Low-density lipoprotein cholesterol management and goal attainment at 1 year in patients with diabetes, pre-diabetes and normoglycaemia: results from the European, prospective, observational SANTORINI study

OBJECTIVE: To assess changes in lipid-lowering therapy (LLT) use and low-density lipoprotein cholesterol (LDL-C) goal attainment through 1-year follow-up in patients stratified by diabetes status in SANTORINI (Treatment of High and Very High riSk Dyslipidemic pAtients for the PreveNTion of CardiOvasculaR Events in Europe - a MultInatioNal ObservatIonal study). DESIGN: Prospective, observational study. SETTING: 623 primary (general practitioners, internal medicine specialists or internists) and secondary (cardiologists, diabetologists, lipidologists or neurologists) care sites in 14 European countries. PARTICIPANTS: A total of 7210 high- and very high-cardiovascular risk adults recruited from 17 March 2020 to 11 February 2021. At baseline, patients were grouped as having diabetes, pre-diabetes or normoglycaemia and analysed if they had LDL-C measurement at baseline and 1-year follow-up. PRIMARY AND SECONDARY OUTCOME MEASURES: The following were assessed by diabetes status at baseline and 1 year: use of LLT, including assessment of monotherapy and combination therapy; LDL-C values and the proportion of patients with LDL-C goal attainment based on the absolute values in the 2019 European Society of Cardiology/European Atherosclerosis Society guidelines (high risk: <1.8 mmol/L (55 mg/dL); very high risk: <1.4 mmol/L (70 mg/dL)); and levels of other lipid profile parameters, including non-high-density lipoprotein cholesterol (non-HDL-C), HDL-C, triglycerides and total cholesterol. RESULTS: Of 7210 patients, 3181 (44.1%) had diabetes, 1202 (16.7%) pre-diabetes and 2827 (39.2%) normoglycaemia. The majority (72.1%) were male; mean (SD) age was 65.0 (10.9) years. From baseline to 1 year, use of combination therapy increased across all groups, with a smaller increase for patients with diabetes (25.9% to 37.9%) compared with pre-diabetes (28.5% to 43.7%) and normoglycaemia (28.9% to 45.1%). The change in LDL-C levels over 1 year was -0.3 mmol/L in patients with diabetes, -0.4 mmol/L in pre-diabetes and -0.4 mmol/L in normoglycaemia. At 1 year, LDL-C goal attainment increased in each group (diabetes: 26.6% to 34.8%; pre-diabetes: 18.3% to 29.0%; normoglycaemia: 16.4% to 27.3%). CONCLUSIONS: LDL-C goal attainment over 1 year was higher for patients with diabetes than for those with pre-diabetes and normoglycaemia. However, two-thirds of patients with diabetes did not attain their LDL-C goals, which may be attributable to low rates of combination therapy use, highlighting the need to improve lipid management in this high-risk population. TRIAL REGISTRATION NUMBER: NCT04271280.