Upper GI bleeds less common with Arcoxia than diclofenac

19 February 2007

US drug major Merck & Co says that the results of a pre-specified upper gastrointestinal safety analysis of data from the MEDAL program indicate that GI bleeding events were less common for its selective COX-2 inhibitor Arcoxia (etoricoxib), than for diclofenac. The findings are published in the February 10 issue of the medical journal, The Lancet.

Specifically, the company said that upper GI clinical events were significantly lower in subjects treated with its drug (0.67 per 100 patient years) versus diclofenac (0.97 per 100 patient years). The firm added that these results were maintained in patients taking proton pump inhibitors for to reduce the risk of GI events, as well as by those using low-dose aspirin for cardio-protection.

However, the rate of complicated upper GI events between the two drugs were comparable (0.30 vs 0.32 per 100 patient years). Loren Laine, co-chair of the trial's steering committee and a professor of gastrointestinal and liver diseases, at the University of Southern California, said: "the significant difference in overall upper GI clinical events demonstrated between etoricoxib and diclofenac was driven by uncomplicated symptomatic ulcers, which, although not life threatening, have clinical impact."

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