Evidence Based Snapshots

The Journal of Informed Pharmacotherapy 2002;10:152.

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


Reviewer: James McCormack, B.Sc. (Pharm), Pharm. D.
Reviewer's email address:
jmccorma@interchange.ubc.ca
Reviewer's profession/specialty:
Associate Editor, Journal of Informed Pharmacotherapy

Original Citation

Lai KC, Lam SK, Chu KM, Wong BCY, Hui WM, Hu WHC, Lau GKK, Wong WM, Yuen MF, Chan AOO, Lai CL, Wong J. Lansoprazole for the Prevention of Recurrences of Ulcer Complications from Long-Term Low-Dose Aspirin Use. N Engl J Med 2002;346:2033-8 PubMed Citation

Overall Study Question

These investigators looked to see if lansoprazole [corrected text] 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 [corrected text]
Placebo 15 [corrected text]
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.


Corrected Text

Originally published as "omeprazole".  Corrected to "lansoprazole" on 9AUG02.

In the results table the percentages for bleeding, perforation or obstruction in the lansoprazole and placebo groups were originally published in reverse.  On 9AUG02, the values were corrected as above.


Copyright © 2002 by the Journal of Informed Pharmacotherapy. All rights reserved.