Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein
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- 20 November 2008
- journal article
- research article
- Published by Massachusetts Medical Society in The New England Journal of Medicine
- Vol. 359 (21), 2195-2207
- https://doi.org/10.1056/nejmoa0807646
Abstract
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. 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. 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. 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.)Keywords
This publication has 28 references indexed in Scilit:
- C-reactive protein levels and coronary artery disease incidence and mortality in apparently healthy men and women: The EPIC-Norfolk prospective population study 1993–2003Atherosclerosis, 2006
- Inflammatory Markers and the Risk of Coronary Heart Disease in Men and WomenThe New England Journal of Medicine, 2004
- Implications of Recent Clinical Trials for the National Cholesterol Education Program Adult Treatment Panel III GuidelinesCirculation, 2004
- C-Reactive Protein Modulates Risk Prediction Based on the Framingham ScoreCirculation, 2004
- Lipoprotein-Associated Phospholipase A 2 , High-Sensitivity C-Reactive Protein, and Risk for Incident Coronary Heart Disease in Middle-Aged Men and Women in the Atherosclerosis Risk in Communities (ARIC) StudyCirculation, 2004
- European guidelines on cardiovascular disease prevention in clinical practice Third Joint Task Force of European and other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of eight societies and by invited experts)European Heart Journal, 2003
- Comparison of C-Reactive Protein and Low-Density Lipoprotein Cholesterol Levels in the Prediction of First Cardiovascular EventsThe New England Journal of Medicine, 2002
- C-Reactive Protein and Other Markers of Inflammation in the Prediction of Cardiovascular Disease in WomenThe New England Journal of Medicine, 2000
- Long-Term Effects of Pravastatin on Plasma Concentration of C-reactive ProteinCirculation, 1999
- Inflammation, Aspirin, and the Risk of Cardiovascular Disease in Apparently Healthy MenThe New England Journal of Medicine, 1997