MSD announces publication of Medal programme results

Merck, Sharp and Dohme (MSD) has announced the publication of the safety analysis of its multinational etoricoxib and diclofenac arthritis long-term (Medal) programme, investigating the use of selective Cox-3 inhibitor Arcoxia (etoricoxib) for the treatment of arthritis and pain, when compared with the widely prescribed non-steroidal anti-inflammatory pharmaceutical diclofenac.

These results showed a less common incidence of overall upper gastrointestinal (GI) events, such as bleeding, perforation, obstructions and ulcers, in patients being administered with Arcoxia compared to those receiving diclofenac.

Furthermore, these results were maintained in patients taking low doses of aspirin for cardiovascular protection and those administered with proton pump inhibitors for GI protection.

Loren Laine, professor of gastrointestinal and liver diseases at the department of medicine, 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.”

She added that while these ulcers are not life-threatening to patients, they have a clinical impact due the need for continued medical follow-up and treatment.

In November 2006, MSD reported that Arcoxia has similar rates of cardiovascular thrombotic events when compared to diclofenac, with the composite endpoint showing no difference between treatment groups with regard to such adverse affects.