Atorvastatin (Lipitor), One down, one to go

In the mid-2000s, two different groups started clinical trials which gave honeymoon type-1 diabetics Atorvastatin (Lipitor®).  One of these trials was at  Children's Hospital of Philadelphia (fondly known as "CHOP") and the other in Germany.  Lipitor is one of the most prescribed drugs in the world, and is used for long periods of time, so safety should not be an issue.  On the other hand, I could never understand exactly why anyone thought it would help cure type-1 diabetes.  Earlier this year, the German group posted their results.  Here is their conclusion:

Atorvastatin [Lipitor] treatment did not significantly preserve beta cell function although there may have been a slower decline of beta-cell function which merits further study.

Which I translate to "It didn't work."

The CHOP study is a little overdue as well.  They were expected to finish collecting data in July 2010, so they've had about 15+ months to publish, but have not as yet.   Since that is the last Lipitor clinical trial that I know of, when we get the results from it, Lipitor is done.
 
My Previous Blogging: http://cureresearch4type1diabetes.blogspot.com/search/label/Lipitor
Abstract: http://www.ncbi.nlm.nih.gov/pubmed/21412424?dopt=Abstract
Clinical Trial Record: http://www.clinicaltrials.gov/ct2/show/NCT00529191
Clinical Trial Record: http://www.clinicaltrials.gov/ct2/show/NCT00974740

A Little Discussion: What was the FDA's Orphan Products group thinking?

One question you might have is do researchers think it would work?  After all, Lipitor is aimed a lowering cholesterol, which doesn't have any obvious connection to type-1 diabetes.  The basic answer is two fold.  First Lipitor is a immune modulator, so it might stop the immune system's attack on self.   Also, studies have shown that atorvastatin (Lipitor), and other statins, preserve beta cell function in a mouse model of type 1 diabetes.  But other studies have show that it did not work on NOD mice specifically.  So it was a known immune modulator, with conflicting results in animals.

But it has two things going for it, separate from the question of "does it work".  First, it is known safe and widely used.  So that makes it very easy to work with and get approvals for.  The second thing is that it has a big company behind it.  (And for that company, it's a big deal drug.)  So they have a strong interest in finding new markets to sell it to, especially if they can somehow get patent coverage over a new use.  Anyway, that was good enough to get two clinical trials started.

But there was one humorous note about this research:  The funders of the two trials.  The first trial was funded by Pfizer, which is just as you would expect.  They are the big pharma company that makes the drug.  But the second trial was funded by the FDA's Office of Orphan Products Development.  So here you have the biggest selling drug, from a huge drug company, and research is being funded by the office of orphan productions.  Both groups are funding research at about the same time, while the drug was still under patent.   It makes no sense to me.

Joshua Levy
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My blog contains a more complete non-conflict of interest statement.
Blog: http://cureresearch4type1diabetes.blogspot.com
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Atorvastatin (Lipitor) in New Onset Type 1 Diabetes Mellitus

This is a "new to me" study, that actually started in July 2007 and is expected to end July 2010. It is phase-II and included 54 people, who are within 6 weeks of dx for type-1 (so honeymooners only). 2/3 of the people will get Atorvastatin (Lipitor) and will be compared against the 1/3 who don't get the drug.

The US clinical trial record is here: http://www.clinicaltrials.gov/ct2/show/NCT00529191

Now, for those of you who did a double take, when you saw that Lipitor was involved: Yes, this is the same statin drug which is used to lower cholesterol, and is the best selling drug in pharmaceutical history. There was no phase-I study for this treatment, because they knew the drug was safe, they went straight to phase-II.

Apparently, Atorvastatin (Lipitor) results in lower insulin requirements when give to "rodent models". I assume they are talking about NOD mice. I'm not sure why this drug might work, but it does lower inflamation, so maybe that's it.

I know of one study which gave Atorvastatin (Lipitor) to people with established type-1 diabetes in the hopes it would limit artery damage. It was not successful. However, I don't see that those guys reported A1C, BG, or insulin usage numbers turning the trial:
http://www.freundpublishing.com/Journal_Pediatric_Endocrinology_Metabolism/JPEM22p65.pdf
Of course, the studies are focused on different time frames, honeymoon vs. non-honeymoon so they may well come to different results.

Joshua Levy