(COGENT) study was a randomized, double-blind, placebo-controlled study to evaluate the ability of a combination pill of omeprazole/clopidogrel to lower rates of GI adverse events versus clopidogrel alone.2 Although the study was discontinued early due to lack of funding, the combination significantly lowered the rate of adverse GI events without showing an increase in the rate of CV events compared to clopidogrel alone. Furthermore, extra GI bleeding (bleeding outside the GI tract) was not different between groups. If the omeprazole were inhibiting the activation of clopidogrel to a clinically relevant degree, the rate of extra GI bleeding would be expected to go down due to lower concentrations of active drug. As this difference in bleeding was not seen, combined with no signal of increased CV events, it suggests that the in vitro interaction does not translate into an in vivo clinical effect.
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