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H. pylori Infection and Risk for Rebleeding from NSAID-Associated Ulcers
The role of Helicobacter pylori infection in bleeding ulcers associated with aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) is controversial. To clarify its role, investigators in Hong Kong compared the efficacy of H. pylori-eradication therapy with that of omeprazole treatment for preventing rebleeding in 2 groups of H. pylori-infected patients with bleeding ulcers: 150 were taking low-dose aspirin, and 250 were taking other NSAIDs. All patients were treated initially with omeprazole, and ulcer healing was documented by endoscopy. Patients then were randomized to receive 1 of 2 treatments: either 1 week of H. pylori-eradication therapy (bismuth subcitrate, tetracycline, and metronidazole, each 4 times daily) followed by placebo for 6 months or omeprazole only (20 mg daily) for 6 months. Patients who had been taking aspirin continued at doses of 80 mg daily, and patients who had been taking other NSAIDs were given naproxen (500 mg twice daily).
After 6 months, patients who took naproxen and were randomized to receive omeprazole had significantly lower rebleeding rates than patients who took naproxen and were randomized to receive H. pylori-eradication therapy (4.4 percent vs. 18.8 percent, P=0.005). There was no significant difference in rebleeding rate among aspirin users who received either omeprazole or H. pylori-eradication therapy (0.9 percent vs. 1.9 percent). The authors concluded that H. pylori-eradication therapy is as effective as omeprazole for preventing rebleeding in patients who take low-dose aspirin, but omeprazole is more effective in patients who take naproxen.
Comment: These results provide more support for the efficacy of omeprazole than for the role of H. pylori eradication in preventing rebleeding from NSAID-associated ulcers. In the absence of a placebo group, which would have provided us with the baseline rebleeding rate in these high-risk patients, we don't know whether rebleeding rates associated with the 2 treatments would be the same with and without H. pylori eradication. It is well established that bleeding risks correlate with NSAID dose; therefore, the low rebleeding rates in the aspirin groups may be attributable to aspirin dose rather than to H. pylori eradication. If this is the case, then the only remaining difference between groups is the dramatic decrease in rebleeding associated with omeprazole therapy in patients who received naproxen. Although this was not the designed endpoint, this is the first study in which decreases in NSAID-associated GI complications were associated with proton-pump inhibitors.
DJ Bjorkman
Published in Journal Watch Gastroenterology April 30, 2001
Citation(s):
Chan FKL et al. Preventing recurrent upper gastrointestinal bleeding in patients with Helicobacter pylori infection who are taking low-dose aspirin or naproxen. N Engl J Med 2001 Mar 29 344 967-973.
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