SAFETY OF MELOXICAM - A GLOBAL ANALYSIS OF CLINICAL-TRIALS

Meloxicam is a new preferential cyclooxygenase-2 (COX-2) inhibitor for the treatment of rheumatic disease. This paper presents a global safe ty analysis of data from meloxicam clinical studies, focusing on gastr ointestinal (GI) adverse events. Meloxicam 7.5 and 15 mg (n = 893 and 3282) were compared with piroxicam 20 mg (n = 906), diclofenac 100 mg slow release (n = 324) and naproxen 750-1000 mg (n = 243). With respec t to all GI adverse events, meloxicam 7.5 and 15 mg were significantly better than all comparators in a pooled analysis of double-blind stud ies in rheumatoid arthritis (RA) and osteoarthritis (OA). When examini ng non-serious GI events, severe GI events, discontinuations due to GI events, dyspepsia, abdominal pain and upper GI events, both meloxicam doses were significantly better than comparator non-steroidal anti-in flammatory drugs (NSAIDs) in most cases. Where statistical significanc e was not demonstrated, there was generally a trend in favour of melox icam. With respect to upper GI perforations, ulcerations and bleedings , the most serious of NSAID-associated side-effects, meloxicam was bet ter tolerated than the comparators, reaching statistical significance for piroxicam and naproxen. Meloxicam's improved GI safety profile is likely to be due to its preferential inhibition of inducible COX-2 rel ative to constitutive COX-1.