Panel disputes Vytorin-cancer link

The Clinical Trials Service Unit at the University of Oxford, U.K., says data "do not provide credible evidence" that the Vytorin lipid-lowering combination product increases cancer risk. The independent oncology review panel says July 21 a previous trial suggesting the cancer link should not derail Vytorin's promise as a cardiovascular therapy. However, the panel said no significant difference appeared between patients taking Vytorin and placebo on the combined primary endpoint of major cardiovascular events caused by either atherosclerosis or aortic valve disease, or by aortic stenosis alone. This finding follows concerns raised about the general efficacy of the combination of Schering-Plough's Zetia (ezetimibe) and Merck's Zocor (simvastatin) by unfavorable results from the companies' Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression trial. The ENHANCE data, released in January two years after the study's conclusion, showed Vytorin had no significant edge over simvastatin alone in preventing formation of arterial plaque (1"The Tan Sheet" Jan. 21, 2008, p. 12)...

The Clinical Trials Service Unit at the University of Oxford, U.K., says data "do not provide credible evidence" that the Vytorin lipid-lowering combination product increases cancer risk. The independent oncology review panel says July 21 a previous trial suggesting the cancer link should not derail Vytorin's promise as a cardiovascular therapy. However, the panel said no significant difference appeared between patients taking Vytorin and placebo on the combined primary endpoint of major cardiovascular events caused by either atherosclerosis or aortic valve disease, or by aortic stenosis alone. This finding follows concerns raised about the general efficacy of the combination of Schering-Plough's Zetia (ezetimibe) and Merck's Zocor (simvastatin) by unfavorable results from the companies' Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression trial. The ENHANCE data, released in January two years after the study's conclusion, showed Vytorin had no significant edge over simvastatin alone in preventing formation of arterial plaque (¹ (Also see "ENHANCE Results Do Little To Enhance Merck’s Statin Product Outlook" - Pink Sheet, 21 Jan, 2008.), p. 12)....