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NICE is under intense pressure to offer guidance on the use of cox-2 inhibitors after experts warned GPs to avoid the drugs in all patients at risk of cardiovascular disease.

A furious debate has raged on the safety of cox-2s in the wake of the fiasco over rofecoxib (Vioxx), leaving GPs confused and angry over the lack of official advice.

A commentary in last week's New England Journal of Medicine claimed the cardiovascular effects associated with rofecoxib could be symptomatic of a class effect.

Dr Garret FitzGerald, of the Institute for Translational Medicine and Therapeutics in Philadelphia, wrote that the trial data that led to the

withdrawal of rofecoxib had 'shifted the burden of proof'.

He said: 'We now have clear evidence of an increase in cardiovascular risk that revealed itself in a manner consistent with a mechanistic explanation that extends to all the coxibs.'

Dr FitzGerald cited data from the TARGET trial finding a non-significant increase in events with lumiracoxib and said retrospective analysis of data from the CLASS trial appraisal committee for cox-2s also revealed signs of an increase in cardiovascular risk with celecoxib. He concluded: 'It would seem prudent to avoid coxibs in patients with cardiovascular risk.'

The NICE cox-2 committee met for 12 hours last week to consider new guidance, but decided only on stopgap

measures to remove rofecoxib from its appraisals of cox-2s.

GPs will now have to wait until next summer for further NICE guidance after it said it would merely keep the situation under review.

Professor Paul Dieppe, MRC professor of health services research at the University of Bristol and an expert in drug safety, told Pulse the withdrawal of rofecoxib was a 'wake-up call' that should be used as a springboard to overhaul the drug regulatory authorities. 'We've got to have processes to make sure this doesn't happen again,' he said.

Dr Steve Longworth, a GP in Leicester and past-president of the Primary Care Rheumatology Society, said: 'It's a bit of a dog's breakfast ­ NICE has been as useful as a chocolate fireguard. The silence from the regulatory authorities is deafening.'

By Rob Finch

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