Auto-generated: February 12 2012 11:51 AM GMT-8

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Source: Lancet  |  Posted 8 years ago

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

High-risk elderly patients with peptic-ulcer disease who receive clopidogrel for anti-platelet therapy have a greater chance of experiencing gastrointestinal bleeding, according to a recent study from Hong Kong.

Clopidogrel is a new alternative therapy that has been shown to be more effective and to cause significantly fewer upper-gastrointestinal events than Aspirin (acetylsalicylic acid) in average-risk patients. The safety of clopidogrel in high-risk patients -- especially those with a previous history of bleeding -- had not previously been studied, and compelled Benjamin Chun-Yu Wong, MBBS, MD, and colleagues at the University of Hong Kong, Queen Mary Hospital, and the Ruttonjee Hospital, Hong Kong to evaluate the safety of clopidogrel in high-risk patients with peptic-ulcer disease.

The retrospective study included 70 patients (39 men and 31 women; average age 74) with peptic-ulcer disease (Aspirin-related in 53 patients, and not Aspirin-related in the remaining 17 patients). All patients received clopidogrel (75 mg/day). Ulcer complications were assessed at an average follow up of 1 year.

Overall, 16% (11) of patients experienced adverse events: nine developed gastrointestinal bleeding, 1 had a perforated peptic ulcer and 2 developed a treatment-related generalised skin rash.

All patients experiencing gastrointestinal bleeding had a previous history of bleeding, including erosive or haemorrhagic gastritis, duodenal ulcer and gastric ulcer, due to H. pylori infection (7 patients) and previous Aspirin therapy (7 patients). One of these patients died of myocardial infarction, and all others recovered from the bleeding episode.

Previous gastrointestinal bleeding was the only significant independent predictive factor of clopidogrel-associated gastrointestinal bleeding. Furthermore, the incidence of clopidogrel-associated gastrointestinal bleeding was 22% in patients with a history of gastrointestinal bleeding and 0% in those without.

The authors conclude that "clopidogrel is associated with a high incidence of upper gastrointestinal bleeding in high-risk patients.

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