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

Abstract

The objective of this study was to compare the efficacy and tolerability of nimesulide with those of diclofenac in patients suffering from osteoarthritis of the hip or knee and with moderate-to-severe pain. In this multicenter, double-masked, parallel-group study, 279 outpatients were randomly allocated to receive nimesulide 100 mg twice daily or diclofenac 50 mg three times 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 stiffness, inactivity stiffness, and the Doyle articular index. Nimesulide was shown to be as effective as diclofenac in the treatment of osteoarthritis of the hip or knee. No between-group differences were reported for either efficacy or overall tolerability. The percentage of patients reporting gastrointestinal adverse events regardless of causality or patient age was significantly lower ( P = 0.042) with nimesulide (36.3%) compared with diclofenac (47.2%). Results of this study suggest that nimesulide is as effective as diclofenac in the long-term treatment of osteoarthritis; however, nimesulide demonstrated a slightly superior gastric safety profile. This finding may be particularly beneficial to the elderly, who are most at risk for these side effects.