Clopidogrel plus omeprazole compared with aspirin plus omeprazole for aspirin-induced symptomatic peptic ulcers/erosions with low to moderate bleeding/re-bleeding risk -- a single-blind, randomized controlled study.
BACKGROUND
Clopidogrel causes significantly less symptomatic peptic ulcer disease and gastrointestinal bleeding than low-dose aspirin in average-risk patients. The gastrotoxicity of clopidogrel in patients with active peptic ulcer disease is unknown.


OBJECTIVE
To compare the incidence of unhealed ulcers in patients receiving clopidogrel or aspirin.


METHODS
Patients with aspirin-induced peptic ulcer disease treated with omeprazole (20 mg/day) were randomized to receive clopidogrel (75 mg/day) or to continue with low-dose aspirin. Success was defined as ulcer/erosion healing at the eighth week.


RESULTS
One hundred and twenty-nine patients were recruited (69 received clopidogrel and 60 continued with aspirin). Thirty-one (45%) in the clopidogrel group and 25 (42%) in the aspirin group had a minor gastrointestinal bleed. No ulcer showed an adherent clot or visible vessel. The distributions of peptic ulcer disease were similar in the clopidogrel and aspirin groups (gastric ulcer: 41% vs. 40%; duodenal ulcer: 10% vs. 12%; gastric ulcer + duodenal ulcer: 6% vs. 3%; gastritis: 32% vs. 37%; duodenitis: 4% vs. 7%; gastritis + duodenitis: 0% vs. 2%). Clopidogrel and aspirin were re-started after 0.86 +/- 1.79 and 0.44 +/- 1.60 days, respectively (P = 0.170). Three (4%) patients stopped clopidogrel due to drug rash. Using per protocol analysis, the treatment success rates of clopidogrel and aspirin were 94% (62/66) and 95% (57/60), respectively.


CONCLUSIONS
In patients with aspirin-associated peptic ulcer disease of low to moderate grade, both early conversion from aspirin to clopidogrel and continuation of aspirin are safe.
Ng
F-H
FH
Department of Medicine, Ruttonjee Hospital, Hong Kong. ngfhong@ctimail3.com
Wong
B C-Y
BC
Wong
S-Y
SY
Chen
W-H
WH
Chang
C-M
CM
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D001241:Aspirin / Q000008:administration & dosage / Q000009:adverse effects*; D000077144:Clopidogrel; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage*; D010437:Peptic Ulcer / Q000139:chemically induced* / Q000188:drug therapy; D010438:Peptic Ulcer Hemorrhage / Q000139:chemically induced* / Q000188:drug therapy; D012307:Risk Factors; D016037:Single-Blind Method; D013988:Ticlopidine / Q000008:administration & dosage* / Q000031:analogs & derivatives*
D000897:Anti-Ulcer Agents; D000077144:Clopidogrel; D009853:Omeprazole; D013988:Ticlopidine; D001241:Aspirin