Aspirin plus esomeprazole reduced recurrent ulcer bleeding more than clopidogrel in high risk patients

doi:10.1136/ebm.10.4.112

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Evidence-Based Medicine 2005;10:112; doi:10.1136/ebm.10.4.112
Copyright © 2005 by the BMJ Publishing Group Ltd.

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Therapeutics

Aspirin plus esomeprazole reduced recurrent ulcer bleeding more than clopidogrel in high risk patients

Chan FK, Ching JY, Hung LC, et al. Clopidogrel versus aspirin and esomeprazole to prevent recurrent ulcer bleeding. N Engl J Med 2005;352:238–44.[Abstract/Free Full Text]

Q In patients with previous aspirin-induced ulcer bleeding, is clopidogrel non-inferior to low dose aspirin plus esomeprazole for preventing recurrent ulcer bleeding?

Clinical impact ratings GP/FP/Primary care $*$ $*$ $*$ $*$ $*$ $*$ $*$ IM/Ambulatory care $*$ $*$ $*$ $*$ $*$ $*$ ${star}$ Internal medicine $*$ $*$ $*$ $*$ $*$ $*$ ${star}$ Cardiology $*$ $*$ $*$ $*$ $*$ $*$ ${star}$ Gastroenterology $*$ $*$ $*$ $*$ $*$ $*$ $*$

Key Words: aspirin • esomeprazole • peptic ulcer haemorrhage

The first 150 words of the full text of this article appear below.

METHODS
Design: randomised placebo controlled trial.

Allocation: concealed.^*

Blinding: blinded (clinicians, patients, outcome assessors, {data collectors,data analysis, and data safety and monitoring committee}).^*

Follow up period: 12 months.

Setting: Prince of Wales Hospital in Hong Kong.

Patients: 320 patients (mean age 72y, 66% men) who had a history of ulcerbleeding and endoscopically confirmed ulcer healing and eithertested negative for Helicobacter pylori or had successful eradicationof H pylori and required antiplatelet therapy during the trial.Exclusion criteria were concomitant use of non-steroidal anti-inflammatorydrugs (NSAIDs), cyclooxygenase-2 inhibitors, anticoagulant agents,or corticosteroids; history of gastric surgery (except patchrepair); allergy to aspirin or clopidogrel; presence of erosiveoesophagitis, gastric-outlet obstruction, terminal illness,or cancer; or requirement for dialysis.

Intervention: clopidogrel, 75 mg, plus placebo (n = 161) or aspirin, 80 mg,plus esomeprazole, 20 mg (n = 159) twice daily for 12 months.

Outcomes: recurrent ulcer bleeding. Secondary . . . [Full text of this article]

Walter L Peterson, MD

University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, USA