Abstract
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AIMS: On the basis of the JUPITER trial, European health authorities
recently approved the use of rosuvastatin to reduce first major
cardiovascular events among 'high' global risk primary prevention
patients defined either by Framingham risk score >20% or European
systematic coronary risk evaluation (SCORE) =5%. However, as these
are post hoc analyses, data describing these subgroups have not
previously been available to the clinical community.
METHODS AND RESULTS: We randomized 17 802 apparently healthy men
aged =50 and women =60 with low-density lipoprotein cholesterol
(LDL-C) <3.4 mmol/L, who were at an increased vascular risk
due to elevated levels of C-reactive protein measured with a high-sensitivity
(hs) assay to rosuvastatin 20 mg daily or placebo. Patients with
high global cardiovascular risk at baseline were identified by
10-year Framingham risk score >20% or SCORE risk =5%. During
1.8-year median follow-up (maximum 5 years) of patients with Framingham
risk >20%, the rate of myocardial infarction/stroke/cardiovascular
death was 9.4 and 18.2 per 1000 person-years in rosuvastatin and
placebo-allocated patients, respectively [hazard ratio (HR): 0.50,
95% confidence interval (CI): 0.27-0.93, P = 0.028]. Among patients
with SCORE risk =5%, the corresponding rates were 6.9 and 12.0
using a model extrapolating risk for age =65 years (HR: 0.57,
95% CI: 0.43-0.78, P = 0.0003) and rates were 5.9 and 12.7 when
risk for age was capped at 65 years (HR: 0.47, 95% CI: 0.32-0.68,
P < 0.0001).
CONCLUSION: In primary prevention patients with elevated hs C-reactive
protein who have high global cardiovascular risk (10-year Framingham
risk score >20% or SCORE risk =5%), but LDL-C levels not requiring
pharmacologic treatment, rosuvastatin 20 mg significantly reduced
major cardiovascular events.
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