The incidences of upper gastrointestinal clinical events have been shown to be significantly less with COX-2 selective inhibitors than traditional NSAIDs in randomised gastrointestinal outcomes trials of 12 weeks - 12 months' duration.
COX-2 selective inhibitors have also been reported to induce less dyspepsia than traditional NSAIDs.
In this trial the authors set out to compare the upper gastrointestinal safety of COX-2 selective inhibitors versus traditional NSAIDs in a way that simulated standard clinical practice.
COX-2 selective inhibitors selectively block the inflammation-producing COX-2 specific enzyme that is produced in arthritic joints, and unlike traditional NSAIDs, do not affect the COX-1 enzyme, which is important for protecting against gastrointestinal problems.
From a clinical perspective, the effectiveness of COX-2 selective inhibitors, in terms of antiinflammatory activity and pain relief, are comparable to those effects of NS-NSAIDs, at least in the studies that have been used as pivotal for approval.
66) Preliminary evidence also suggests overall reduced GI complications with the COX-2 selective inhibitors compared with NS-NSAIDs, even with concomitant use of proton pump inhibitors.
Collectively, these studies demonstrate significantly reduced GI complications with COX-2 selective inhibitors, compared with NS-NSAIDs, and a reduction in potential fatalities resulting from GI complications.
It is also unknown whether the COX-2 selective inhibitors will demonstrate these same effects although studies show that agents in these drug classes may have different effects from each other, possibly unrelated to prostaglandin inhibition.
Serious GI or CV events are more frequent side effects in patients treated with NSAIDs and COX-2 selective inhibitors than serious hepatic events, as confirmed in TARGET with a more than ten times higher frequency of serious GI and CV events than hepatic events.