Re: JAMA on FDA & PHARMA: Lack of vigilance, lack of trust
From: David Rind (drind_at_caregroup.harvard.edu)
Date: 11/25/04
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Date: Wed, 24 Nov 2004 21:47:55 -0500
Ed Mathes wrote:
> David: Regarding Zetia. EASE demonstrated an additional 23% reduction
> in LDL when ezitimibe is added to a statin.
> True, there is no hard endpoint data yet available.
There are several trials showing additional LDL lowering when ezitimibe
is added to a statin. The problem is that we don't know that that means
that ezitimibe does anything useful or is even safe. No one feels better
just because their LDL is lower. Remember that niacin and the fibrates
appeared to increase total mortality when given for primary prevention,
despite favorable effects on lipids.
I'm not raising this just to make debating points. I think people should
be very hesitant to prescribe anything other than a statin for primary
prevention until we have some studies showing clinical benefits. If you
tell me you're caring for a 45 yo male smoker with hypertension who had
three brothers die of MIs at age 47, and you can't get his LDL below 170
with 80 mg of atorvastatin, I'd probably say roll the dice and add
ezitimibe. But that's the sort of clinical scenario it would take to get
me to prescribe a non-statin for primary prevention in the absence of
clinical endpoint studies. And I'd do it knowing that I had essentially
no evidence to support my decision -- that I was just making a guess
that it might be helpful in a person at sky high risk for having a bad
cardiovascular event.
-- David Rind drind@caregroup.harvard.edu
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