PPI not beneficial to patients receiving low-dose anticoagulation, aspirin
Use of the proton pump inhibitor (PPI) pantoprazole does not cut the risk of upper gastrointestinal (GI) events but may reduce the risk of bleeding from gastroduodenal lesions in patients on low-dose anticoagulants and/or antiplatelet therapy, a study has shown.
Researchers conducted a three-by-two partial factorial double-blind trial, randomly assigning 17,598 individuals with stable cardiovascular disease and peripheral artery disease to one of the following treatment groups: pantoprazole 40 mg daily or placebo, as well as rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily, rivaroxaban 5 mg twice daily, or aspirin 100 mg alone.
The primary outcome of time to first upper GI event (composite of overt bleeding, upper GI bleeding from a gastroduodenal lesion or of unknown origin, occult bleeding, symptomatic gastroduodenal ulcer or ≥5 erosions, upper GI obstruction, or perforation) did not significantly differ between the pantoprazole and placebo groups (102 of 8,791 events vs 116 of 8,807 events, respectively; hazard ratio [HR], 0.88, 95 percent CI, 0.67–1.15; p=0.35).
However, compared with placebo, the PPI was significantly associated with a decrease in bleeding from gastroduodenal lesion events (HR, 0.52, 0.28–0.94; p=0.03). The reduction proved to be greater when a posthoc definition of bleeding gastroduodenal lesion was applied (HR, 0.45, 0.27–0.74), although the number needed to treat was still high (n=982).
The present data suggest that routine use of PPI therapy is not warranted in patients initiating low-dose anticoagulants and/or antiplatelet therapy, according to the researchers. PPIs may be appropriate for patients at high risk of peptic ulcer disease.