Panel disputes Vytorin-cancer link
This article was originally published in The Tan Sheet
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)...
You may also be interested in...
The Merck/Schering-Plough combination cholesterol therapy Vytorin has failed to demonstrate significant benefit over simvastatin alone in preventing formation of arterial plaque in the ENHANCE trial
OCE Director Richard Pazdur was less sanguine, however, noting that while the Pepaxto withdrawal may have been faster than others, it still required more than 60 meetings to complete.
Singulair’s Psychiatric AE Risks Still A Problem, But US FDA Has Limited Mitigation Options Remaining
Stakeholders suggested a ‘Dear Healthcare Provider’ letter or speaking about the risks to professional societies to emphasize the psychiatric adverse events that prompted a boxed warning for the now-generic asthma drug montelukast. The NY Attorney General is adding more pressure.