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I believe your story 'Cox-2s no better on GI safety than standard NSAIDs, says EU' (News, June 28) was rather sensationalised. The key points are that the CPMP review found an acceptable risk-benefit profile in their assessment of the cox-2s, and that no contraindications have been added to cox-2 product information as a result of the review.

The clarification of labelling you refer to as 'warnings' is nothing new, and reflects what clinicians are already practising in relation to coxib prescribing. Therefore, the implications of the CPMP conclusion for GPs in the UK are negligible.

There is a wealth of data to support cox-2s in

relation to GI events, much of which provided the evidence base for NICE when they developed their

cox-2 guidance.

NICE found that existing evidence suggests cox-2s are less likely to produce symptomatic gastrointestinal tract adverse events compared with standard NSAIDs and therefore recommend that cox-2s should be considered for patients at risk from GI complications and those aged over 65.

Dr Stott's comment that 'GPs will be caught between a rock and a hard place' incites unnecessary concern and contradicts the fundamental purpose of such guidance being available. NICE guidance regarding cox-2s has not been changed, and GPs should continue to follow it regarding cox-2s and other therapeutic areas until a review of such guidance suggests otherwise.

Dr Niel Amin


The editor replies:

Pulse stands by the tone and content of its news item which accurately reflected the conclusion of the

CPMP report.

This stated: 'Available data indicate that significant and consistent GI benefit of cox-2 inhibitors compared with conventional NSAIDs has not been demonstrated.'

Our item clearly reported the CPMP's view that there was an acceptable risk-benefit profile. However, the EU review also concluded: 'With respect to CV risk, there may be a small safety disadvantage of cox-2 inhibitors compared with conventional NSAIDs.'

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