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Gastrointestinal safety profile of meloxicam: a meta-analysis and systematic review of randomized controlled trials
1Division of Gastroenterology, National Naval Medical Center, Bethesda, Maryland 20889, USA. pssmd@aol.com
Abstract:
This article provides a systematic review of the frequency and severity of adverse gastrointestinal (GI) events among patients using meloxicam, a cyclooxygenase (COX)-2-selective nonsteroidal anti-inflammatory drug (NSAID). A MEDLINE search of English language articles from 1990-1998, a manual search of citations from primary trials and review articles, and a manual search of proceedings from international gastroenterology meetings were conducted. Randomized clinical trials comparing the frequency of GI adverse events for meloxicam versus non-COX-2-selective NSAIDs were selected. Specific data about the frequency of dyspepsia; perforations, ulcers, and bleeds (PUBs); and withdrawal of medication because of adverse GI events was also extracted. From a pool of 62 potentially relevant citations, 12 randomized trials were identified. All trials concerning symptomatic GI adverse events used the World Health Organization's Adverse Reaction Terminology List (WHO-ARTL) to code adverse events. Patients using meloxicam had fewer GI adverse events compared with non-COX-2-selective NSAIDs (odds ratio = 0.64; 95% confidence interval [CI], 0.59-0.69). Patients using meloxicam experienced less dyspepsia (odds ratio = 0.73; 95% CI, 0.64-0.84), fewer PUBs (odds ratio = 0.52; 95% CI, 0.28-0.96), and less frequent discontinuation of NSAID because of adverse GI events (odds ratio = 0.59; 95% CI, 0.52-0.67) compared with non-COX-2 selective NSAIDs. Meloxicam, a COX-2-selective NSAID, appears to cause fewer adverse GI events than standard, non-COX-2-selective NSAIDs. However, the generalizability 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.
Insights
Meloxicam, a COX-2 selective NSAID, causes fewer gastrointestinal adverse events than non-COX-2 selective NSAIDs. This systematic review found reduced dyspepsia, fewer perforations, ulcers, and bleeds (PUBs), and less medication withdrawal due to GI issues.
Area of Science:
- Gastroenterology
- Pharmacology
- Clinical Medicine
Background:
- Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used for pain and inflammation.
- Traditional NSAIDs carry a risk of gastrointestinal (GI) adverse events.
- Cyclooxygenase (COX)-2 selective NSAIDs were developed to reduce GI toxicity.
Purpose of the Study:
- To systematically review the frequency and severity of GI adverse events associated with meloxicam.
- To compare GI adverse events of meloxicam with non-COX-2 selective NSAIDs.
Main Methods:
- Systematic review of randomized clinical trials published between 1990-1998.
- Searches included MEDLINE, citation tracking, and conference proceedings.
- Data extracted on dyspepsia, perforations, ulcers, and bleeds (PUBs), and medication withdrawal due to GI events.
Main Results:
- Meloxicam use was associated with significantly fewer GI adverse events compared to non-COX-2 selective NSAIDs (OR=0.64).
- Specific reductions observed in dyspepsia (OR=0.73), PUBs (OR=0.52), and NSAID discontinuation due to GI issues (OR=0.59).
- All adverse events were coded using the World Health Organization's Adverse Reaction Terminology List (WHO-ARTL).
Conclusions:
- Meloxicam, a COX-2 selective NSAID, demonstrates a favorable GI safety profile compared to non-COX-2 selective NSAIDs.
- The findings suggest meloxicam may be a safer option for patients at risk of GI complications.
- Generalizability may be limited by low meloxicam doses and WHO-ARTL coding in reviewed trials.