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JUPITER TRIAL |
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| Problem | Primary prevention (raised CRP) |
| Format | Double-blinded multi-center RCT |
| Treatment | Rosuvastatin |
| Control | Placebo |
| Population | 17,802 patients |
| Inclusion criteria | All of: Men 50 years of age or older and women 60 years of age or older No history of cardiovascular disease LDL cholesterol level of less than 130 mg per deciliter (3.4 mmol per liter) High-sensitivity C-reactive protein level of 2.0 mg per liter or more Triglyceride level of less than 500 mg per deciliter (5.6 mmol per liter). Needed to pass a 4 week placebo run-in |
| Exclusion criteria | Previous or current use of lipid-lowering therapy Current use of postmenopausal hormone-replacement therapy Evidence of hepatic dysfunction (an alanine aminotransferase level that was more than twice the upper limit of the normal range) Creatine kinase level that was more than three times the upper limit of the normal range Creatinine level that was higher than 2.0 mg per deciliter (176.8 Î_mol per liter) Diabetes Uncontrolled hypertension (systolic blood pressure >190 mm Hg or diastolic blood pressure >100 mm Hg) Cancer within 5 years before enrollment (with the exception of basal-cell or squamous-cell carcinoma of the skin) Uncontrolled hypothyroidism (a thyroid-stimulating hormone level that was more than 1.5 times the upper limit of the normal range) Recent history of alcohol or drug abuse or another medical condition that might compromise safety or the successful completion of the study Patients with inflammatory conditions such as severe arthritis, lupus, or inflammatory bowel disease were excluded, as were patients taking immunosuppressant agents such as cyclosporine, tacrolimus, azathioprine, or long-term oral glucocorticoids (due to the trial's investigation of high-sensitivity CRP) |
| Follow-up | Median 1.9 years; max 5 years |
| Primary endpoint | First major cardiovascular event, defined as nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, an arterial revascularization procedure, or confirmed death from cardiovascular causes |
| Secondary endpoint(s) | Secondary end points included the components of the primary end point considered individually — arterial revascularization or hospitalization for unstable angina, myocardial infarction, stroke, or death from cardiovascular causes — and death from any cause. |
| Details | - |
| Brief summary: | Rosuvastatin reduces mortality in low LDL but raised CRP patients |
| PAPER: Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein | |
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| Date | 20 Nov 2008 |
| Journal | N Engl J Med. 2008 Nov 20;359(21):2195-207. |
| Information | Rosuvastatin 20 vs Placebo in -'Healthy' men > 50 & women > 60 -With LDL < 3.4 (130) & CRP > 2.0 Significant reduction in -Combined primary end-point -All-cause mortality, MI, stroke & CV death -Arterial revascularization or unstable angina |