Combination of a Cox-2-Inhibitor and Proton Pump Inhibitor for Prevention of Recurrent Ulcer Bleeding

A prospective, randomized, double-blind trial 1 included 441 consequtive patients from a single centre who were taking non-selective NSAIDs for arthritis and were admitted for upper gastrointestinal bleeding. Patients were enrolled after their ulcers had healed and a histological test for Helicobacter pylori was negative. All patients received selecoxib 200 mg daily, and either esomeprazole 20 mg twice daily or placebo. The 13-month cumulative incidence of recurrent ulcer bleeding was 12 cases (8.9%, 95% CI 4.1 to 13.7%) in the controls and 0 (0%) in the combined treatment group (p=0.0004, intention to treat analysis). The combined treatment group included 22 patients (incidence of recurrent ulcer bleeding 0%) and the control group included 21 patients (recurrent ulcer bleeding 19%, 95% CI 2.2 to 35.8) who started concomitant low-dose aspirin.

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

References

• Chan FK, Wong VW, Suen BY, Wu JC, Ching JY, Hung LC, Hui AJ, Leung VK, Lee VW, Lai LH, Wong GL, Chow DK, To KF, Leung WK, Chiu PW, Lee YT, Lau JY, Chan HL, Ng EK, Sung JJ. Combination of a cyclo-oxygenase-2 inhibitor and a proton-pump inhibitor for prevention of recurrent ulcer bleeding in patients at very high risk: a double-blind, randomised trial. Lancet 2007 May 12;369(9573):1621-6. [PubMed]