Long term tolerability profile of nimesulide in the treatment of osteoarthritis.

As a primary objective, the safety profile of nimesulide was assessed in a nonblinded study that recruited 134 patients (aged 41 to 82 years) with osteoarthritis requiring long term treatment (> or = 1 year). Nimesulide (100mg orally twice daily) was well tolerated. No statistically significant differences were found between the number of patients of varying ages reporting adverse events. Moreover, most adverse experiences were found to be mild to moderate in intensity, with a prevalence of gastrointestinal disorders. The number of adverse episodes reported steadily decreased over the duration of the trial and no pathological changes in haematology and blood chemistry tests were found. Evaluation of efficacy revealed a progressive reduction in pain intensity with time.