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

Abstract

BACKGROUND

In 2019, the ESC/EAS updated the 2016 guidelines for the management of dyslipidaemias recommending more stringent LDL-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

The Swiss Diabetes Registry is a multicentre longitudinal observational study of outpatients in tertiary diabetes care. Patients with DM2 and a visit 01.01.2018-31.08.2019 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 MACE prevented by treatment intensification was estimated.

RESULTS

294 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%; PCSK9 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 versus 2019 target would reduce the estimated 4-year MACE from 24.9 to 18.6 versus 17.4 events, at an additional annual cost of medication of 2,140 CHF versus 3,681 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.