Statins (rosuvastatin) and Their Use Among Individuals With Normal "Bad" Cholesterol (LDL) Levels

Statins, also known as HMG-CoA reductase inhibitors, are a class of drugs that reduce the level of "bad" cholesterol in your blood known as low-density lipoprotein cholesterol (LDL-c). Statin therapy has been approved for patients who have been diagnosed with vascular disease, diabetes, or who have an increased level of cholesterol in their blood (hyperlipidemia). However, nearly 50% of all heart attacks (myocardial infarctions) occur in individuals with levels of LDL-c (bad cholesterol) are low enought that they would not be required to even take a statin medication.

Because of the high number of individuals how have heart attacks without elevated levels of cholesterol, a group of physicians became interested in determining if statins are useful in people with near normal levels of cholesterol. The authors of the JUPITER (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin) trial, a paper published in the November 2008 issue of The New England Journal of Medicine, wanted to see if patients without increased levels of "bad" cholesterol (LDL-C) would benefit from the use of statins. The authors decided to use high sensitivity C-reactive protein (an inflammatory biomarker that can predict cardiovascular events) as the variable which could determine patient outcome.

The authors believed that even healthy people with levels of LDL cholesterol below current treatment levels BUT with increased levels of high-sensitivity C-reactive protein might benefit from statin therapy. The study was conducted on men 50 years of age or older and women 60 years of age or older who had a LDL cholesterol level of less than 130 mg per deciliter, a high sensitivity C-reactive protein level of 2.0 mg per liter or greater, and no history of cardiovascular disease. The experimental group received 20 mg of rosuvastatin and the control group received a placebo. Patients were followed for approximately 2 years.

The study found patients on rosuvastatin (marketed by AstraZeneca under the name Crestor) had a significant reduction in the incidence of major cardiovascular events when compared to the placebo group. The study also demonstrated reductions in cadiovascular events for women and black and hispanic populations who took rosuvastatin when compared to placebo. Incidence of myopathy, hepartic injury, and cancer occurred less frequently within the rosuvastatin group than with placebo. The rosuvastatin group experienced a reduction in LDL cholesterol levels by 50% and a reduction in high-sensitivity C-reactive protein levels by 37%.

Whether or not patients with normal levels of LDL-cholesterol but increased levels of high-sensitivity C-reactive protein should be placed on statin thereapy remains uncertain. The question also remains whether or not physicians should be screening individuals for elevated levels of high-sensitivity C-reactive protein. Clearly, patients with normal levels of LDL-cholesterol and increased levels of high-sensitivity C-reactive protein benefit from statin therapy. However, the JUPITER trial did not address if statin therapy was beneficial in patients with both normal LDL-cholesterol and high-sensitivity C-reactive protein levels. This group of patients should be evaluated before all "healthy" patients at an increased age should be placed on statin therapy. For more information regarding critique of the JUPITER trial can be found in the January 2009 issue of the Cleveland Clinic Journal of Medicine.

Currently, some physicians are prescribing statins, specifically rosuvastatin (Crestor), in patients over the age of fifty who do not have increased levels of "bad" cholesterol. Though the benefits discovered in the JUPITER trial were exciting, the long term effects of taking statins in individuals with normal levels of LDL-c are not known.

All patients should continue to lead a life of exercise and maintain a balanced diet in order to keep LDL-cholesterol and total cholesterol at or below normal levels.