Cited by 329Lipoproteins and Cardiovascular HealthCholesterol and Lipid MetabolismLipid metabolism and disorders

The DOI matches its Crossref record; 28 of the 28 references it cites were found in a registry or an index.

Long-term efficacy and safety of inclisiran in patients with high cardiovascular risk and elevated LDL cholesterol (ORION-3): results from the 4-year open-label extension of the ORION-1 trial

Open access

Ray, Kausik K, Troquay, Roel P T, Visseren, Frank L J, Leiter, Lawrence A, Scott Wright, R, Vikarunnessa, Sheikh, Talloczy, Zsolt, Zang, Xiao, Maheux, Pierre, Lesogor, Anastasia, Landmesser, Ulf·2023·The Lancet Diabetes & Endocrinology

DOI 10.1016/s2213-8587(22)00353-9

Open this paper in CoChat — free account Open PDF

Abstract

INTRODUCTION: Whether long-term treatment with the twice-yearly, siRNA therapeutic inclisiran, which reduces hepatic production of proprotein convertase subtilisin/kexin type 9 (PCSK9), results in sustained reductions in LDL cholesterol with an acceptable safety profile is not known. The aim of this study was to assess the effect of long-term dosing of inclisiran in patients with high cardiovascular risk and elevated LDL cholesterol. METHODS: ORION-3 was a 4-year open-label extension study of the placebo-controlled, phase 2 ORION-1 trial, conducted at 52 sites across five countries. Patients with prevalent atherosclerotic cardiovascular disease or high-risk primary prevention and elevated LDL cholesterol despite maximally tolerated statins or other LDL-lowering treatments, or with documented statin intolerance, who had completed the ORION-1 trial were eligible. Patients receiving inclisiran in ORION-1 received twice-yearly 300 mg subcutaneous inclisiran sodium throughout ORION-3 (inclisiran-only arm), whereas patients receiving placebo in ORION-1 first received subcutaneous evolocumab 140 mg every 2 weeks until day 360 thereafter transitioning to inclisiran twice-yearly for the remainder of ORION-3 study (switching arm). The primary efficacy endpoint was the percentage change in LDL cholesterol with inclisiran from the start of ORION-1 through to day 210 of the open label extension phase in the inclisiran-only arm (approximately 570 days of total inclisiran exposure in the modified intention-to-treat population). Secondary and exploratory endpoints included changes in LDL-C cholesterol and PCSK9 concentrations levels up to day 1440 (4 years) in each arm, and safety. ORION-3 is registered with ClinicalTrials.gov, NCT03060577. FINDINGS: Of the original ORION-1 cohort of 497 patients, 290 of 370 patients allocated to drug continued into the inclisiran-only arm and 92 of 127 patients allocated to placebo entered the switching-arm in the ORION-3 extension study conducted between March 24, 2017, and Dec 17, 2021. In the inclisiran-only arm, LDL cholesterol was reduced by 47·5% (95% CI 50·7-44·3) at day 210 and sustained over 1440 days. The 4-year averaged mean reduction of LDL-C cholesterol was 44·2% (95% CI: 47·1-41·4), with reductions in PCSK9 ranging from 62·2% to 77·8%. Adverse events at the injection site were reported in 39 (14%) of 284 patients in the inclisiran-only arm and 12 (14%) of 87 patients in the switching arm. The incidence of treatment-emergent serious adverse events possibly related to the study drug was 1% (three of 284) in the inclisiran-only arm and 1% (one of 87) in the switching arm. INTERPRETATION: Twice-yearly inclisiran provided sustained reductions in LDL cholesterol and PCSK9 concentrations and was well tolerated over 4 years in the extension study. This is the first prospective long-term study to assess repeat hepatic exposure to inclisiran. FUNDING: Novartis Pharma.

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

Integrity signals

Registry

Crossref · 10.1016/s2213-8587(22)00353-9

Cites

28 of 28 references verified0 citation errors · 0 not checkable

Statistics

Claims the paper makes

The claims and statistics of this paper haven’t been checked yet.

Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The self-check needs the paper’s full text.

