Diclofenac/misoprostol. A review of the major clinical trials evaluating its clinical efficacy and upper gastrointestinal tolerability in rheumatoid arthritis and osteoarthritis.

The results of 4 pivotal multicentre double-blind trials demonstrating the clinical efficacy of diclofenac/misoprostol in the treatment of rheumatoid and osteoarthritis are reviewed. In each study, diclofenac 50mg and diclofenac/misoprostol 50mg/200 micrograms 2 or 3 times daily were of similar therapeutic efficacy. Upper gastrointestinal endoscopy performed at baseline (day 0) and at study completion, in one study in patients with rheumatoid arthritis and one study in patients with osteoarthritis, indicated that fewer patients receiving diclofenac/misoprostol than those receiving diclofenac alone had significant erosions or ulcers at study completion. Thus, the antiarthritic efficacy of diclofenac/misoprostol was similar to that of diclofenac in the treatment of the signs and symptoms of rheumatoid and osteoarthritis, and, in addition, was associated with significantly fewer gastroduodenal mucosal erosions and ulcers than diclofenac.