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Wednesday, May 25, 2005

More Bad News for Crestor possible good news for Vytorin

A recent article in Circulation indicates that rosuvastatin leads the other statins in the adverse effect category. Although the absolute rate of AERs ( adverse effect reports) are low for all of the categories of side effects (muscle, liver, kidney) Crestor has the highest in each. Since Crestor lowers the LDL to a greater degree than the others, we would like to know the side effect rates for various doses of the drugs but that data are not provided.
This should be good news for Vytorin which seems to lower the LDL better than large doses of the statins and seems safe but we do not have a long track record to prove its safety. In addition, we don't know that lowering LDL with Vytorin works as well ( in the sense of decreasing coronary artery events) as large doses of the statins. It could be that one or more non-LDL lowering effects of larger doses of statins does good things to the vessel wall or something to decrease coronary events above and beyond the LDL effect.
With the current data available, even though the absolute risk from Crestor seems very small, personally, I would see almost no reason to use Crestor at this time ( perhaps in someone in whom nothing else works to adequately lower LDL).
If you can't hit the magic LDL target with Zocor or Lipitor or Pravachol you can always add Zetia or change to Vytorin if the patient was taking Zocor.
On June 9, 2004 The FDA issued an advisory and on 3/3/05 issued an alert calling attention to possible muscle damage and the need for lower doses in Asian patients but indicated they had no data indicating a higher risk than with the other statins. Stay tuned for what FDA will do now with the new data.


Anonymous said...

Do you relly believe there is a true difference between 4 and 12 per million deaths in a retrospective study done with repoted adverse events. There isn't enough staistical magic in the world to convince me there is any diffence. I am deeply disturbed by the hype the authors gave this so called difference. what they really proved is that statins are some of the safest drugs we have available.

james gaulte said...

I am by no means sure there is a real difference.However,with the bad press this will generate and the malpractice mine field we tiptoe through I still think it makes good sense to use Crestor when the others don't work, don't work good enough or cause side effects and basically restrict its use otherwise.I agree that statins are a very safe class of drugs and I have spent considerable time telling patients about very the low incidence of any serious problems.