2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk
Mach, F., Baigent, C., Catapano, A. L., Koskinas, K. C., Casula, M., Badimon, L., Chapman, M. J., De Backer, G. G., Delgado, V., Ference, B. A., et al. (2020) · European Heart Journal · doi:10.1093/eurheartj/ehz455 · Cited by 8,961
Self-citation
Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease
Sabatine, M. S., Giugliano, R. P., Keech, A. C., Honarpour, N., Wiviott, S. D., Murphy, S. A., Kuder, J. F., Wang, H., Liu, T., Wasserman, S. M., et al. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1615664 · Cited by 6,138
Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome
Schwartz, G. G., Steg, P. G., Szarek, M., Bhatt, D. L., Bittner, V. A., Diaz, R., Edelberg, J. M., Goodman, S. G., Hanotin, C., Harrington, R. A., et al. (2018) · New England Journal of Medicine · doi:10.1056/nejmoa1801174 · Cited by 3,634
CRISPR-Cas9 In Vivo Gene Editing for Transthyretin Amyloidosis
Gillmore, J. D., Gane, E., Taubel, J., Kao, J., Fontana, M., Maitland, M. L., Seitzer, J., O’Connell, D., Walsh, K. R., Wood, K., et al. (2021) · New England Journal of Medicine · doi:10.1056/nejmoa2107454 · Cited by 1,801
Two Phase 3 Trials of Inclisiran in Patients with Elevated LDL Cholesterol
Ray, K. K., Wright, R. S., Kallend, D., Koenig, W., Leiter, L. A., Raal, F. J., Bisch, J. A., Richardson, T., Jaros, M., Wijngaard, P. L. J., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa1912387 · Cited by 1,665
Self-citation
Multivalent N -Acetylgalactosamine-Conjugated siRNA Localizes in Hepatocytes and Elicits Robust RNAi-Mediated Gene Silencing
Nair, J. K., Willoughby, J. L. S., Chan, A., Charisse, K., Alam, M. R., Wang, Q., Hoekstra, M., Kandasamy, P., Kel’in, A. V., Milstein, S., et al. (2014) · Journal of the American Chemical Society · doi:10.1021/ja505986a · Cited by 1,141
Inclisiran in Patients at High Cardiovascular Risk with Elevated LDL Cholesterol
Ray, K. K., Landmesser, U., Leiter, L. A., Kallend, D., Dufour, R., Karakas, M., Hall, T., Troquay, R. P. T., Turner, T., Visseren, F. L. J., et al. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1615758 · Cited by 992
Self-citation
Effect of Long-Term Exposure to Lower Low-Density Lipoprotein Cholesterol Beginning Early in Life on the Risk of Coronary Heart Disease
Ference, B. A., Yoo, W., Alesh, I., Mahajan, N., Mirowska, K. K., Mewada, A., Kahn, J., Afonso, L., Williams, K. A., & Flack, J. M. (2012) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2012.09.017 · Cited by 898
EU-Wi d e Cross-Section a l Obser v at i o n al Study of Lipid-Modifying Therapy Use in Se c ondary and Pr i mary Care: the DA VINCI study
Ray, K. K., Molemans, B., Schoonen, W. M., Giovas, P., Bray, S., Kiru, G., Murphy, J., Banach, M., De Servi, S., Gaita, D., et al. (2021) · European Journal of Preventive Cardiology · doi:10.1093/eurjpc/zwaa047 · Cited by 839
Self-citation
Inclisiran for the Treatment of Heterozygous Familial Hypercholesterolemia
Raal, F. J., Kallend, D., Ray, K. K., Turner, T., Koenig, W., Wright, R. S., Wijngaard, P. L. J., Curcio, D., Jaros, M. J., Leiter, L. A., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa1913805 · Cited by 818
Self-citation

