A comparison of aspirin and clopidogrel with or wi... [Clin Ther. 2009] - PubMed

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 -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 person-year 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.