Landmesser Ulf, Laufs Ulrich, Schatz Ulrike, Winzer Ephraim B, Nowak Bernd, Kassner Ursula, Gouni-Berthold Ioanna, Esteban Alicia, Lubyayi Lawrence, Krueger Andre, Streich Jan Hendrik, Hentschke Christian, Achouba Assya, Banach Maciej
Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum der Charité; Charité-Universitätsmedizin Berlin, German Center for Cardiovascular Research (DZHK), Partner Site Berlin, Germany.
Department of Cardiology, Klinik und Poliklinik für Kardiologie, Leipzig University Hospital, Leipzig, Germany.
Am Heart J. 2025 May 26;289:117-126. doi: 10.1016/j.ahj.2025.05.014.
Twice-yearly inclisiran (after the initial and 3-month doses) provides effective and sustained low-density lipoprotein cholesterol (LDL-C) reduction in individuals with hyperlipidemia with a favorable long-term safety profile. Limited studies have assessed the impact of inclisiran on the quality of life (QoL) of patients with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalent. The VICTORION-Difference study will evaluate the early efficacy, safety, and QoL outcomes with inclisiran compared to placebo on top of individually optimized lipid-lowering therapy.
This phase 4, randomized, double-blind, placebo-controlled trial includes participants aged ≥18 years with hypercholesterolemia at high or very high cardiovascular (CV) risk despite being treated with an individualized maximally tolerated statin dose. Participants are randomized 1:1 to receive either subcutaneous injections of 300-mg inclisiran sodium (equivalent to 284-mg inclisiran) or placebo. In addition to the treatment with inclisiran/placebo, open-label rosuvastatin (starting dose of 5 mg/day or 10 mg/day) is sequentially and optimally titrated to the maximally tolerated dose, if the individual LDL-C goals are not achieved. The primary objective is to assess the achievement of LDL-C goals at day 90. Secondary objectives include the assessment of muscle-related adverse events, pain-related QoL scores, and mean LDL-C reduction.
The results of the study will be disseminated through peer-reviewed journals, conference presentations, and other scientific forums to inform clinical practice and future research in the field of hypercholesterolemia and CV disease management.
Unique identifier: NCT05192941.
对于高脂血症患者，每半年注射一次inclisiran（初始剂量和3个月剂量后）可有效且持续降低低密度脂蛋白胆固醇（LDL-C），并具有良好的长期安全性。仅有有限的研究评估了inclisiran对动脉粥样硬化性心血管疾病（ASCVD）或ASCVD风险等同疾病患者生活质量（QoL）的影响。VICTORION-Difference研究将评估与安慰剂相比，在个体化优化降脂治疗基础上加用inclisiran的早期疗效、安全性和QoL结局。
这项4期随机、双盲、安慰剂对照试验纳入了年龄≥18岁、尽管接受了个体化最大耐受他汀剂量治疗但仍处于高或极高心血管（CV）风险的高胆固醇血症患者。参与者按1:1随机分组，分别接受皮下注射300mg inclisiran钠（相当于284mg inclisiran）或安慰剂。除了接受inclisiran/安慰剂治疗外，如果未达到个体LDL-C目标，则将开放标签的瑞舒伐他汀（起始剂量为5mg/天或10mg/天）依次并最佳滴定至最大耐受剂量。主要目标是评估第90天时LDL-C目标的达成情况。次要目标包括评估与肌肉相关的不良事件、与疼痛相关的QoL评分以及LDL-C的平均降低情况。
该研究结果将通过同行评审期刊、会议报告及其他科学论坛进行传播，以为高胆固醇血症和CV疾病管理领域的临床实践和未来研究提供信息。
唯一标识符：NCT05192941。
