INTRODUCTION: Elevated low-density lipoprotein cholesterol (LDL-C) is a causative, modifiable risk factor for atherosclerotic cardiovascular disease (ASCVD) events. Bempedoic acid (180 mg) and its fixed-dose combination (FDC) with ezetimibe (EZE, 10 mg) are available in several European countries for patients with inadequate cholesterol control for their level of ASCVD risk based on LDL-C–lowering efficacy in phase 3 trials. We used model simulation to estimate long-term reduction in ASCVD events potentially achievable with the additional use of this FDC in Europe.
METHODS: The simulation used a Markov model accepted by health technology assessment agencies. Baseline LDL-C and other ASCVD risk factors were from 1-year follow-up in the real-world, observational SANTORINI study (NCT04271280) in patients with hypercholesterolaemia with high/very high ASCVD risk in 14 European countries. The number of such patients in Western Europe was estimated using ESC Atlas prevalence estimates. LDL-C reduction was from a network meta-analysis, including the 5 pivotal bempedoic acid trials and mapped to ASCVD risk reduction using established CTTC meta-analysis. FDC’s LDL-C reduction versus EZE + background therapy was 27.3% in statin-intolerant (SI) patients and 12.4% in patients on maximum tolerated statin (MTS); versus background therapy alone, reduction was 54.1% (SI) and 29.9% (MTS). ASCVD event reduction in these 4 patient groups was calculated for Western Europe overall and individual SANTORINI countries.
RESULTS: The number of people with high/very high ASCVD risk in Western Europe was estimated as 39,623,567. Over 10 years, treatment with FDC would potentially avoid an estimated 1,557,087 ASCVD events (39 per 1,000 patients) versus no additional treatment. Simulated reductions were predominantly myocardial infarction and ASCVD death, with smaller reductions in ischaemic stroke, unstable angina, and revascularisation.
CONCLUSIONS: FDC use after statins in the oral lipid-lowering treatment pathway in Western Europe could lead to a substantial reduction in the number of ASCVD events.
