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Combinations of ezetimibe and simvastatin help reduce cardiovascular events in patients with chronic kidney disease (CKD), the FDA's professional staff indicated in briefing documents
prepared for an advisory committee meeting later this week.
The FDA reviewers found little fault with data from the so-called SHARP study of the ezetimibe-simvastatin combination -- available in a single tablet (Vytorin) or as separate products of
ezetimibe (Zetia) and simvastatin (Zocor) -- submitted to the agency by Merck/Schering-Plough, manufacturer of all three products, to support proposed label changes.
The company wants to be able to market the products "to reduce the risk of major cardiovascular events in patients with CKD."
SHARP (Study for Heart and Renal Protection), results of which were presented last November at a scientific meeting, found that the single-tablet treatment was associated with a 17%
reduction in major atherosclerotic events and a 15% reduction in the risk of major vascular events, both compared with placebo (P