Nimesulide versus diclofenac in the treatment of osteoarthritis of the hipor knee: An active controlled equivalence study

The objective of this study was to compare the efficacy and tolerability of nimesulide with those of diclofenac in patients suffering from osteoarthri tis of the hip or knee and with moderate-to-severe pain, In this multicente r, double-masked, parallel-group study, 279 outpatients were randomly alloc ated to receive nimesulide 100 mg twice daily or diclofenac 50 mg three tim es daily over a 24-week period. The main efficacy assessment was a combined analysis of 7 individual criteria: patient's global evaluation of efficacy , the Lequesne functional index, global pain, nocturnal pain, morning stiff ness, inactivity stiffness, and the Doyle articular index, Nimesulide was s hown to be as effective as diclofenac in the treatment of osteoarthritis of the hip or knee. No between-group differences were reported for either eff icacy or overall tolerability. The percentage of patients reporting gastroi ntestinal adverse events regardless of causality or patient age was signifi cantly lower (P = 0.042) with nimesulide (36.3%) compared with diclofenac ( 47.2%), Results of this study suggest that nimesulide is as effective as di clofenac in the long-term treatment of osteoarthritis; however, nimesulide demonstrated a slightly superior gastric safety profile. This finding may b e particularly beneficial to the elderly, who are most at risk for these si de effects.