Show all 28 references

Sorted by citations

Items 101–200 of 329

A Comprehensive Review of the Latest Approaches to Managing Hypercholesterolemia: A Comparative Analysis of Conventional and Novel Treatments: Part II
Jianu, N., Nițu, E.-T., Merlan, C., Nour, A., Buda, S., Suciu, M., Luca, S. A., Sbârcea, L., Andor, M., & Buda, V. O. (2025) · Pharmaceuticals · doi:10.3390/ph18081150 · Cited by 14
Proprotein Convertase Subtilisin/Kexin Type 9 Inhibition: The Big Step Forward in Lipid Control
Rikhi, R. R., & Shapiro, M. D. (2023) · European Cardiology Review · doi:10.15420/ecr.2023.14 · Cited by 13
Reduction of visit-to-visit LDL-C intraindividual variability in patients treated with PCSK9 inhibitors and inclisiran vs standard lipid-lowering therapy
Cesaro, A., Acerbo, V., Scialla, F., Zito, A., Porcelli, G., Panico, D., Argenziano, G., Iaria, D., Monaco, M. G., De Sio, V., et al. (2026) · Journal of Clinical Lipidology · doi:10.1016/j.jacl.2025.10.066 · Cited by 11
New Insights into Cardiovascular Diseases Treatment Based on Molecular Targets
Wojtasińska, A., Kućmierz, J., Tokarek, J., Dybiec, J., Rodzeń, A., Młynarska, E., Rysz, J., & Franczyk, B. (2023) · International Journal of Molecular Sciences · doi:10.3390/ijms242316735 · Cited by 13
Review of Evolocumab for the Reduction of LDL Cholesterol and Secondary Prevention of Atherosclerotic Cardiovascular Disease
Leiter, L. A., Hegele, R. A., Brown, V., Bergeron, J., Mackinnon, E. S., & Mancini, G. B. J. (2024) · Reviews in Cardiovascular Medicine · doi:10.31083/j.rcm2505190 · Cited by 12
Self-citation
Inclisiran: Efficacy in Real World—Systematic Review and Meta-Analysis
Rodrigo-Alaíz, Á., Corral-Gudino, L., de Isla, L. P., Pardo, H. G., Calle, D. G., & Miramontes‐González, J. P. (2025) · Journal of Clinical Medicine · doi:10.3390/jcm14124163 · Cited by 14
Inclisiran for the Treatment of Hyperlipidemia and for Atherosclerotic Cardiovascular Disease Risk Reduction: A Narrative Review
Cowart, K., Singleton, J., & Carris, N. W. (2023) · Clinical Therapeutics · doi:10.1016/j.clinthera.2023.06.011 · Cited by 11
Treatment with Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors (PCSK9i): Current Evidence for Expanding the Paradigm?
Giglio, R. V., Muzurović, E. M., Patti, A. M., Toth, P. P., Agarwal, M. A., Almahmeed, W. A., Klisic, A. N., Ciaccio, M., & Rizzo, M. (2023) · Journal of Cardiovascular Pharmacology and Therapeutics · doi:10.1177/10742484231186855 · Cited by 11
High density lipoprotein as a therapeutic target: Focus on its functionality
Rosso, L. A. G., Davico, B., Chiappe, E. L., Tetzlaff, W., Boero, L. E., Brites, F. D., & Martín, M. (2023) · Biocell · doi:10.32604/biocell.2023.031063 · Cited by 10
Established and Emerging Nucleic Acid Therapies for Familial Hypercholesterolemia
Damase, T. R., Sukhovershin, R. A., Godin, B., Nasir, K., & Cooke, J. P. (2024) · Circulation · doi:10.1161/circulationaha.123.067957 · Cited by 11
Management of dyslipidaemia in patients with comorbidities—facing the challenge
Frühwald, L., Fasching, P., Dobrev, D., Kaski, J. C., Borghi, C., Waßmann, S., Huber, K., Semb, A. G., Agewall, S., & Drexel, H. (2024) · European Heart Journal - Cardiovascular Pharmacotherapy · doi:10.1093/ehjcvp/pvae095 · Cited by 10
In Situ Self‐Assembly of Artificial Topological Nanostructures Enhances In Vivo Efficacy of PCSK9 Inhibitory Peptides
Li, Q., Mu, Z., Dong, Y., Ouyang, Z., Zuo, J., Wu, Y., Yang, Y., Sun, S., Liang, H., & Bai, L. (2025) · Angewandte Chemie International Edition · doi:10.1002/anie.202502559 · Cited by 10
Familial hypercholesterolemia and its manifestations: Practical considerations for general practitioners
Anagnostis, P. G., Antza, C., Florentin, M., & Kotsis, V. (2023) · Kardiologia Polska · doi:10.33963/v.kp.97845 · Cited by 10
Nonstatin therapy to reduce low-density lipoprotein cholesterol and improve cardiovascular outcomes
Singh, A., & Cho, L. S. (2024) · Cleveland Clinic Journal of Medicine · doi:10.3949/ccjm.91a.23058 · Cited by 12
Inclisiran siRNA technology in the management of dyslipidemia: A narrative review of clinical trials
Olatunji, G. D., Kokori, E., Yusuf, I. A., Akinmoju, O. D., Egbunu, E. O., Muogbo, I., Lema, K. F., Kanagala, S. G., Owolabi, S., Muili, A. O., et al. (2024) · Current Problems in Cardiology · doi:10.1016/j.cpcardiol.2024.102419 · Cited by 10
Safety and Efficacy of Inclisiran in Hyperlipidemia: An Updated Meta‐Analysis of Randomised Controlled Trials
Basit, J., Ahmed, M., Singh, P., Ahsan, A., Zulfiqar, E., Iqbal, J., Fatima, M., Upreti, P., Hamza, M., & Alraies, M. C. (2025) · Endocrinology Diabetes & Metabolism · doi:10.1002/edm2.70039 · Cited by 10
Efficacy and safety of inclisiran based on background lipid-lowering treatment
Landmesser, U., Köenig, W., Leiter, L. A., Raal, F. J., Ray, K. K., Schwartz, G. G., Han, J., Conde, L. G., & Wright, R. S. (2025) · European Journal of Preventive Cardiology · doi:10.1093/eurjpc/zwaf214 · Cited by 9
Self-citation
The Era of Gene Therapy: The Advancement of Lentiviral Vectors and Their Pseudotyping
Jargalsaikhan, B.-E., Muto, M., & Ema, M. (2025) · Viruses · doi:10.3390/v17081036 · Cited by 12
The RNA revolution in medicine: from gene regulation to clinical therapeutics
Jeong, J., & Jeong-Yu, S. (2025) · Animal Cells and Systems · doi:10.1080/19768354.2025.2548253 · Cited by 9
Unlocking the regulatory code of RNA: launching the Human RNome Project
Adams, M. D., Boileau, E., Bujnicki, J. M., Cheung, V. G., Conticello, S. G., Dedon, P. C., Dieterich, C., Gallo, A., Göke, J., Helm, M., et al. (2025) · Genome biology · doi:10.1186/s13059-025-03824-y · Cited by 9
