The FDA has approved Crestor (rosuvastatin) for the primary prevention of cardiovascular disease in individuals who have no clinically evident heart disease but exhibit all three of the following risk factors:

  • Age (>50 years in men; >60 years in women)
  • Elevated high-sensitivity C-reactive protein (hsCRP) (>2 mg/L)
  • Presence of at least one additional cardiovascular risk factor (i.e., high BP, low HDL, a smoking habit, or a family history of premature heart disease)

The new indication expands Crestor’s previously approved uses as an agent to lower cholesterol and triglycerides in combination with diet and exercise in patients with high cholesterol and/or triglycerides, and to slow the progression of atherosclerosis. The FDA notes that this is the first time the drug has been approved for use in the prevention of heart disease in individuals with normal LDL levels and no clinically evident heart disease.

The approval is based on results from the JUPITER trial (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluation Rosuvastatin), which showed that Crestor-treated individuals with no clinically evident heart disease and LDL <130 mg/dL had a lower risk of suffering a major cardiovascular event (cardiovascular death, nonfatal heart attack, nonfatal stroke, hospitalization for unstable angina, and arterial revascularization) compared with individuals receiving a placebo (44% relative risk reduction). Based on these results, the JUPITER trial was stopped after only two years.

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JUPITER participants with impaired fasting glucose at baseline showed a 34% reduction in major cardiovascular events with the use of Crestor, but an unexpected increase in the development of diabetes was also seen among the Crestor users. (Previous research suggested that this may be an effect of all statins and not unique to Crestor.)

The FDA states that Crestor should not be used in all patients with an elevated hsCRP level and that clinicians should interpret the study findings with caution. For more information, visit the FDA Web site.