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FDA Review Results in Supported Use of Vytorin

January 9, 2009

The US Food and Drug Administration on Thursday backed the cholesterol-lowering drug Vytorin following a review lasting almost one year.

Agency officials said patients should not stop taking Vytorin or other drugs in its class, noting they observed no significant difference in carotid artery thickness between patients taking Merck, Schering-Plough’s Vytorin and patients taking the drug Zocor.

What’s more, levels of LDL (bad) cholesterol decreased by 56 percent in the Vytorin group compared to 39 percent for the Zocor group, agency officials said.

The review was spurred by reports of a preliminary trial study called ENHANCE that showed the drug had little benefit over Zocor at reducing plaque buildup in neck arteries. The number of Vytorin prescriptions dropped 39 percent between January and November as a result of these findings.

“Based on current available data, patients should not stop taking Vytorin or other cholesterol lowering medications and should talk to their doctor if they have any questions about Vytorin, Zetia, or the Enhance trial,” the FDA said.

“Following two years of treatment,” the statement said, “carotid artery thickness increased by 0.011 mm (millimeters) in the Vytorin group and by 0.006 mm in the simvastatin group. The difference in the changes in carotid artery thickness between the two groups was not statistically significant. However . . . the difference in the reductions in LDL cholesterol between the two groups was statistically significant,” the FDA said in a statement.

Dr. Timothy Gardner, the current heart association president, said he agreed with the FDA’s findings.

“Patients who are taking Vytorin without difficulty should continue until there’s any further relevant information,” he told the Associated Press.

Dr. Valentin Fuster, current director of the Mount Sinai Heart Center in New York and former American Heart Association President said he never stopped prescribing Vytorin for his patients for several reasons.

“There is no evidence from any trial that (significantly) lowering cholesterol does not decrease coronary events,” Fuster said.

A study conducted last year, called SEAS, suggested that Vytorin might boost the chances of developing cancer. According to the report, 101 participants taking Vytorin developed cancer, compared with 65 in the control group.

However, an additional study in September 2008 concluded that it found no link between the drug and cancer risk.

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