GASTRODUODENAL TOLERABILITY OF NIMESULIDE AND DICLOFENAC IN PATIENTS WITH OSTEOARTHRITIS

This 1-month, randomized, double-masked, parallel-group study was conducted to compare nimesulide (100 mg twice daily) with diclofenac (50 mg three times daily) with respect to gastroduodenal tolerability and efficacy in patients with osteoarthritis. Results of gastroduodenal endoscopy in 83 patients (42 receiving nimesulide, 41 receiving diclofenac) revealed that, after 30 days, 4 patients (1 nimesulide, 3 diclofenac) had developed ulcers and 6 patients (4 nimesulide, 2 diclofenac) had developed erosions; however, differences between the treatment groups were not statistically significant. Both study drugs were well tolerated. Ten patients (5 in each group) withdrew from the study prematurely because of adverse events. Efficacy was assessed by measuring pain on visual analogue scales, using the functional index of Lequesne, and by scoring spontaneous pain, pain on passive movement, and functional impairment. Nocturnal pain was also checked. All efficacy variables showed a significant improvement during the study, and no statistically significant differences were observed between the treatment groups.