BMJ  2005;330 (21 May), doi:10.1136/bmj.330.7501.0-f

Filler

POEM^*

Aspirin + PPI is safer than clopidogrel if patient has history of GI bleeding

Question What is the best antithrombotic for patients with a history of upper gastrointestinal (GI) bleeding?

Synopsis Clopidogrel has been recommended by the American College of Cardiology as the preferred drug for patients who require an antithrombotic agent to prevent heart disease but who also have a history of bleeding peptic ulcer. This study compared clopidogrel with the combination of aspirin and esomeprazole in this setting. Patients with a source of upper gastrointestinal bleeding (52% gastric ulcer, 34% duodenal ulcer, 8% both, 6% other erosions) who had healing confirmed by endoscopy were randomised to clopidogrel 75 mg daily plus esomeprazole placebo twice daily or aspirin 80 mg daily plus esomeprazole 20 mg twice daily. Groups were fairly well balanced at the outset, allocation was concealed, and analysis was by intention to treat. Patients were treated for 12 months. The primary outcome (haematemesis, melaena, or a decrease in haemoglobin of at least 20 g/l accompanied by endoscopic evidence of ulcer or erosion) was seen in 8.6% of the clopidogrel group and 0.7% of the aspirin plus esomeprazole group (P = 0.001; number needed to treat = 13). Three patients in the clopidogrel group had severe bleeding complications not related to the gastrointestinal tract, including two intraventricular haemorrhages, one of which was fatal; there were no bleeding complications in the aspirin group. More deaths occurred in the clopidogrel group (8 v 4), but this difference was not statistically significant. There was no difference between groups in the likelihood of adverse cardiovascular events (9 v 11).

Bottom line For patients with a history of bleeding peptic ulcer, the combination of aspirin and a proton pump inhibitor twice a day was safer than clopidogrel in terms of bleeding side effects. Although esomeprazole (Nexium) was used in this study, generic omeprazole 20 mg given twice a day provides nearly the same degree of acid suppression at a much lower cost. This study calls into question the overall safety of clopidogrel (Plavix), which has been claimed to not significantly increase the risk of bleeding.

Level of evidence 1b (see www.infopoems.com/levels.html). Individual randomised controlled trials (with narrow confidence interval).

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Chan FK, Ching JY, Hung LC, et al. Clopidogrel versus aspirin and esomeprazole to prevent recurrent ulcer bleeding. N Engl J Med 2005;352: 238-44[Abstract/Free Full Text].

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^* Patient-Oriented Evidence that Matters. See editorial ( BMJ 2002;325: 983[Free Full Text])

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Rapid Responses:

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Study size?

Suzanna H van Schaick
bmj.com, 22 May 2005 [Full text]

Clopidogrel - useful but by how much?

Phil Coates
bmj.com, 23 May 2005 [Full text]

Aspirin and PPI vs clopidogrel - comparing apples and pears

Sarah C Jarvis
bmj.com, 7 Jun 2005 [Full text]

Aspirin, PPI, and bleeding ulcers

George Kassianos
bmj.com, 9 Jun 2005 [Full text]

Interesting but overextrapolating.

Andrew P Mimnagh
bmj.com, 10 Jun 2005 [Full text]

Clopidogrel and Bleeding Peptic Ulcers

Gerard Stansby
bmj.com, 10 Jun 2005 [Full text]

More pneumonia and GI infections?

Jed Rowe
bmj.com, 20 Jun 2005 [Full text]