Sunday, February 14, 2010

Cholesterol Drug Approved for People Without High Cholesterol

Are you willing to take Statin medication if you have normal or mild elevation of LDL-Cholesterol level, but with elevated CRP?

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).
Now there is even a study claiming that the Statin prevention in patients with elevated c-reaction protein deems to be cost-effective.

3 comments:

Anonymous said...

There have been quite a few CRP related trials, such as AFPCAPS, TexCAPS, PROV IT-TIMI, REVERSAL, A to Z, etc.

Lynn Shaffer said...

A question about JUPITER that is still unanswered for me is whether the effects of rosuvastatin were due to lowering CRP or lowering LDL-c, since both occurred in the intervention group. Even though LDL levels were "normal," you should still see a benefit from reducing LDL. Has anyone seen data from this trial which "teases out" these two effects?

Anonymous said...

According to "http://clinicaltrials.gov/ct2/show/NCT00239681?term=jupiter&rank=1", the inclusion criteria include subjects with "Low to normal levels of low density lipoprotein (LDL) cholesterol (< 130mg/dL)".
I believe that the subject group analysis was performed for subjects with normal LDL and with lower LDL.