IMPROVEMENT IN GASTROINTESTINAL TOLERABILITY OF THE SELECTIVE CYCLOOXYGENASE (COX)-2 INHIBITOR, MELOXICAM, COMPARED WITH PIROXICAM - RESULTS OF THE SAFETY AND EFFICACY LARGE-SCALE EVALUATION OF COX-INHIBITING THERAPIES (SELECT) TRIAL IN OSTEOARTHRITIS

SELECT is a large-scale, prospective, international, :multicentre, dou ble-blind, double-dummy, randomized, parallel-group trial. Patients wi th exacerbation of osteoarthritis were treated with the recommended do se of meloxicam (7.5 mg) or piroxicam (20 mg) once daily for 28 days;; 4320 patients were administered meloxicam and 4336 piroxicam. The inc idence of adverse events was significantly lower in the meloxicam grou p (22.5%) compared with the piroxicam group (27.9%; P < 0.001), mainly due to the significantly lower incidence of gastrointestinal (GI) adv erse events in the meloxicam than in the piroxicam group (10.3% vs 15. 4%; P < 0.001), while the efficacy of both drugs-was equivalent. Indiv idual GT events occurred significantly less often with meloxicam than piroxicam: dyspepsia (3.4% vs 5.8%; P < 0.001), nausea/vomiting (2.5% vs 3.4%; P < 0.05) and abdominal pain (2.1% vs 3.6%; P < 0.001). There were 16 patients with perforations, ulcerations or bleeding (PUBs) of the upper GI tract in the piroxicam group compares with Seven-in the meloxicam group (relative risk piroxicam:meloxicam = 1.4). Four PUBs w ere complicated:(perforations or bleedings); none of these occurred in the meloxicam group(relative risk piroxicam:meloxicam = 1.9). The out come of SELECT is consistent with that of the large-scale clinical tri al of similar design and size which compared 7.5 mg meloxicam with 100 mg:diclofenac in patients with osteoarthritis, and with: a previous g lobal analysis of the safety of meloxicam. It adds further data to the proposed relationship between selective inhibition of cyclooxygenase- 2 and improved GI tolerability of non-steroidal anti-inflammatory drug s.