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January 1, 2010International Heart JournalOpen Access

Effects of Omeprazole on the Antiplatelet Activity of Clopidogrel

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Why the study?

Does omeprazole reduce the antiplatelet effect of clopidogrel in healthy volunteers?

Population

20 healthy volunteers, mean age 33, 60% male, based in Korea. Exclusion criteria: previous treatment with…

Comparison

Clopidogrel coadministered with omeprazole 20… vs Clopidogrel coadministered with matching placebo…

Design

RCT, single blind protocol

Follow-up

14 days

Authors

KYKyeong Ho YunSRSang Jae RheeHPHyun‐Young Park

Discussion

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Overview

Coadministration warrants caution in clopidogrel users; confirms interaction and supports alternative PPIs.

Key Points

  • To evaluate the impact of the proton pump inhibitor omeprazole on the antiplatelet effectiveness of clopidogrel.
  • Conducted a two-period crossover trial in 20 healthy volunteers divided into two groups (n = 10 each).
  • Administered a 300 mg clopidogrel loading dose followed by 14 days of 75 mg/day clopidogrel plus placebo versus 75 mg/day clopidogrel plus 20 mg/day omeprazole, separated by a 3-week interval.
  • Assessed antiplatelet activity using P2Y12 reaction units (PRU) and percentage platelet inhibition via the VerifyNow P2Y12 assay.
  • PRU values were significantly higher after 14 days with omeprazole compared to without omeprazole (281.3 ± 54.0 vs 240.0 ± 72.2, P = 0.048).
  • Percentage platelet inhibition significantly decreased following 14 days of omeprazole coadministration (22.7 ± 29.9% vs 35.1 ± 18.7%, P = 0.014).

Structured PICO

Does omeprazole reduce the antiplatelet effect of clopidogrel in healthy volunteers?

P
Population
20 healthy volunteers, mean age 33, 60% male, based in Korea. Exclusion criteria: previous treatment with clopidogrel or a PPI, history of thrombocytopenia or bleeding disorder, liver disease or increase of liver enzymes over 2 times higher the normal upper limit, gastrointestinal ulcer, or pregnancy.
I
Intervention
Clopidogrel (300 mg loading dose, followed by 75 mg/day) coadministered with omeprazole 20 mg/day oral for 14 days
C
Comparator
Clopidogrel (300 mg loading dose, followed by 75 mg/day) coadministered with matching placebo oral for 14 days
O
Outcome
Antiplatelet activity assessed by P2Y12 reaction unit (PRU) and percentage inhibition using a VerifyNow P2Y12 assay system at day 14surrogate

Coadministration of omeprazole significantly reduces the antiplatelet efficacy of clopidogrel, highlighting a clinically relevant drug interaction that may impact cardiovascular outcomes.

Limitations

  • small number of subjects
  • single blind protocol
  • did not conduct any mechanistic investigations
  • did not test real clinical setting where patients are prescribed clopidogrel with aspirin, cilostazole, or another antiplatelet agent

Cite This Study

Yun et al. (2010) studied this question.

synapsesocial.com/papers/6a724718660549caf2c68afbhttps://doi.org/10.1536/ihj.51.13
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