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Jupiter Trial

Cholesterol Lowering Drug (Jupiter) Trial Shenanigans

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ARE THE DATA FROM ASTRAZENICA, CRESTOR JUPITER TRIAL ON STATINS LOOKING FISHY?

Wow.  I really think if most of the American public knew the real story of what goes behind some of these trials we’d all be sickened.  In it’s essence, the Jupiter trial looked at the prevention of heart disease in patients who had NORMAL cholesterol, but elevated inflammation.  Essential understanding that the “cholesterol blame game” was going away and they needed to find a new lab value that they could use the drug for.

The study was stopped early and declared a rousing success.  Much fanfare was heard and the medical journals and editorials sung it’s praise.  Oops.  A little too soon.  A closer look at the data raises some serious suspicions.  Basically, the trial was stopped early when predetermined events occurred just 2 yrs into the trial.

Furthermore, when you look at a population, certain statistics are expected.  Here’s the quick details:

  • The study found that statin drugs did NOT protect against deaths from heart attack and stroke.
  • In the general population, cardiovascular deaths account for about 40% of the total number of deaths.  Of these heart attacks, around 50% of these are fatal.

But in the Jupiter trial?  Apparently miracles occurred.  Cardiovascular mortality accounted for under 20% (instead of 50%) of the deaths, and the fatality rate of these heart attacks was very low (instead of the expected 50%).  This raises serious questions about the validity of the data and suggests that funding of the trial may have had a strong influence on the interpretation of the data.

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Statins Have Shocking Benefits in Diabetics

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Back to my favorite topic.  The statin class of drugs to lower cholesterol and prevent heart attacks.  Regular readers of the Rantings will know how I feel about this class of drugs.

To sum it up, they suck at preventing a first heart attack.  Without going into detail here, you can read an overview by clicking on a previous blog article here.

For those of you who have been living in a cave, the statin class of drugs (think Lipitor, Crestor) was designed and promoted to lower cholesterol.  By lowering cholesterol, we made a big jump in assuming that your risk of heart disease would also go down.  After years of the drugs being given out like candy, we realized that the statins just weren’t that good at preventing heart attacks.

Then the studies came out that found that total cholesterol really wasn’t all that great of a risk factor for heart disease anyway.  This left the statins in a huge vacuum.

Luckily, some creative researchers were able to create the idea that statins had “pleiotropic” effects–meaning that their benefit on heart disease was due to other factors besides cholesterol lowering.  The race was on to determine what these additional benefits might be.  Make sense, right?  We have a drug making billions of dollars, so we should find out what they’re good for, right?

First came inflammation as measured by CRP.  Trials (the biggest being the Jupiter trial) were done that looked at whether statins could lower inflammation as measured by CRP.  And it seems like statins were able to lower CRP levels.  Great, so now we have an expensive medication with a long list of side effects that lowers CRP.  The problem?  So does:

  1. Avoiding refined carbohydrates
  2. Losing weight lowers CRP
  3. Exercise lowers CRP
  4. Healthy fats lower CRP levels
  5. Increasing dietary fiber intake lowers CRP levels
  6. Increasing fruit and vegetable intake will lower CRP levels

Overall, when you compare lifestyle changes to statins in preventing heart disease and lowering CRP levels, there is no comparison.

So, scratch the possibility that we should look at statins and CRP levels and hang our prescription hat on this.

Which brings us to this particular study.  Researchers looked at 26 patients with type 2 diabetes taking either simvastatin 40 mg (Zocor) or atorvastatin 10 mg (Lipitor).  Here are the jaw dropping conclusions:

  1. Both lowered cholesterol levels about the same.
  2. Vitamin D levels were increased more in the atorvastatin group.
  3. While inflammation (CRP) and markers of oxidative stress (MDA) were lower, it was because of the higher vitamin D levels.

Sooooo..

Atorvastatin increases vitamin D levels.

A long list of side effects, $200 / month and really sucks at preventing heart attacks.  Why not just take vitamin D?