Vytorin study raises new questions about cholesterol drug

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Vytorin, the combination drug prescribed to lower cholesterol, sustained another blow today, when the author of a major clinical trial announced that the medication had failed to drive down hospitalization and death due to heart failure in patients with narrowing of the aortic valve. In the process, researchers in Norway detected a significant blip in cancers in the 1,800 subjects they followed.

This is the second time in less than six months that Vytorin, the widely-prescribed -- and heavily advertised -- combination of the blockbuster drugs simvastatin (better known by its commercial name Zocor) and ezetimibe (known as Zetia) has fallen short on the goal of preventing heart attacks. In March, a study known as the ENHANCE trial found that Vytorin fared no better than a placebo at reducing plaque buildup on the walls of patients’ arteries.

Today’s findings suggested something more ominous: the incidence of cancer -- and of dying of cancer -- was significantly higher in the patients taking Vytorin. Altogether, 67 patients on placebo developed cancer during the trial. Among subjects on Vytorin, 102 developed cancers of various kinds.

Researchers involved in Vytorin trials believe the surprising blip in cancer rates among those on the cholesterol-lowering drug may be a statistical blip, but promised to continue to explore any link between the two. Vytorin did lower the risk of ischemic events -- heart attacks or strokes caused by blockage of blood flow by a clot -- by 20%, researchers said.

Sales of Vytorin already have dropped significantly since last March on the strength of the ENHANCE trial. The latest study results are limited: Only about 3% of those over 75 have aortic stenosis. But they still might accelerate a brisk retreat by cardiologists from Vytorin to simvastatin alone.

-- Melissa Healy