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, 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.
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