SLOWING DOWN
METEOR trial shows rosuvastatin delays progression of atherosclerosis in people at low risk of coronary heart disease
Rosuvastatin (Crestor) slows down the progression of atherosclerosis in patients with moderately increased levels of bad cholesterol and at a low risk of developing coronary heart disease (CHD).
This was the highlight of the results of the METEOR (Measuring Effects on intima media thickness: an Evaluation of Rosuvastatin) trial, the first study to show a positive effect on atherosclerosis in people with early signs of carotid-artery disease and at low risk of CHD.
The results, presented at the recent 56th scientific sessions of the American College of Cardiology and published in the Journal of the American Medical Association on March 28, showed that patients given 40-mg rosuvastatin had a significantly slower rate of atherosclerosis progression than those given placebo. When assessed versus baseline, no significant progression was observed in the 40-mg-rosuvastatin arm over the two-year duration of the study, while significant progression was observed in the placebo arm.
 |
The data demonstrated that patients with moderately increased levels (mean 154 mg/dL) of low-density lipoproteints (LDL) and no established atherosclerosis who were given rosuvastatin 40 mg experienced a 0.0014 mm per year decrease in the mean maximum carotid-intima-media thickness (IMT)-a marker of atherosclerotic burden. On the other hand, those given placebo experienced a progression of 0.0131 mm/year (p < 0.0001). Rosuvastatin was well tolerated during the two years of the study.
With the completion of this study, rosuvastatin has now been studied across the atherosclerosis-disease spectrum, first with ASTEROID (A Study To Evaluate the Effect of Rosuvastatin On Intravascular Ultrasound-Derived Coronary Atheroma Burden), which included patients with established coronary- artery disease and at a high risk of CHD events, and now with METEOR, which evaluated rosuvastatin in asymptomatic subjects with early disease and at low CHD risk.
People at low risk of CHD as described in the METEOR study had a Framingham 10-year risk of less than 10 percent. The Framingham risk score is a method to determine an individual's risk of having either a fatal or nonfatal heart attack over the following 10 years. The risk score is based on an individual's cholesterol level, blood pressure, smoking status, age, and gender.
"It's exciting to see that by using rosuvastatin we can potentially slow or even stop the disease progression in people with relatively modest atherosclerosis," said lead investigator Dr. John Crouse III, professor of medicine and public-health sciences and associate director of the Wake Forest University School of MedicineGeneral Clinical Research Center. "METEOR provides evidence that the effect of rosuvastatin on dyslipidemia translates into a beneficial effect on the progression of atherosclerosis."
Atherosclerosis occurs when there is a buildup of fatty or fibrous deposits to form plaques in the artery wall. The buildup of plaques causes the artery to narrow, which can reduce the blood supply to vital organs such as the heart and brain, resulting in symptoms such as angina or transient ischemic attacks. Plaques can also rupture leading to thrombus formation, which can result in a sudden, complete blockage of blood flow. In the heart, this causes a heart attack, and in the brain, this causes a stroke. Atherosclerosis is a progressive disease and the main cause of cardiovascular disease-the number-one killer worldwide.
 |
A recently published independent post hoc analysis combining data from four prospective trials including ASTEROID showed that by substantially both decreasing LDL and increasing high-density lipoproteins by more than 7.5 percent, a beneficial effect on atherosclerosis can be achieved. In METEOR, rosuvastatin was associated with a 48.8-percent reduction in LDL and an eight-percent increase in HDL (both p < 0.0001 v. placebo). These results were consistent with those of ASTEROID and provide additional confirmation that the lowering of LDL and raising of HDL offered by rosuvastatin translate into beneficial effects on atherosclerosis.
METEOR was a 24-month, randomized, double-blind, placebo-controlled, international study to evaluate the effect of rosuvastatin 40 mg in 984 asymptomatic, hypercholesterolemic patients with a low risk of CHD (Framingham 10 year risk <10 percent) and evidence of subclinical atherosclerotic disease as determined by a thickened carotid-artery wall (maximum IMT >1.2 and <3.5 mm). METEOR used B-mode ultrasound imaging to assess and measure change in mean maximum IMT of 12 vessel sites in the carotid artery. The study evaluated low-risk subjects not indicated for statin therapy to permit inclusion of a comparative placebo arm.
These new results from METEOR add to the wealth of efficacy data on rosuvastatin from the extensive GALAXY clinical-trials program designed to address important unanswered questions in statin research and to investigate the impact of rosuvastatin on cardiovascular-risk reduction and patient outcomes. Currently, more than 63,000 patients have been recruited from 55 countries worldwide to participate in the GALAXY program.
M
|
