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Global analysis of gastrointestinal safety of a new nsaid, meloxicam

  • IVth International Meeting on Side-Effects of Anti-Inflammatory Drugs 7–9 August 1995, Sheffield, UK
  • Published:
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Abstract

Meloxicam is a new preferential cyclo-oxygenase-2 inhibitor. This paper presents a global safety analysis of data from meloxicam clinical studies, focusing on gastrointestinal (GI) adverse events. Meloxicam 7.5 mg 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 mg and 15 mg were significantly superior to all comparators in a pooled analysis of double-blind studies in rheumatoid arthritis and osteoarthritis. When examining nonserious GI events, severe GI events, discontinuations due to GI events, dyspepsia, abdominal pain and upper GI events, both meloxicam doses were significantly superior to comparator NSAIDs in most cases. Where statistical significance was not demonstrated, there was generally a clear 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 cyclo-oxygenase-2 relative to constitutive cyclooxygenase-1.

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Author notes

  1. M. Sistel

    Present address: Boehringer Ingelheim S.A., Chile 80, 1098, Buenos Aires, Argentina

Authors and Affiliations

  1. Medical Department, Dr Karl Thomas GmbH, Biberach, Germany

    M. Sistel

  2. Department of Data Management, Dr Karl Thomas GmbH, Biberach, Germany

    C. Mueller

  3. Department of Biostatistics, Dr Karl Thomas GmbH, Biberach, Germany

    E. Bluhmki

Authors
  1. M. Sistel
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  2. C. Mueller
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  3. E. Bluhmki
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Sistel, M., Mueller, C. & Bluhmki, E. Global analysis of gastrointestinal safety of a new nsaid, meloxicam. Inflammopharmacology 4, 71–81 (1996). https://doi.org/10.1007/BF02735561

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  • DOI: https://doi.org/10.1007/BF02735561

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