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Vytorin makers say cancer results likely an anomaly

WASHINGTON
Wed Jul 23, 2008 4:52pm EDT

WASHINGTON (Reuters) - Cancer findings in a new study of cholesterol drug Vytorin are "likely to be an anomaly" unrelated to the drug, makers Merck & Co and Schering-Plough Corp said in a letter to doctors.

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The study, called SEAS, found a higher incidence of cancer among patients who took Vytorin compared with a placebo, according to findings released on Monday. Researchers also reported more deaths from cancer among Vytorin patients, although that difference was not statistically significant.

"The cancer finding in SEAS is likely to be an anomaly that, taken in the light of all the available data, does not support an association with Vytorin," the companies said in a letter dated July 22.

The letter was posted on a website of the companies' joint venture on Wednesday, Merck spokeswoman Amy Rose said.

"It is a letter to health-care professionals that they can use if asked about the study," she said.

The letter's characterization of the cancer cases as an "anomaly" matches the interpretation drawn by the lead investigator for the SEAS trial and an Oxford University cancer epidemiologist who analyzed the data, Rose said.

The letter also notes the SEAS study failed to meet its main goal of showing Vytorin reduced major cardiovascular events in patients with an irregular thickening of the main valve of the aorta. The drug did, however, meet a secondary goal of reducing atherosclerotic events such as nonfatal heart attacks and bypass surgery.

The SEAS findings did little to remove the cloud hanging over Vytorin since January from a previous study. Vytorin use has declined since that study failed to show the combination drug worked any better in cutting arterial plaque than the cheaper generic statin that is one of its two components.

(Reporting by Lisa Richwine and Ransdell Pierson; editing by Carol Bishopric, Gary Hill)



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