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Abstract
Objective: This study was conducted to compare the risk of recurrent hospitalization for major
gastrointestinal (GI) complications (peptic ulcer, bleeding, and perforation) in patients
at high GI risk who require ongoing antiplatelet therapy (aspirin [acetylsalicylic
acid] or clopidogrel) with or without proton pump inhibitors (PPIs).
Methods: This population-based, retrospective cohort study employed data from the Taiwanese
National Health Insurance database (January 2001 through December 2006) for patients
who had a history of hospitalization for GI complications before the initiation of
antiplatelet therapy with aspirin or clopidogrel. Recurrent hospitalizations for major
GI complications were analyzed using a Cox proportional hazards model, with adjustment
for age, sex, ulcer-related medical history, ulcer-related risk factors, and use of
ulcer-related medications during follow-up. The propensity score method was applied
to adjust for selection bias.
Results: The analysis included data from 14,627 patients (12,001 receiving aspirin, 2626 receiving
clopidogrel). The incidence of recurrent hospitalization for major GI complications
was 0.125 per person-year in aspirin users, 0.103 per person-year in users of aspirin
plus a PPI, 0.128 per person-year in clopidogrel users, and 0.152 per person-year
in users of clopidogrel plus a PPI. Among aspirin users, those taking PPIs had a significantly
lower adjusted risk of hospitalization for major GI complications than did non-PPI
users (hazard ratio [HR] = 0.76; 95% CI, 0.64–0.91). Use of a PPI was not associated
with a significant risk reduction among clopidogrel users (HR = 1.08; 95% CI, 0.89–1.33).
An adjusted survival curve for the risk of recurrent hospitalization for major GI
complications indicated that the risk increased numerically faster in clopidogrel
users compared with those using aspirin plus a PPI, although the mean drug cost per
personyear was 5.08 times higher in clopidogrel users than in users of aspirin plus
a PPI.
Conclusions: In this analysis in patients at high GI risk who were receiving antiplatelet therapy
for the secondary prevention of cardiovascular events, aspirin plus a PPI was associated
with a reduced risk of recurrent hospitalization for major GI complications. This
was not the case for clopidogrel plus a PPI.
Key words
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Article info
Publication history
Accepted:
July 9,
2009
Identification
Copyright
© 2009 Excerpta Medica Inc. All rights reserved. Published by Elsevier Inc.
