OMEPRAZOLE TAB,SA
Clinical Criteria Summary
Pharmacology & Drug Interaction
- Clopidogrel is a prodrug requiring biotransformation to its active metabolite via the hepatic cytochrome P450 (CYP) 2C19 enzyme.
- Omeprazole and other proton pump inhibitors (PPIs) utilize the same CYP450 metabolic pathway, theoretically causing competitive inhibition and decreased concentration of the active clopidogrel moiety.
Gastrointestinal Risk Management
- PPI therapy is indicated for patients receiving any antithrombotic regimen who are at high risk of gastrointestinal bleeding.
- PPIs reduce the risk of upper gastroduodenal bleeding in patients treated with antiplatelet agents.
- For patients with GERD on clopidogrel presenting with LA grade C or D esophagitis or uncontrolled GERD symptoms, established benefits of PPI treatment outweigh proposed cardiovascular risks.
Cardiovascular Risk Management
- Concomitant use of omeprazole and clopidogrel does not demonstrate significant adverse cardiovascular effects; no significant differences in MACE, MI, or all-cause death are observed in randomized controlled trials and propensity score-matched studies.
- No interaction has been observed between PPIs and aspirin, prasugrel, or ticagrelor.
Prescribing Criteria
- Deprescribe PPIs as much as possible per established de-prescribing guidelines.
- Do not limit omeprazole use in patients on clopidogrel due to the lack of demonstrated adverse cardiovascular effects.