Re: What about VYTORIN?

From: Steve Marcus (smarcus_spamout__at_cox.net)
Date: 11/30/04 

Date: Tue, 30 Nov 2004 18:59:39 -0500

"outrider" <outrider@despammed.com> wrote in message
news:1101838293.480651.252050@z14g2000cwz.googlegroups.com...
>
> Janis wrote:
>> Ok, we see a lot about Crestor and other cholesterol lowering
> medications but
>> what about VYTORIN? Is this one just too new and they don't know as
> much about
>> bad side effects? I have been taking Crestor and my doctor is about
> to switch
>> me to VYTORIN. I'm just curious if anyone here has taken it or has
> any input
>> about it. I need to do more research for sure.
>
>
>
>
> Yes. Ezetimibe is new. Approved summer 2003 in Canada. I have Baycol
> induced side effects older than that.
>
> And here again are snippets from Ed Mathes and David Rind discussing
> Vytorin, Ezetimibe and statins. I give the link so you can also read in
> context:
>
> http://tinyurl.com/6njgm
>
>
> Rind:
> Actually, I think you could go further than that. There's no published
> evidence that ezitimibe, one part of the combination being discussed,
> has any clinical benefits either alone or in combination with other
> drugs for cholesterol. It has been shown to reduce LDL levels, but that
> is not the same as showing that it has a favorable effect on clinical
> outcomes. (There are no trials showing it doesn't have clinical
> benefits
> either. No clinical endpoint trials have been published.)

And again, that's about as disingenuous a post as one is likely to read on
Usenet. First, Zetia, (ezitimibe) _has_ been shown to block absorption of
cholesterol in the digestive tract. Second, reduction of LDL levels _has_
been shown, *in general*, to produce favorable effects on clinical outcomes;
there's no need to show that reduction of LDL _by ezitimibe_ produces
favorable effects on clinical outcomes.

>
>
> Mathes:
> 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. I guess use depends
> on whether you think LDL reduction alone is enough OR in the school
> that needs (demands?) hard endpoint data. This could be said about some
> of the statins also. NCEP recommends an LDL <100, but how do we get
> there? Will any statin do ("class effect")?
>
> Or do you want something with hard data? Or a combination of both. Will
> we still get the hard endpoint data achieved in Heart Protection Study
> or will the Zetia confound the data?
> What are you willing to ask your patients to risk?
>
>
> Rind
> 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.

Lower LDLlevels have been shown to be beneficial. No one has shown
ezitimibe to be harmful per se, hence its approval for consumption. If one
follows the logic of Mr. Rind's comment, no drug for anything can possibly
be approved for consumption, since one can never know (even after 10 years
of testing) whether the drug might be harmful to certain people in certain
circumstances not part of the tested population. So any drug that has
beneficial effect, and has not proved harmful after appropriate clinical
testing ought, therefore, to be kept off the market. It's simply nonsense.

>
> 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.

There are plenty of studies showing the clinical benefits of reducing LDL.

Steve 

-- 
The above posting is neither a legal opinion nor legal advice,
because we do not have an attorney-client relationship, and
should not be construed as either.  This posting does not
represent the opinion of my employer, but is merely my personal
view.  To reply, delete _spamout_ and replace with the numeral 3

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