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Rosiglitazone risk highlighted in new NICE guidance

By Lilian Anekwe

The safety of rosiglitazone for the management of type 2 diabetes has again been called into question in new draft NICE guidance that states there is a ‘clinically important' risk of heart attacks.

The new draft guidance, on the newer agents available for the management of type 2 diabetes, highlights evidence suggesting rosiglitazone increases the risk of heart attacks, although not mortality.

The safety profile of rosiglitazone has been the subject of speculation since the publication of a meta-analysis of 42 trials, published in the New England Journal of Medicine in May 2007, finding rosiglitazone raised the risk of myocardial infarction by 43% and risk of death from all cardiovascular causes by 64%.

The guidance document's evidence review on rosiglitazone states ‘the current evidence suggests rosiglitazone increases the risk of heart attacked and cardiovascular mortality but that pioglitazone reduces it'.

But it adds: ‘The statistical significance of the increased risk for rosiglitazone is still debated.'

The drug's manufacturer, GlaxoSmithKline, has rejected the findings, saying the paper was 'based on incomplete evidence and a methodology that the author admits has significant limitations'.

Overall, the draft guidance concludes that several reviews assessed by the guidance development group did show a ‘statistically significant and clinically important increased risk of non-fatal myocardial infarction and heart failure, but not mortality, with rosiglitazone'.

‘Although the magnitude of the risk was not consistent, the increased risk… was consistent across the review.'

The draft document, which is out for consultation until 5 November, also recommends the DPP-4 inhibitors sitagliptin or vildagliptin as second-line therapy in patients taking sulfonylurea or intolerant of metformin. Exanetide is also recommended, but only in patients with a BMI of more than 335 kg/m2.

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