Review of gastrointestinal tolerability and safety of Meloxicam

Abstract

Selective COX-2 inhibition relative to COX-1 has consistently been demonstrated for meloxicam in various in vitro test systems. In human platelets ex vivo COX-1-dependent thromboxane formation is partially and dose dependently inhibited, however no significant inhibition of platelet aggregation has been observed with the recommended doses of 7.5 mg and 15 mg meloxicam daily. With once daily dosing, meloxicam has demonstrated efficacy in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. Meloxicam was granted its first marketing authorization in 1995 and is now available in more than 100 countries. Meloxicam has been studied in clinical trials involving more than 30 000 patients and is estimated to have been prescribed for more than 30 million patients worldwide to date. Clinically, meloxicam offers similar efficacy to recommended doses of well-established nonsteroid anti-inflammatory drugs (NSAIDs), including diclofenac, piroxicam and naproxen. Meloxicam distinguishes itself from established NSAIDs with a reduced risk of certain gastrointestinal adverse events. This has consistently been demonstrated in randomized clinical trials, large scale clinical outcome studies, pooled analyses and meta-analyses. Post-marketing experience is consistent with the safety profile established in these studies and analyses.