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Randomised controlled trial
Addition of omeprazole to dual antiplatelet therapy with clopidogrel plus aspirin lowers the risk of upper gastrointestinal bleeding
  1. Jolanta M Siller-Matula1,
  2. Georg Delle-Karth1
  1. 1Department of Cardiology, Medical University of Vienna, Vienna, Austria
  1. Correspondence to: Jolanta M Siller-Matula
    Department of Cardiology, Medical University of Vienna, Währinger Gürtel 18– 20, A-1090 Vienna, Austria; jolanta.siller-matula{at}meduniwien.ac.at

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Context

Antiplatelet therapy represents the mainstay of treatment for patients undergoing percutaneous coronary intervention.1 However, an increased risk for gastrointestinal bleeding is associated with use of aspirin and clopidogrel. To reduce the bleeding risk, proton pump inhibitors (PPIs) are prescribed in combination with platelet inhibitors, a strategy that is recommended by existing consensus guidelines2 though no randomised trial has proved this. Recently, a pharmacodynamic drug–drug interaction has been shown for clopidogrel and omeprazole but not for pantoprazole.3 4 Whether this interaction has an impact on patient outcomes has not been investigated in a randomised trial.

Methods

Clopidogrel and the Optimization of Gastrointestinal Events (COGENT) was a randomised, double-blind, placebo-controlled, phase III trial of the efficacy and safety of CGT-2168 (clopidogrel 75 mg and omeprazole 20 mg) compared with clopidogrel 75 mg alone. Patients were included in the trial if they were ≥21 years of age and treatment with clopidogrel and aspirin was anticipated for at least 12 months. Exclusion criteria: hospitalised patients for whom discharge within 48 h after randomisation was not anticipated; the need …

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