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Medical Forum / General / Cardiology / February 2006

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Anti-cholesterol drug combo okay for muscles

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listener - 22 Feb 2006 23:26 GMT
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NEW YORK (Reuters Health) - Ezetimibe plus simvastatin, a combination of
two anti-cholesterol drugs marketed by Merck/Schering-Plough
Pharmaceuticals as Vytorin, is no more damaging to muscles than simvastatin
alone, a team at Rush University Medical Center in Chicago reports in the
American Journal of Cardiology.

Dr. Michael H. Davidson and colleagues note that ezetimibe reduces
cholesterol levels by blocking dietary absorption, while simvastatin works
by reducing cholesterol produced by the body.

Previous reports have linked "statin" drugs, like simvastatin, with muscle
side effects, but it was unclear if adding ezetimibe would lead to even
greater risks.

The investigators compared the muscle safety profiles of 4500 patients in
17 studies who were treated with simvastatin, ezetimibe, or both drugs. The
primary comparison was between 1234 patients treated with simvastatin alone
and 1236 patients treated with ezetimibe plus simvastatin.

The authors found that the likelihood of muscle problems did not increase
(or decrease) when ezetimibe was used in combination with simvastatin.
Moreover, none of the patients developed rhabdomyolysis, a potentially
fatal condition involving muscle breakdown.

Ezetimibe plus simvastatin does not increase the risk of muscle problems
any more than simvastatin alone. However, the combination provides enhanced
cholesterol-lowering effects, Davidson told Reuters Health.

SOURCE: American Journal of Cardiology, February 2006.


Susan - 22 Feb 2006 23:34 GMT
Pantethine is better.

And no one is paying me to post about it.

Susan

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listener - 23 Feb 2006 00:13 GMT
Better? You're entitled to your opinion, of course.

I know you and Sharon justify your one-sided viewpoint by claiming that
people who post articles that are not critical of statins are employed by
or paid by pharma to do that. I ain't one of them. This is the
sci.MED.cardiology group, afterall, and statins are some of the most
widely used and researched cardiology-related meds.

Notice, too that I did not edit out parts of the article (i.e. "Previous
reports have linked "statin" drugs, like simvastatin, with muscle side
effects.."), like Sharon does in her posts.

L.

> x-no-archive: yes
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>>  
Susan - 23 Feb 2006 13:52 GMT
> Better? You're entitled to your opinion, of course.
>
> I know you and Sharon justify your one-sided viewpoint by claiming that
> people who post articles that are not critical of statins are employed by
> or paid by pharma to do that. I ain't one of them.

You only post press releases and information promoting statins for
everything but tooth decay.  The rest of your posts are personal attacks
on those who post otherwise.

Sharon and I have very different experiences and perspectives on the
statin issue.

 >This is the
> sci.MED.cardiology group, afterall, and statins are some of the most
> widely used and researched cardiology-related meds.

They are widely used due to a triumph of marketing over science, in my
estimation.  We've seen ample proof and examples of what passes for
"research" results when the investigators have a financial stake in the
outcome of the research.  We have no reliable data on statins, in my
estimation, for this very reason.  Not my paranoia, just an established
and much published fact.

> Notice, too that I did not edit out parts of the article (i.e. "Previous
> reports have linked "statin" drugs, like simvastatin, with muscle side
> effects.."), like Sharon does in her posts.

I don't edit articles or citations I post, either.  I quote or link to
full text.  I don't post my opinions as facts without supporting
documentation.  Since there is a safe, atoxic HMG-CoA inhibitor and
anti-inflammatory with no adverse effects cheaply available, I think
statins should be avoided, given their inferior risk/benefit ratio.

Susan

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>>>
>>>SOURCE: American Journal of Cardiology, February 2006.
Sharon Hope - 23 Feb 2006 05:24 GMT
The studies referenced may not have allowed patients to go into
rhabdomyolysis, or they may not have selected patients who are subject to
rhabdomyolysis, or they may not have tested a large enough population, but
according to Merck, rhabdomyolysis has been reported for Ezetimibe (brand
name Zetia) even without statins.

The Prescribing Information states: "However, rhabdomyolysis has been
reported very rarely with
ZETIA monotherapy and very rarely with the addition of ZETIA to agents known
to be associated with

increased risk of rhabdomyolysis, such as fibrates."

Read the full 14 pages of the Prescribing Information from Merck's Zetia
page, 29480915T, REV 09, at:

http://www.zetia.com/zetia/shared/documents/zetia_pi.pdf
ZETIA® (EZETIMIBE) TABLETS

The context of the quote, from page 10 of 14:

"In clinical trials, there was no excess of myopathy or rhabdomyolysis
associated with ZETIA compared

with the relevant control arm (placebo or HMG-CoA reductase inhibitor
alone). However, myopathy and

rhabdomyolysis are known adverse reactions to HMG-CoA reductase inhibitors
and other lipid-lowering

drugs. In clinical trials, the incidence of CPK >10 X ULN was 0.2% for ZETIA
vs 0.1% for placebo, and

0.1% for ZETIA co-administered with an HMG-CoA reductase inhibitor vs 0.4%
for HMG-CoA reductase

inhibitors alone.

In post-marketing experience with ZETIA, cases of myopathy and
rhabdomyolysis have been reported

regardless of causality. Most patients who developed rhabdomyolysis were
taking an HMG-CoA

reductase inhibitor prior to initiating ZETIA. However, rhabdomyolysis has
been reported very rarely with

ZETIA monotherapy and very rarely with the addition of ZETIA to agents known
to be associated with

increased risk of rhabdomyolysis, such as fibrates. All patients starting
therapy with ezetimibe should be

advised of the risk of myopathy and told to report promptly any unexplained
muscle pain, tenderness or

weakness. ZETIA and any HMG-CoA reductase inhibitor or fibrate that the
patient is taking concomitantly

should be immediately discontinued if myopathy is diagnosed or suspected.
The presence of these

symptoms and a creatine phosphokinase (CPK) level >10 times the ULN
indicates myopathy."

Note Merck says patients should be advised to promptly report muscle
symptoms, which is not the overall message conveyed by the press release.

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>> SOURCE: American Journal of Cardiology, February 2006.
Bill - 23 Feb 2006 09:02 GMT
This does not mention any sort of proven association between Zetia and
rhabdomyolysis. Your speculation on reasons for this does not make a case.

Your often repeated argument is "after that, therefore because of that." That
is, if event B happens after event A, then event B was caused by A. So the
fact that rhabdomyolysis happened after taking Zetia implies (or strongly
suggests) that the rhabdomyolysis was caused by the Zetia.

Bill

> The studies referenced may not have allowed patients to go into
> rhabdomyolysis, or they may not have selected patients who are subject to
[quoted text clipped - 102 lines]
>>>
>>> SOURCE: American Journal of Cardiology, February 2006.
Jim Chinnis - 23 Feb 2006 16:15 GMT
"Sharon Hope" <shope@anet.net> wrote in part:

>according to Merck, rhabdomyolysis has been reported for Ezetimibe (brand
>name Zetia) even without statins.

It also has been reported without Zetia or statins or any drugs at all.
--
Jim Chinnis   Warrenton, Virginia, USA
 
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