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Measuring Effects on Intima-Media Thickness: An Evaluation of Rosuvastatin - METEOR – Presented at ACC 2007
Description:
The goal of the trial was to evaluate the effect of rosuvastatin compared with placebo on carotid intima-media thickness (CIMT) over 2 years among asymptomatic patients at low risk for cardiovascular disease.
Study Design
Study Design:
Patients Screened: 5,751
Patients Enrolled: 984
Mean Follow Up: 2 years
Mean Patient Age: Mean age, 57 years
Female: 40
Patient Populations:
Asymptomatic patients with moderately elevated cholesterol and low risk of cardiovascular disease according to the National Cholesterol Education Program Adult Treatment Panel III guideline criteria (0-1 risk factor and LDL 120-190 mg/dl or ≥2 risk factors and LDL 120 to <160 mg/dl with a 10-year coronary heart disease risk <10%); HDL-C ≤60 mg/dl; triglycerides <500 mg/dl; and evidence of thickening of the walls of the extracranial carotid arteries, as measured by B-mode ultrasound (maximum CIMT between 1.2 mm and <3.5 mm)
Exclusions:
Use of lipid-lowering therapies in the previous 12 months, clinical evidence of coronary artery disease or other peripheral atherosclerotic disease, prior revascularization procedures, 10-year coronary heart disease risk of 10% or more, diabetes mellitus, uncontrolled hypertension or familial hypercholesterolemia, or serum creatinine concentration >2 mg/dl
Primary Endpoints:
Annualized rate of change in maximum CIMT
Secondary Endpoints:
Annualized rate of change in maximum CIMT derived from the near and far walls of the right and left common carotid artery, the right and left carotid bulb, the right and left internal carotid artery, and annualized rate of change in mean CIMT for the near and far walls of the right and left common carotid artery
Drug/Procedures Used:
Patients were randomized 5:2 in a double-blind manner to rosuvastatin (40 mg; n = 702) or placebo (n = 282). Patients underwent carotid ultrasound prior to randomization and at 6, 12, 18, and 24 months. CIMT measurements were analyzed at a core laboratory blinded to treatment assignment.
Principal Findings:
At baseline, mean CIMT was 1.15 mm in the rosuvastatin group and 1.17 mm in the placebo group. Average low-density lipoprotein (LDL) levels were 155 mg/dl and 154 mg/dl, respectively. During treatment, LDL levels declined to a greater extent in the rosuvastatin group compared with the placebo group (to 78 mg/dl, a 48.8% decrease vs. to 152 mg/dl, a 0.3% decrease, p < 0.001), as did total cholesterol (-33.7% vs. +0.3%, p < 0.001). HDL levels increased from 50 mg/dl to 53 mg/dl in the rosuvastatin group and from 49 to 50 mg/dl in the placebo group (p < 0.001).
The primary endpoint of change in CIMT for 12 carotid artery sites showed nonsignificant regression in the rosuvastatin group (-0.0014 mm/year) and progression in the placebo group (0.0131 mm/year, p < 0.001 for rosuvastatin vs. placebo). Change in maximum CIMT for four common carotid artery sites also showed regression in the rosuvastatin group (-0.0038 mm/year) and progression in the placebo group (0.0084 mm/year, p < 0.001 for rosuvastatin vs. placebo).
Myalgia occurred in 12.7% of the rosuvastatin group and 12.1% of the placebo group. Serious adverse cardiovascular events were low in both groups (0.86% of the rosuvastatin group and 0% of the placebo group).
Interpretation:
Among asymptomatic patients at low risk for cardiovascular disease, treatment with rosuvastatin was associated with a reduction in CIMT compared with placebo at 2 years.
The ASTEROID trial previously showed regression in atherosclerosis disease, as assessed by intravascular ultrasound with rosuvastatin, but did not have a comparator arm. The impact of aggressive lipid lowering on clinical events was not evaluated in this trial, particularly given the low risk of the population. The larger JUPITER trial will evaluate the impact of rosuvastatin therapy on clinical events in patients with low to normal levels of LDL, but elevated levels of C-reactive protein.
References:
Crouse JR III, Raichlen JS, Riley WA, et al. Effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis: the METEOR Trial. JAMA 2007;297:1344-53.
Presented by Dr. John R. Crouse III at the American College of Cardiology Annual Scientific Session, New Orleans, LA, March 2007.
Keywords: Fluorobenzenes, Carotid Artery, Common, C-Reactive Protein, Atherosclerosis, Carotid Intima-Media Thickness, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Pyrimidines, Risk Factors, Hypercholesterolemia, Triglycerides, Sulfonamides, Myalgia
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