BMJ  2005;331:1474-1475 (17 December), doi:10.1136/bmj.331.7530.1474-c

Letter

Risk of gastrointestinal effects with COX-2 inhibitors and NSAIDs

What does evidence from randomised trials show about celecoxib?

The first 150 words of the full text of this article appear below.

EDITOR—With reference to Feczko's comments (first letter in this cluster), Hippisley-Cox et al's study was an observational study.¹ This occupies a lower place on the hierarchy of evidence than large, prospective randomised controlled trials measuring outcomes that are important to patients (patient oriented evidence that matters, or POEMs).

The only POEM evidence for celecoxib is the CLASS study.² CLASS showed no significant difference between celecoxib and the comparators (diclofenac and ibuprofen) in terms of the primary outcome of the study—gastrointestinal ulcer complications.³ Only when a post-hoc sub-group analysis of these data was performed in those not taking aspirin was a significant benefit seen (with a P value of 0.04). This was one of over 34 post-hoc analyses performed on this study (so, by chance, we would expect at least one of these to show a difference with a P value slightly less than 0.05).⁴ Others have recently highlighted . . . [Full text of this article]

National Prescribing Centre, The Infirmary, Liverpool L69 3GF jonathan.underhill@npc.nhs.uk

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