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Gastrointestinal outcomes: evidence for risk reduction in patients using coxibs
1Division of Gastroenterology, University of Michigan Medical Center, Ann Arbor, USA.
Abstract:
This paper examines the importance of clinically relevant gastrointestinal (GI) outcomes in patients using nonsteroidal anti-inflammatory drugs (NSAIDs) and the risk reduction for adverse GI events associated with cyclooxygenase (COX)-2-selective inhibitors. Four large outcomes trials are reviewed, 2 each with celecoxib and rofecoxib. The results of outcomes studies are consistent with randomized controlled trials and demonstrate that coxibs are associated with significant reductions in clinically relevant GI outcomes. The reductions are observed in patients without GI risk factors as well as in those at risk, suggesting that these drugs have the potential to improve outcomes for all patients requiring NSAIDs.
Insights
Cyclooxygenase (COX)-2-selective inhibitors significantly reduce gastrointestinal (GI) adverse events in patients taking nonsteroidal anti-inflammatory drugs (NSAIDs). These benefits apply to both at-risk and not-at-risk patients, improving overall outcomes.
Area of Science:
- Gastroenterology
- Pharmacology
- Clinical Research
Background:
- Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used for pain and inflammation.
- NSAID use is associated with significant risks of gastrointestinal (GI) adverse events.
- Cyclooxygenase (COX)-2-selective inhibitors (coxibs) were developed to mitigate these GI risks.
Purpose of the Study:
- To evaluate the clinical relevance of GI outcomes in patients using NSAIDs.
- To assess the risk reduction for adverse GI events with COX-2 selective inhibitors.
- To review evidence from major outcomes trials of coxibs.
Main Methods:
- Review of four large outcomes trials (two each for celecoxib and rofecoxib).
- Analysis of data from randomized controlled trials (RCTs).
- Assessment of clinically relevant GI outcomes.
Main Results:
- Coxibs demonstrated significant reductions in clinically relevant GI outcomes.
- Risk reduction was observed in patients with and without pre-existing GI risk factors.
- Results from outcomes studies align with findings from RCTs.
Conclusions:
- COX-2 selective inhibitors offer substantial GI safety benefits compared to traditional NSAIDs.
- These agents have the potential to improve GI outcomes for a broad range of patients requiring NSAIDs.
- The findings support the use of coxibs for patients needing NSAIDs, irrespective of their GI risk profile.