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Doubts grow over NICE backing for ezetimibe

By Nigel Praities

Doubts over NICE's decision to recommend ezetimibe as an add-on option to statins have intensified after a trial has shown the combination has no benefit on atherosclerosis progression compared to simvastatin alone.

In December NICE recommended ezetimibe as an adjunct treatment for patients who do not reach their LDL goals on statins alone.

But data from the controversial ENHANCE study - conducted over 2 years in 720 patients with familial hypercholesterolaemia – showed no significant difference in carotid intima-media thickness with ezetimibe/simvastatin compared with simvastatin alone.

LDL cholesterol levels were 17% lower with the combination of ezetimibe-simvastatin treatment compared with simvastatin treatment alone, but no differences were seen in cardiovascular event rates.

Dr George Kassianos, a GP in Bracknell, Berkshire, and a fellow of the European Society of Cardiology, said while the ENHANCE trial was too short to see any benefit, the trial raised serious concerns about NICE's recommendations.

‘It is the most unclear guidance from NICE we've ever had. The ENHANCE study shows us again that just lowering LDL cholesterol is not enough, you should be increasing HDL and reducing C-reactive protein, and ezetimibe does none of those,' he said.

The results have created a media storm in the US and Dr Steven Nissen, a cardiologist at the Cleveland Clinic, Ohio and a former president of the American College of Cardiology, said the study results were ‘troubling' and came at a bad time for NICE.

‘There is no outcomes data, so we just don't know if this mechanism of lowering LDL cholesterol will result in the same health outcomes benefits that statins provide,' he said.

Dr Terry McCormack, a GP in Whitby and executive director of the Primary Care Cardiovascular Society, said the ENHANCE trial was ‘singularly useless.'

‘There was no significant result here, so you can't read anything into it,' he said and added GPs should wait for clarification from forthcoming trial evidence specifically looking at cardiovascular outcomes with ezetimibe.

MSD said while no incremental benefit in cardiovascular outcomes for ezetimibe/simvastatin treatment over simvastatin has been demonstrated, they had three large ongoing outcomes trials looking at this question.

Around 130,000 patients in the UK were taking ezetimibe in December 2007, a 30% increase on the year before, according to figures Pulse has obtained from Cegedim Strategic Data. This compares to nearly 2m on simvastatin.

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