Comments on: Vytorin: Dis-Enhance-d

By: Razwell

Razwell — Tue, 26 Feb 2008 20:50:58 +0000

Dr. Eades

Cholesterol Theory proponents are now saying that the median LDL level of 134 mg/dl in the study was not low enough for any atherosclerotic plaque regression . They say you need to have LDL levels 100 mg/dl.

The study was flawed they say.

I know this is nonsense though.

Razwell

Nonsense to the max.

By: Razwell

Razwell — Tue, 19 Feb 2008 18:52:36 +0000

Dr. Mike

MISREPRESENTING the data in the ENHANCE trial . I am NOT for the Lipid Hypothesis but atherosclerosis did NOT increase.

There was no benefit from an LDL reduction of 58 % but the plaque did NOT increase.

That NY Times article is incorrect.

Hey Razwell–

Actually you are correct, sort of. Plaque did increase, just not significantly. The amazing thing, however, for believers in the lipid hypothesis is that it didn’t DEcrease markedly. An element of the lipid hypothesis is the notion that elevated LDL increases plaque formation and reducing LDL decreases plaque formation. In the ACCORD study we have a situation in which a substantial reduction in LDL concentration not only didn’t reduce plaque, but actually increased it (although not to a statistically significant level).

The NY Times article wasn’t incorrect because there was an increase in plaque in the subjects taking Vytorin. Where they were wrong is in not reporting it as a non-statistically-significant increase in plaque. (I’m assuming the Times didn’t do that – I didn’t actually go back and read the article again.)

Cheers–

MRE

By: Carl D. Marks

Carl D. Marks — Sat, 09 Feb 2008 15:07:58 +0000

Hello Mike,

Thanks for the article. I’ve been on Vytorin for 2 years, and was on Zocor prior to that for several years. Last week, I requested that my cardiologist prescribe something other than Vytorin for me.

I just checked my mail order prescription center to find that he prescribed Vytorin AGAIN! How can I convince my cardiologist that I am not comfortable continuing with Vytorin and that I want to return to Zocor or some other alternative?

Do you believe that continuing on Vytorin could be risky?

Yikes!

Carl.

This is a call you’re going to have to make with your own physician. I can’t give you medical advice over the internet.

By: Max

Max — Tue, 22 Jan 2008 14:57:15 +0000

I used to love those commercials. Forget the content, they had striking visuals that got the message (two sources of cholesterol: genes and food) across very cleanly. I think they’re only really annoying with repetition. I haven’t tracked formally, but find a high concentration during football, the nightly news and other things that tend to draw a lot of middle aged and older men to viewing. When I watch the NBA, much lower incidence of Vytorin ads and very few of Dr. Jarvik from the Forbidden Zone on the PotApes. Law and Order, in reruns, tends to have a lower density of these ads (and ED ads) as well.

Quick question: Recently, saw an ED ad (I am immature, I find any ad where a man comes on and talks about his inability to rise to the occasion amusing, even if they are all actors) that targets people with diabetes and high blood pressure. If you have these conditions, apparently, you’re more liable to go on TV and brag about your difficulties. Or at least have difficulties. But, fortunately for you, there is ED Drug X (I can’t remember which one it is that’s plugging with this commercial… maybe the one with the bathtubs). Now, on to the question:

Perhaps a growth opportunity for PP/PPLP/The Next Book would be to tout it as a cure for ED. Since diabetes and high blood pressure are associated with ED, perhaps the best treatment for both would be the best treatment for ED.

Just a thought.

Last thing: given the media buying prerogatives of statin merchants, perhaps the cure is to watch less football.

By: Davd LaCivta

Davd LaCivta — Mon, 21 Jan 2008 14:25:06 +0000

Dr. Mike, Can it be said that this study just proves our point about low cholesterol? Regardless of how it gets lowered, low LDL levels and small particles will always increase plaque? Am I coming to an conclusion that is not supported by these particular datum or is it something being completely overlooked? Did they bother to look at why the plaque increased, was it something related to the medication or a result of the lower cholesterol?
Thanks,
Dave

Hey Dave–

I don’t know that anyone really knows at this point why the plaque increased. And remember, although the plaque almost doubled, the change didn’t reach the level of statistical significance. We’ll have to see a lot more data to figure out what really went on hear. Another thing to remember is that these subjects were not normal subjects with high cholesterol levels, but were subjects who had familial hypercholesterolemia, a genetic disorder. Whatever happened to these subjects can’t necessarily be extrapolated to what would happen to subjects without this genetic disorder.

