Posted on 03/30/2008 4:21:15 PM PDT by neverdem
AP Medical Writer
Full results of a failed trial on Vytorin, a medicine taken by millions of Americans to lower cholesterol, left doctors stunned that the drug did not improve heart disease even though it worked as intended to lower three key risk factors.
Use of Vytorin and a related drug, Zetia, seemed sure to continue to fall after the findings reported Sunday and fresh questions about why drugmakers took nearly two years after the study ended to give results.
"A lot of us thought that there would be some glimmer of benefit," said Dr. Roger Blumenthal, a Johns Hopkins University cardiologist and spokesman for the American Heart Association.
Many doctors were prescribing Vytorin without trying older, proven medications first, as guidelines advise. The key message from the study is "don't do that," Blumenthal said.
Doctors have long focused on lowering LDL or bad cholesterol as a way to prevent heart disease. Statins like Merck & Co.'s Zocor, which recently became available in generic form, do this, as do niacin, fibrates and other medicines.
Vytorin, which came out in 2004, combines Zocor with Schering-Plough Corp.'s Zetia, which came on the market in 2002 and attacks cholesterol in a different way.
The study tested whether Vytorin was better than Zocor alone at limiting plaque buildup in the arteries of 720 people with super high cholesterol because of a gene disorder.
The results show the drug had "no result - zilch. In no subgroup, in no segment, was there any added benefit" in terms of reducing plaque, said Dr. John Kastelein, the Dutch scientist who led the study.
That happened even though Vytorin dramatically lowered LDL, other fats in the blood called triglycerides and a measure of artery inflammation called CRP.
Results were presented at an American College of Cardiology conference in Chicago and published on the Internet by the New England Journal of Medicine.
The journal also published a report showing that Vytorin and Zetia's use soared in the United States amid a $200 million-marketing blitz. In Canada, where advertising drugs to consumers is not allowed, sales were four times lower.
Congress and state officials in New York have been investigating why results were not released for nearly two years after the study ended.
The drug appeared safe in the study, and patients should not discontinue using it or any heart drug without talking with their doctors, heart specialists stressed.
However, doctors prescribing Vytorin in the mistaken belief it always works "should be thinking twice," said Duke University cardiologist Dr. Robert Califf.
He is co-leader of an even more pivotal study of the drug that was expanded to include more patients because early signs suggest it will be harder than anticipated to see if Vytorin is any better than Zocor alone.
Califf himself takes the drug because he cannot tolerate the high dose of statins he otherwise would need.
"It will be 2012 - ten years after the drug was introduced - before we know the answer," said Dr. Steven Nissen, a Cleveland Clinic cardiologist who has no role in the Vytorin studies and has criticized the drugmakers' handling of the one reported Sunday.
Dr. James Stein, director of preventive cardiology at the University of Wisconsin-Madison, said Vytorin "has always been a second- or third-line drug," after trying statins and other recommended medicines first.
Stein believes Zetia and Vytorin are safe and will prove effective, "but the reason we do research us so we don't have to rely on our "beliefs" - we can rely on data."
Merck is based in Whitehouse Station, N.J.; Schering-Plough, in Kenilworth, N.J.
No, it didn't. They measured the changes in thickness of sections of the carotid arteries as a surrogate for coronary artery atherosclerosis.
Beware of pdf links.
There's free open access to the NEJM articles and editorials in question.
I’m taking enalapil and zetia which were the separate generic components of another drug whose name I can’t remember.
Can anyone out there make any sense of this article for me?
Why should I be afraid of PDF links, especially on a legitimate site?
Those with very high cholesterol should use guar gum, which is a common food additive. It is a water soluble fiber with the odd ability to bind with bile. A major component of bile is cholesterol.
A 50/50 mix with non-water soluble fiber, like Metamucil psyllium, or just psyllium husks, combines with the guar gum so that a whole bunch of bile is flushed out of the system.
There is an additional benefit in that the body recycles bile for re-use, but the bile tends to build up contaminants like metals, that it is not bad to get rid of as well.
Taking a guar gum/Metamucil mix twice a week for a month might drop a sky high cholesterol down into the normal range.
It would seem to be a better methodology than using statins, which alter the normal body processes, in that it just uses natural body processes.
They used to sell guar gum powder in health food stores, but it is now only available by mail order.
Insert here the typical caution about taking any kind of medical advice off the Internet. Guar gum is a nutritional supplement, not a medicine.
I still feel that a high HDL is much more beneficial than a low LDL. In my family all the males have a high total cholesterol but we also all have a very high HDL. I’m 44, my father 68, and my grandfather is 98. All of us have been told by our doctors that we should be on cholesterol medicines. None of us are, and none of us has ever had heart problems.
OMG! What to do, what to do?
I read recently somewhere that statins caused calcifications in the vessels that were maybe worse for you than cholesterol.
I cannot make myself take the statins I have been prescribed. Doing the fish oil and flax oil thing.
My experience has been that opening pdf links can be problematic if too many other windows are open, i.e. it won't open and I have to restart the computer, losing any comments that I may have been composing.
ping
100 years from now they will look back, and snicker we'd been better off with leeches!
Now that is interesting....I am a taker or Vytorin,...and it drops the cholesterol count for me,...but gives me a problem with sore muscles....
I am running Linux with 4 gigs of memory ,...don’t have that problem,...
Doctors practice medicine, ie they put their faith in drugs. I hope someday they will learn how to help promote health via more natural means, and will learn to look at the big picture rather than just lab numbers.
FYI:
http://www.wellnessresources.com/newsroom/index.php/content/articles/the_statin_scam_marches_on/
A very good friend who knew a lot about medical research told me the studies that linked cholsesterol and hardening of the arteries were not authoratative, the medical profession ran with them anyway. He thought it was mostly genetic that many people can eat/ have high cholesterol and never have hardening of the arteries/ heart disease. However, cholesterol might still be a contributing factor to those predisposed to those conditions.
The entire diet/heart/cholesterol theory is a scam. Much along the same lines as human induced global warming.
bttt
Why exactly were you on statins??? Great numbers without.
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