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Reduction in Uncomplicated Upper Gastrointestinal Events was Consistent with or without Use of Proton Pump Inhibitors and Maintained in Patients Taking Low-Dose Aspirin Regularly
WHITEHOUSE STATION, N.J. — The results from a pre-specified upper gastrointestinal safety analysis of the MEDAL (Multinational Etoricoxib and Diclofenac Arthritis Long-Term) Program comparing the investigational selective COX-2 inhibitor ARCOXIA([R]) (etoricoxib) and diclofenac, the most widely prescribed non-steroidal anti-inflammatory drug (NSAID) in the world, were published in the February 10, 2007 issue of The Lancet.

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The results showed that overall upper gastrointestinal (GI) events (bleeding, perforation, obstruction or ulcer) were significantly less common with ARCOXIA compared to diclofenac in a broad patient population. These results were maintained in patients taking proton pump inhibitors (PPIs) for GI protection and in patients taking low dose aspirin regularly for cardiovascular protection. Upper GI clinical events were significantly lower with ARCOXIA (0.67 per 100 patient years, 95 percent CI: 0.57-0.77) than with diclofenac (0.97 per 100 patient years, 95 percent CI: 0.85-1.10); RR (relative risk): 0.69; 95 percent CI 0.57, 0.83. However, there was no significant difference in the rates of complicated upper GI events (perforations, obstructions and significant bleeding) between ARCOXIA and diclofenac (0.30 vs. 0.32 per 100 patient years), respectively.
“These results demonstrate significantly fewer upper GI clinical events with etoricoxib as compared to diclofenac,” said Loren Laine, M.D., MEDAL steering committee co-chair and professor of Gastrointestinal & Liver Diseases, Department of Medicine, University of Southern California. “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 because they require further medical follow-up and therapy.” Professor Laine stated that the difference in the results between complicated and uncomplicated events could potentially relate to diclofenac’s lack of anti-platelet effect.
In the MEDAL Program, arthritis patients who had GI risk factors were encouraged to use PPIs and those with cardiovascular risk factors were encouraged to use low-dose aspirin to simulate real-world practice. The MEDAL Program provides the first comparison of a selective COX-2 inhibitor and a traditional NSAID to assess the effect of concomitant GI co-therapy with PPI’s on long-term risk of upper GI clinical events and upper GI symptoms, and is the largest comparison of these agents in low-dose aspirin users. Therefore, subgroup analyses related to concomitant use of PPI co-therapy and/or low-dose aspirin use were conducted.
“The results of the subgroup analyses furthermore indicate that the reduction in uncomplicated upper GI events with etoricoxib is maintained in PPI users and in patients taking low-dose aspirin regularly,” said Professor Laine.
Upper GI clinical event characteristics
In the MEDAL Program, potential upper GI clinical events included bleeding, perforation, obstruction or ulcer. The subset of complicated events included those with perforation, obstruction and complicated bleeding. Uncomplicated events included uncomplicated bleeding and uncomplicated ulcer. Patients with both a complicated and uncomplicated event were counted in the overall clinical event patient group and the complicated event patient group, but not the uncomplicated event patient subgroup.
Concomitant low-dose aspirin (