Financiado en parte por Novartis Pharma, Novartis Pharma AG
Inclisiran-based treatment strategy in hypercholesterolaemia: the VICTORION-difference trial
Landmesser U, Laufs U, Schatz U, Winzer EB, Nowak B, Kassner U, Gouni-Berthold I, Esteban A, Lubyayi L, Krueger A, Hentschke C, Wilke A, Winkelmann BR, Achouba A, Banach M
European heart journal · 10 citas
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Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiado por la industria
- Empresa
- Novartis Pharma
- Empresa
- Novartis Pharma AG
- Autores
- Al menos un autor declara un vínculo económico con la industria
- Subvenciones
- Novartis Pharma (NCT05192941)
Según 2 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2025-08-19 · Eur Heart J · vol. 47 · número 25 · págs. 3241–3253
- Editorial
- Oxford University Press
- Citado
- 13 citas · más que el 99% de estudios similares · 11.4× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 42 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY
- Áreas de investigación
- Lipoproteins and Cardiovascular Health · Cholesterol and Lipid Metabolism · Lipid metabolism and disorders
- Palabras clave
- inclisiran, hypercholesterolemia, LDL cholesterol lowering, PCSK9 inhibition, siRNA, rosuvastatin, LDL-C goal attainment, atherosclerotic cardiovascular disease, statin intolerance
- MeSH
- humans, hypercholesterolemia, rna, small interfering, hydroxymethylglutaryl-coa reductase inhibitors, treatment outcome, drug therapy, combination, double-blind method, aged, middle aged, female, male, cholesterol, ldl, rosuvastatin calcium, proprotein convertase 9
15 autores
- Ulf Landmesser🇩🇪 · autor de correspondenciaHumboldt-Universität zu Berlin; Deutsches Herzzentrum der Charité; German Centre for Cardiovascular Research; Charité - Universitätsmedizin Berlin
- Ulrich Laufs🇩🇪University Hospital Leipzig
- Ulrike Schatz🇩🇪University Hospital Carl Gustav Carus; Technische Universität Dresden
- Ephraim B. Winzer🇩🇪Herzzentrum Dresden Universitätsklinik; Technische Universität Dresden
- Bernd Nowak🇩🇪Cardiovascular Center Bethanien
- Ursula Kassner🇩🇪Humboldt-Universität zu Berlin; Freie Universität Berlin; Charité - Universitätsmedizin Berlin
- Ioanna Gouni‐Berthold🇩🇪University of Cologne; University Hospital Cologne
- Alicia Esteban🇨🇭Novartis (Switzerland)
- Lawrence Lubyayi🇬🇧Novartis (United Kingdom)
- Andre Krueger🇨🇭Novartis (Switzerland)
- Christian Hentschke🇩🇪Novartis (Germany)
- Andreas Wilke🇩🇪🇺🇬Kardiologie Frankfurt-Sachsenhausen; Uganda Heart Institute
- Bernhard Rudolf Winkelmann🇩🇪Cardiovascular Center Frankfurt
- Assya Achouba🇨🇭Novartis (Switzerland)
- Maciej Banach🇵🇱🇺🇸John Paul II Catholic University of Lublin; Johns Hopkins University; Johns Hopkins Medicine; Medical University of Lodz
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background and aims
Low-density lipoprotein cholesterol (LDL-C) is a causal risk factor for atherosclerotic cardiovascular (CV) disease development and progression. The European Society of Cardiology guidelines recommend combination treatment to achieve CV risk-based LDL-C treatment goals. Inclisiran, a small interfering ribonucleic acid (siRNA) that targets hepatic proprotein convertase subtilisin/kexin type 9 (PCSK9) messenger RNA, can provide sustained and effective LDL-C reduction.
Methods
VICTORION-Difference, a phase 4 double-blind, placebo-controlled randomized clinical trial included adults with hypercholesterolaemia at high- or very high CV risk. Participants were randomized 1:1 to receive inclisiran sodium (300 mg subcutaneous injections; equivalent to 284 mg inclisiran) or placebo together with individually optimized lipid-lowering therapy (ioLLT), including up-titration with rosuvastatin (open-label) until either their individual LDL-C goal or maximally tolerated statin dose (open-label rosuvastatin) was achieved. The primary objective was assessment of LDL-C goal achievement at Day 90. Key secondary objectives were muscle-related adverse events (MRAEs) and mean LDL-C reduction. Overall, 1770 individuals (mean age, 63.7 years) were randomized to receive inclisiran (n = 898) or ioLLT (n = 872). At Day 90, a significantly higher proportion of participants receiving inclisiran vs. ioLLT achieved their individual LDL-C goals [84.9% vs 31.0%; odds ratio (OR) 12.09, P < .001]. The mean percentage reduction in LDL-C from baseline to Day 360 was -59.5% and -24.3% in the inclisiran and ioLLT arms, respectively [least squares mean treatment difference (LSMTD) = -35.14%, P < .001]. Fewer participants receiving inclisiran vs ioLLT reported a MRAE (11.9% vs 19.2%; OR 0.57, P < .001). The mean reduction in Short Form-Brief Pain Inventory pain severity and interference scores favoured inclisiran over ioLLT (LSMTD = -0.11, P = .039; LSMTD = -0.11, P = .029, respectively). No new safety concerns were identified.
Results
Overall, 1770 individuals (mean age, 63.7 years) were randomized to receive inclisiran (n=898) or ioLLT (n=872). At Day 90, a significantly higher proportion of participants receiving inclisiran vs. ioLLT achieved their individual LDL-C goals (84.9% vs. 31.0%; odds ratio [OR] 12.09, p<0.001). The mean percentage reduction in LDL-C from baseline to Day 360 was -59.5% and -24.3% in the inclisiran and ioLLT arms, respectively (least squares mean treatment difference [LSMTD]=-35.14%, p<0.001). Fewer participants receiving inclisiran vs. ioLLT reported a MRAE (11.9% vs. 19.2%; OR 0.57, p<0.001). The mean reduction in Short Form-Brief Pain Inventory pain severity and interference scores favoured inclisiran over ioLLT (LSMTD=-0.11, p=0.039; LSMTD=-0.11, p=0.029, respectively). No new safety concerns were identified.
Conclusions
An inclisiran-based treatment strategy was superior to ioLLT in LDL-C goal achievement, delivering early and sustained LDL-C reduction, with fewer MRAEs in individuals with hypercholesterolaemia.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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