Applications of Genome Editing Technologies in CAD Research and Therapy with a Focus on Atherosclerosis
Mak, M. C. E., Gurung, R., & Foo, R. (2023) · International Journal of Molecular Sciences · doi:10.3390/ijms241814057 · Cited by 10
An update on inclisiran for the treatment of elevated LDL cholesterol
Barkas, F., & Ray, K. (2024) · Expert Opinion on Pharmacotherapy · doi:10.1080/14656566.2024.2337253 · Cited by 9
Self-citation
Safety of Inclisiran: A Disproportionality Analysis from the EudraVigilance Database
Cicala, G., Rottura, M., Gianguzzo, V. M., Cristiano, F., Drago, S. F. A., Pallio, G., Irrera, N., Imbalzano, E., Spina, E., & Arcoraci, V. (2024) · Pharmaceuticals · doi:10.3390/ph17101365 · Cited by 8
Advances in conjugate drug delivery System: Opportunities and challenges
Zhu, Y., Wu, J., & Zhi, F. (2024) · International Journal of Pharmaceutics · doi:10.1016/j.ijpharm.2024.124867 · Cited by 8
Tunable fano-like resonances in graphene metasurface for quad-frequency optoelectronic sensing
Wang, M., Cui, W., Wang, Y., Li, M., & Qie, X. (2025) · Physica E Low-dimensional Systems and Nanostructures · doi:10.1016/j.physe.2025.116191 · Cited by 8
Therapeutic potential of siRNA PMP22-SQ nanoparticles for Charcot-Marie-Tooth 1A neuropathy in rodents and non-human primates
Boutary, S., Khalaf, G., Landesman, Y., Madani, M. E., Desmaële, D., Piguet, F., Alonso, R., Banchi, E.-G., Adams, D., Massaad, C., et al. (2025) · International Journal of Pharmaceutics · doi:10.1016/j.ijpharm.2025.125234 · Cited by 8
Impact of Sex Differences on Lipids and Statin Utilization
Rodriguez, C. P., Burka, S., & Michos, E. D. (2025) · Current Atherosclerosis Reports · doi:10.1007/s11883-025-01286-y · Cited by 9
The impact of inclisiran on lipid profiles in adults with hyperlipidemia: a meta-analysis and meta-regression of randomized controlled trials
Khalil, I., Rahman, M. T., & Hossain, I. (2025) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2025.04.013 · Cited by 8
Eurasian Association of Cardiology (EAC)/ Russian National Atherosclerosis Society (RNAS) Guidelines for the diagnosis and correction of dyslipidemia for the prevention and treatment of atherosclerosis (2025)
Владиславович, Е. М., Kukharchuk, V. V., Балахонова, Т. В., Gurevich, V. S., Сергиенко, И. В., Sokolov, A. A., Анатольевич, С. А., Иосифович, Ш. И., Ахмеджанов, Н. М., Барбараш, О. Л., et al. (2025) · Eurasian heart journal · doi:10.38109/2225-1685-2025-2-6-34 · Cited by 10
PCSK9 Inhibitor Inclisiran Attenuates Cardiotoxicity Induced by Sequential Anthracycline and Trastuzumab Exposure via NLRP3 and MyD88 Pathway Inhibition
Quagliariello, V., Berretta, M., Bisceglia, I., Iovine, M., Barbato, M., Arianna, R., Canale, M. L., Paccone, A., Inno, A., Scherillo, M., et al. (2025) · International Journal of Molecular Sciences · doi:10.3390/ijms26146617 · Cited by 10
Design and rationale of a randomized clinical trial assessing the effect of inclisiran on atherosclerotic plaque in individuals without previous cardiovascular event and without flow- limiting lesions identified in an in-hospital screening: The VICTORION-PLAQUE primary prevention trial
Revaiah, P. C., Serruys, P. W. J. C., Onuma, Y., Andreini, D., Budoff, M. J., Sharif, F., Chernofsky, A., Vikarunnessa, S., Wiethoff, A. J., Yates, D. P., et al. (2025) · American Heart Journal · doi:10.1016/j.ahj.2025.08.001 · Cited by 10
Self-citation
Lipoprotein(a) and Venous Thromboembolism: Association, Causality, and Medications
Pfeferman, M. B., Rashedi, S., Lip, G. Y. H., Weber, C., O’Donoghue, M. L., Nissen, S. E., Nicholls, S. J., Natarajan, P., Plutzky, J., Libby, P., et al. (2025) · Thrombosis and Haemostasis · doi:10.1055/a-2674-5114 · Cited by 10
Focus on Prevention: Peripheral Arterial Disease and the Central Role of the Cardiologist
Fioretti, V., Gerardi, D., Giugliano, G., Fazio, A. D., & Stabile, E. (2023) · Journal of Clinical Medicine · doi:10.3390/jcm12134338 · Cited by 10
Beyond Statins: Novel Lipid-Lowering Agents for Reducing Risk of Atherosclerotic Cardiovascular Disease
Kayani, T., Ahmad, B., Chang, R., Qian, F., Sahinoz, M., Rehan, M., Giaimo, A., Spatz, E. S., & Hu, J. (2024) · Pharmacoepidemiology · doi:10.3390/pharma3010009 · Cited by 9
Classical and Novel Lipid-Lowering Therapies for Diabetic Patients with Established Coronary Artery Disease or High Risk of Coronary Artery Disease—A Narrative Clinical Review
Velidakis, N., Stachteas, P., Gkougkoudi, E., Papadopoulos, C. E., & Kadoglou, N. P. E. (2024) · Pharmaceuticals · doi:10.3390/ph17050568 · Cited by 8
Evolution of LDL-C lowering medications and their cardiovascular benefits: Past, present, and future
Faluk, M. A., Wardhere, A., Mohamoud, A. A., Nor, M. A., Bampastsias, D., Oikonomou, E., Almubaid, Z., & Hemyari, B. A. (2024) · Current Problems in Cardiology · doi:10.1016/j.cpcardiol.2024.102637 · Cited by 8
The future of siRNA-mediated approaches to treat von Willebrand disease
Linthorst, N. A., van Vlijmen, B. J. M., & Eikenboom, J. C. J. (2025) · Expert Review of Hematology · doi:10.1080/17474086.2025.2459259 · Cited by 8
Hyperlipidaemia in diabetes: are there particular considerations for next-generation therapies?
Béliard, S., Mourre, F., & Valéro, R. (2024) · Diabetologia · doi:10.1007/s00125-024-06100-z · Cited by 8
Translation of genomics into routine cardiological practice: insights from a European Society of Cardiology Cardiovascular Round Table
Dimmeler, S., Ferri, L. D. A. F., Nioi, P., O’Donnell, C. J., Damy, T., Gómez‐Outes, A., Giacca, M., Guo, W., Kavousi, M., Kupatt, C., et al. (2025) · European Heart Journal · doi:10.1093/eurheartj/ehaf041 · Cited by 7
Self-citation
