# VICTORION-INITIATE: inclisiran monotherapie bij patiënten zonder ASCVD

*geplaatst 2025-07-22 · Cholesterol · Journal of the American College of Cardiology · doi 10.1016/j.jacc.2025.04.049 · https://hartvaat.nl/2025/07/22/victorion-initiate-inclisiran-monotherapie-bij-patienten-zonder-ascvd/*

Trial onderzocht inclisiran als monotherapie bij patiënten zonder ASCVD maar met hypercholesterolemie. Het middel verlaagde LDL effectief als standalone therapie, wat het gebruik verbreedt.

## English: Safety and Lipid-Lowering Efficacy of Inclisiran Monotherapy in Patients Without ASCVD: The VICTORION-Mono Randomized Clinical Trial.

The VICTORION-Mono trial demonstrated that inclisiran monotherapy (without statins) effectively lowers LDL cholesterol in patients without established ASCVD, expanding the potential role of twice-yearly siRNA therapy to primary prevention.

## Abstract (original, from the publication)

BACKGROUND: Inclisiran administration twice-yearly (after initial and 3-month doses) effectively reduces low-density lipoprotein cholesterol (LDL-C) in patients on maximally tolerated statins with atherosclerotic cardiovascular disease (ASCVD), risk equivalents, or heterozygous familial hypercholesterolemia. OBJECTIVES: In this study, the authors sought to evaluate whether inclisiran is superior as monotherapy over placebo and ezetimibe in reducing LDL-C in a primary prevention population without ASCVD. METHODS: VICTORION-Mono (V-Mono), a 6-month, randomized, double-blind, multicenter, placebo- and active-comparator controlled phase 3 trial, assessed inclisiran monotherapy in adult participants (aged 18-75 years) without prior ASCVD, diabetes, or familial hypercholesterolemia, with a fasting LDL-C of 100-190 mg/dL and 10-year predicted ASCVD risk of <7.5% according to pooled cohort equation, who were not receiving any lipid-lowering therapy. Participants were randomized (2:1:1) to inclisiran, ezetimibe, or placebo. The primary endpoint was percentage change in LDL-C from baseline, and key secondary endpoints included absolute change in LDL-C and percentage change in proprotein convertase subtilisin/kexin type 9 (PCSK9) from baseline to day 150. The study did not evaluate twice-yearly inclisiran dosing beyond the first 180 days. Safety was also assessed. RESULTS: Overall, 350 participants were randomized (n = 174, 89, and 87 to inclisiran, ezetimibe, or placebo, respectively) and received the assigned treatments. The study included a diverse population: 62.6% of participants were female, 10.6% were Black or African American, and 39.7% were Hispanic/Latino. Mean participant age was 46.1 years, mean baseline LDL-C level was 135.4 mg/dL, mean body mass index was 29.8 kg/m2, and median 10-year predicted ASCVD risk score was 2.2%. The mean percentage change in LDL-C from baseline at day 150 for placebo was 1.4%, for ezetimibe -11.2%, and inclisiran -46.5%. The difference in the change from baseline with inclisiran vs placebo was -47.9% and vs ezetimibe was -35.4% (both P < 0.0001). Inclisiran treatment also demonstrated favorable improvements in other lipid and lipoprotein(a) levels. Inclisiran was well tolerated, with no new safety concerns. CONCLUSIONS: V-Mono demonstrates for the first time that in patients not receiving lipid-lowering therapy, inclisiran as monotherapy, is superior to both placebo and ezetimibe in reducing LDL-C levels over a 6-month follow-up period and was well tolerated. These findings are consistent with previous observations in statin-treated patients. (Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-Lowering Therapy [VICTORION-Mono]; NCT05763875).

Auteurs: Pam R Taub, Alexis Gutierrez, Donavon Wewers, Elias Garcia Cantu, Hui Cao, Catrin Deck, Anastasia Lesogor, Denise Ott, Jorge Mena-Madrazo, Xiao Zang, R Scott Wright

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Bron: Journal of the American College of Cardiology, https://doi.org/10.1016/j.jacc.2025.04.049. Bijgewerkt 2026-07-03T13:30:45Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.