Sunday, April 19, 2009

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

2 comments:

Nicole said...

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Joshua Levy said...

That web site doesn't have any information about how Specter intends to improve clinical trials. There is one vague reference to reducing red tape, but that's it. What exactly does "Specter for the cure" intend to do to make things better?

Joshua