section name header

Evidence summaries

Gastrointestinal Effects of Rofecoxib

Rofecoxib appears to produce fewer gastrointestinal adverse effects than ibuprofen, diclofenac or nabumetone. Level of evidence: "B"

An analysis of 8 double-blind, randomized trials on rofecoxib vs. NSAIDs in osteoarthritis patients assessed the incidence of upper GI tract perforations, symptomatic gastroduodenal ulcers, and upper GI tract bleedings (PUBs) 1. The incidence of PUBs over 12 months was significantly lower with rofecoxib vs. NSAIDs (ibuprofen, diclofenac, nabumetone): 1.3% vs 1.8%, p=0.046, rate per 100 patient-years 1.33 vs 2.60, relative risk 0.51 (95% CI 0.26 to 1.00).

Comment: The quality of evidence is downgraded by sparse data.

Note: Rofecoxib (Vioxx® ) was withdrawn from the market at the end of September 2004 after it was shown that its use increases the risk of heart attack and stroke.

    References

    • Langman MJ, Jensen DM, Watson DJ, Harper SE, Zhao PL, Quan H, Bolognese JA, Simon TJ. Adverse upper gastrointestinal effects of rofecoxib compared with NSAIDs. JAMA 1999 Nov 24;282(20):1929-33. [PubMed]

Primary/Secondary Keywords