Cheers–

MRE

By: Razwell

Razwell — Sat, 19 Jan 2008 21:03:42 +0000

Did you ever notice that more Jarvik lowers his cholesterol, the more he looks like Gollum.

Hey Razwell–

Good observation. Maybe you’re on to something.

Cheers–

MRE

By: gretchen

gretchen — Sat, 19 Jan 2008 01:26:03 +0000

Is it possible that Vytorin reduced cholesterol without reducing apo-B so that in effect it reduced the size of the LDL and hence increased plaque?

Did they measure apo-B?

Could be. I don’t know if they measured apoB or not. As far as I know this study isn’t available in printed form. All I know about it is what the drug companies released in their press releases. I would like to see the actual study. If anyone comes across it, send it my way.

Cheers–

MRE

By: gretchen

gretchen — Sat, 19 Jan 2008 01:23:08 +0000

You said, “In this study Vytorin unquestionably brought LDL down better than statins alone.” My point was that there are people in whom STATINS ALONE DO NOTHING.

Hence their choice is total cholesterol levels over 400 or taking something like Zetia.

So the logic that they should just take a statin doesn’t apply to them. No one is addressing the problems of this population.

Whether or not a microscopic difference in plaque, with a poor P value, assuming that artery thickness is, indeed, directly related to plaque, means anything in terms of cardiac events remains to be seen. It’s my understanding that it’s unstable plaque that is the problem.

The CV events, although larger (something like 2 events instead of 1) were suggestive but not statistically significant.

I am committed to LC, as I think it has a lot of other benefits, especially for a person with diabetes. But someone needs to address the problems of those in whom LC alone is not sufficient to reduce astronomical cholesterol levels.

Even if you don’t believe in the cholesterol hypothesis when cholesterol levels are in a highish range, we know that people with really astronomical levels in familial hypercholesterolemia do often die from heart attacks in their 20s. Therefore, it can’t be totally irrelevant.

Hey Gretchen–

The data indicates that people with familial hypercholesterolemia (FH) do indeed die at greater rates from heart disease than do those without the disorder, although not to as great an extent as might be imagined. But people with FH also die a little less frequently from other diseases, namely cancer, as compared to those without FH. Overall, in terms of all cause mortality there really isn’t much difference – if any – in those with FH and those without.

I suppose then that it would be an individual choice as to whether or not pursue cholesterol lowering at all costs verses just leaving it alone.

By: Elle

Elle — Fri, 18 Jan 2008 16:03:13 +0000

Oops, Dr Mike, I just realized my dose of Vitamin D3 is 2,000 IU. Sorry about that!

By: labrat

labrat — Fri, 18 Jan 2008 14:20:53 +0000

Ok – I don’t see that this study demonstrated anything other than an elaborate waste of money to demonstrate absolutely nothing.

They measured IMT changes in a bunch of folks all treating their cholesterol numbers.

Baseline mean for Vytorin group 0.68mm – after 2 years treatment mean = 0.6911mm
Baseline mean for Zocor group 0.69mm – after 2 years treatment mean = 0.6958mm
Baseline mean for no treatment ??? after 2 years no treatment ??? unknown

mean IMT for Zocor group after 2 yrs 0.0047mm > Vytorin group

Can anyone point me to a study that establishes any clinical significance to a change of 1/2 of a thousanth of a mm in an IMT measurement? Can anyone point me to a study that establishes the acceptable SD for the measurement of IMT?

Sorry – but for me this study was snake oil from the very beginning.

Hi Labrat–

It demonstrated that a very expensive drug taken for 2 years didn’t do squat in terms of treating that which is was prescribed for.

Cheers–

MRE