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Vytorin Side Effects May Result In Clogged Arteries Lawsuits

Vytorin | Lawyers, Lawsuits | Side Effects: Clogged Arteries, Heart Attack, Stroke

On January 14, 2008, the results of a long-awaited study on the effectiveness of Vytorin to reduce artery clogging plaque in patients with high cholesterol were released.   The ENHANCE study found that Vytorin, a combination of cholesterol lowering Zetia and the statin Zocor, worked no better to reduce clogged arteries than a high dose of a less-expensive, generically available statin alone. Our Vytorin Side Effects Lawyer Have Many Experienced Years Handling Defective Drug Lawsuits.

Vytorin

Vytorin, developed and marketed jointly by Merck and Schering-Plough, is a combination of cholesterol-lowering Zetia and the statin Zocor.Vytorin was approved by the Food & Drug Administration in 2004 to treat both sources of cholesterol - absorption in the intestine of both biliary and dietary cholesterol, and production in the liver and peripheral tissues. It was believed that the treatment of cholesterol from both sources would likely to result in lower cholesterol levels. It was likewise theorized that this reduction in cholesterol would in turn reduce the amount of plaque buildup in the arteries, thus reducing the risk of heart attack and stroke. However, the results of the ENHANCE study showed that Vytorin brought about no measurable reduction in the amount of artery plaque buildup.


The ENHANCE Study

The ENHANCE study, which was funded by Merck and Schering-Plough, focused on a group of 720 patients with a rare condition predisposing them to high cholesterol. The patients were given either Vytorin or a high dose of simvastatin, the generic form of Zocor.  While both Vytorin and Zetia were found to have significantly reduced cholesterol in these patients, neither drug provided any significant benefit versus the statin drug Zocor in slowing down clogging of the arteries.  Overall, the study failed to meet its primary goal, which was to show whether Vytorin was more effective than Zocor alone in preventing progression of atherosclerosis in the carotid artery, which is in the neck.

Such plaque buildup is a major risk factor for heart attacks and stroke.  Many doctors had been prescribing Vytorin or Zetia on the theory that the drugs would reduce this risk in people with high cholesterol.  The ENHANCE study was a serious blow to this theory.

There is some evidence that Merck and Schering-Plough tried to suppress the ENHANCE studies findings.   The data from the ENHANCE trial was supposed to be released by March 2007, but that didn’t happen.    In November 2007, the doctor who supervised the ENHANCE trial told the New York Times that the drug’s’ makers, who controlled the study’s raw data, blocked its release. In December, a congressional committee requested more information on the ENHA NCE study.  Merck and Schering-Plough maintained that the ENHANCE results were delayed because of the complexity of the data.

According to the New York Times, Merck and Schering-Plough also tried at one point to change the ENHANCE study’s endpoint.  The endpoint is the main medical result the study was meant to measure, and it is generally accepted among scientists that for a clinical trial to be valid, the endpoint must never change.  Following a great deal of outcry, Merck and Schering-Plough backed off changing the ENHANCE endpoint in December.

It is understandable that Merck and Schering-Plough would have wanted to delay the disappointing results of the ENHANCE study.  Combined Vytorin and Zetia sales were about $3.7 billion for the nine months ended Sept. 30, up 33% from the year-earlier period.  The disappointing results of ENHANCE put those sales at risk, as many doctors may opt to prescribe the generic version of the Zocor alone, rather than the combo pill Vytorin.   Generic versions of Zocor cost roughly $1 per pill, compared with about $3 per Vytorin tablet.

Legal Help For Victims Affected By Vytorin

If you or a loved one used Vytorin under the assumption that it would reduce the risk of clogged arteries, heart attack and stroke, you may have valuable legal rights.  Please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney or call us at 1-800-YOURLAWYER (1-800-968-7529).

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Vytorin, Zetia Disappoint Again

Nov 16, 2009 | Parker Waichman LLP
Vytorin and Zetia, Merck & Co.'s anti-cholesterol medications, are coming under fire again.  A new study has found that a much older - and cheaper - drug reduced artery plaque much better in eight months than ezetimibe, the active ingredient in both Vytorin and Zetia.According to USA Today, this latest study was  released Sunday at an American Heart Association meeting and published online by the New England Journal of Medicine.Vytorin, developed and marketed jointly by Merck and...

Lawsuit Claims Execs Knew Vytorin Study Wouldn't Be Favorable

Oct 15, 2009 | Parker Waichman LLP
A lawsuit alleges that marketing executives at Schering-Plough, one of the makers of Vytorin, knew long before it was released that the ENHANCE study would not be favorable.Vytorin is a combination of Zetia and the statin Zocor that is marketed jointly by Merck & Co. and Schering-Plough. It has been under the microscope since the ENHANCE study was released, showing it was no better at preventing clogged arteries than a cheaper statin.  ENHANCE raised serious questions about the...

Vytorin Makers Spent Millions on Medical Education

Sep 15, 2009 | Parker Waichman LLP
Merck & Co. and Schering-Plough, the makers of Vytorin, spent millions over the past four years to educate doctors about  the latest treatments for heart disease, according to The Wall Street Journal.  Critics of the pharmaceutical industry assert that  marketing, not medical education, is usually behind such generosity.According to the Journal,  Merck and Schering-Plough paid out a total of $60 million to a small group of medical schools and health groups, including...

No Proof Combo Pills Like Vytorin Work Better, Study Finds

Sep 3, 2009 | Parker Waichman LLP
A new study says there is no proof that combo cholesterol lowering drugs like Vytorin work better than high doses of statins.   Vytorin, developed and marketed jointly by Merck and Schering-Plough, is a combination of cholesterol-lowering Zetia and the statin Zocor.   Vytorin was approved by the Food & Drug Administration in 2004 to treat both sources of cholesterol - absorption in the intestine of both biliary and dietary cholesterol, and production in the liver and...

Vytorin Makers Announce $41.5 Million Class Action Settlement

Aug 6, 2009 | Parker Waichman LLP
The makers of Vytorin are settling more lawsuits.  According to a Reuters report, Merck and Schering-Plough will pay $41.5 million to settle class-action lawsuits involving Vytorin and its sister-drug, Zetia.Vytorin is a combination of Zetia and the statin Zocor.  It has  been under the microscope since the ENHANCE study  was released in January 2008. ENHANCE found that  the drug was no better than a cheaper, generic statin in preventing clogged arteries, and raised...

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