The Food and Drug Administration (FDA) has approved new labeling of rosuvastatin (Crestor®) for the primary prevention of coronary heart disease (CHD).

The approval was based on the Justification for the Use of statins in Prevention: an Intervention Trial Evaluation Rosuvastatin (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 low-density lipoprotein (LDL) of less than 130 mg/dL and a highly sensitive C-reactive protein (hsCRP) concentration of 2 mg/L or higher. The patients were randomized to rosuvastatin 20 mg for 1.9 years, which reduced median LDL cholesterol from a median of 108 mg/dL at baseline to 55 mg/dL. The corresponding relative reduction in the rate of myocardial infarction (MI), stroke, arterial revascularization, or cardiovascular death was 44% (P<0.00001).

There were adverse events noted throughout JUPITER, including 13 deaths due to gastrointestinal disorders in the rosuvastatin arm, and 18 patients reported experiencing a “confused state” while taking the drug. As expected, myalgia was among the most common side effects leading to discontinuation of the drug. There was a significant increase in investigator-reported, new-onset diabetes mellitus in the treatment arm—2.8% versus 2.3% (P<0.01)—and the number of patients with a glycosylated hemoglobin A_1c (HbA_1c) > 6.5% at the end of the trial was significantly higher in rosuvastatin-treated versus placebo-treated patients.

The new indication is for men 50 years of age and older and women 60 years of age and older with elevated hsCRP. Patients must also have at least one risk factor for coronary artery disease (CAD), such as high blood pressure, low high-density lipoprotein (HDL)-C, smoking, or a family history of premature CHD.

The FDA urges healthcare professionals to interpret the results of the JUPITER trial with caution when considering rosuvastatin. The results do not support the use of rosuvastatin in all patients with an elevated hsCRP. For example, there was no evidence that rosuvastatin provided benefit to people with an elevated hsCRP but no traditional cardiovascular risk factors.

Crestor is marketed by AstraZeneca, which sponsored the JUPITER trial.

1. Food and Drug Administration (FDA) [website]. Drugs. Questions and Answers for Healthcare Professionals: Crestor and the JUPITER Trial. Updated February 9, 2010. Available at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm199891.htm. Accessed February 10, 2010.

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This entry was posted on Wednesday, February 10th, 2010 at 12:00 pm.