FDA Expands Rosuvastatin Use to People with Normal LDL

The FDA has approved the statin for reducing the risk of stroke, myocardial infarction, and revascularization procedures in individuals who have normal low-density lipoprotein (LDL) levels. The new labeling, recommended by an FDA advisory panel late last year, also marks the first time that a drug label will include an indication based on the biomarker highly-sensitive C-reactive protein, an inflammatory marker….

The new indication would be for men 50 or older and women 60 or older who have fasting LDL of less than 130 mg/dL, a highly-sensitive CRP of 2.0 mg/L or greater, triglycerides of less than 500 mg/dL, and no prior history of heart attack or stroke, or coronary heart disease risk.

The basis for the new labeling was the JUPITER trial, a randomized, placebo-controlled trial of 17,802 men and women with a mean age of 66 and no history of atherosclerosis. All participants had LDL of less than 130 mg/dL and a highly-sensitive C-reactive protein concentration of 2 mg/L or higher.

Patients were randomized to 20 mg of rosuvastatin for 1.9 years, which reduced median LDL cholesterol to 55 mg/dL, down from a median of 108 mg/dL at baseline. The corresponding relative reduction in the rate of MI, stroke, arterial revascularization, or cardiovascular death was 44% (P<0.00001).

The number needed to treat to avoid one cardiovascular event was 25.

Those results, according to Melvyn Rubenfire, MD, of the University of Michigan, were a “home run for JUPITER,” but it is not clear whether the results would be the same with another statin.

And there were some risks associated with rosuvastatin, including 13 deaths due to gastrointestinal disorders in the rosuvastatin arm, and 18 patients reported experiencing a “confused state” while taking the drug.

The most troubling adverse event, however, was an uptick in investigator-reported, new onset diabetes mellitus in the treatment arm, 2.8% versus 2.5% (P=0.015).

Press Release:AstraZeneca. US FDA approves new indication for Crestor (rosuvastatin calcium). February 9, 2010.