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Evinacumab in Patients with Refractory Hypercholesterolemia
Open accessAbstract
BACKGROUND: Patients with refractory hypercholesterolemia, who have high low-density lipoprotein (LDL) cholesterol levels despite treatment with lipid-lowering therapies at maximum tolerated doses, have an increased risk of atherosclerosis. In such patients, the efficacy and safety of subcutaneous and intravenous evinacumab, a fully human monoclonal antibody against angiopoietin-like 3, are not known. METHODS: In this double-blind, placebo-controlled, phase 2 trial, we enrolled patients with or without heterozygous familial hypercholesterolemia who had refractory hypercholesterolemia, with a screening LDL cholesterol level of 70 mg per deciliter or higher with atherosclerosis or of 100 mg per deciliter or higher without atherosclerosis. Patients were randomly assigned to receive subcutaneous or intravenous evinacumab or placebo. The primary end point was the percent change from baseline in the LDL cholesterol level at week 16 with evinacumab as compared with placebo. RESULTS: In total, 272 patients were randomly assigned to the following groups: subcutaneous evinacumab at a dose of 450 mg weekly (40 patients), 300 mg weekly (43 patients), or 300 mg every 2 weeks (39 patients) or placebo (41 patients); or intravenous evinacumab at a dose of 15 mg per kilogram of body weight every 4 weeks (39 patients) or 5 mg per kilogram every 4 weeks (36 patients) or placebo (34 patients). At week 16, the differences in the least-squares mean change from baseline in the LDL cholesterol level between the groups assigned to receive subcutaneous evinacumab at a dose of 450 mg weekly, 300 mg weekly, and 300 mg every 2 weeks and the placebo group were -56.0, -52.9, and -38.5 percentage points, respectively (P<0.001 for all comparisons). The differences between the groups assigned to receive intravenous evinacumab at a dose of 15 mg per kilogram and 5 mg per kilogram and the placebo group were -50.5 percentage points (P<0.001) and -24.2 percentage points, respectively. The incidence of serious adverse events during the treatment period ranged from 3 to 16% across trial groups. CONCLUSIONS: In patients with refractory hypercholesterolemia, the use of evinacumab significantly reduced the LDL cholesterol level, by more than 50% at the maximum dose. (Funded by Regeneron Pharmaceuticals; ClinicalTrials.gov number, NCT03175367.).
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“Another phase 2 trial studied evinacumab in 272 patients with refractory hypercholesterinaemia (either HeFH or established atherosclerosis). At a dose of 450 mg per week, evinacumab reduced LDL-C levels by − 56% compared with baseline [151].”
From Established and Emerging Lipid-Lowering Drugs for Primary and Secondary Cardiovascular Prevention (2023) · cites this paper as [151]
Experimental — accuracy not yet measuredIn the citing paper
“In comparison, evinacumab, a monoclonal antibody against ANGPTL3 that is thought to cause near-total suppression of ANGPTL3 activity, 7,14,15 reduces ApoB levels by >40% in adults with refractory hypercholesterolemia or homozygous familial hypercholesterolemia in its intravenous formulation administered at a dose of 15 mg/kg.14,15”
From Effect of Vupanorsen on Non–High-Density Lipoprotein Cholesterol Levels in Statin-Treated Patients With Elevated Cholesterol: TRANSLATE-TIMI 70 (2022) · cites this paper as [15]
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“Similar results were also found when evinacumab was evaluated in patients with refectory hypercholesteremia who were on maximum tolerated doses of lipid-lowering therapies [63].”
ResultTargeted drug delivery systems for atherosclerosis
Tu, L., Zou, Z., Ye, Y., Wang, S., Xing, B., Feng, J., Jin, Y., & Cheng, M. (2025) · Journal of Nanobiotechnology · doi:10.1186/s12951-025-03384-0 · Cited by 31
“V a s c u l a r a n d i mm u n e s y s t e m l e ss [ 181 ] C u r c u m i n B l o c k i n g t h e N F - κ β p a t h w a y i n e n d o t h e l i a l c e ll s i nh i b i t s t h e r e l e a s e o f i n fl a m - m a t o r y f a c t o r s .”
