Statins are effective in lowering the production of lipids in the liver by inhibiting an enzyme involved in lipid synthesis. As with all drugs, statins also have numerous side effects, and Crestor (Rosuvastatin) blocks lipid production in other tissues causing severe pain.
Another side effect, with an unknown action mechanism, is lowering of inflammation. The large Justification for the Use of Statins in Primary Prevention: An Intervention Trial Evaluating Rosuvastatin (JUPITER) experiment revealed that lowering serum lipids, “blood cholesterol,” was not as important in decreasing cardiovascular risk, as lowering inflammation. The study showed, however, that Crestor could inexplicably lower cardiovascular risk by lowering inflammation. An FDA panel recently voted to recommend that the FDA consider approving Crestor to reduce cardiovascular risk in individuals with normal blood cholesterol, but elevated chronic inflammation.
JUPITER Study Showed that Lowering Inflammation Was More Important than Lowering Blood Cholesterol to Reduce Cardiac Risk
Numerous recent studies have failed to demonstrate that lowering dietary saturated fats and increasing polyunsaturated fats was effective in lowering rates of cardiovascular disease. At the same time, there was a puzzling contradiction that for some patients, statins, which effectively lower serum cholesterol, were still effective in improving the risk of heart disease. The JUPITER study solved the puzzle by using only individuals who already had low blood cholesterol. This group was separated into groups based on their level of chronic inflammation, as judged by blood tests for CRP. Treatment with Crestor reduced chronic inflammation, lowered CRP levels and also reduced the incidence of cardiovascular events. Thus, the ability of Crestor to decrease inflammation as an incidental side effect reduced cardiovascular risk.
Many Lifestyle Changes Are Safer and More Effective than Statins for Inflammation Control
The JUPITER study showed that control of inflammation lowered cardiac risk, but inflammation has already been identified as a major risk factor. Anti-inflammatory diets and exercise, when conscientiously used, are very effective in reducing cardiac risk. The JUPITER study demonstrated that an expensive drug designed to inhibit lipid metabolism and with significant negative side effects, could also lower inflammation. The question is why statins would be used to control inflammation when diet and exercise are more effective.
Many Anti-Inflammatory Drugs Are Available
Many steroidal and non-steroidal anti-inflammatory drugs are available by prescription and over-the-counter. These anti-inflammatory drugs have been evaluated for efficacy in reducing cardiovascular risk and for safety. If the statins represent a new class of anti-inflammatory drug, then it would make sense to develop that activity and eliminate the activities on lipid metabolism that cause the dangerous side effects of the statins.
FDA Evaluation of Statins as Anti-inflammatory Drugs
The JUPITER study showed that the health benefit from Crestor use was at least partially due to an unexpected anti-inflammatory activity. It is not known if other statins, with different structures and different side effects, also have anti-inflammatory activity. It would seem to make sense that clinical trials comparing the efficacy and safety of Crestor and other statins, to other existing anti-inflammatory drugs with demonstrated effectiveness in reducing cardiovascular risk, would be assessed before the FDA considers recommending any statins for use in reducing the inflammation-based risk of otherwise healthy individuals who have normal blood cholesterol, but elevated CRP.