OMEPRAZOLE TAB,ORAL DISINTEGRATING

Criteria for Clopidogrel TAB and Omeprazole Formulations (CAP,EC; PWDR,RENST-ORAL; TAB,ORAL DISINTEGRATING; TAB,SA; /SODIUM BICARBONATE CAP,PWDR,SUSP)

• Clinical Indication: Gastroesophageal Reflux Disease (GERD) and Esophagitis
• For patients with GERD on clopidogrel who have LA grade C or D esophagitis or whose GERD symptoms are not adequately controlled with alternative medical therapies, the established benefits of PPI treatment outweigh proposed but highly questionable cardiovascular risks.
• Clinical Indication: Prevention of Gastrointestinal Bleeding in Dual Antiplatelet Therapy (DAPT)
• Clopidogrel is a prodrug requiring biotransformation via the hepatic cytochrome P450 (CYP) 2C19 enzyme, the same metabolic pathway used by PPIs. Concomitant use may result in competitive inhibition, potentially decreasing active clopidogrel moiety concentration and platelet aggregation effect.
• FDA prescribing information states to avoid concomitant use of clopidogrel with omeprazole or esomeprazole; a boxed warning was added to avoid use of omeprazole with clopidogrel and other potent CYP 2C19 inhibitors.
• Meta-analyses demonstrate concomitant use is correlated with an increased CV event risk, though significance is lost when evaluation is limited to RCTs and propensity score matching.
• PPI use is associated with a reduced risk of gastrointestinal bleeding in patients treated with DAPT after PCI, with no significant differences observed in MACE, MI, or all-cause death.
• PPIs reduce the risk of upper gastroduodenal bleeding in patients receiving antithrombotic regimens who are at high risk of GI bleeding.
• No interaction between concomitant use of PPIs and aspirin, prasugrel, or ticagrelor has been observed.
• VA Practice Recommendations
• Deprescribe PPIs according to the 2022 ACG Clinical Practice Update on De-Prescribing of PPIs as much as possible.
• Do not limit omeprazole use in patients on clopidogrel given the lack of adverse cardiovascular effects outlined in recent guidelines.