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Ezetimibe plus statin 'halves death risk'

A cholesterol-lowering drug that has been blacklisted by some PCTs on financial grounds has been shown to reduce mortality in patients following a first acute myocardial infarction.

Ezetimibe was approved for use in the NHS by NICE in 2007 as an add-on therapy for patients with high cholesterol that is not controlled on statins.

But recent Pulse investigations have uncovered the drug is often blacklisted by PCTs who are drafting lists of high-cost drugs GPs banned from prescribing, as part of drastic measures to save £250 million from drug prescribing budgets.

A major analysis of general practice prescribing data presented at the European Society of Cardiology congress in Paris last week found ezetimibe was associated with a 55% reduction in all-cause mortality compared with patients taking statins alone.

The study was submitted to ESC, but later withdrawn due to the need for more complex analysis, which is still ongoing.

Researchers looked at the effectiveness of ezetimibe in combination with simvastatin on all-cause mortality over 4.3 years on a cohort of 14,944 patients, in a retrospective study from the UK General Practice Research Database.

Some 10,268 patients were prescribed simvastatin, 3,314 atorvastatin or rosuvastatin and 1,362 patients were started on any dose of ezetimibe in addition to simvastatin.

There were 2,233 deaths from all causes during the follow up period. The hazard ratio for death in the ezetimibe group was 0.45 compared with a control group taking just simvastatin. The hazard ratio for the group prescribed atorvastatin or rosuvastatin – another drug commonly blacklisted by PCTs – was 0.63 compared to controls.

Study leader Dr Maheshwar Pauriah, associate faculty member at the centre for cardiovascular and lung biology at the University of Dundee, concluded: ‘Our findings suggest that post-MI use of ezetimibe in combination with a statin is associated with a 55% decrease in all-cause mortality compared to patients taking simvastatin alone.'

But he added: ‘This is an observational study and more research is needed to confirm this result.'

Dr John Ashcroft, a GP in Hallam, Derbyshire, said randomised controlled trials were needed to prove the case for ezetimibe to be removed from PCT blacklists.

He said: ‘There's been a move in our practice to stop people on ezetimibe because of the lack of evidence, and pressure from the PCT for cost savings. Ezetimibe would give us an extra option for very high risk patients.'

He added that atorvastatin is due to come off-patent, which will reduce its price considerably. ‘This should give extra benefits for patients with little or no extra cost. Then the question is: is ezetimibe worth paying for, for the diminishing returns?' he added.

Dr Peter Fellowes, a GP in Lydney, Gloucestershire and a member of the GPC clinical and prescribing subcommittee, said: ‘I don't think it should be blacklisted. It is very useful in patients who are statin intolerant. The arguments against ezetimibe and the more potent statins are entirely cost based as I see it, and that is a sorry state of affairs.'

BOX: Key figures

37% - lower risk of all-cause mortality in patients on atorvastain or rosuvastatin compared with simvastatin

55% - lower risk of all-cause mortality in patients on ezetimibe and a statin compared with simvastatin alone

Source: ESC 2011, abstract 2845 (abstract later withdrawn)

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