Findings presented at the annual American Cardiology Conference (ACC) in Chicago this week, cast doubt on a NICE technology appraisal issued in November, which recommended second-line use of ezetimibe in familial hypercholesterolaemia.
The ENHANCE trial involved 720 familial hypercholesterolaemia patients, aged 30-75, randomly assigned to receive daily simvastatin (80mg) alone or with ezetimibe (10mg) for two years.
Although ezetimibe lowered LDL cholesterol by 16 per cent, it failed to reduce carotid-artery intima-media thickness, a measure of atherosclerosis and the primary end point of the study.
Concerns over the effectiveness of ezetimibe in familial hypercholesterolaemia were raised earlier this year, after a US Congressional Inquiry forced manufacturers Merck and Schering-Plough Pharmaceuticals to reveal the results of ENHANCE.
Dr Harlan Krumholz, a cardiologist at Yale University Medical School, told conference delegates that the results of the ENHANCE study made it look less likely that ezetimibe could lower the risk of CVD.
‘Just because ezetimibe lowered LDL levels does not mean that it should be used to reduce CVD risk,' he said. ‘We know that HRT can also lower LDL levels.
‘It is now time to turn back to statins. We should be looking to optimise statin therapy and be increasing statin doses and trying out different statins,' added Dr Krumholz.
But Dr Terry McCormack, chairman of the Primary Care Cardiovascular Society and a GP in Yorkshire, described the result of the ENHANCE trial as a ‘no result'.
‘This is a negative study that has not told us anything,' he said. ‘GPs should continue to use ezetimibe for those patients who have failed to control their LDL cholesterol levels using statins.
‘I would definitely not take anyone who is already on ezetimibe off the drug.'
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