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Design and rationale of the VICTORION-Difference study: A phase 4 randomized, double-blind, placebo-controlled clinical trial to assess inclisiran's early efficacy, safety, tolerability, as well as its impact on quality of life in individuals with hypercholesterolemia.

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Title: Design and rationale of the VICTORION-Difference study: A phase 4 randomized, double-blind, placebo-controlled clinical trial to assess inclisiran's early efficacy, safety, tolerability, as well as its impact on quality of life in individuals with hypercholesterolemia.
Authors: Landmesser U; 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. Electronic address: ulf.landmesser@dhzc-charite.de., Laufs U; Department of Cardiology, Klinik und Poliklinik für Kardiologie, Leipzig University Hospital, Leipzig, Germany., Schatz U; Department of Internal Medicine III, University Hospital Carl Gustav Carus, Faculty of Medicine at the Technical University of Dresden, Dresden, Germany., Winzer EB; Department for Internal Medicine and Cardiology, Heart Center Dresden, University Clinic, Technische Universität Dresden, Dresden, Germany., Nowak B; Department of Cardiology, CardioVascular Center Bethanien (CCB), Frankfurt, Germany., Kassner U; Department of Endocrinology, Division of Lipid Disorders, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany., Gouni-Berthold I; Center for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany., Esteban A; Novartis Pharma AG, Basel, Switzerland., Lubyayi L; Novartis Pharmaceuticals UK Ltd, London, UK., Krueger A; Novartis Pharma AG, Basel, Switzerland., Streich JH; Novartis Pharma GmbH, Nuremberg, Germany., Hentschke C; Assya Achouba: Novartis Pharma AG, Basel, Switzerland., Achouba A; Assya Achouba: Novartis Pharma AG, Basel, Switzerland., Banach M; Faculty of Medicine, The John Paul II Catholic University of Lublin, Lublin, Poland; Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Liverpool Centre for Cardiovascular Science (LCCS), Liverpool, UK.
Source: American heart journal [Am Heart J] 2025 Nov; Vol. 289, pp. 117-126. Date of Electronic Publication: 2025 May 26.
Publication Type: Journal Article; Clinical Trial Protocol
Journal Info: Publisher: Mosby Country of Publication: United States NLM ID: 0370465 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-6744 (Electronic) Linking ISSN: 00028703 NLM ISO Abbreviation: Am Heart J Subsets: MEDLINE
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  Data: Design and rationale of the VICTORION-Difference study: A phase 4 randomized, double-blind, placebo-controlled clinical trial to assess inclisiran's early efficacy, safety, tolerability, as well as its impact on quality of life in individuals with hypercholesterolemia.
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  Data: <searchLink fieldCode="AU" term="%22Landmesser+U%22">Landmesser U</searchLink>; 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. Electronic address: ulf.landmesser@dhzc-charite.de.<br /><searchLink fieldCode="AU" term="%22Laufs+U%22">Laufs U</searchLink>; Department of Cardiology, Klinik und Poliklinik für Kardiologie, Leipzig University Hospital, Leipzig, Germany.<br /><searchLink fieldCode="AU" term="%22Schatz+U%22">Schatz U</searchLink>; Department of Internal Medicine III, University Hospital Carl Gustav Carus, Faculty of Medicine at the Technical University of Dresden, Dresden, Germany.<br /><searchLink fieldCode="AU" term="%22Winzer+EB%22">Winzer EB</searchLink>; Department for Internal Medicine and Cardiology, Heart Center Dresden, University Clinic, Technische Universität Dresden, Dresden, Germany.<br /><searchLink fieldCode="AU" term="%22Nowak+B%22">Nowak B</searchLink>; Department of Cardiology, CardioVascular Center Bethanien (CCB), Frankfurt, Germany.<br /><searchLink fieldCode="AU" term="%22Kassner+U%22">Kassner U</searchLink>; Department of Endocrinology, Division of Lipid Disorders, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.<br /><searchLink fieldCode="AU" term="%22Gouni-Berthold+I%22">Gouni-Berthold I</searchLink>; Center for Endocrinology, Diabetes and Preventive Medicine, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany.<br /><searchLink fieldCode="AU" term="%22Esteban+A%22">Esteban A</searchLink>; Novartis Pharma AG, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Lubyayi+L%22">Lubyayi L</searchLink>; Novartis Pharmaceuticals UK Ltd, London, UK.<br /><searchLink fieldCode="AU" term="%22Krueger+A%22">Krueger A</searchLink>; Novartis Pharma AG, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Streich+JH%22">Streich JH</searchLink>; Novartis Pharma GmbH, Nuremberg, Germany.<br /><searchLink fieldCode="AU" term="%22Hentschke+C%22">Hentschke C</searchLink>; Assya Achouba: Novartis Pharma AG, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Achouba+A%22">Achouba A</searchLink>; Assya Achouba: Novartis Pharma AG, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Banach+M%22">Banach M</searchLink>; Faculty of Medicine, The John Paul II Catholic University of Lublin, Lublin, Poland; Ciccarone Center for the Prevention of Cardiovascular Disease, Johns Hopkins University School of Medicine, Baltimore, MD, USA; Liverpool Centre for Cardiovascular Science (LCCS), Liverpool, UK.
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