Harnessing RNA therapeutics: novel approaches and emerging strategies for cardiovascular disease management
Dui, W., Xiao-bin, Z., Haifeng, Z., Lijuan, D., Wenhui, H., Zhengfeng, Z., & Jinling, S. (2025) · Frontiers in Cardiovascular Medicine · doi:10.3389/fcvm.2025.1546515 · Cited by 8
Proprotein convertase subtilisin/kexin Type 9 inhibitors: past, present, and future
Sabatine, M. S., & Laufs, U. (2026) · European Heart Journal · doi:10.1093/eurheartj/ehag148 · Cited by 7
From clinical development to real-world outcomes with inclisiran
Connolly, D. L., Sharma, V., & Ray, K. K. (2024) · Current Opinion in Lipidology · doi:10.1097/mol.0000000000000954 · Cited by 9
Self-citation
Filling the gap: Genetic risk assessment in hypercholesterolemia using LDL‐C and LPA genetic scores
Schwaninger, G., Forer, L., Ebenbichler, C. F., Dieplinger, H., Kronenberg, F., Zschocke, J., & Witsch‐Baumgartner, M. (2023) · Clinical Genetics · doi:10.1111/cge.14387 · Cited by 10
Ups and downs in PCSK9 inhibition in the cardiovascular arena: a review
McClintick, D. J., & Giugliano, R. P. (2023) · Current Opinion in Lipidology · doi:10.1097/mol.0000000000000897 · Cited by 7
Estimating potential cardiovascular health benefits of improved population level control of LDL cholesterol through a twice-yearly siRNA-based approach: A simulation study of a health-system level intervention
Ray, K. K., Gunn, L. H., Conde, L. G., Raal, F. J., Wright, R. S., Gosselin, N. H., Leiter, L. A., Köenig, W., Schwartz, G. G., & Landmesser, U. (2024) · Atherosclerosis · doi:10.1016/j.atherosclerosis.2024.117472 · Cited by 8
Self-citation
Atherosclerosis Residual Lipid Risk-Overview of Existing and Future Pharmacotherapies
Omari, M., & Alkhalil, M. (2024) · Journal of Cardiovascular Development and Disease · doi:10.3390/jcdd11040126 · Cited by 9
First-in-human gene editing for lipid lowering: the initial results
Tual‐Chalot, S., & Stellos, K. (2024) · Cardiovascular Research · doi:10.1093/cvr/cvae037 · Cited by 6
Pleiotropic Effects of PCSK9 Inhibitors on Cardio-Cerebrovascular Diseases
Li, Z., Zhu, L., Xu, Y., Zhang, Y., Liu, Y., Sun, H., Li, S., Wang, M., Jiang, T., Zhou, J., et al. (2024) · Biomedicines · doi:10.3390/biomedicines12122729 · Cited by 6
Silencing hepatic PCSK9 via novel chimeric AAV8 mitigates the progression of atherosclerosis by inhibiting inflammation in ApoE−/− mice
Chen, X., Sun, M., Ma, X., Ma, Y., & Chen, B. (2024) · Molecular Therapy — Methods & Clinical Development · doi:10.1016/j.omtm.2024.101390 · Cited by 6
Adverse events associated with inclisiran: a real-world pharmacovigilance study of FDA adverse event reporting system (FAERS)
Li, B., Chen, Y., Zhang, Y., Qian, M., Shan, Q., Qian, J., & Guo, J. (2026) · Expert Opinion on Drug Safety · doi:10.1080/14740338.2025.2468855 · Cited by 6
Designing nucleic acid-based therapeutics for cancer treatment: Updates on the state of the art
Peng, B., Jayasinghe, M. K., Le, A. H., Tran, N. M., & Le, M. T. N. (2025) · Molecular Therapy · doi:10.1016/j.ymthe.2025.09.041 · Cited by 7
Functional bioconjugates for precision delivery of nucleic acid therapeutics
Sharma, H., Kumar, V., & Bahal, R. (2025) · Trends in Chemistry · doi:10.1016/j.trechm.2025.10.002 · Cited by 6
Design of VICTORION-2 Prevent: A randomized double-blind, placebo-controlled trial, assessing the impact of inclisiran on major adverse cardiovascular events in patients with established cardiovascular disease
Steg, P. G., Goodman, S. G., Jukema, J. W., Martens, P., Zirlik, A., Bhatt, D. L., Menon, V., Szarek, M. J., Lesogor, A., Stratz, C., et al. (2026) · American Heart Journal · doi:10.1016/j.ahj.2026.107493 · Cited by 7
Self-citation
The Role of Cardiovascular Rehabilitation in the Elderly Patient
Díez‐Villanueva, P., Jiménez-Méndez, C., Pardo, H. G., Alarcón, J. A., & Campuzano, R. (2024) · Cardiology · doi:10.1159/000539766 · Cited by 9
Early, Intensive and Persistent Lipid-Lowering Therapy for Secondary Prevention of Acute Coronary Syndrome
Okada, K., Haze, T., Kikuchi, S., Kirigaya, H., Hanajima, Y., Tsutsumi, K., Kirigaya, J., Nakahashi, H., Gohbara, M., Kimura, Y., et al. (2024) · Journal of Atherosclerosis and Thrombosis · doi:10.5551/jat.64988 · Cited by 6
Inclisiran versus alirocumab in improving lipid profile parameters: A systematic review and meta‐analysis
Cleto, A. S., Schirlo, J. M., Gomes, V. H. O., Beraldo, M. L. J., Neiverth, G. S., Beltrame, M. L., Machozeki, J., & Martins, C. M. (2024) · Diabetes Obesity and Metabolism · doi:10.1111/dom.16091 · Cited by 7
RNA therapeutics to control fibrinolysis: review on applications in biology and medicine
Ferraresso, F., Leung, J., & Kastrup, C. J. (2024) · Journal of Thrombosis and Haemostasis · doi:10.1016/j.jtha.2024.04.006 · Cited by 7
Analysis of Inclisiran in the US FDA Adverse Event Reporting System (FAERS): a focus on overall patient population and sex-specific subgroups
He, Y., Guan, X., Zhang, Y., Zhu, Z., Zhang, Y., Feng, Y., & Li, X. (2024) · Expert Opinion on Drug Safety · doi:10.1080/14740338.2024.2348562 · Cited by 8
Inclisiran SiRNA therapy for durable LDL-C reduction: a systematic review and meta-analysis highlighting a breakthrough in long-term cardiovascular risk management
Satyam, S. M., El-Tanani, M., Patni, M. A., Rehman, A., Irshad, S. M., Raheem, R., Junais, E., John, A. A., Rassal, R. Y., Kumari, R., et al. (2026) · BMC Cardiovascular Disorders · doi:10.1186/s12872-026-05515-3 · Cited by 5
“The research findings demonstrate that Inclisiran functions as a safe and effective treatment for lipid reduction among diverse patient groups [70].”
Insights from a real-world experience with inclisiran at a large United States lipid clinic
