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Rosiglitazone risks questioned

Early findings from a major international trial suggest rosiglitazone may not increase cardiovascular risk after all, contradicting results from a recent meta-analysis.

Primary care diabetes experts urged GPs to hold off on switching patients from the drug, insisting concerns over its safety remained unproven.

A meta-analysis of 42 trials, published in the New England Journal of Medicine last month, found rosiglitazone raised the risk of heart attack 43% and death from all cardiovascular causes by 64%.

But an interim analysis of the 4,447-patient RECORD study, published online again by the NEJM, found no significant differences in rates of heart attack or cardiovascular death in patients taking rosiglitazone and those not.

Study leader Professor Philip Home, professor of diabetes medicine at Newcastle University and vice-chair of the NICE appraisals committee, said: 'There is no evidence of any increase in death from either cardiovascular causes or all causes.'

He said the trial was not due to finish until late 2008, but 'in light of the questions raised recently about rosiglitazone, we felt it critical interim data be made available immediately'.

A second study, published in Pharmacoepidemiology and Drug Safety, found the hospitalisation rate for heart attack and coronary revascularisation surgery was the same for those on rosiglitazone or other treatments.

But editorials accompanying the RECORD findings warned there was continued uncertainty over the cardiovascular safety of rosiglitazone.

Dr David Nathan, professor of medicine at Harvard Medical School, said: 'It is reasonable to ask whether physicians should feel comfortable using a drug that might have an 8% excess risk of severe cardiovascular disease or death from cardiovascular causes. Given the choices the answer should be no.

'But Dr Stephen Lawrence, diabetes lead for Medway PCT and a GP in Chatham, Kent, said the results were 'promising'. He had advised colleagues not to switch type 2 diabetes patients off rosiglitazone, but to be 'cautious' of using it in patients with a strong history of heart disease.

Dr Peter Tasker, former head of Primary Care Diabetes UK and a GP in King's Lynn, Norfolk, said: 'I think it is too early to put a nail in the coffin of this glitazone.'

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