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The waiting game

Safety fears over high-dose simvastatin spark generic targets row

By Nigel Praities

NHS prescribing advisers have rejected calls to suspend generic statin indicators after trial results raised serious safety concerns over use of high-dose simvastatin.

A row over the Government's drive to increase use of generic simvastatin has blown up after the release of findings from a UK trial linking use of 80mg simvastatin to a 180% increase in risk of myopapthy and big jump in cases of rhabdomyolosis.

The British Heart Foundation and Primary Care Cardiovascular Society both issued statements calling for NICE to reconsider its secondary prevention guidance, which advises GPs to ramp up simvastatin doses before switching to alternative drugs.

The pressure on the institute came as a pharmaceutical companies MSD and Schering Plough released a survey of 500 GPs finding 60% routinely increased the simvastatin dose to 80mg for patients who do not reach their targets.

The SEARCH trial, in 12,000 men and women, compared 80mg with 20mg simvastatin and was presented at the American Heart Association conference in New Orleans last week.

It found higher-dose simvastatin resulted in a 6% drop in heart attacks, strokes and revascularisations, compared with the lower dose. But it also resulted in far more cases of rhabdomyolysis, with 53 patients receiving 80 mg of simvastatin developing the problem, compared with just three receiving the 20 mg dose.

Professor Neil Poulter, professor of preventive cardiovascular medicine at Imperial College London and a board member the British Hypertension Society, said Government statin indicators were placing cost concerns ahead of patient safety.

‘It is purely driven by costs and people are just being blinkered. The highest dose of simvastatin has not looked good for a long time, but this proves it in spades.'

Dr Terry McCormack, former chair of the Primary Care Cardiovascular Society and a GP in Whitby, North Yorkshire, said some GPs were coming under great pressure from their PCTs to prescribe simvastatin 80mg. ‘If you get away with it then it is cheaper, but you are often going to get side effects,' he said.

But Dr Neal Maskrey, director of evidence-based therapeutics at the National Prescribing Centre, said there was no need to look again at generic statins indicators and advised GPs to follow NICE guidelines. ‘If you increase the dose of any medicine, side-effects increase and that is not new. I'm quite sure NICE and the NPC will be looking closely on a continuing basis at this, but at the moment there is nothing that would make one change.'

The DH stood by its: 'Our guidance makes clear prescribing should be based on an assessment of the patient's individual clinical circumstances.'

The SEARCH Study

- Largest randomised trial to assess directly the efficacy and safety of intensive LDL lowering
- 12,000 patients randomised to receive either 20 mg or 80 mg of simvastatin
- Simvastatin 80 mg treatment resulted in an additional 0.35 mmol/L drop in LDL-cholesterol and 6% fewer myocardial infarctions, strokes and revascularisations
- But 53 of the 6,000 patients receiving 80 mg of simvastatin developed myopathy, compared with just 3 of the 6,000 taking the 40 mg dose

Simvastatin 40mg - safety concerns over the higher 80mg dose have prompted a row over generics targets Simvastatin 40mg - safety concerns over the higher 80mg dose have prompted a row over generics targets

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