The Effect of a Proton Pump Inhibitor on the Development of Ulcer Complication Recurrences in Patients taking 100 mg ASA Daily

Overall Study Question

These investigators looked to see if lansoprazole administration could decrease the chance of gastrointestinal toxicity from low dose (100 mg) ASA in patients who had previously developed gastrointestinal toxicity on 325 mg of ASA.

Patients

123 patients with a previous history of bleeding or gastric outlet obstruction due to gastroduodenal ulcer while receiving 325 mg of ASA daily. Their average age was 70, approximately 72% were male, and all had proven H. pylori infection.

Treatment

All patients received one-week of anti-helicobacter treatment. After that time patients were randomized to receive either placebo or lansoprazole 30 mg PO daily. The study was stopped when an interim analysis revealed a significant treatment effect, according to prespecified stopping rules.

Duration

The median duration of follow up was 12 months.

Results

Bleeding, perforation or obstruction (%)
Lansoprazole 2
Placebo 15
Relative Risk Reduction 87
Absolute Risk Reduction 13
NNT/NNH over 12 mos 8

Other results

Side effects were not reported

How does this study contribute to the drug therapy of prevention of gastrointestinal toxicity from ASA used for cardiovascular prophylaxis?

This study demonstrates that a proton pump inhibitor decreases the chance of clinically important gastrointestinal toxicity from ASA in patients who had already experienced gastrointestinal toxicity on ASA.

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