New Indication for Rosuvastatin

The US FDA has granted an additional indication for rosuvastatin (Crestor, AstraZeneca), as an adjunct to diet to slow the progression of atherosclerosis in patients with elevated cholesterol. Currently, those with a 10-year Framingham risk of less than 10% usually receive conservative management focused on lifestyle interventions. Doctors will now have the option of prescribing rosuvastatin in such patients, something that provides the statin with an important advantage in the cholesterol-lowering marketplace, AstraZeneca notes.

The approval is based on the results of the Measuring Effects on Intima-Media Thickness: an Evaluation of Rosuvastatin (METEOR) trial, presented at the American College of Cardiology (ACC) meeting in March and published simultaneously in the Journal of the American Medical Association. The METEOR study showed that in low-risk individuals—those with a Framingham risk score of less than 10%—treatment with 40 mg of rosuvastatin slowed progression of carotid intima-media thickness (CIMT) compared with placebo.

Experts said the core clinical message from METEOR was that aggressive statin therapy seems to slow progression of atherosclerosis even in people in whom low-density lipoprotein (LDL)-cholesterol levels are low. And although there was no reduction in clinical events from rosuvastatin use, the investigators noted that increased CIMT has been linked to increased cardiovascular risk in asymptomatic adults, "and a reduced progression of CIMT in statin trials is congruent with a reduction in cardiovascular events."

Therapy did not produce disease regression, however, but this may have been related to the overall lower risk of patients in METEOR compared with participants in other studies that have shown disease regression with statins, the investigators noted at the time.

Practice Pearls

• Rosuvastatin 40 mg/day can reduce the progression of atherosclerosis in patients at low risk for symptomatic coronary artery disease with elevated LDL cholesterol and subclinical disease.
• Rosuvastatin significantly reduced the risk for disease progression (absence of progression, 52.1% vs 37.7%) but did not induce disease regression.

AstraZeneca. CRESTOR now indicated to slow the progression of atherosclerosis in patients with elevated cholesterol. November 9, 2007. Available at: https://www.astrazeneca.com/pressrelease/5359.aspx.
Crouse JR, Raichlen JS, Riley WA, et al for the METEOR Study Group. Effect of rosuvastatin on progression of carotid intima-media thickness in low-risk individuals with subclinical atherosclerosis: The METEOR trial. JAMA 2007; 297:1344-1353, 1376-1378.

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DID YOU KNOW:
The Long-term effects of fenofibrate in type 2 diabetes: The purpose of the study was to assess the effects of fenofibrate in type 2 diabetic patients. The study included participants with type 2 diabetes, aged 50-70 years and with serum cholesterol 3.0-5.5 mmol/l, plus either serum triacyl-glycerol 1.0-5.0 mmol/l or serum cholesterol:HDL-C ratio > 4. The patients were randomly assigned to placebo or micronized fenofibrate (200 mg per day) in a double-blind design for a period of five years. Statin use was allowed after randomization. Fenofibrate markedly reduced large VLDL particles and produced a clear shift in HDL subspecies towards smaller particles. It was concluded that fibrates continue to have a role in a subset of type 2 diabetic patients with moderate-to-severe hypertriacylglycerolaemia and that the fibrates should preferably be used in combination with statins.  Diabetologia,50 (2067-2075) 

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