JUPITER
Trial question
What is the role of rosuvastatin in preventing vascular events among healthy males and females with elevated CRP?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 17802
17802 patients (6801 female, 11001 male).
Inclusion criteria: healthy males and females with LDL-C levels < 130 mg/dL and hs-CRP levels ≥ 2.0 mg/L.
Key exclusion criteria: previous or current use of lipid-lowering therapy, current use of postmenopausal hormone-replacement therapy, evidence of hepatic dysfunction, diabetes, uncontrolled hypertension, uncontrolled hypothyroidism, and a recent history of alcohol or drug abuse.
Interventions
N=8901 rosuvastatin (20 mg daily).
N=8901 placebo (matching placebo daily).
Primary outcome
Incidence of MI, stroke, arterial revascularization, hospitalization for unstable angina, or CV death
0.77
1.36
1.4/100 py
1.0/100 py
0.7/100 py
0.3/100 py
0.0/100 py
Rosuvastatin
Placebo
Significant
decrease ▼
Significant decrease in the incidence of MI, stroke, arterial revascularization, hospitalization for unstable angina, or CV death (0.77/100 py vs. 1.36/100 py; HR 0.56, 95% CI 0.46 to 0.69).
Secondary outcomes
Significant decrease in the incidence of MI (0.17/100 py vs. 0.37/100 py; HR 0.46, 95% CI 0.3 to 0.7).
Significant decrease in the incidence of stroke (0.18/100 py vs. 0.34/100 py; HR 0.52, 95% CI 0.34 to 0.79).
Significant decrease in MI, stroke, or CV death (0.45 vs. 0.85; HR 0.53, 95% CI 0.4 to 0.69).
Safety outcomes
No significant differences in serious adverse events (15.2% vs. 15.5%, p=0.60), myopathy (0.1% vs. 0.1%, p=0.82) or cancer (3.4% vs. 3.5%, p=0.51).
Significant differences in physician-reported diabetes (3.0% vs. 2.4%, p = 0.01).
Conclusion
In healthy males and females with LDL-C levels < 130 mg/dL and hs-CRP levels ≥ 2.0 mg/L, rosuvastatin was superior to placebo with respect to the incidence of MI, stroke, arterial revascularization, hospitalization for unstable angina, or CV death.
Reference
Ridker PM, Danielson E, Fonseca FA et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008 Nov 20;359(21):2195-207.
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