Ezetimibe 'effective' for cholesterol14th January 2009
The United States drug regulator has said patients should not stop taking ezetimibe, which can be taken alone or in combination with simvastatin (Vytorin), to curb cholesterol.
The Food and Drug Administration (FDA) said it reaffirmed its position that ezetimibe should continue to be used to lower cholesterol levels, following a review of study data announced last year.
Findings of the ENHANCE trial presented at the American Cardiology Conference in Chicago last April were reviewed by the agency in recent months.
The FDA investigated the safety and efficacy of ezetimibe after the study found that the drug, currently recommended in the UK for use in patients with familial hypercholesterolaemia who cannot tolerate statins, failed to reduce artery thickness.
Carotid artery intima-media thickness, which is used as a gauge of atherosclerosis, was not seen to be reduced in the ENHANCE trial, although ezetimibe lowered LDL cholesterol by 16%.
Manufacturers, Merck & Co and Schering-Plough of the US, handed over the study data to the FDA for review last year.
The agency said it decided to comment publicly about the results because of public health concerns about how they might be interpreted.
Neither the ezetimibe/simvastatin label, nor the ezetimibe label, indicate that the drug reduces the risk of cardiovascular events, only that they reduce LDL, or "bad" cholesterol.
The ENHANCE trial was completed in April 2006, and was the subject of rumour and speculation after a delay of several months in publishing the results.
FDA officials say that high LDL cholesterol is a well-established surrogate marker that reliably predicts the risk of myocardial infarction, stroke, and cardiovascular death.
By contrast, the atherosclerosis surrogate used in the ENHANCE trial - carotid intima-media thickness as measured by ultrasound - is not a well-validated marker.
The FDA has now 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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Title: Ezetimibe 'effective' for cholesterol
Author: Luisetta Mudie
Article Id: 9801
Date Added: 14th Jan 2009