Authors |
PM Ridker, E Danielson, FAH Fonseca, J Genest, AM Gotto Jr , JJP Kastelein, W Koenig, P Libby, AJ Lorenzatti, JG MacFadyen, BG Nordestgaard, J Shepherd, JT Willerson, RJ Glynn, for the JUPITER Study Group. |
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Title |
Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein |
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Full source | N Engl J Med 2008;359:2195-207 | |
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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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