1. Home>
2. Specialties>
3. General Medicine>
4. Summary and Comment

GI Toxicity of Rofecoxib vs. Naproxen

Endoscopic studies have shown that COX-2 inhibitors induce less asymptomatic gastroduodenal ulceration than do traditional NSAIDs. Whether this translates into fewer symptomatic ulcers was controversial until a recent trial demonstrated a lower incidence of symptomatic or complicated ulcers with celecoxib than with ibuprofen or diclofenac (JW Oct 15 2000, p. 159, accession number 000922001, and JAMA 2000; 284:1247). But what about rofecoxib, the other available COX-2 inhibitor?

In a double-blind, randomized, multicenter trial sponsored by the manufacturer, 8076 patients with rheumatoid arthritis received either rofecoxib (50 mg daily) or naproxen (500 mg twice daily). Patients requiring aspirin therapy were excluded. During an average follow-up of 9 months, the incidence of symptomatic or complicated upper gastrointestinal ulcers was significantly lower with rofecoxib than with naproxen (2.1 vs. 4.5 events per 100 patient-years). Interestingly, the incidence of myocardial infarction (MI) was significantly higher in the rofecoxib group than in the naproxen group (0.4 percent vs. 0.1 percent).

Comment: This 2 percent absolute difference in the yearly incidence of symptomatic or complicated ulcer is similar to that noted in the celecoxib trial cited above. An unexpected finding in the current study is the lower rate of MI with naproxen. This outcome might be explained by the fact that naproxen (but not rofecoxib) inhibits platelet aggregation, and aspirin use was not permitted. The question, then, is whether low-dose aspirin for cardiovascular prophylaxis would negate the gastroduodenal benefits of rofecoxib, as it did in the celecoxib study.

— AS Brett

Published in Journal Watch General Medicine December 8, 2000

Citation(s):

Bombardier C et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000 Nov 23 343 1520-1528.

• Original article (Subscription may be required)
• Medline abstract (Free)