Why the study?
In an observational study, clopidogrel activity on platelets was diminished in patients receiving proton pump inhibitors, prompting evaluation of the influence of omeprazole on clopidogrel efficacy.
Population
124 consecutive patients undergoing coronary artery stent implantation
Comparison
Omeprazole (20 mg/day) vs placebo
Design
Double-blind placebo-controlled randomized trial
Follow-up
7 days
Key result
Omeprazole significantly decreased the antiplatelet effect of clopidogrel, resulting in a higher mean platelet reactivity index at 7 days compared to placebo (51.4% vs 39.8%; p < 0.0001).
Authors
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Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“The data on which the FDA warning was based came mostly from laboratory assays of platelet function. Preliminary results from a randomized, controlled clinical trial with hard end points show that, for the time being, we should not change the way we manage patients.”
“Although we should not take such warnings lightly, we also should not be alarmed. The data on which the FDA warning was based came mostly from laboratory assays of platelet function.”
Randomized double-blind trial demonstrates omeprazole significantly blunts clopidogrel antiplatelet response in stented cardiac patients, indicating a critical drug interaction.
RCT (n=124)
Double-blind
randomized
Absolute Event Rate: 51.4% vs 39.8%
p-value: p=< 0.0001
Gilard et al. (2008) conducted an RCT in Coronary artery stent implantation (n=124). Omeprazole vs. Placebo was evaluated on Platelet reactivity index (PRI) value at the 7-day treatment period (p=< 0.0001). Omeprazole significantly decreased the antiplatelet effect of clopidogrel, resulting in a higher mean platelet reactivity index at 7 days compared to placebo (51.4% vs 39.8%; p < 0.0001).
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