Cited by 722Lipoproteins and Cardiovascular HealthLipid metabolism and disordersCholesterol and Lipid Metabolism

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A 52-Week Placebo-Controlled Trial of Evolocumab in Hyperlipidemia

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Blom, Dirk J., Hala, Tomas, Bolognese, Michael, Lillestol, Michael J., Toth, Phillip D., Burgess, Lesley, Ceska, Richard, Roth, Eli, Koren, Michael J., Ballantyne, Christie M., Monsalvo, Maria Laura, Tsirtsonis, Kate, Kim, Jae B., Scott, Rob, Wasserman, Scott M., Stein, Evan A.·2014·New England Journal of Medicine

DOI 10.1056/nejmoa1316222

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Abstract

BACKGROUND: Evolocumab, a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), significantly reduced low-density lipoprotein (LDL) cholesterol levels in phase 2 studies. We conducted a phase 3 trial to evaluate the safety and efficacy of 52 weeks of treatment with evolocumab. METHODS: We stratified patients with hyperlipidemia according to the risk categories outlined by the Adult Treatment Panel III of the National Cholesterol Education Program. On the basis of this classification, patients were started on background lipid-lowering therapy with diet alone or diet plus atorvastatin at a dose of 10 mg daily, atorvastatin at a dose of 80 mg daily, or atorvastatin at a dose of 80 mg daily plus ezetimibe at a dose of 10 mg daily, for a run-in period of 4 to 12 weeks. Patients with an LDL cholesterol level of 75 mg per deciliter (1.9 mmol per liter) or higher were then randomly assigned in a 2:1 ratio to receive either evolocumab (420 mg) or placebo every 4 weeks. The primary end point was the percent change from baseline in LDL cholesterol, as measured by means of ultracentrifugation, at week 52. RESULTS: Among the 901 patients included in the primary analysis, the overall least-squares mean (±SE) reduction in LDL cholesterol from baseline in the evolocumab group, taking into account the change in the placebo group, was 57.0±2.1% (P<0.001). The mean reduction was 55.7±4.2% among patients who underwent background therapy with diet alone, 61.6±2.6% among those who received 10 mg of atorvastatin, 56.8±5.3% among those who received 80 mg of atorvastatin, and 48.5±5.2% among those who received a combination of 80 mg of atorvastatin and 10 mg of ezetimibe (P<0.001 for all comparisons). Evolocumab treatment also significantly reduced levels of apolipoprotein B, non-high-density lipoprotein cholesterol, lipoprotein(a), and triglycerides. The most common adverse events were nasopharyngitis, upper respiratory tract infection, influenza, and back pain. CONCLUSIONS: At 52 weeks, evolocumab added to diet alone, to low-dose atorvastatin, or to high-dose atorvastatin with or without ezetimibe significantly reduced LDL cholesterol levels in patients with a range of cardiovascular risks. (Funded by Amgen; DESCARTES ClinicalTrials.gov number, NCT01516879.).

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Authors: Blom, D. J., Hala, T., Bolognese, M., Lillestol, M. J., Toth, P. D., Burgess, L., Ceska, R., Roth, E., Koren, M. J., Ballantyne, C. M., Monsalvo, M. L., Tsirtsonis, K., Kim, J. B., Scott, R., Wasserman, S. M., & Stein, E. A.
Affiliations: University of Cape Town (ZA)
National Institutes of Health (US)
Midwest Institute for Clinical Research (US)
Stellenbosch University (ZA)
Sterling Research Group (US)
Jacksonville Center for Clinical Research (US)
Houston Methodist (US)
Amgen (United States) (US)
Amgen (United Kingdom) (GB)
ORCID: Blom, Dirk J.
Bolognese, Michael
Burgess, Lesley
Roth, Eli
Koren, Michael J.
Ballantyne, Christie M.
Monsalvo, Maria Laura
Kim, Jae B.
Wasserman, Scott M.
Venue: New England Journal of Medicine
Publisher: Massachusetts Medical Society
Published: 2014-05-08
Volume: 370
Issue: 19
Pages: 1809-1819
ISSN: 0028-4793 (ISSN-L)
1533-4406
DOI: 10.1056/nejmoa1316222
OpenAlex: W2155259933
Semantic Scholar: 8d480541d9ba40d0cf45fea465f3b42bfc2b2f19
Cited by: 720
References: 16
Citations by year: 2026: 25 · 2025: 35 · 2024: 44 · 2023: 44 · 2022: 26 · 2021: 33 · 2020: 46 · 2019: 49 · 2018: 62 · 2017: 92 · 2016: 110 · 2015: 103 · 2014: 48
FWCI: 116.60
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: New England Journal of Medicine (publishedVersion)
PubMed (publishedVersion)
Open University of Cape Town (University of Cape Town) (submittedVersion)
Funders: Amgen
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: evolocumab, PCSK9 inhibition, hyperlipidemia, LDL cholesterol lowering, monoclonal antibodies, atorvastatin, ezetimibe, apolipoprotein B, lipoprotein(a), triglycerides, non-HDL cholesterol, treatment safety
MeSH terms: Atorvastatin, Ezetimibe, Proprotein Convertase 9, Adult, Aged, Antibodies, Monoclonal, Azetidines, Combined Modality Therapy, Double-Blind Method, Female, Heptanoic Acids, Humans, Hyperlipidemias, Cholesterol, LDL, Male, Middle Aged, Pyrroles, Serine Endopeptidases, Least-Squares Analysis, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Proprotein Convertases, Antibodies, Monoclonal, Humanized

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A 52-Week Placebo-Controlled Trial of Evolocumab in Hyperlipidemia

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