Mazdeyasnan, D., Birs, A. S., Chiou, T. T., Diano, L., & Wilkinson, M. J. (2025) · Journal of clinical lipidology · doi:10.1016/j.jacl.2025.06.015 · Cited by 5
PCSK9 Regulation of Lipid Metabolism in the Nervous System: Implications for Schwann Cell Function and Peripheral Neuropathy
Nowacka, A., Śniegocki, M., & Ziółkowska, E. (2025) · Cells · doi:10.3390/cells14181479 · Cited by 5
Management of dyslipidaemia in patients with comorbidities: facing the challenge: type 2 diabetes mellitus
Drexel, H., Festa, A., Schmidt, T. A., Rocca, B., Dobrev, D., Agewall, S., Tamargo, J. L., & Kaser, S. (2025) · European Heart Journal - Cardiovascular Pharmacotherapy · doi:10.1093/ehjcvp/pvaf076 · Cited by 6
Machine Learning Model for Atherosclerosis Evaluation and Cardiovascular Risk Prediction Based on Coronary CT Angiography-Analysis From the CREATION Registry
Song, Y., Xu, N., Zheng, J., Jia, S., Cui, C., Zhang, Y., Gao, L., Gao, Z., Chen, J., Song, L., et al. (2025) · Circulation Cardiovascular Imaging · doi:10.1161/circimaging.125.018443 · Cited by 5
Lipid-Lowering RNA Therapeutics for Atherosclerotic Cardiovascular Disease Prevention: A State−of−the−Art Review
Maidman, S. D., & Rosenson, R. S. (2025) · BioDrugs · doi:10.1007/s40259-025-00731-3 · Cited by 7
Safety profile of proprotein convertase subtilisin/kexin type 9 inhibitors alirocumab and evolocumab: an updated meta-analysis and meta-regression
Rivera, F. B., Cha, S. W., Magalong, J. V., Bantayan, N. R. B., Cruz, L. L. A., Arias-Aguirre, E., Aguirre, Z., Varona, M. C., Co, E. M. F., Lumbang, G. N. O., et al. (2024) · Current Medical Research and Opinion · doi:10.1080/03007995.2024.2363971 · Cited by 5
Review of Recent Literature and Updates in Nonstatin Cholesterol Management
Wang, E. M., Asias-Dinh, B. D., & Rosario, N. (2024) · Mayo Clinic Proceedings · doi:10.1016/j.mayocp.2024.03.001 · Cited by 6
Post-marketing pharmacovigilance study of inclisiran: mining and analyzing adverse event data from the FDA Adverse Event Reporting System database
Zou, D., Hu, Q., Liu, Y., & Yu, L. (2024) · International Journal of Clinical Pharmacy · doi:10.1007/s11096-024-01784-0 · Cited by 5
A retrospective study of people with familial hypercholesterolaemia in a Belgian lipid clinic
Ide, V., Cock, D. D., Pazmiño, S., Vangoitsenhoven, R., der Schueren, B. V., & Mertens, A. C. (2023) · Acta cardiologica. Supplementum · doi:10.1080/00015385.2023.2266647 · Cited by 5
Adherence to pharmacotherapy: sine qua non for reducing cumulative risk of premature coronary disease in familial hypercholesterolemia
Pang, J., Sanfilippo, F. M., Chan, D. C., & Watts, G. F. (2023) · Current Opinion in Endocrinology Diabetes and Obesity · doi:10.1097/med.0000000000000842 · Cited by 5
Expanding therapeutic options: overview of novel pharmacotherapies for dyslipidemia
ALGhasab, N. S., Fogacci, F., Арманович, А. А., & Cicero, A. F. G. (2024) · Expert Opinion on Pharmacotherapy · doi:10.1080/14656566.2024.2406270 · Cited by 5
Relative Efficacy of Alirocumab, Evolocumab, Inclisiran, and Bempedoic Acid on Lipids in Patients with Cardiovascular Disease or Familial Hypercholesterolaemia
Khattak, S., Ochoa-Ferraro, A. F., Khan, N., George, S., Khan, S. Q., Townend, J., Dawson, C., & Thomas, M. R. (2025) · Journal of Clinical Medicine · doi:10.3390/jcm14227946 · Cited by 4
Dyslipidemia management in stroke prevention: An individualized approach
Stefanou, M., Panagiotopoulos, E., Liberopoulos, E. N., Milionis, H. J., Theodorou, A., Mira, K., de Sousa, D. A., Palaiodimou, L., Vlachopoulos, C., Siasos, G., et al. (2026) · International Journal of Stroke · doi:10.1177/17474930261418388 · Cited by 4
2024 Egyptian consensus statement on the role of non-statin therapies for LDL cholesterol lowering in different patient risk categories
Taha, H., Kandil, H., Badran, H. M., Farag, N. M., Khamis, H., Nasr, G. M., Samy, M., Abdrabou, M., Abuelezz, M., & Shaker, M. M. (2024) · The Egyptian Heart Journal · doi:10.1186/s43044-024-00562-7 · Cited by 5
From physiopathology to treatment of familial hypercholesterolemia: Existing and emerging pharmacotherapies
Cicero, A. F. G., Mahjoubin-Tehran, M., Reiner, Ž., Eid, A. H., Jamialahmadi, T., & Sahebkar, A. (2025) · Pharmacological Reviews · doi:10.1016/j.pharmr.2025.100110 · Cited by 5
Focus on the Prevention of Acute Limb Ischemia: Centrality of the General Practitioner from the Point of View of the Internist
Enea, I., & Martelli, E. (2023) · Journal of Clinical Medicine · doi:10.3390/jcm12113652 · Cited by 5
Inclisiran: the preclinical discovery and development of a novel therapy for the treatment of atherosclerosis
Tsamoulis, D., Rallidis, L. S., & Kosmas, C. E. (2024) · Expert Opinion on Drug Discovery · doi:10.1080/17460441.2024.2360415 · Cited by 4
Estimating the effect of inclisiran on hypercholesterolemia and primary prevention of cardiovascular disease: the NHANES 1999–2018 study
Li, H., Zhao, S., Wu, J., Han, J., Xu, Y., Shi, S., & Zhang, Y. (2024) · Lipids in Health and Disease · doi:10.1186/s12944-024-02294-8 · Cited by 5
PCSK9 levels and diabetic retinopathy: opportunities for a potential target and novel therapeutic approach in conjunction with treating dyslipidaemia
Varughese, M. S., Nayak, A., & Jacob, S. (2024) · Eye · doi:10.1038/s41433-024-03523-1 · Cited by 4
Efficacy, benefit and safety of inclisiran
López-Miranda, J. (2024) · Clínica e Investigación en Arteriosclerosis (English Edition) · doi:10.1016/j.artere.2025.100730 · Cited by 4
A novel lncRNA FLJ promotes castration resistance in prostate cancer through AR mediated autophagy
