. Overall, 27% were classified as high cardiovascular (CV) risk and 56% as very high CV risk. Regarding LLT, 19% of patients received high-intensity statin monotherapy, 38% were treated with a statin–ezetimibe combination, 11% with a regimen including PCSK9 inhibitors or inclisiran, and 7% with bempedoic acid. Taken together, these therapies were used in 75% of patients in Observatory II, compared with 61% in Observatory I. Compared with Observatory I, statin monotherapy use decreased, accompanied by a shift towards combination therapies in Observatory II. Overall differences in LLT use between Observatories were statistically significant. Baseline patient characteristics for both studies are presented in Table 1. Based on real-world clinical practice, LDL-C targets were achieved in 55%, 44%, 33% and 39% of patients at low, moderate, high and very high CV risk, respectively. These figures represent an improvement compared with Observatory I (47%, 36%, 22% and 25%, respectively), with statistically significant differences for all risk categories except low CV risk (Figure 1). Conclusions LDL-C target achievement has improved in the last 4 years reflecting the positive impact of treatment intensification; however, a substantial proportion of patients remain uncontrolled, particularly those at high and very high CV risk.Figure 1.Lipid control in RWE by CV riskTable 1.Baseline patients characteristics