Q&A

Aspirin plus PPI safer than clopidogrel if there is history of GI bleeding

J Fam Pract. 2005 April;54(4):303-309
Author and Disclosure Information

  • Clinical Question: What is the best antithrombotic for patients with a history of upper gastrointestinal bleeding?
  • Study Design: Randomized controlled trial (double-blinded)
  • Allocation: Concealed
  • Setting: Inpatient (any location) with outpatient follow-up
  • 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 randomized 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.
PDF Download

 

Bottom Line

For patients with a history of bleeding peptic ulcer, the combination of aspirin and a proton pump inhibitor (PPI) 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 give 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. (LOE=1b)

Next Article:

Study Design May Miss Hypnotherapy's Benefits