By Lilian Anekwe
GPs have been advised to review all of their patients on 80mg simvastatin in the wake of new safety concerns highlighted by the UK’s drug regulator.
Pulse exclusively revealed last month that the Medicines and Healthcare products Regulatory Agency (MHRA) will issue a revised label for simvastatin 80mg, after data from an unpublished study found the highest dose of the drug ‘did not provide any significant benefit’ over lower doses.
The warning was based on the unpublished results of the SEARCH trial by researchers at the University of Oxford, which found 1% of patients on the highest dose of simvastatin developed myopathy – 50 times higher than the rate of 0.02% seen in those on simvastatin 20mg.
In response, the MHRA told Pulse future prescribing simvastatin 80mg will be restricted, but this week went even further and said GPs should review patients on high-dose simvastatin.
An MHRA spokesperson told Pulse: ‘In the light of the new evidence for those patients who are on simvastatin 80mg or for those who are being considered for an up-titration to that dose, GPs may need to review their treatment during their next visit.’
And in a significant shift from its prior guidance, NICE is now advising GPs to follow the MHRA’s safety advice and consider alternative statins where appropriate.
A spokesperson for NICE told Pulse the institute would consider the SEARCH data on simvastatin when it reviews it lipid modification guidance next May.
The spokesperson added: ‘It is expected that prescribers will follow the safety advice of the MHRA when prescribing simvastatin. The guideline already states that, if there are potential drug interactions, or simvastatin 40 mg is contraindicated, a lower dose or alternative preparation such as pravastatin may be chosen.
Dr Alan Begg, a GP in Montrose, Scotland and a member of the SIGN guideline steering group on coronary heart disease, said going back through patients records ‘would be a huge workload.’
‘Simvastatin 40mg is the standard that is used across the UK today. Prescribing advisors have gone out of their way to encourage GPs to do that, whereas perhaps a more evidence based approach would be to use a more potent statin.’
Most patients on a statin are on simvastatin 40mg