A multidisciplinary international team assessed the incidence of clinically important upper gastrointestinal events among patients with rheumatoid arthritis. They determined whether taking rofecoxib, a selective inhibitor of cyclooxygenase-2, was associated with a lower incidence of events than the non-selective NSAID, naproxen.
8076 patients, who were at least 50 years of age (or at least 40 years of age and receiving long-term glucocorticoid therapy) and who had rheumatoid arthritis, were included in the study. The patients were randomly assigned either 50 mg of rofecoxib daily or 500 mg of naproxen twice daily.
The primary end point measured was confirmed clinical upper gastrointestinal events (gastroduodenal perforation or obstruction, upper gastrointestinal bleeding, and symptomatic gastroduodenal ulcers).
The team found that rofecoxib and naproxen had similar efficacy against rheumatoid arthritis.
GI events per 100 patient-years:
During a median follow-up of 9 months, 2.1 confirmed gastrointestinal events per 100 patient-years occurred with rofecoxib, as compared with 4.5 per 100 patient-years with naproxen.
The respective rates of complicated confirmed events (perforation, obstruction, and severe upper gastrointestinal bleeding) were 0.6 per 100 patient-years and 1.4 per 100 patient-years.
The incidence of myocardial infarction was lower among patients in the naproxen group than among those in the rofecoxib group (0.1 % vs. 0.4 %). The overall mortality rate and the rate of death from cardiovascular causes were similar in the two groups.
Dr Claire Bombardier, based in Toronto, Canada, concluded that, "In patients with rheumatoid arthritis, treatment with rofecoxib is associated with significantly fewer clinically important upper gastrointestinal events than treatment with the non-selective inhibitor, naproxen."