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Evidence summaries

Gastrointestinal Safety Profile of Meloxicam

Meloxicam may cause less gastrointestinal adverse events than standard, non-COX-2-selective NSAIDs. Level of evidence: "C"

A systematic review 1 included 10 studies with a total of 20 374 subjects. Patients using meloxicam had fewer GI adverse events compared with non-COX-2-selective NSAIDs (OR 0.64, 95% CI 0.59 to 0.69). Patients using meloxicam experienced less dyspepsia (OR 0.73, 95% CI 0.64 to 0.84), fewer bleeds (OR 0.52, 95% CI 0.28 to 0.96) and less frequent discontinuation of NSAID because of adverse GI events (OR 0.59, 95% CI 0.52 to 0.67) compared with non-COX-2 selective NSAIDs. Results from two additional trials using endoscopy to assess the affect of meloxicam on gastric mucosa of healthy volunteers suggested that piroxicam caused no greater mucosal damage than meloxicam.

Comment: The quality of evidence is downgraded by limitations in review methodology and indirectness of evidence. The authors note that the generalisability of these data may be limited by the low dose of meloxicam used in most trials and the use of the WHO-ARTL to code adverse events.

Another review 2 included 28 studies with a total of 24 196 subjects. Data was pooled from clinical trials of meloxicam at doses of 7.5 or 15 mg/d, and the follow-up time was mostly 60 days. 13 118 subjects received meloxicam (10 158 a daily dose of 7.5 mg and 2 960 received 15 mg), 5 283 were treated with diclofenac 100 mg, 181 received diclofenac 150 mg, 5 371 were treated with piroxicam 20 mg, and 243 received naproxen 500 mg twice daily. Patients using meloxicam 7.5 mg/d had a 0.03% risk of serious upper gastrointestinal events, significantly lower than with diclofenac, naproxen, or piroxicam (P<0.02). With the 15 mg/d dose of meloxicam, this risk was significantly different only when compared with piroxicam (P=0.03). The risk of thromboembolic events in patients treated with meloxicam at either dose was lower than with diclofenac, but similar to that observed with piroxicam and naproxen.

    References

    • Schoenfeld P. Gastrointestinal safety profile of meloxicam: a meta-analysis and systematic review of randomized controlled trials. Am J Med 1999 Dec 13;107(6A):48S-54S. [PubMed]
    • Singh G, Lanes S, Triadafilopoulos G. Risk of serious upper gastrointestinal and cardiovascular thromboembolic complications with meloxicam. Am J Med 2004;117(2):100-6. [PubMed]

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