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.
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.
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.
The median duration of follow up was 12 months.
|Bleeding, perforation or obstruction (%)|
|Relative Risk Reduction||87|
|Absolute Risk Reduction||13|
|NNT/NNH over 12 mos||8|
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.