BACKGROUND

Elevated low-density lipoprotein cholesterol (LDL-C) levels are a major risk factor for the development of cardiovascular diseases. Inclisiran is a small interfering RNA (siRNA) therapeutic agent for the treatment of primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia.

In Germany, Inclisiran is reimbursed in a restricted patient population, which is significantly smaller than in the pivotal study population and narrower than the population covered in the EMA approved label. This population includes patients with heterozygous familial or non-familial hypercholesterolemia or mixed dyslipidemia with therapy-refractory courses, for whom the LDL-C level cannot be lowered sufficiently despite a documented maximum dietary and lipid-lowering therapy for 12 months, and it is therefore assumed that LDL-apheresis is indicated. The non-interventional study VICTORION-Implement aims to collect data on this specific population receiving inclisiran and also on patients undergoing lipid apharesis or receiving escalated oral lipid-lowering treatments (LLT).

PURPOSE

Characterization of patient population on Inclisiran and other lipid-lowering treatments to better understand the burden of disease, including quality of life, impact of treatment paradigms in real world and safety profiles in clinical routine.

METHODS

In the non-interventional study VICTORION-Implement, 1000 patients with hypercholesterolemia newly initiated with oral LLT on top of statins (cohort A), 1000 patients newly initiated with Inclisiran (B1: 60% PCSK9 naive, B2: 40% with previous PCSK9), and 30 patients treated with Inclisiran on top of lipid apheresis (cohort C) are followed up for up to 24 months. A digital dashboard available to study sites enables a real-time benchmarking of LDL-C target attainment rates among study sites and regions.

RESULTS

The study is being conducted between 01/2022 and 02/2025 in up to 300 centers, including cardiology, nephrology, endocrinology, angiology, and apheresis centers across Germany. Continuous data of real-time analyses and benchmarking of LDL-C against peer groups and cohorts will be shown in combination with baseline characteristics. As of May 25, 153 patients were included with a balanced age and time since first CV event. Interestingly, the median LDL-C level at baseline was higher in patients starting an Inclisiran treatment when compared to oral LLTs (see table 1).

The poster will show these and further updated baseline characteristics focusing on differences between cohorts and the first-of its kind real time LDL-C benchmarking eCRF.

Table 1: Baseline demographics of the first 153 patients

Table 1: 

CONCLUSIONS