This site is intended for health professionals only

No ‘significant benefit’ of simvastatin above 20mg, says drugs regulator

By Nigel Praities

Exclusive: The UK medicines regulator is set to run into conflict with NICE guidance by advising there is ‘no significant benefit' in using doses of simvastatin over 20 mg.

A spokesperson from the Medicines and Healthcare products Regulatory Agency told Pulse they were intending to issue a revised label for simvastatin in the next few weeks after a review raised concerns over the risk of myopathy with the 80 mg dose.

The spokesperson also said the review had concluded there was little evidence doses over 20 mg provided any additional benefit.

This causes a problem for NICE guidelines on lipid modification, which advise GPs to initiate patients on 40 mg simvastatin and titrate up to 80 mg for secondary prevention if they do not reach their cholesterol goals.

The change was prompted by a review of the unpublished SEARCH study that compared the outcomes of patients on simvastatin 80mg versus those on simvastatin 20 mg.

‘SEARCH showed that overall, treatment with simvastatin (Zocor) 80mg did not provide any significant benefits over simvastatin 20mg. However the rate of myopathy was much higher in patients treated with the highest dose, 1% for patients on Zocor 80mg compared with 0.02 % for patients on 20mg,' she said.

The new simvastatin label will restrict the 80 mg dose to patients with severe hypercholesterolaemia and those at high risk who have not achieved their treatment goals on lower doses, but only if the benefits outweigh the risks.

The US Food and Drug Administration has also issued a ‘safety announcement' in the past week warning doctors should review the clinical history of patients to see if simvastatin is clinically appropriate, and should discuss the benefits and risks with patients.

The British Heart Foundation and Primary Care Cardiovascular Society have both previously issued calls calling for NICE to reconsider its guidance on simvastatin.

Dr Alan Begg, a GP in Montrose, Scotland, and a member of the PCCS, said the statement had ‘big ramifications' for NICE.

‘It really is a no brainer – you should not move from 40 mg to 80 mg simvastatin. I have been advocating for years that you consider a more effective statin – or as many have done in England where there has been a big drive to use simvastatin – add ezetimibe,' he said.

He disputed the MHRA's conclusion that there is no benefit over 20 mg of simvastatin. ‘There is a lot of evidence for this dose, particularly from the Heart Protection Study,' he said.

The drugs regulator has warned of an increased risk of muscle damage with simvastatin 80mg