FDA tells patients to keep taking Merck & Co/S-P's Vytorin after ENHANCE review

19 January 2009

The US Food and Drug Administration has reaffirmed its position that elevated amounts of low-density lipoprotein are a risk factor for  cardiovascular diseases and sudden death, and that lowering LDL  cholesterol reduces the risk of these diseases.

The FDA said patients should continue to use Vytorin (ezetimibe and  simvastatin), which is a fixed-dose combination of a cholesterol  absorption blocker and a statin, developed by US pharmaceutical majors  Merck & Co and Schering-Plough.

Disappointing study findings released last year prompted leading  cardiologists to suggest that ezetimibe, which is sold on its own as  Zetia, was potentially just an "expensive placebo" (Marketletter April  7, 2008).

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