Wu, Y., Cheng, S., Zhang, T., Wang, L., Li, T., Zheng, Y., Yang, G., Wu, X., Luo, C., Chen, T., et al. (2025) · Journal of Translational Medicine · doi:10.1186/s12967-025-06294-9 · Cited by 4
Targeting PCSK9 beyond the liver: evidence from experimental and clinical studies
Dalt, L. D., Baragetti, A., & Norata, G. D. (2025) · Expert Opinion on Therapeutic Targets · doi:10.1080/14728222.2025.2482545 · Cited by 4
2024 KSoLA Update on New Lipid-Lowering Agents: Inclisiran and Bempedoic Acid
Kim, H., Cha, J., & Lee, S. (2025) · Journal of Lipid and Atherosclerosis · doi:10.12997/jla.2025.14.2.135 · Cited by 6
25 years of lipid-lowering therapy: secular trends in therapy of coronary patients
Ratz, M., Vogel, J. B., Kuehrer, H., Säly, C., Mündlein, A., Vonbank, A., MADER, A., Fraunberger, P., Leiherer, A., & Drexel, H. (2024) · Wiener klinische Wochenschrift · doi:10.1007/s00508-024-02365-x · Cited by 4
Small interfering RNA (siRNA) in dyslipidemia: a systematic review on safety and efficacy of siRNA
Alla, S. S. M., Shah, D. J., Meyur, S., Agarwal, P., Alla, D., Moraboina, S. L., Ghadvaje, G. V., Bayeh, R. G., Malireddi, A., Shajan, T., et al. (2025) · Journal of Experimental Pharmacology · doi:10.2147/jep.s521579 · Cited by 4
Proprotein convertase subtilisin/kexin type 9-inhibition across different patient populations
Stürzebecher, P. E., & Laufs, U. (2024) · Current Opinion in Lipidology · doi:10.1097/mol.0000000000000935 · Cited by 3
Evaluating the role of PCSK9 inhibitors in reducing cardiovascular events among statin-intolerant patients: a systematic review and meta-analysis
Farhan, M., Hussein, G. A., Alom, T., Das, A., Durrani, T., Hayani, Z. M., Alkassar, A., Oweis, H. A., Nazir, M. H., Dhillon, D. K., et al. (2025) · Annals of Medicine and Surgery · doi:10.1097/ms9.0000000000002927 · Cited by 3
Inhibition of PCSK9 with polypurine reverse hoogsteen hairpins: A novel gene therapy approach
López-Aguilar, E., Pacheco-Velázquez, S. C., Busquets, M.-A., Hay, J., Mueller, P. A., Fazio, S., Ciudad, C. J., Noé, V., & Pamir, N. (2025) · Biochemical Pharmacology · doi:10.1016/j.bcp.2025.116976 · Cited by 3
PCSK9 in vascular smooth muscle cells: biology, pathology, and inhibition to fight atherosclerosis
Amorosi, A., & Varret, M. (2026) · Atherosclerosis Plus · doi:10.1016/j.athplu.2025.12.001 · Cited by 5
Low‐Density Lipoprotein Cholesterol Lowering With Inclisiran Plus Usual Care in Recent Acute Coronary Syndrome: VICTORION‐INCEPTION, a Randomized, Controlled, Open‐Label Trial
Knowlton, K. U., Návar, A. M., Anderson, J. L., Brown, A. S., Muhlestein, J. B., Kleeman, K., Sarwat, S., Abbas, C. A., Ramirez, M. A., Grines, C. L., et al. (2026) · Journal of the American Heart Association · doi:10.1161/jaha.125.043655 · Cited by 3
Inclisiran in patients with acute ischemic stroke: first data
Cherepianskii, M. S., Ponomareva, G. M., Skiba, I. B., Abakarov, R. M., Дудайте, В. В., & Cherepianskaia, A. A. (2023) · Kardiologiia · doi:10.18087/cardio.2023.10.n2560 · Cited by 3
Mining of adverse event signals associated with inclisiran: a post-marketing analysis based on FAERS
Shi, X., Qiao, Y., Yang, Y., Wang, N., Zhang, Y., Shi, S., Shen, G., & Jia, X. (2024) · Expert Opinion on Drug Safety · doi:10.1080/14740338.2024.2409707 · Cited by 3
Evaluating the implementation of inclisiran in primary care: process evaluation interim findings from interviews with key stakeholders
Wilson, P. M., Elvey, R., Mathieson, A., Bower, P., Gibson, M., Vell, T., & Dixon, S. (2025) · BMJ Open · doi:10.1136/bmjopen-2023-083441 · Cited by 4
The Effects of Inclisiran on the Subclinical Inflammatory Markers of Atherosclerotic Cardiovascular Disease in Patients at High Cardiovascular Risk
Maligłówka, M., Dec, A., Bułdak, Ł., & Okopień, B. (2025) · Pharmaceuticals · doi:10.3390/ph18060832 · Cited by 3
Comprehensive insights into peripheral artery disease: an overview from the working groups of pathogenesis of atherosclerosis and thrombosis of the Italian Society of Cardiology
Muscoli, S., Cimmino, G., Canonico, M. E., Cesaro, A., Rosa, G. D., Rosa, S. D., Coronelli, M. M., Natale, F., Perrone, M. A., Sticchi, A., et al. (2025) · Journal of Cardiovascular Medicine · doi:10.2459/jcm.0000000000001740 · Cited by 4
Emerging therapies targeting lipoprotein(a): Pharmacologic advances and future directions
Perez, A. D., Simpson, R. J., Komé, A. M., & Lopez, S. T. (2025) · Journal of Pharmacology and Experimental Therapeutics · doi:10.1016/j.jpet.2025.103695 · Cited by 3
Small Interfering Ribonucleic Acid as Lipid-Lowering Therapy: Inclisiran in Focus
Rakočević, J., Dobric, M. R., Vučić, R. M., Furtula, M., Zaletel, I. V., Milutinović, K., Ilijevski, A., Labudović‐Borović, M., Tomasevic, M. V., & Bajčetić, M. (2023) · International Journal of Molecular Sciences · doi:10.3390/ijms24066012 · Cited by 5
PCSK9 siRNA INHIBITOR INCLISIRAN AS A TREATMENT OPTION IN HYPERCHOLESTEROLEMIA: A BRIEF REVIEW
Kılıç, M. E. (2023) · TURKISH MEDICAL STUDENT JOURNAL · doi:10.4274/tmsj.galenos.2023.2023-5-1 · Cited by 3
PCSK9 inhibitors and inclisiran with or without statin therapy on incident muscle symptoms and creatine kinase: a systematic review and network meta-analysis
Li, W., Sun, L., & Yan, S. (2024) · Frontiers in Cardiovascular Medicine · doi:10.3389/fcvm.2024.1375040 · Cited by 4
Familial Hypercholesterolemia
Pirillo, A., Casula, M., Baragetti, A., & Catapano, A. L. (2024) · Elsevier eBooks · doi:10.1016/b978-0-443-15734-9.00001-7 · Cited by 3
INCLISIRAN - A NEW SOLUTION FOR THE PREVENTION AND TREATMENT OF ATHEROSCLEROTIC CARDIOVASCULAR DISEASE
Lis, P., Lis, A. E., Kaźmierski, W., Jurek, J., Ziomek, M., Kocur, K., Ziobro, A., & Camlet, K. (2024) · Prospects in Pharmaceutical Sciences · doi:10.56782/pps.241 · Cited by 3

