Gastrointestinal tolerability of meloxicam compared to diclofenac in osteoarthritis patients. International MELISSA Study Group. Meloxicam Large-scale International Study Safety Assessment.

摘要: SUMMARY Although widely used, non-steroidal anti-inflammatory drugs (NSAIDs) are associated with a high incidence of gastrointestinal (GI ) side-eVects. Inhibition the cyclooxygenase (COX enzyme is basis for both eYcacy and toxicity NSAIDs. The discovery two COX isoforms, constitutive COX-1 inducible COX-2, has led to hypothesis that selective inhibition COX-2 will minimize potential GI without compromising eYcacy. Meloxicam Large-scale International Study Safety Assessment (Melissa) trial reported here was therefore set up investigate tolerability meloxicam, preferential inhibitor compared diclofenac. Melissa large-scale, double-blind, randomized, international, prospective trial, conducted over 28 days in patients symptomatic osteoarthritis. Patients received either meloxicam 7.5 mg or diclofenac 100 slow release, recommended doses treatment Evaluation profile adverse events main aim together assessment A total 9323 (4635 4688 groups, respectively). Significantly fewer were by receiving meloxicam. This attributable (13%) (19%; P< 0.001). Of most common events, there significantly less dyspepsia (P< 0.001), nausea vomiting 0.05), abdominal pain 0.001) diarrhoea Five on experienced perforation, ulcer bleed vs seven (not significant). No endoscopically verified complication detected group four There five patient hospitalization 121 Adverse caused withdrawal from study 254 (5.48%) 373 (7.96%) These diVerences (3.02% 6.14% diclofenac; DiVerences eYcacy, as assessed visual analogue scales, consistently favoured In all instances, 95% confidence intervals did not cross zero, suggesting statistically significant eVect. However, small (4.5‐9.0% diVerence) reach pre-determined levels clinical significance. Nevertheless, more discontinued because lack (80 out 4635 49 4688; 0.01). confirms earlier studies improved comparison other NSAIDs, including results may part reflect selectivity although dose aspects be important. provide support relative might an eVective approach towards NSAID therapy.