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Preventing GI bleeds with low dose aspirin

 

Clinical bottom line

Lansoprazole is effective in preventing gastrointestinal bleeding with low dose aspirin.


Reference

KC Lai et al. Lansoprazole for the prevention of recurrences of ulcer complications from long-term low-dose aspirin use. New England Journal of Medicine 2002 346: 2033-2038.

Study

One hundred and twenty-three patients who had an ulcer complication after using low dose aspirin for more than one month, and who had Helicobacter pylori infection had their ulcers healed with triple therapy with PPI and antibiotics for one week was followed by 20 mg famotidine twice a day for a further five weeks. Patients in whom Helicobacter infection was still present were further treated with another regimen containing bismuth.

Those patients whose Helicobacter infection had been cured were randomised (random number generator) to 100 mg aspirin and 30 mg lansoprazole or 100 mg aspirin and matching lansoprazole placebo, for 12 months, with follow up every two months. Patients were told to avoid taking NSAIDs. Endoscopy was repeated with any signs of ulcer complication (epigastric pain, dyspepsia not relieved by antacids, melena, haemetemesis).

The primary end point was the recurrence of ulcer complications of bleeding, perforation or obstruction.

Results

Patients were 71 years old on average, and 70% were men. During the 12 months of the study, 14 upper gastrointestinal tract events were adjudicated by an end-points committee, and 10 were confirmed. One occurred in the 62 patients taking lansoprazole (2%) and nine in the 61 patients taking placebo (15%) (Figure 1). The relative risk was 0.11 (0.01 to 0.84) and the number needed to treat with 30 mg lansoprazole for one year to prevent one upper gastrointestinal bleed was 8 (4 to 27).

Figure 1: Bleeding, perforation or obstruction with lansoprazole or placebo with low dose aspirin


Comment

It is unlikely that this trial from Hong Kong could be now replicated, given the high efficacy demonstrated with proton pump inhibitor with low dose aspirin. The implication is that those patients who have to take low dose aspirin and who are at any increased risk of gastrointestinal bleeding, prophylactic proton pump inhibitor might need to be added.