An estimation of the consequences of reinforcing the 2016 and 2019 European Society of Cardiology/European Atherosclerosis Society guidelines on current lipid-lowering treatment in patients with type 2 diabetes in tertiary care-a SwissDiab study

Aims In 2019, the European Society of Cardiology/European Atherosclerosis Society updated the 2016 guidelines for the management of dyslipidaemias recommending more stringent low-density lipoprotein cholesterol (LDL-C) targets in diabetes mellitus type 2 (DM2). Based on a real-world patient population, this study aimed to determine the feasibility and cost of attaining guideline-recommended LDL-C targets, and assess cardiovascular benefit. Methods and results The Swiss Diabetes Registry is a multicentre longitudinal observational study of outpatients in tertiary diabetes care. Patients with DM2 and a visit between 1 January 2018 and 31 August 2019 that failed the 2016 LDL-C target were identified. The theoretical intensification of current lipid-lowering medication needed to reach the 2016 and 2019 LDL-C target was determined and the cost thereof extrapolated. The expected number of major adverse cardiovascular events (MACE) prevented by treatment intensification was estimated. Two hundred and ninety-four patients (74.8%) failed the 2016 LDL-C target. The percentage of patients that theoretically achieved the 2016 and 2019 target with the indicated treatment modifications were high-intensity statin, 21.4% and 13.3%; ezetimibe, 46.6% and 27.9%; proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i), 30.6% and 53.7%; ezetimibe and PCSK9i, 1.0% and 3.1%; whereas one (0.3%) and five patients (1.7%) failed to reach target, respectively. Achieving the 2016 vs. 2019 target would reduce the estimated 4-year MACE from 24.9 to 18.6 vs. 17.4 events, at an additional annual cost of medication of 2140 Swiss francs (CHF) vs. 3681 CHF per patient, respectively. Conclusions For 68% of the patients, intensifying statin treatment and/or adding ezetimibe would be sufficient to reach the 2016 target, whereas 57% would require cost-intensive PCSK9i therapy to reach the 2019 target, with limited additional medium-term cardiovascular benefit. Lay Summary Based on 294 patients with type 2 diabetes and elevated low-density lipoprotein (LDL) cholesterol, this study looked at how much patients' lipid-lowering medication would need to be intensified for them to be able to reach the old and the new, lower treatment target for LDL-cholesterol that was introduced in 2019, along with the cost and feasibility, and estimated cardiovascular benefits of doing so.The majority of patients would reach the old LDL-cholesterol target by optimizing therapy with statin and ezetimibe, with a clear expected cardiovascular benefit. It would however be difficult for the majority of patients to reach the new, lower LDL-cholesterol target, as this would require treatment with a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor. This expensive treatment would not be reimbursed for the majority of patients that would need them. The additional expected cardiovascular benefit was also less clear.Tools that help physicians to weigh the additional reduction in cardiovascular risk that the patient might benefit from by reaching the new rather than the old LDL-cholesterol target against known benefits of targeting other important risk factors (e.g. smoking, physical inactivity, overweight, and obesity) would help guide efficient cardiovascular risk management, and identify patients that would most benefit from PCSK9 inhibitor therapy.