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METEOR Trial

Measuring Effects of Intima-Media Thickness: An Evaluation of Rosuvastatin. METEOR Trial. Presented at the American College of Cardiology Annual Scientific Session March, 2007 Presented by Dr. John R. Crouse III. METEOR: Background.

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METEOR Trial

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  1. Measuring Effects of Intima-Media Thickness: An Evaluation of Rosuvastatin METEOR Trial Presented at the American College of Cardiology Annual Scientific Session March, 2007 Presented by Dr. John R. Crouse III

  2. METEOR: Background • Previous results from A Study to Evaluate the Effect of Rosuvastatin on Intravascular Ultrasound [ASTEROID] illustrated that intensive lipid lowering with rosuvastatin over 24 months resulted in a significant regression of coronary atherosclerosis as measured by intravascular ultrasound. • However, ASTEROID was not a placebo controlled study and did not have clinical end points. ACC 2007

  3. METEOR: Background • The goal of the present 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. ACC 2007

  4. METEOR Trial: Study Design 984 asymptomatic patients with moderately elevated cholesterol and low risk of CVD according to the National Cholesterol Education Program Adult Treatment Panel III guidelines criteria (0-1 risk factor and LDL 120-190mg/dL or > 2 risk factors and LDL 120 to <160mg/dL with a 10-year coronary heart disease risk < 10%); HDL-C <60mg/dL; triglycerides <500mg/dL; evidence of thickening of the walls of the extracranial carotid arteries as measured by B-mode ultrasound (max CIMT between 1.2 and <3.5mm) 5:2 Randomized. Double-blinded. Placebo-controlled. Mean age = 57 years. 40% Female. R Rosuvastatin (40mg) n=702 Placebo n=282 6, 12, 18 and 24 mos. follow-up • Primary Endpoint: Annualized rate of change in maximum CIMT • Secondary Endpoint: 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. ACC 2007

  5. METEOR Trial: Primary Endpoint Change in maximum CIMT with rosuvastatin vs. placebo • After two years, treatment with rosuvastatin was associated with a statistically significant reduction in the rate of progression of CIMT thickening in overall carotid segments, while the placebo group displayed progression (p<0.001). p < 0.001 Change in CIMT for 12 Carotid Artery sites (mm/year) Rosuvastatin n = 282 n = 702 Placebo ACC 2007

  6. METEOR Trial: Secondary Endpoint Change in maximum CIMT with rosuvastatin vs. placebo • After two years, treatment with rosuvastatin was associated with a statistically significant reduction in the rate of progression of CIMT thickening in common carotid sites, while the placebo group displayed progression (p<0.001). p < 0.001 Change in CIMT for common carotid sites (mm/year) Rosuvastatin n = 282 n = 702 Placebo ACC 2007

  7. METEOR Trial: Secondary Endpoint Change in maximum CIMT with rosuvastatin vs. placebo • After two years, treatment with rosuvastatin was associated with a statistically significant reduction in the rate of progression of CIMT thickening in carotid bulb sites, while the placebo group displayed progression (p<0.001). p < 0.001 Change in CIMT for carotid bulb sites (mm/year) Rosuvastatin n = 282 n = 702 Placebo ACC 2007

  8. METEOR Trial: Secondary Endpoint Change in maximum CIMT with rosuvastatin vs. placebo • After two years, treatment with rosuvastatin was associated with a statistically significant lower progression in CIMT thickening in internal carotid sites as compared with the placebo group (p=0.02) p = 0.02 Change in CIMT for internal carotid artery sites (mm/year) n = 702 n = 282 Rosuvastatin Placebo ACC 2007

  9. METEOR Trial: Limitations • 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 CRP. ACC 2007

  10. METEOR Trial: Summary • 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. ACC 2007

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