Lipid-Modifying Therapies and Stroke Prevention
Hackam, D. G., & Hegele, R. A. (2022) · Current Neurology and Neuroscience Reports · doi:10.1007/s11910-022-01197-4 · Cited by 30
Inhibition of angiopoietin-like 3 for the management of severe hypercholesterolemia
Mohamed, F., Botha, T. C., & Raal, F. J. (2021) · Current Opinion in Lipidology · doi:10.1097/mol.0000000000000755 · Cited by 29
Bchetnia, M., Bouchard, L., Mathieu, J., Campeau, P. M., Morin, C., Brisson, D., Laberge, A., Vézina, H., Gaudet, D., & Laprise, C. (2021) · Journal of Medical Genetics · doi:10.1136/jmedgenet-2021-107809 · Cited by 40
Self-citationRizos, C. V., Skoumas, I., Rallidis, L. S., Skalidis, E. I., Τζιόμαλος, Κ., Garoufi, A., Anagnostis, P. G., Sfikas, G., Kotsis, V., Doumas, M. N., et al. (2021) · International Journal of Cardiology · doi:10.1016/j.ijcard.2021.10.024 · Cited by 29
New and emerging lipid-modifying drugs to lower LDL cholesterol
Kosmas, C. E., Pantou, D., Sourlas, A., Papakonstantinou, E. J., Uceta, R. E., & Guzman, E. (2021) · Drugs in Context · doi:10.7573/dic.2021-8-3 · Cited by 32
Current and Emerging Treatment Options for Hypertriglyceridemia: State-of-the-Art Review
Zimodro, J. M., Rizzo, M., & Gouni‐Berthold, I. (2025) · Pharmaceuticals · doi:10.3390/ph18020147 · Cited by 31
“Primarily, evinacumab reduces LDL-C levels by up to 50% [83].”
Zimerman, A., Wiviott, S. D., Park, J., Murphy, S. A., Ran, X., Bramson, C., Curto, M., Ramos, V., Jevne, A., Kuder, J., et al. (2024) · European Journal of Preventive Cardiology · doi:10.1093/eurjpc/zwae090 · Cited by 28
New approaches to triglyceride reduction: is there any hope left?
Filtz, A., Parihar, S., Greenberg, G. S., Park, C. M., Scotti, A., Lorenzatti, D., Badimon, J. J., Soffer, D. E., Toth, P. P., Lavie, C. J., et al. (2024) · American Journal of Preventive Cardiology · doi:10.1016/j.ajpc.2024.100648 · Cited by 26
“…HoFH trial and a double-blind, placebo-controlled, phase 2 trial in patients with or without heterozygous familial hypercholesterolemia (HeFH), evinacu-mab also induced significant reductions in TG (up to 61.5 %); hence, evinacumab is being considered for the management of severe HTG [149 – 152].”
BackgroundInfluentialEffect of ANGPTL3 Inhibition With Solbinsiran in Preclinical and Early Human Studies
Ray, K. K., Linnebjerg, H., Michael, L. F., Shen, X. P., Ma, X., Lim, S., Zhen, Y., Dudek, H., Abrams, M., Saxena, U. H., et al. (2025) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2025.03.005 · Cited by 30
Drug development advances in human genetics‐based targets
Zhang, X., Yu, W., Li, Y., Wang, A., Cao, H., & Fu, Y. (2024) · MedComm · doi:10.1002/mco2.481 · Cited by 26
“132 Data from preclinical and clinical studies of evinacumab, a monoclonal antibody to ANGPTL3, provide additional support for a pathway independent of LDLR. 155 Therefore, inhibition of ANGPTL3 is expected to produce better therapeutic effects in patients with LDLR deficiency, such as HoFH.”
BackgroundDyslipidemia: A Narrative Review on Pharmacotherapy
de Oliveira, L. D., de Assis, A. C. R., Giraldez, V. Z. R., Scudeler, T. L., & Soares, P. R. (2024) · Pharmaceuticals · doi:10.3390/ph17030289 · Cited by 26
“…defined as an LDL-C level of 70 mg/dL or higher with clinical ASCVD or a level of 100 mg/dL or higher without clinical ASCVD and refractory to treatment with a PCSK9 inhibitor and a statin at a maximum tolerated dose, with or without ezetimibe; 72% of the sample had a diagnosis of HeFH [139].”
MethodThe Role of RNA-Targeted Therapeutics to Reduce ASCVD Risk: What Have We Learned Recently?
