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Summary
The local tolerability, safety and efficacy of meloxicam 15 mg suppositories were compared with piroxicam 20 mg suppositories over a 3-week period in a single-blind, randomized study in patients with osteoarthritis. Patients were randomized 2:1 to receive meloxicam (n = 216) or piroxicam (n = 109). More than 90% of patients and investigators assessed local tolerability of both treatments as good or very good (primary endpoint). There was no significant difference between the groups. Global efficacy was reported by approximately 80% of patients in both groups to be good or very good. Pain on movement and at rest and joint mobility showed statistically significant improvements compared with baseline with both meloxicam and piroxicam; there were no statistically significant differences between treatment groups. Piroxicam and meloxicam suppositories were equally well tolerated, with no serious adverse events recorded in either treatment group. Local adverse events occurred in 11.9% of patients receiving piroxicam and 6.9% of those receiving meloxicam. Overall, gastrointestinal adverse events were the most frequent of all adverse events reported in both groups (9.2% of meloxicam-treated patients and 11.9% of piroxicam-treated patients). In both groups, about 90% of global tolerability assessments were classified, by the investigator and the patient, as either very good or good In conclusion, meloxicam 15 mg suppositories showed excellent local tolerability accompanied by good safety and efficacy in osteoarthritis, which was comparable to that of an established non-steroidal anti-inflammatory drug (NSAID) administered by the rectal route, and to that previously observed with oral formulations of meloxicam 15 mg.