Previous studies have suggested that nonsteroidal anti-inflammatory drugs (NSAIDs) increase the risk for lower gastrointestinal (GI) clinical events. However, data from prospective trials are lacking.
Cyclooxygenase (COX)-2-selective inhibitors decrease upper GI clinical events but the effect on lower GI events has not been determined.
In this study, a team of international researchers assessed serious lower GI clinical events with a nonselective NSAID and a COX-2–selective agent using a prospective, double-blind, randomized trial.
The team randomly assigned 8076 rheumatoid arthritis patients, expected to require NSAIDs for 1 year or more, to naproxen 500 mg twice daily, or rofecoxib 50 mg daily.
|Serious lower GI events accounted for 39% of all serious GI events in patients taking naproxen.|
Patients in the study were 50 years or older, or 40 years or older if on corticosteroid therapy.
The researchers determined the rate of serious lower GI clinical events. These were defined as bleeding with a 2g/dl drop in hemoglobin or hospitalization, or hospitalization for perforation, obstruction, ulceration, or diverticulitis.
They found that the rate of serious lower GI events per 100 patient-years was 0.41 for rofecoxib and 0.89 for naproxen (relative risk, 0.46).
Furthermore, serious lower GI events accounted for 39% of all serious GI events in patients taking naproxen, and 43% in those taking rofecoxib.
Dr Loren Laine’s team concluded, “Serious lower GI events occurred at a rate of 0.9% per year in rheumatoid arthritis patients taking the nonselective NSAID naproxen, accounting for nearly 40% of the serious GI events that developed in these patients”.
“Serious lower GI events were 54% lower with the use of the selective COX-2 inhibitor rofecoxib.”