Miname, M. H., Rocha, V. Z., & Santos, R. D. (2021) · Current Atherosclerosis Reports · doi:10.1007/s11883-021-00936-1 · Cited by 25
Angiopoietin-Like 3 Antibody Therapy in Patients With Suboptimally Controlled Hyperlipidemia
Xie, X., Shi, X., Zhang, Y., Su, S., Jiang, C., Liu, M., Wang, J., Peng, D., Lv, L., Chai, X., et al. (2025) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2025.03.008 · Cited by 25
Atualização da Diretriz Brasileira de Hipercolesterolemia Familiar – 2021
Izar, M. C. D. O., Rocha, V. Z., Bertolami, A., Santos, R. D., Lottenberg, A. M., Assad, M. H. V., Saraiva, J. F. K., Chacra, A. P. M., Martinez, T. L. D. R., Bahia, L., et al. (2021) · Arquivos Brasileiros de Cardiologia · doi:10.36660/abc.20210788 · Cited by 35
May, L. T., Bartolo, B. A. D., Harrison, D. G., Guzik, T. J., Drummond, G. R., Figtree, G. A., Ritchie, R. H., Rye, K., & de Haan, J. B. (2022) · Clinical Science · doi:10.1042/cs20210862 · Cited by 23
New Therapeutic Approaches to the Treatment of Dyslipidemia 1: ApoC-III and ANGPTL3
Kim, J. Y., & Kim, N. H. (2023) · Journal of Lipid and Atherosclerosis · doi:10.12997/jla.2023.12.1.23 · Cited by 23
Alsayed, N., Almahmeed, W. A., Alnouri, F., Al-Waili, K., Sabbour, H. M., Sulaiman, K., Zubaid, M., Ray, K. K., & Al‐Rasadi, K. (2021) · Atherosclerosis · doi:10.1016/j.atherosclerosis.2021.11.022 · Cited by 23
Ballantyne, C. M., & Norata, G. D. (2025) · European Heart Journal · doi:10.1093/eurheartj/ehaf606 · Cited by 23
Unravelling lipoprotein metabolism with stable isotopes: tracing the flow
Ying, Q., Chan, D. C., Barrett, P. H. R., & Watts, G. F. (2021) · Metabolism · doi:10.1016/j.metabol.2021.154887 · Cited by 21
Albuquerque, E. L., Fulco, U. L., Caetano, E. W. S., & Freire, V. N. (2020) · Cambridge University Press eBooks · doi:10.1017/9781108774956.011 · Cited by 21
Umbrella Review on Non-Statin Lipid-Lowering Therapy
Beshir, S. A., Hussain, N., Elnour, A. A., & Said, A. S. A. (2021) · Journal of Cardiovascular Pharmacology and Therapeutics · doi:10.1177/10742484211002943 · Cited by 21
Angiopoietin-like 3: An important protein in regulating lipoprotein levels
Burks, K. H., Basu, D., Goldberg, I. J., & Stitziel, N. O. (2022) · Best Practice & Research Clinical Endocrinology & Metabolism · doi:10.1016/j.beem.2022.101688 · Cited by 21
Recent advances in targeted therapy for inflammatory vascular diseases
Zhao, K., Zeng, Z., He, Y., Zhao, R., Niu, J., Sun, H., Li, S., Dong, J., Jing, Z., & Zhou, J. (2024) · Journal of Controlled Release · doi:10.1016/j.jconrel.2024.06.063 · Cited by 21
Efficacy and Safety of Evinacumab for the Treatment of Hypercholesterolemia: A Meta-Analysis
Jin, M., Meng, F., Yang, W., Liang, L., Wang, H., & Zhenyan, F. (2021) · Journal of Cardiovascular Pharmacology · doi:10.1097/fjc.0000000000001073 · Cited by 22
The year in cardiovascular medicine 2021: dyslipidaemia
Tokgözoğlu, L. S., Orringer, C. E., Ginsberg, H. N., & Catapano, A. L. (2021) · European Heart Journal · doi:10.1093/eurheartj/ehab875 · Cited by 22
Hepatic fat changes with antisense oligonucleotide therapy targeting ANGPTL3
Zimerman, A., Wiviott, S. D., Park, J., Murphy, S. A., Ran, X., Bramson, C., Curto, M., Ramos, V., Jevne, A., Kuder, J., et al. (2023) · Journal of clinical lipidology · doi:10.1016/j.jacl.2023.12.001 · Cited by 22
Sawhney, J. P. S., & Madan, K. (2024) · Indian Heart Journal · doi:10.1016/j.ihj.2023.12.002 · Cited by 19
Gu, Z., Liu, T., Rao, W., Li, D., Zhang, Q., Dai, J., Huang, L., Wang, J., & Hou, X. (2024) · Advanced Functional Materials · doi:10.1002/adfm.202412335 · Cited by 20
Recent advances in the management and implementation of care for familial hypercholesterolaemia
Lan, N. S. R., Bajaj, A., Watts, G. F., & Cuchel, M. (2023) · Pharmacological Research · doi:10.1016/j.phrs.2023.106857 · Cited by 19
Targeting PCSK9 and Beyond for the Management of Low-Density Lipoprotein Cholesterol
Mohamed, F., Mansfield, B. S., & Raal, F. J. (2023) · Journal of Clinical Medicine · doi:10.3390/jcm12155082 · Cited by 20
“Safety and efficacy data of inclisiran, with a twice-yearly administration, could improve long-term adherence, making it a suitable alternative to traditional LLT and PCSK9 mAbs in patients who cannot achieve target LDL-C, particularly in patients with FH. 2.5.3.”
