BACKGROUND

The aim of the non-interventional study VICTORION-Implement is to characterize patients treated with inclisiran and newly initiated oral lipid-lowering treatments (LLT) to better understand the burden of disease including quality of life, impact of treatment paradigms, and safety profiles outside of randomized trials.

METHODS

In the non-interventional study VICTORION-Implement, 1000 patients with hypercholesterolemia newly initiated with oral LLT on top of statins (cohort A) for the first time, 1000 patients newly initiated with inclisiran (60% in cohort B1 without prior PCSK9 treatment, 40% in cohort B2 with previous PCSK9), and 30 patients treated with inclisiran on top of lipid apheresis (cohort C) are followed up for up to 24 months. This first interim analysis reports demographics, patient characteristics as well as LDL-C and Lp(a) concentrations of the first 403 patients (data cut-off 25 October 2022).  

RESULTS

Patients receiving inclisiran with no prior Anti-PCSK9 monoclonal antibody (mAB) treatment were younger than patients on oral LLT or PCSK9 mAB pre-treated patients. The median LDL-C and Lp(a) concentrations at baseline were higher in patients prior treated with Anti-PCSK9mAB when compared to PCSK9  treatment naive patients and patients on oral LLT (see Table 1). Upon acceptance the poster will show further updated baseline characteristics and detailed follow-up data of ≥ 300 patients analyzing the effect of inclisiran and oral LLT on concomitant medications, e.g., prior PCSK9 antibody vs. PCSK9 treatment naive patients, LDL-C and Lp(a) target achievement 3 months after baseline. 

CONCLUSIONS

This interim analysis will contribute to a better understanding of the patient population treated with inclisiran in Germany. The ongoing follow-up will provide detailed insights in the management of hypercholesterolemia and LDL-C attainment of these patients in Germany.