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GPs told to 'stick to statins' for high LDL patients

By Mark Pownall

Results of a controversial lipids study have prompted heart experts to call on GPs to ‘stick to statins' when treating patients with high levels of LDL-cholesterol.

Dr Harlan Krumholz, from the school of public health at Yale University, speaking for an American College of Cardiology expert consensus panel at its scientific meeting in Chicago said: ‘Our message is stick to statins.

‘Premature use of [the cholesterol uptake inhibitor] ezetimibe before the use of higher doses of statins is exhausted is not in the best interest of patients. Where statins alone do not work we need to go back and use resins, fibrates and niacin as well. We know they are not tolerated well, but they are worth trying.'

The comments follow the publication of the ENHANCE study at the meeting and simultaneously in the New England Journal of Medicine, which found no benefit of the addition of ezetimibe (Ezetrol) to simvastatin over high dose simvastatin alone in atherosclerosis progression.

The study was carried out on 720 patients with familial hypercholesterolaemia who had been treated for a mean 10 years with high doses of statins before they entered the trial. They were then randomly assigned to 80mg simvastatin or 80mg simvastatin with 10mg ezetimibe.

Although there was a further reduction of a mean 16.5% in LDL levels and a further 26% fall in levels of the cardiovascular risk factor C-reactive protein (CRP) in those taking the combination, there was no difference in atherosclerosis on the wall of the carotid artery, as measured by carotid intima-media thickness.

The statins first call was echoed by Berkshire GP Dr George Kassianos. He said: ‘We need to maximise statin therapy before we add ezetimibe. The strategy is to start with simvastatin 40mg. If that does not achieve your clinical target the next step is to use a more effective statin such as 10 or 20mg rosuvastatin, which I prefer because atorvastatin can reduce HDL levels and is expensive. If you want to reduce atherosclerosis, you need to increase HDL as well as reduce LDL.'

The researcher behind the study, Professor John Kastelein, at the centre of a storm of controversy over an 18-month delay before publication, and questions asked in the US Congress about approval of the drug based on its ability to lower LDL, said that how LDL is lowered may be more important than how much.

‘There may be something in statins that is over and above LDL-lowering, but the real reasons for the discreprancy remain unclear.'

Data on safety of ezetimibe in combination with statins were reassuring. There had been speculation that the combination caused more hepatic side-effects, but the study found no differences in liver enzyme levels between those on statins and ezetimibe, and statins alone.

Dr Krumholz said patients needed to be told of the extent of the evidence for ezetimibe before they were prescribed it.


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