Esomeprazole with aspirin versus clopidogrel for prevention of recurrent gastrointestinal ulcer complications.
OBJECTIVE
The role of clopidogrel in patients at risk for gastrointestinal complications is uncertain, although it has been recommended for patients who have gastrointestinal intolerance to aspirin. We tested the hypothesis that clopidogrel is as effective as esomeprazole and aspirin in preventing recurrences of ulcer complications.


METHODS
This was a prospective, double-blind, randomized, controlled study of 170 patients who developed ulcer bleeding after the use of low-dose aspirin between November 2002 and January 2005. After healing of ulcers and eradication of Helicobacter pylori, if present, patients were assigned randomly to treatment with esomeprazole 20 mg/day and aspirin 100 mg/day (n = 86) or clopidogrel 75 mg/day (n = 84) for 52 weeks. The primary end point was recurrent ulcer complications.


RESULTS
During a median follow-up period of 52 weeks, no patient in the esomeprazole group, as compared with 9 patients in the clopidogrel group, developed recurrent ulcer complications. The cumulative incidences of recurrent ulcer complications were 0% in patients receiving esomeprazole and aspirin and 13.6% in patients receiving clopidogrel (absolute difference, 13.6%; 95% confidence interval for the difference, 6.3-20.9; log-rank test, P = .0019).


CONCLUSIONS
The combination of esomeprazole and aspirin is superior to clopidogrel in preventing ulcer complications in patients who have a past history of aspirin-related peptic ulcer bleeding.
Lai
Kam-Chuen
KC
Department of Medicine, University of Hong Kong, Queen Mary Hospital, Hong Kong, China. kclai@hku.hk
Chu
Kent-Man
KM
Hui
Wai-Mo
WM
Wong
Benjamin Chun-Yu
BC
Hung
Wai-Ka
WK
Loo
Ching-Kong
CK
Hu
Wayne Hsing-Ching
WH
Chan
Annie On-On
AO
Kwok
Ka-Fai
KF
Fung
Tang-Tat
TT
Wong
John
J
Lam
Shiu-Kum
SK
D000368:Aged; D000369:Aged, 80 and over; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D001241:Aspirin / Q000008:administration & dosage*; D000077144:Clopidogrel; D015331:Cohort Studies; D004311:Double-Blind Method; D064098:Esomeprazole / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010438:Peptic Ulcer Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D055502:Secondary Prevention; D013276:Stomach Ulcer / Q000150:complications; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome
D000897:Anti-Ulcer Agents; D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D064098:Esomeprazole; D013988:Ticlopidine; D001241:Aspirin