Double-blind study evaluating by endoscopy the tolerability of nimesulide and diclofenac on the gastric mucosa in osteoarthritic patients.

The gastric tolerability of nimesulide, a new nonsteroidal anti-inflammatory drug (NSAID), was compared with diclofenac, an established NSAID for the treatment of osteoarthritis (OA). A randomised, double-blind parallel group study was undertaken comparing the tolerability and efficacy of nimesulide (100 mg bds) with diclofenac (50 mg tds) over a one month period. Gastroduodenal endoscopy revealed that after 30 days 4 patients had developed ulcers (1 nimesulide patient) and 6 patients had developed erosions (4 nimesulide patients). However, there was no statistically significant difference between the two treatments. Both drugs were clinically very well tolerated and only 10 patients withdrew from the study due to adverse events (5 in each group). Efficacy was assessed by measuring pain on visual analogue scales, by means of the functional index of Lequesne and by scoring spontaneous pain, pain on passive movement and functional impairment. Nocturnal pain was also checked. All efficacy parameters showed a significant improvement during the study without any observed treatment differences.