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Saturday 28 April 2012

12-fold increased risk of severe muscle damage with simvastatin 80mg.

GPs have called for an urgent review of ‘outdated' NICE guidelines on hyperlipidaemia after an analysis showed a 12-fold increased risk of severe muscle damage with simvastatin 80mg.

Researchers showed patients taking simvastatin across its doses were 2.6 times more likely to suffer rhabdomyolysis than patients taking other statins, in the first indication of a potential raised incidence of rhabdomyolysis in the community with simvastatin.

But the 80mg dose continues to be recommended in NICE guidance for patients who are not controlled on lower doses, and latest prescribing figures from the NHS Information Centre reveal over 550,000 prescriptions of simvastatin 80mg were made in primary care in England last year.

At a dose of 80mg, it was associated with an rhabdomyolysis incidence of 64.8 per 100,000 person-years, a 12.2-fold increase in risk compared with lower doses of 20-39mg.
Study leader Dr James Floyd, a lecturer in epidemiology at the University of Washington, said: ‘Most of the risk of high-dose simvastatin is up front, within the first year.'
Dr Rubin Minhas, clinical director of the BMJ Clinical Evidence Centre and a GP in Hoo, Kent, said future NICE guidance should be changed in line with the evidence: ‘The risk of muscle damage adds to the evidence for considering atorvastatin at higher doses.'
Dr Ahmet Fuat, a cardiology GPSI in Darlington, said: ‘This study highlights the folly of the "fire and forget" approach to monitoring bloods in statin takers suggested by outdated NICE guidelines.

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