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FDA maintains view on lowering bad cholesterol


ROCKVILLE, Md. The Food and Drug Administration has updated its safety review on drugs for lowering cholesterol, the agency announced Thursday, reiterating its position that lowering low-density lipoprotein, or "bad cholesterol," reduces the risk of cardiovascular diseases.

The comments are part of an update to the Jan. 25, 2008 early communication describing the FDA's review of the ENHANCE study, which compared Merck's Zocor (simvastatin) to Vytorin, a combination of Zocor and Zetia (ezemtimibe). An early communication is an official FDA disclosure that the agency has begun evaluating new data about a drug and is considering regulatory action, but has not yet reached a conclusion.

Preliminary results from ENHANCE had indicated no significant difference between the thickness of the walls in the carotid arteries, an indication of the risk of cardiovascular disease‹between patients treated with Zocor and those treated with Vytorin. On the other hand, levels of LDL cholesterol decreased by 56% in the Vytorin group and 39% in the Zocor group.

The FDA said the results from the ENHANCE study do not change its position on lowering LDL cholesterol. Based on the data, the agency said patients should not stop taking cholesterol-lowering drugs and should talk to physicians or other healthcare professionals if they have questions about the study.

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