NeLM news service
FDA approves updated label but not new indication for Vytorin®(ezetimibe/simvastatin) to incorporate data from SHARP

Source: BioSpace , Reuters Health News

Date published: 26/01/2012 16:57

Summary
by: Yuet Wan

The FDA has approved an updated label for Vytorin® (ezetimibe/simvastatin) that includes results from the Study of Heart and Renal Protection (SHARP). In SHARP, Vytorin 10/20 mg lowered LDL cholesterol in patients with moderate to severe chronic kidney disease (CKD), and major vascular events were reduced in the treatment group compared to placebo. Merck had been hoping to win approval for use to prevent heart attacks and strokes in patients with CKD. Because SHARP studied the combination of simvastatin and ezetimibe compared with placebo, it was not designed to assess the independent contributions of each drug to the observed effect; therefore the study's efficacy results have not been incorporated into the label for ezetimibe.

 

In the UK the combination therapy is sold under the brand name Inegy®.

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