A randomised clinical trial investigating the effect of rosuvastatin versus placebo in apparently healthy individuals with low LDL-cholesterol levels of less than 130 mg per deciliter but elevated C-reactive-protein (high-sensitivity C-reactive protein levels of 2.0 mg per liter or higher)
| Studied treatment | rosuvastatin 20 mg daily |
| Control treatment | placebo |
| Women (%) | 38% |
| Total cholesterol (mmol/l) | 185 mg/dl |
| LDL change, end of study (%) | -50% |
| Patients | apparently healthy individuals with low LDL-cholesterol levels of less than 130 mg per deciliter but elevated C-reactive-protein (high-sensitivity C-reactive protein levels of 2.0 mg per liter or higher) |
| Group sizes | 8901 / 8901 |
| Inclusion criteria | males aged 50 years and older and females aged 60 years and older with no history of MI, stroke, or arterial revascularisation; 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) |
| 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), a creatine kinase level that was more than three times the upper limit of the normal range, a creatinine level that was higher than 2.0 mg per deciliter (176.8 ìmol 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), and a recent history of alcohol or drug abuse or another medical condition that might compromise safety or the successful completion of the study |
| prior MI or CHD (%) | |
| LDL (mmol/l) | 108 mg/dl |
| HDL (mmol/l) | 49 mg/dl |
| Triglycerides (mg/dl) | 118 mg/dl |
| Diabetes(%) | |
| BMI (kg/m2) | 28.3 |
| Stroke history | |
| LV hypertrophy | |
| History of hypertension (%) |
| Blindness | double blind | Inclusion period | feb 2003 - dec 2006 |
| Follow-up duration | median 1.9 year | Centers | 1200 |
| Lost to FU | geographical localisation | 26 countries | |
| Primary endpoint | MI, stroke, arterial revascularization, hospitalization for unstable angina, cardiovascular death | Design | Parallel groups |
| PeriodeInclusion | feb 2003 - dec 2006 | ||
| Hypothese | Superiority |
Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJ, Koenig W, Libby P, Lorenzatti AJ, Macfadyen JG, Nordestgaard BG, Shepherd J, Willerson JT, Glynn RJ Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein. N Engl J Med 2008 Nov 9;: [PMID: 18997196] link to pdf add to Mendeley
Links
ClinicalTrial.gov record NCT00239681
Appears in following systematic reviews:
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