High incidence of clopidogrel-associated gastrointestinal bleeding in patients with previous peptic ulcer disease

Aliment Pharmacol Ther. 2003 Aug 15;18(4):443-9. doi: 10.1046/j.1365-2036.2003.01693.x.


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.

Publication types

  • Evaluation Study

MeSH terms

  • Aged
  • Aspirin / adverse effects
  • Clopidogrel
  • Cohort Studies
  • Female
  • Follow-Up Studies
  • Gastrointestinal Hemorrhage / chemically induced*
  • Humans
  • Longitudinal Studies
  • Male
  • Peptic Ulcer / complications*
  • Peptic Ulcer / drug therapy
  • Platelet Aggregation Inhibitors / adverse effects*
  • Recurrence
  • Retrospective Studies
  • Risk Factors
  • Ticlopidine / adverse effects*
  • Ticlopidine / analogs & derivatives


  • Platelet Aggregation Inhibitors
  • Clopidogrel
  • Ticlopidine
  • Aspirin