More on Zetia: IMPROVE-IT Study

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I'm sure you all have been seeing the publicity of the IMPROVE-IT study showing benefit of zetia added to zocor follow cardiovascular events (secondary prevention). I've not been a fan of zetia, so have approached the article with some skepticism, but hopefully what I share below is objective enough. 
Some points:

  •  secondary prevention study
  • zocor study, with 26% on zocor 80 mg (no longer recommended)
  • no difference in all cause mortality nor any mortality difference in stroke or MI. FYI: zocor had a nnt of 30 over 5 years for all cause mortality benefit and 31 for coronary mortality (over 5 years)
  • benefit found in stroke with a number needed to treat of 186 for 7 years to prevent 1 stroke (if just ischemic stroke, nnt is better, but higher hemorrhagic strokes in zetia with zocor arm). FYI: The NNT from sparcl for Lipitor to prevent one cva in 5 years was 45.
  • Benefit for non-fatal MI: nnt of 66 (7 years again)
  • benefits in revascularlization but not in hospitalization for unstable angina. FYI: Lipitor 80 mg had nnt of 38 for revascularlization over 16 weeks if given within 4 days of revascularlization. 

Some thoughts:

  • I'm always bothered by the lack of mortality benefit, but the assumption would be that preventing strokes and MI's will eventually lead to mortality benefit. 
  • the comparison was not with high potency statins which have stronger data (Lipitor). Of course, the question is whether zetia would have helped improve the Lipitor data. 
     

My take away:

I'll add zetia for:

  • those patients who can not tolerate high dose, high potency statin.
  • For patients who are the disaster vasculopath.

For patients who are on high dose, high potency statin, I do not feel there is sufficient data. At best, it may prevent some events but no mortality benefit at 7 years. 


**please note, several of the NNTs were my own calculations and I could have certainly made a few errors!