The Pharmaceutical Journal
Vol 270 No 7231 p43
11 January 2003

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Celecoxib as good as diclofenac plus omeprazole in gastric bleeds

Celecoxib (Celebrex) is as effective as diclofenac plus omeprazole at preventing recurrent bleeds among arthritis patients with a recent history of ulcer bleeding, a randomised controlled trial has shown.

However, the authors of the study warn that neither regimen completely protected against recurrent episodes among patients with a history of bleeding ulcers. They also found that renal toxic effects among high-risk patients taking celecoxib or diclofenac plus omeprazole were common.

In all, 287 arthritis patients who tested negative for Helicobacter pylori were randomised to receive 200mg celecoxib twice daily or 75mg extended release diclofenac twice daily plus 20mg omeprazole once daily for six months. Safety and compliance with each regimen were assessed every two months. The main end point of the trial was recurrent ulcer bleeding within the six-month study period.

At six months 4.9 per cent of patients who had received celecoxib suffered recurrent ulcer bleeding compared with 6.4 per cent of patients treated with diclofenac plus omeprazole (seven vs nine patients). Patients' assessments of their arthritis pain did not differ between the two groups. Discontinuation rates were similar for both groups, at 13.3 per cent among patients taking celecoxib and 11.9 per cent for patients taking diclofenac plus omeprazole.

Renal adverse events such as hypertension, peripheral oedema and renal failure were common, the authors report. Among patients with renal impairment at the start of the study, half of those receiving celecoxib and 41 per cent of those receiving diclofenac plus omeprazole suffered renal adverse events.

"The substantial proportion of our patients with co-existing medical conditions, such as renal disease, diabetic nephropathy and heart failure, probably accounts for the high incidence of adverse renal events," the study authors write. They add that the renal toxicity of cyclo-oxygenase (COX) 2 inhibitors is probably similar to non-selective non-steroidal anti-inflammatory drugs.

The researchers call for further studies to see whether a combination of a COX-2 selective inhibitor and proton pump inhibitor can reduce the risk of ulcer complications among patients with multiple risk factors (New England Journal of Medicine 2002;347:2104).