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.

objectiveTo 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).

designProspective, observational study.

setting623 primary (general practitioners, internal medicine specialists or internists) and secondary (cardiologists, diabetologists, lipidologists or neurologists) care sites in 14 European countries.

participantsA 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.

resultsOf 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%).

conclusionsLDL-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.