Background: In average-risk patients, the new anti-platelet agent, clopidogrel, causes less upper gastrointestinal adverse events than aspirin. However, there are no safety data on the use of clopidogrel in high-risk patients.
Aim: To evaluate the safety of clopidogrel in patients with peptic ulcer disease in a retrospective cohort longitudinal study.
Methods: During the period from January 2000 to May 2002, 70 patients who were prescribed clopidogrel (75 mg/day) for a previous history of non-aspirin-related peptic ulcer disease or a history of aspirin-related gastrointestinal complications (dyspepsia or peptic ulcer) were recruited. The occurrence of ulcer complications (bleeding/perforation/obstruction) was the primary end-point.
Results: After a median follow-up of 1 year, nine patients (12%) developed gastrointestinal bleeding and one had a perforated peptic ulcer. Clopidogrel-associated gastrointestinal bleeding was significantly more common in patients with a history of gastrointestinal bleeding than in those without (22% vs. 0%; P = 0.007; odds ratio, 1.3; 95% confidence interval, 1.1-1.5).
Conclusions: Clopidogrel is associated with a high incidence of upper gastrointestinal bleeding in high-risk patients. A previous history of gastrointestinal bleeding appears to be a predictor of adverse gastrointestinal events.