Last week, FDA approved new indication for Crestor - one of the Statin class cholesterol lowering drug. This new indication has nothing to do with cholesterol level, but it is based on the CRP (c-reaction protein). Wall Street Jounal Health Blog had an article titled "Cholesterol drug approved for people without high cholesterol". It seems to me that we have now invented another disease - perhpas hyperCRP (instead of hypercholesterolemia). American are now perhaps inventing more diseases/indications than ever before. In the end, both cholesterol level and CRP level are surrogate endpoint. While the relationship between high cholesterol level and the major cardiovascular events (mortality, MI, stroke,...) has been generally recognized, the relationship between high CRP and the major cardiovascular events mainly relies on one study - JUPITER study - a study stopped early for efficacy.When the conflict of interest issue is considered, the purpose of the study is questioned and skeptical. According to the web blog, there are two conflict of interest issues in this study: "first, the study was funded by AstraZeneca, maker of the study drug, rosuvastatin (Crestor); second, the first author, Paul Ridker of Harvard, owns a patent on the high-sensitivity test for C-reactive protein, the test that would be widely used if the study results are accepted."
It will be inevitable that the next step for pharmaceutical companies like AstraZeneca is to push for routine testing of CRP (CRP screening) in clinical practice to identify the patients with normal or mild elevated LDL-Cholesterol level, but with elevated CRP. A cut point (or normal range) for CRP will be established. This is just how it works in capitalism world.
To find out how convincing of the evidences from JUPITER trial, you can read the publications by yourself. While the evidences seem to be convincing, I just don't want to take medications just for the elevated CRP. Perhaps, instead of the benefit from taking long-term treatment of Crestor, the treatment effect is really due to the detrimental effect of long-term treatment of Placebo. Perhaps, the treatment effect will be gone if we compare the Crestor with no-treatment (instead of Placebo).
- JUPITER hits New Orleans: landmark study shows statins benefit healthy individuals with high CRP levels
- Rosuvastatin to prevent vascular events in men and women with elevated c-reaction protein
- JUPITER study slides
- The Jupiter Study, CRP Screening, and Aggressive Statin Therapy-implications for the Primary Prevention of Cardiovascular Disease