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Cited by 6,674Lipoproteins and Cardiovascular HealthAtherosclerosis and Cardiovascular DiseasesCancer, Lipids, and Metabolism

Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein

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Ridker, Paul M, Danielson, Eleanor, Fonseca, Francisco A.H., Genest, Jacques, Gotto, Antonio M., Kastelein, John J.P., Koenig, Wolfgang, Libby, Peter +6 more·2008·New England Journal of Medicine
DOI 10.1056/nejmoa0807646
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Abstract

BACKGROUND: Increased levels of the inflammatory biomarker high-sensitivity C-reactive protein predict cardiovascular events. Since statins lower levels of high-sensitivity C-reactive protein as well as cholesterol, we hypothesized that people with elevated high-sensitivity C-reactive protein levels but without hyperlipidemia might benefit from statin treatment. METHODS: We randomly assigned 17,802 apparently healthy men and women with low-density lipoprotein (LDL) cholesterol levels of less than 130 mg per deciliter (3.4 mmol per liter) and high-sensitivity C-reactive protein levels of 2.0 mg per liter or higher to rosuvastatin, 20 mg daily, or placebo and followed them for the occurrence of the combined primary end point of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from cardiovascular causes. RESULTS: The trial was stopped after a median follow-up of 1.9 years (maximum, 5.0). Rosuvastatin reduced LDL cholesterol levels by 50% and high-sensitivity C-reactive protein levels by 37%. The rates of the primary end point were 0.77 and 1.36 per 100 person-years of follow-up in the rosuvastatin and placebo groups, respectively (hazard ratio for rosuvastatin, 0.56; 95% confidence interval [CI], 0.46 to 0.69; P<0.00001), with corresponding rates of 0.17 and 0.37 for myocardial infarction (hazard ratio, 0.46; 95% CI, 0.30 to 0.70; P=0.0002), 0.18 and 0.34 for stroke (hazard ratio, 0.52; 95% CI, 0.34 to 0.79; P=0.002), 0.41 and 0.77 for revascularization or unstable angina (hazard ratio, 0.53; 95% CI, 0.40 to 0.70; P<0.00001), 0.45 and 0.85 for the combined end point of myocardial infarction, stroke, or death from cardiovascular causes (hazard ratio, 0.53; 95% CI, 0.40 to 0.69; P<0.00001), and 1.00 and 1.25 for death from any cause (hazard ratio, 0.80; 95% CI, 0.67 to 0.97; P=0.02). Consistent effects were observed in all subgroups evaluated. The rosuvastatin group did not have a significant increase in myopathy or cancer but did have a higher incidence of physician-reported diabetes. CONCLUSIONS: In this trial of apparently healthy persons without hyperlipidemia but with elevated high-sensitivity C-reactive protein levels, rosuvastatin significantly reduced the incidence of major cardiovascular events. (ClinicalTrials.gov number, NCT00239681.)

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  1. [2]2. National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation 2002;106:3143-421.

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Authors
Ridker, P. M., Danielson, E., Fonseca, F. A. H., Genest, J., Gotto, A. M., Kastelein, J. J. P., Koenig, W., Libby, P., Lorenzatti, A. J., MacFadyen, J. G., Nordestgaard, B. G., Shepherd, J., Willerson, J. T., & Glynn, R. J.
Affiliations
  • Brigham and Women's Hospital (US)
  • Universidade Federal de São Paulo (BR)
  • McGill University Health Centre (CA)
  • Amsterdam UMC Location University of Amsterdam (NL)
  • Herlev Hospital (DK)
  • University of Glasgow (GB)
  • Baylor St. Luke's Medical Center (US)
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2008-11-20
Volume
359
Issue
21
Pages
2195-2207
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa0807646
OpenAlex
W2137983259
Cited by
6,674
References
72
Citations by year
2026: 257 · 2025: 247 · 2024: 271 · 2023: 269 · 2022: 312 · 2021: 293 · 2020: 305 · 2019: 315 · 2018: 314 · 2017: 312 · 2016: 367 · 2015: 366 · 2014: 441 · 2013: 448 · 2012: 445
FWCI
598.35
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • Data Archiving and Networked Services (DANS) (submittedVersion)
  • Pure Amsterdam UMC (submittedVersion)
  • UNIFESP Institutional Repository (Universidade Federal de São Paulo) (submittedVersion)
  • Repositorio Institucional (Pontificia Universidad Javeriana) (submittedVersion, cc-by-nc)
Topics
  • Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
  • Life Sciences › Immunology and Microbiology › Immunology › Atherosclerosis and Cardiovascular Diseases
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer, Lipids, and Metabolism
Keywords
rosuvastatin, high-sensitivity C-reactive protein, statin therapy, cardiovascular disease prevention, inflammation, LDL cholesterol, myocardial infarction, stroke, vascular events, low LDL cholesterol, cardiovascular risk reduction, primary prevention, men, revascularization, unstable angina, cardiovascular mortality, cardiovascular hospitalization, LDL cholesterol lowering
MeSH terms
Rosuvastatin Calcium, Aged, C-Reactive Protein, Cardiovascular Diseases, Diabetes Mellitus, Double-Blind Method, Female, Fluorobenzenes, Follow-Up Studies, Glycated Hemoglobin, Humans, Cholesterol, LDL, Male, Middle Aged, Muscular Diseases, Myocardial Infarction, Pyrimidines, Sulfonamides, Biomarkers, Proportional Hazards Models, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Stroke, Kaplan-Meier Estimate

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