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Vol 278 No 7439 p183
17 February 2007

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Upper GI safety of etoricoxib superior to that of diclofenac for arthritis, study suggests

Using etoricoxib (Arcoxia) rather than diclofenac reduces the number of uncomplicated upper gastrointestinal events in patients with arthritis, a new analysis of data from the MEDAL study suggests.

The cardiovascular results of the MEDAL (multinational etoricoxib and diclofenac arthritis long-term) programme, which includes 34,701 patients with osteoarthritis or rheumatoid arthritis, were announced last year (PJ, 18 November 2006, p599; Lancet 2006; 368:1771). Last week saw publication of an assessment of the upper gastrointestinal safety of etoricoxib and diclofenac in the MEDAL patients (Lancet 2007;369:465).

The new analysis shows that overall upper gastrointestinal clinical events were less common with etoricoxib than with diclofenac, due to a decrease in uncomplicated events (hazard ratio 0.59, 95 per cent confidence interval 0.45–0.74; P<0.0001), but that there was no difference in the number of complicated events.

The authors of an accompanying editorial (ibid, p439) argue that the results could have important ramifications, because the use of these drugs in a susceptible population is often limited by gastrointestinal toxicity. However, the editorial also highlights the shortcomings of the findings. “We would need to treat 259 patients with etoricoxib to prevent one uncomplicated gastrointestinal event in one patient,” the authors say. “So, although the effect might well be statistically significant, the effect is certainly not large and might not be clinically relevant.”

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