A 4-WEEK, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO COMPARE THE GASTROINTESTINAL EFFECTS OF MELOXICAM 7.5 MG, MELOXICAM 15 MG, PIROXICAM 20 MG AND PLACEBO BY MEANS OF FECAL BLOOD-LOSS, ENDOSCOPY AND SYMPTOM EVALUATION IN HEALTHY-VOLUNTEERS

Meloxicam is a new non-steroidal anti-inflammatory drug (NSAID) which preferentially inhibits cyclooxygenase-2 (COX-2) over cyclooxygenase-1 (COX-1). Gastrointestinal (GI) tolerability of meloxicam 7.5 and 15 m g vs piroxicam 20 mg was evaluated in a 4-week, double-blind, parallel -group, placebo-controlled study in 51 healthy male volunteers, using a combination of oesphago-gastro-duodenal endoscopy, faecal blood loss measurement and symptom evaluation. Analysis of covariance found no s ignificant difference in faecal blood loss between the groups. However , significantly higher bleeding was found with piroxicam 20 mg compare d with placebo using a Student's t-test on the weighted means. Endosco py scores were significantly higher with piroxicam than with meloxicam 7.5 mg or placebo (P < 0.01). A significant difference from baseline was observed in the meloxicam 15 mg and piroxicam groups (P < 0.05), b ut not in the meloxicam 7.5 mg and placebo groups. Six piroxicam-treat ed volunteers were withdrawn following a poor endoscopic score, but no such withdrawals occurred in the meloxicam and placebo groups (P < 0. 01). Meloxicam 7.5 mg caused less GI damage compared with piroxicam 20 mg when administered to healthy young volunteers for 28 days; a possi ble dose dependency effect in GI tolerability was also suggested for m eloxicam 7.5 and 15 mg, in relation to endoscopic findings.