The two prevailing approaches to decrease risks of nonsteroidal anti-inflammatory drug (NSAID)-associated gastrointestinal (GI) events are the use of a COX-2 inhibitor or co-therapy with a proton-pump inhibitor (PPI). A major limitation of each approach is that, in patients at the highest risk for NSAID-induced ulcers, neither treatment is effective when used as a stand-alone strategy. An important question is whether combination therapy with a COX-2 inhibitor plus a PPI has improved GI safety compared to a traditional NSAID plus a PPI. This study evaluated high GI risk patients who were taking, along with their NSAID or COX-2 inhibitor, either the PPI, esomeprazole, or the placebo. It confirms that our current approach of adding PPIs to reduce NSAIDs' ulcer risks is an effective strategy. However, this study did not show a safety advantage for using a COX-2 inhibitor instead of a traditional NSAID in high GI risk patients who take PPIs. Thus, there continues to be no prospective data to support a GI benefit of COX-2 inhibitor plus a PPI over traditional NSAID plus a PPI in high-risk patients.
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