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© 1996 British Society for Rheumatology

Safety of Meloxicam: A Global Analysis of Clinical Trials

M. Distel*, C. Mueller{dagger}, E. Bluhmki{ddagger} and J. Fries§

* Medical Department, Boehringer Ingelheim GmbH, Birkendorfer Strasse 65 8839 7 Biberach/Riss, Germany
{dagger} Department of Data Management, Boehringer Ingelheim GmbH, Birkendorfer Strasse 65 8839 7 Biberach/Riss, Germany
{ddagger} Department of Biostatistics, Boehringer Ingelheim GmbH, Birkendorfer Strasse 65 8839 7 Biberach/Riss, Germany
§ Department of Immunology and Rheumatology, Stanford University School of Medicine 1000 Welch Road, Suite 203, Palo Alto, CA 94304-1808, USA

Correspondence to: Correspondence to: Dr. M. Distel, Medical Department, Boehringer Ingelheim SA, Calle Chile 80, 1098 Buenos Aires, Argentina.


  Abstract

Meloxicam is a new preferential cyclooxygenase-2 (COX-2) inhibitor for the treatment of rheumatic disease. This paper presents a global safety analysis of data from meloxicam clinical studies, focusing on gastrointestinal (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 respect to all GI adverse events, meloxicam 7.5 and 15 mg were significantly better than all comparators in a pooled analysis of double-blind studies in rheumatoid arthritis (RA) and osteoarthritis (OA). When examining 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-inflammatory drugs (NSAIDs) in most cases. Where statistical significance was not demonstrated, there was generally a trend in favour of meloxicam. With respect to upper GI perforations, ulcerations and bleedings, the most serious of NSAID-associated side-effects, meloxicam was better 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 relative to constitutive COX-1.

KEY WORDS: Meloxicam, NSAID, Safety, Gastrointestinal, PUB, Cydooxygenase


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