Biotech Values

[iwfal]

AGIX and Liver Failure:

A good meta-analysis paper hereon 80mg atorvastatin:

http://medicaidprovider.hhs.mt.gov/pdf/atorvastatinstudy3.pdf

In total there were about 0.2% of 80mg atorvastatin patients (n=5000) who had serious liver adverse events (liver damage, jaundice or hepatitis). In contrast the 10mg dose (n=7000) had about 0.01% (although it should be noted that the only case of liver damage was on the 10mg dose - where it was the only SAE in the 10mg cohort). Note that this is very stat sig.

Note also that I still don't know how this maps to the "Recoverable Liver Failure") - but given that the current SOC is high dose statins, it would appear that the one liver failure in ARISE probably isn't an issue.

---------------------------------------------

BTW - An interesting note: You'd think that PFE would have asked for a changed label as a result of PROVE_IT and TNT - so you could find the liver side effects rate. Nope. They appear not to have asked for such a label expansion, so the label still reads the same as it did in 2001:

a) Lots of graphs about the benefits of 10mg Atorvastatin.

b) Mention of 1 case of jaundice.

Given the fact that they have, at this point, run many times more patients through controlled, randomized trials than they had by 2001 this seems odd?


---------------------------------------


FWIW. Last post on the issue for a while. But suffice it to say that at this point it appears to a good bet that the one case of a liver SAE in ARISE is probably within the noise for this patient class. Also note that there is some reason to believe that liver SAEs due to statins go up due to patient illness and concommitant drug usage. And ARISE had sicker patients than most statin trials.