"Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein". The New England Journal of Medicine. 2008. 359(21):2195-2207. PubMed
Links to original sources: Wiki Journal Post Full Journal Article
Contents 1 Clinical Question 2 Bottom Line 3 Major Points 4 Guidelines 5 Design 6 Population 6.1 Inclusion Criteria 6.2 Exclusion Criteria 6.3 Baseline Characteristics 7 Interventions 8 Outcomes 8.1 Primary Outcome 8.2 Secondary Outcomes 9 Criticisms 10 Funding 11 Further Reading
Does rosuvastatin treatment reduce the incidence of major cardiovascular events in men and women with normal LDL levels but elevated C-reactive protein?
Rosuvastatin significantly reduced the incidence of major cardiovascular events in apparently healthy persons with elevated high-sensitivity C-reactive protein and without hyperlipidemia.
The JUPITER trial showed that in healthy adults with normal LDL but elevated high-sensitivity C-reactive protein (CRP), treatment with rosuvastatin significantly reduced rates of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, and cardiovascular death.
Updated guidelines should consider rosuvastatin therapy for primary prevention in individuals with elevated CRP.
- Multicenter, randomized, double-blind, placebo-controlled trial - N=17,802 - Rosuvastatin 20mg daily (n=8,901) vs. placebo (n=8,901) - Median follow-up: 1.9 years (maximum: 5.0 years) - Analysis: Intention-to-treat - Primary outcome: Occurrence of major cardiovascular events defined as nonfatal myocardial infarction, nonfatal stroke, arterial revascularization, hospitalization for unstable angina, or death from cardiovascular causes.
- Inclusion Criteria: Men ≥50 years and women ≥60 years with no history of cardiovascular disease, LDL cholesterol <130 mg/dL, high-sensitivity C-reactive protein ≥2.0 mg/L - Exclusion Criteria: Previous use of lipid-lowering therapy, postmenopausal hormone replacement therapy, hepatic dysfunction, creatinine kinase >3x upper limit, diabetes, uncontrolled hypertension, inflammatory diseases, or recent drug/alcohol abuse. - Baseline Characteristics: Varied population including 38.2% women and 25.2% Black or Hispanic; median LDL cholesterol 108 mg/dL.
- Rosuvastatin 20 mg daily or matching placebo.
- Primary Outcome: Rosuvastatin reduced the rate of the primary endpoint by 44% compared to placebo (HR 0.56; 95% CI 0.46-0.69; P<0.00001). - Secondary Outcomes: Significant reductions in the rates of myocardial infarction, stroke, arterial revascularization, and unstable angina. Modest but significant reduction in all-cause mortality with rosuvastatin.
- Early termination of the trial might have underestimated the rates of adverse events. - Increased rate of physician-reported diabetes in the rosuvastatin group.
Supported by AstraZeneca.
For full details on the JUPITER trial and discussion regarding its impact on clinical practice, refer to the New England Journal of Medicine article and supplementary materials.