GASTRODUODENAL TOLERABILITY OF NIMESULIDE AND DICLOFENAC IN PATIENTS WITH OSTEOARTHRITIS

This 1-month, randomized, double-masked, parallel-group study was cond ucted to compare nimesulide (100 mg twice daily) with diclofenac (50 m g three times daily) with respect to gastroduodenal tolerability and e fficacy in patients with osteoarthritis. Results of gas-troduodenal en doscopy in 83 patients (42 receiving nimesulide, 41 receiving diclofen ac) revealed that, after 30 days, 4 patients (1 nimesulide, 3 diclofen ac) had developed ulcers and 6 patients (4 nimesulide, 2 diclofenac) h ad developed erosions; however, differences between the treatment grou ps mere not statistically significant. Both study drugs were well tole rated. Ten patients (5 in each group) withdrew from the study prematur ely because of adverse events. Efficacy was assessed by measuring pain on visual analogue scales, using the functional index of Lequesne, an d by scoring spontaneous pain, pain on passive movement, and functiona l impairment. Nocturnal pain was also checked. All efficacy variables showed a significant improvement during the study, and no statisticall y significant differences were observed between the treatment groups.