Multi-centre double-blind study to define the most favourable dose of nimesulide in terms of efficacy/safety ratio in the treatment of osteoarthritis.

A parallel group study for one month of 392 patients was undertaken to define the optimal dose of nimesulide for the treatment of painful osteoarthritis (OA). By the final visit, the mean values for pain intensity for the nimesulide groups (50 mg, 100 mg and 200 mg bd) were similar and significantly lower than the mean for the placebo group. The onset of analgesia was rapid and continued throughout the 12-hour period after drug intake, a significant analgesic effect was demonstrated with nimesulide 100 mg and 200 mg within 1.5 hours. The patients' and the physicians' overall judgements of the drug efficacy demonstrated significant differences between the treatment groups with the most successful outcomes occurring with nimesulide 100 mg and 200 mg. Nimesulide 50 mg and 100 mg were generally well-tolerated but at the highest dose level, nimesulide 200 mg, the incidence of adverse events was greater although not significantly. Results of this study demonstrate nimesulide 100 mg twice daily to be the optimal dose for the treatment of OA.