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Another Vytorin Failure

Jul 22, 2008 | Parker Waichman LLP

Yesterday's news that Vytorin failed to meet the primary endpoint in another important study has not done much to restore faith in the controversial cholesterol drug.   First shown to be ineffective in preventing clogged arteries, it now seems Vytorin does little to help patients with aortic stenosis avoid other heart problems.  Concerns have also been raised that Vytorin could also be linked to an increased risk of cancer.  Doctors have already cut way back on the number of Vytorin prescriptions they have been writing, and it seems unlikely that yesterday's developments will discourage that trend.

The study results released  yesterday - from the so-called SEAS trial - involved nearly 1,900 patients whose heart valves were partially blocked, participants were given either Vytorin or a placebo pill that contained no medicine. Scientists hoped that the trial would show that patients taking Vytorin would have a lower risk of needing valve replacement surgery or having heart failure. But the drug did not show those benefits.

However, patients taking Vytorin in the trial did have a much  higher risk of developing and dying from cancer. In the trial 102 patients taking Vytorin developed cancer, compared with 67 taking the placebo. Of those, 39 people taking Vytorin died from their cancer, compared with 23 taking placebo.   Researchers conducting the study said that while those numbers don't prove a definitive cancer link, they were "statistically significant", meaning the odds were less than 5 percent that they were the result of chance.

Dr. Steven Nissen, a former president of the American College of Cardiology and a longtime critic of Vytorin, told The New York Times that the results of the SEAS trial will increase concerns over the safety and effectiveness of Vytorin.   Earlier this year, after a study called ENHANCE failed to show Vytorin reduced clogged arteries, leading a panel of top cardiologists to recommend using Vytorin only as a last resort.

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