BackgroundMethodInfluentialBurks, K. H., Xie, Y., Gildea, M. A., Jung, I., Mukherjee, S. K., Lee, P. C., Pudupakkam, U., Wagoner, R., Patel, V., Santana, K., et al. (2024) · Journal of Lipid Research · doi:10.1016/j.jlr.2024.100500 · Cited by 19
“With regards to LDL clearance, studies of humans (including those with familial hypercholesterolemia (FH)) receiving evinacumab have yielded similar re-sults, demonstrating LDL lowering independently of LDLR (12, 30, 31, 35, 36).”
ResultGurevitz, C., & Rosenson, R. S. (2024) · European Journal of Preventive Cardiology · doi:10.1093/eurjpc/zwae388 · Cited by 19
Self-citationLow cholesterol states: clinical implications and management
Gill, P. K., & Hegele, R. A. (2023) · Expert Review of Endocrinology & Metabolism · doi:10.1080/17446651.2023.2204932 · Cited by 19
“cholesterol with remarkable efficacy in patients with severe and refractory familial hypercholesterolemia [132,133].”
BackgroundNewer and Emerging LDL-C Lowering Agents and Implications for ASCVD Residual Risk
Rikhi, R. R., & Shapiro, M. D. (2022) · Journal of Clinical Medicine · doi:10.3390/jcm11154611 · Cited by 19
“5% by subcutaneous and intravenous evinacumab at 16 weeks, respectively [57].”
Background
Metadata
- Authors
- Rosenson, R. S., Burgess, L. J., Ebenbichler, C. F., Baum, S. J., Stroes, E. S. G., Ali, S., Khilla, N., Hamlin, R., Pordy, R., Dong, Y., Son, V., & Gaudet, D.
- Affiliations
- Innsbruck Medical University (AT)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2020-12-10
- Volume
- 383
- Issue
- 24
- Pages
- 2307-2319
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W3098138308
- Semantic Scholar
- ac311c54adb72af58fcfc75c3ae055aadb835e6b
- Cited by
- 302
- References
- 41
- Citations by year
- 2026: 27 · 2025: 45 · 2024: 52 · 2023: 55 · 2022: 55 · 2021: 65 · 2020: 3
- FWCI
- 40.62
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- Regeneron Pharmaceuticals
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Lipid metabolism and disorders
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Biochemistry › Cholesterol and Lipid Metabolism
- Keywords
- evinacumab, LDL cholesterol lowering, ANGPTL3, heterozygous familial hypercholesterolemia, atherosclerosis, subcutaneous administration, intravenous administration, monoclonal antibodies, lipid-lowering therapy, adverse events, dose comparison, treatment efficacy and safety, atherosclerotic cardiovascular disease
- MeSH terms
- Angiopoietin-like Proteins, Angiopoietin-Like Protein 3, Adult, Antibodies, Monoclonal, Anticholesteremic Agents, Double-Blind Method, Drug Administration Schedule, Drug Resistance, Female, Humans, Hyperlipoproteinemia Type II, Infusions, Intravenous, Injections, Subcutaneous, Cholesterol, LDL, Male, Middle Aged, Antibodies, Monoclonal, Humanized
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