The Pharmaceutical Journal
Vol 269 No 7216 p383
21 September 2002

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BMJ (bmj.com)

COX-2s less likely to cause gastric side effects, says new research

The risk of gastrointestinal (GI) side effects associated with COX-2 inhibitors is lower than that with conventional non-steroidal anti-inflammatory drugs (NSAIDs), two new studies have concluded.

Researchers in Oxford reviewed nine randomised trials involving over 15,000 arthritis patients and found that the rate of withdrawal from celecoxib (Celebrex) treatment due to adverse GI events was 46 per cent lower than that in patients taking other NSAIDs. In addition, the incidence of ulcers detectable by endoscopy was 71 per cent lower and the incidence of symptoms of ulcers, perforations, bleeds and obstructions was 39 per cent lower in the celecoxib group than in the NSAID group.

In the second study, Canadian researchers found that, relative to rofecoxib (Vioxx) users, non-selective NSAID users were almost twice as likely to suffer GI haemorrhage (relative risk ratio=1.9, CI 1.0–3.5).

Their observational study compared GI haemorrhage among patients aged over 66 years who were taking non-selective NSAIDs (n=5,391), diclofenac plus misoprostol (5,087), rofecoxib (14,583), celecoxib (18,908) and controls not exposed to NSAIDs (100,000). Relative to controls, patients treated with celecoxib did not have an increased short-term risk of GI haemorrhage, whereas the relative risk ratio for patients taking the other drugs ranged from 1.9 for rofecoxib to 4.0 for non-selective NSAIDs.

Both studies are published in the BMJ (2002;325:619). In an accompanying editorial (ibid, p607), Dr Roger Jones, professor of general practice at Guy's, King's and St Thomas' School of Medicine, says many questions remain unanswered because neither study had commented on death rates. He adds that it may not be appropriate to view COX-2 inhibitors as a homogeneous group and that more research is needed before doctors can make rational decisions about this class of drugs, particularly in older people with multiple diseases.