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Vytorin Safety In Doubt

Posted by Jane Akre
Tuesday, September 02, 2008 4:05 PM EST
Category: Major Medical, Protecting Your Family
Tags: Vytorin, Statins, Cholesterol, FDA and Prescription Drugs, Dangerous Drugs, Drug Products, Heart Attack

More doubt that  Vytorin is an effective and safe cholesterol drug.


  • New England Journal of Medicine study
  • Injuryboard on Vytorin Help Center
  •  Injuryboard on Vytorin News


 IMAGE SOURCE: ©iStockphoto/ cholesterol lowering drugs/ author: dlerick


Use the cholesterol lowering drug Vytorin with caution.

That’s the advice of editors of  the New England Journal of Medicine (NEJM) which has published results from one study and partial results of two others that look into Vytorin’s cancer concern.

The review finds more Vytorin patients died from cancer when compared to patients taking placebos, but that the rate of cancer weren’t higher. Merck and Schering-Plough are defending their drugs Vytorin and Zetia (ezetimibe).  The companies jointly make both and say there is no cancer risk in animal trials.

Schering-Plough and Merck & Co may see sales of Vytorin further erode after a link to cancer deaths in a three-study published analysis that was supposed to put to rest any concerns.

Vytorin is a combination drug made up of Merck’s Zocor, a statin drug, and Schering-Plouugh’s Zetia, a newer cholesterol lowering drug.

The drug was approved by the Food and Drug Administration in 2002, on the basis of drug trials involving 3,900 patients for 12 weeks, not long enough to determine if the drug reduced heart attacks or cardiovascular disease.

Finally in 2008, Vytorin was the subject of two clinical trials meant to show benefits. It did not show a benefit and scientists have observed there might be a link between Vytorin and cancer.

In July, researchers reported that patients taking Vytorin had a 40 percent chance of dying from cancer when compared to those taking a placebo.

The New York Times is reporting that some prominent cardiologist say the drug should not be sold.

“The only place people should be taking it is in a clinical trial,” Dr. Allen J. Taylor of the Walter Reed Army Medical Center said of Zetia. The older form of cholesterol medication, statins such as Lipitor are not the subject of questions of effectiveness or safety.

Merck and Schering say larger drug trials are underway but the results may not be available for several more years.

Earlier this year the companies announced the Vytorin had failed a clinical trial that was supposed to show it could slow the growth of arterial plaque leading to heart attacks.

In July, the possible increased cancer risk arose during that test by Dr. Terje Pederson of Oslo, Norway.

Pedersen’s study looked at nearly 2,000 people who were starting to have aortic valve problems and were given Vytorin or a placebo to lower cholesterol to ward off heart problems.

Among those given Vytorin, 105 developed cancers compared to 70 patients taking the placebos who developed cancer. Dr. Pederson, doubts that Vytorin caused the excess of cancers.

The duration of the trial is not long enough to believe that the treatment would cause cancer,” Dr. Pedersen said to the New York Times.

The medical journal says the studies are short-term and not long enough to find any trends in cancer to emerge, but they conclude a link cannot be ruled out.  In the meantime, patients are left with uncertainty about the drug and its safety.

Other doctors also were not convinced that Vytorin is safe.

"The jury is still out as to whether there's a cancer signal," said Dr. Gordon Tomaselli, cardiology chief at Johns Hopkins Hospital and a spokesman for the American Heart Association tells Associated Press.   He wasn’t connected to the research.

Dr. Douglas Weaver, president of the American College of Cardiology says “If I was on this medication and it was the only way to get my cholesterol down, I would not change my therapy based on this.”

Both the American College of Cardiology and the American Heart Association accept funding from Merck.

Dr. Christer Hoglund, a cardiologist at the Karolinska Institute in Sweden says there’s no proof that Vytorin is working.

“We don’t know that this drug is bad, but we don’t know that it’s any good either.” he said to Associated Press. 

Merck/Schering-Plough Pharmaceuticals makes Zetia and Vytorin and have been criticized for sitting on the bad news while raking in billions in drug sales.

The Enhance study on Vytorin was completed in 2006.  It found Vytorin didn’t lead to less plaque in heart arteries compared to simvastatin (Zocor) alone.  In fact, even though cholesterol was lowered, the deposit of artery-clogging plaques almost doubled in pace among patients taking Vytorin when compared to Zocor.

The drug makers say they were taking extra time to evaluate the study results. A lawsuit seeking class-action certification was filed following the news that the company may have withheld data.

Patients looking to lower their cholesterol through drugs Lipitor might be a better choice say doctors. Dr. Harlan M. Krumholz, a professor of medicine at Yale University School of Medicine, says “this [Vytorin] is really a second-line drug," 

He tells Forbes, “We really should be guided by evidence, not marketing, and the evidence is really strong for statins. If lifestyles aren't sufficient to lower cholesterol, the next place they should go is statins. Only after those have failed should you go to the next step," he added, referring to Vytorin. #

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