Currently, the drug is recommended by NICE for use in patients with familial hypercholesterolaemia who cannot tolerate statins or have failed to lower their cholesterol levels sufficiently.
The announcement follows a review by the FDA into the findings of the ENHANCE trial, presented last year at the American Cardiology Conference (ACC) in Chicago (GP, 4 April 2008).
The trial found that although ezetimibe lowered LDL cholesterol by 16%, it failed to reduce carotid artery intima-media thickness, a measure of atherosclerosis and the primary end point of the study.
However, the FDA concluded that the results of the ENHANCE trial do not change its position on the benefits of the drug.
It says that, based on currently available data, patients should not stop taking the drug.
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