Authors: Ray, K. K., Troquay, R. P. T., Visseren, F. L. J., Leiter, L. A., Scott Wright, R., Vikarunnessa, S., Talloczy, Z., Zang, X., Maheux, P., Lesogor, A., & Landmesser, U.
Affiliations: Imperial College London (GB)
VieCuri Medisch Centrum (NL)
University Medical Center Utrecht (NL)
St. Michael's Hospital (CA)
Novartis (Switzerland) (CH)
German Centre for Cardiovascular Research (DE)
Corresponding author: Ray, Kausik K
ORCID: Ray, Kausik K
Visseren, Frank L J
Leiter, Lawrence A
Zang, Xiao
Landmesser, Ulf
Venue: The Lancet Diabetes & Endocrinology
Publisher: Elsevier BV
Published: 2023-02
Volume: 11
Issue: 2
Pages: 109-119
ISSN: 2213-8587 (ISSN-L)
DOI: 10.1016/s2213-8587(22)00353-9
OpenAlex: W4313554841
Cited by: 328
References: 28
Citations by year: 2026: 55 · 2025: 102 · 2024: 103 · 2023: 67
FWCI: 87.61
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
creativecommons.org/licenses/by/4.0/ (vor)
Locations: The Lancet Diabetes & Endocrinology (publishedVersion, cc-by)
PubMed (publishedVersion)
Utrecht University Repository (Utrecht University) (submittedVersion, cc-by)
Funders: Novartis
NIHR Imperial Biomedical Research Centre
Topics: Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
Life Sciences › Biochemistry, Genetics and Molecular Biology › Biochemistry › Cholesterol and Lipid Metabolism
Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
Keywords: inclisiran, PCSK9 inhibition, siRNA therapeutics, LDL cholesterol lowering, high cardiovascular risk, atherosclerotic cardiovascular disease, statin intolerance, long-term efficacy, safety
MeSH terms: Proprotein Convertase 9, Heart Disease Risk Factors, Anticholesteremic Agents, Cardiovascular Diseases, Humans, Cholesterol, LDL, Prospective Studies, Risk Factors, Hydroxymethylglutaryl-CoA Reductase Inhibitors, RNA, Small Interfering

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review

Long-term efficacy and safety of inclisiran in patients with high cardiovascular risk and elevated LDL cholesterol (ORION-3): results from the 4-year open-label extension of the ORION-1 trial

Abstract

Overview

Integrity signals

Verification

Claims the paper makes

Claims other papers make about this one

Self-check

Citations

Cites

Cited by

Related

Metadata

Record

About these checks