A LARGE, OPEN-LABEL TRIAL OF NIMESULIDE IN PATIENTS WITH OSTEOARTICULAR CONDITIONS TREATED IN A GENERAL PRACTICE SETTING

Abstract In an uncontrolled, open-label trial, 885 patients with painful osteoarticular conditions—(738 patients with nonarticular rheumatism, including 167 with painful spinal problems [cervical, dorsal, or low-back pain, or several of these problems combined] and 571 with soft-tissue rheumatism [194 with tendinitis and bursitis, 117 with painful shoulder, and 260 with minor traumas such as strains, sprains, and tears], and 147 patients with other painful conditions)—received nimesulide 100 mg twice daily (BID) for a maximum of 14 days. Patients had the opportunity to stop treatment after 7 days if symptoms were relieved. The efficacy and safety of nimesulide were assessed for all patients on an intent-to-treat basis. In addition, each subgroup of patients was assessed separately. After 7 days of treatment, a significant improvement in locomotor function and a significant reduction in pain, as well as significant reductions in swelling, heat, and redness, were observed in the entire group of patients as well as in each subgroup. The incidence of side effects (11.2%), mainly gastrointestinal (9.2%), was low compared with that described in the literature for nonsteroidal anti-inflammatory drugs (NSAIDs). At the end of the study, a significant percentage of patients and investigators estimated that, globally, both the efficacy and tolerability of nimesulide were satisfactory or excellent. Results of the present study suggest that nimesulide 100 mg BID is a safe and effective NSAID for the treatment of painful osteoarticular conditions, especially nonarticular rheumatism.