The DOI matches its Crossref record; 25 of the 25 references it cites were found in a registry or an index.
Low-Density Lipoprotein Cholesterol–Lowering Effects of AMG 145, a Monoclonal Antibody to Proprotein Convertase Subtilisin/Kexin Type 9 Serine Protease in Patients With Heterozygous Familial Hypercholesterolemia: The Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder (RUTHERFORD) Randomized Trial
Abstract
Background—: Despite statin treatment, many patients with heterozygous familial hypercholesterolemia do not reach desired low-density lipoprotein cholesterol (LDL-C) targets. AMG 145, a fully human monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK9) serine protease, demonstrated significant reductions in LDL-C in phase 1 studies. This phase 2, multicenter, double-blind, randomized, placebo-controlled, dose-ranging study evaluated the efficacy and safety of AMG 145 in heterozygous familial hypercholesterolemia patients. Methods and Results—: Patients with heterozygous familial hypercholesterolemia diagnosed by Simon Broome criteria with LDL-C ≥2.6 mmol/L (100 mg/dL) despite statin therapy with or without ezetimibe were randomized 1:1:1 to AMG 145 350 mg, AMG 145 420 mg, or placebo-administered subcutaneously every 4 weeks. The primary end point was percentage change from baseline in LDL-C at week 12. Of 168 patients randomized, 167 received investigational product and were included in the full analysis set (mean [SD] age, 50 [13] years; 47% female; 89% white; mean [SD] baseline LDL-C, 4.0 [1.1] mmol/L (156 [42] mg/dL)). At week 12, LDL-C reduction measured by preparative ultracentrifugation (least squares mean [standard error (SE)]) was 43 (3)% and 55 (3)% with AMG 145 350 mg and 420 mg, respectively, compared with 1 (3)% increase with placebo ( P <0.001 for both dose groups). Serious adverse events (not considered treatment-related) occurred in 2 patients on AMG 145. Conclusions—: AMG 145 administered every 4 weeks yielded rapid and substantial reductions in LDL-C in heterozygous familial hypercholesterolemia patients despite intensive statin use, with or without ezetimibe, with minimal adverse events and good tolerability. Clinical Trial Registration—: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01375751.
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Self-citationDyslipidemia in obesity: Mechanisms and potential targets
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“process of the LDL receptor, which is regulated by the proprotein convertase subtilisin/kexin type 9 (PCSK9) [32,33].”
BackgroundEfficacy and Safety of Evolocumab in Reducing Lipids and Cardiovascular Events
Sabatine, M. S., Giugliano, R. P., Wiviott, S. D., Raal, F. J., Blom, D. J., Robinson, J., Ballantyne, C. M., Somaratne, R., Legg, J., Wasserman, S. M., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1500858 · Cited by 1,509
Self-citationA Century of Cholesterol and Coronaries: From Plaques to Genes to Statins
Goldstein, J. L., & Brown, M. S. (2015) · Cell · doi:10.1016/j.cell.2015.01.036 · Cited by 1,233
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Metadata
- Authors
- Raal, F., Scott, R., Somaratne, R., Bridges, I., Li, G., Wasserman, S. M., & Stein, E. A.
- Venue
- Circulation
- Published
- 2012-11-13
- Volume
- 126
- Issue
- 20
- Pages
- 2408-2417
- ISSN
- 0009-7322 (ISSN-L)
- 1524-4539
- OpenAlex
- W2103487568
- Cited by
- 508
- References
- 25
- FWCI
- 75.16
- Type
- journal article
- Language
- en
- Open access
- closed
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- CoChat. (2026). Citation check: Low-Density Lipoprotein Cholesterol–Lowering Effects of AMG 145, a Monoclonal Antibody to Proprotein Convertase Subtilisin/Kexin Type 9 Serine Protease in Patients With Heterozygous Familial Hypercholesterolemia: The Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder (RUTHERFORD) Randomized Trial. https://app.cochat.ai/papers/10.1161/circulationaha.112.144055
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- Raal, F., Scott, R., Somaratne, R., Bridges, I., Li, G., Wasserman, S. M., & Stein, E. A. (2012). Low-Density Lipoprotein Cholesterol–Lowering Effects of AMG 145, a Monoclonal Antibody to Proprotein Convertase Subtilisin/Kexin Type 9 Serine Protease in Patients With Heterozygous Familial Hypercholesterolemia: The Reduction of LDL-C With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder (RUTHERFORD) Randomized Trial. Circulation. https://doi.org/10.1161/circulationaha.112.144055
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