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

In an uncontrolled, open-label trial, 885 patients with painful osteoa rticular conditions-(738 patients with nonarticular rheumatism, includ ing 167 with painful spinal problems [cervical, dorsal, or low-back pa in, or several of these problems combined] and 571 with soft-tissue rh eumatism [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 opportun ity to stop treatment after 7 days if symptoms were relieved. The effi cacy and safety of nimesulide were assessed for all patients on an int ent-to-treat basis. In addition, each subgroup of patients was assesse d separately. After 7 days of treatment, a significant improvement in locomotor function and;a significant reduction in pain, as well as sig nificant reductions in swelling, heat, and redness, were: observed in the entire group of patients as well as in each subgroup. The incidenc e of side effects (11.2%), mainly gastrointestinal (9.2%), was low com pared with that described in the literature for nonsteroidal antiinfla mmatory drugs (NSAIDs). At the end of the study, a significant percent age of patients and investigators estimated that, globally, both the e fficacy 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 c onditions, especially nonarticular rheumatism.