Data on Clopidogrel and Omeprazole Offer 'Reassurance' on Cardiovascular Risk, Researchers Say

Patients on dual antiplatelet therapy showed no increase in cardiovascular events while receiving omeprazole to lower risks for gastrointestinal bleeding, according to a New England Journal of Medicine study.

In a double-blind trial, 3700 patients were randomized to receive the proton-pump inhibitor (PPI) omeprazole or placebo, while taking both aspirin and clopidogrel. The study had two primary endpoints: gastrointestinal bleeding or pain, and cardiovascular events, such as cardiovascular death, MI, or ischemic stroke. (Cogentus Pharmaceuticals, the manufacturer of the clopidogrel-omeprazole combination pill, designed and sponsored the trial, but the company is now defunct.)

Over the course of a median follow-up of 106 days, gastrointestinal events were significantly less frequent with clopidogrel-omeprazole. Cardiovascular event rates were also less frequent, but not significantly so (4.9% vs. 5.7%).

The authors say the outcome "provides reassurance that there is no clinically significant cardiovascular interaction between PPIs and clopidogrel."

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