Pantoprazole does not reduce upper gastrointestinal bleeding during anticoagulation treatment
Proton pump inhibitor therapy, particularly with pantoprazole, does not reduce upper gastrointestinal bleeding events in patients taking low-dose anticoagulation/aspirin treatment, reports a recent study.
Researchers randomly assigned 17,598 patients with stable cardiovascular and peripheral artery disease to receive either daily 40-mg pantoprazole (n=8,791; mean age, 67.6±8.1 years; 22 percent female) or placebo (n=8,807; mean age, 67.7±8.1 years; 21 percent female). Participants were also given rivaroxaban 2.5 mg twice daily with 100-mg aspirin once daily, rivaroxaban 5 mg twice daily or aspirin 100 mg alone.
The primary efficacy outcome of clinically significant events in the upper gastrointestinal tract occurred in 1.2 percent (n=102) of the pantoprazole arm and in 1.3 percent (n=116) of the placebo group. The difference did not reach significance (hazard ratio [HR], 0.88, 95 percent CI, 0.67–1.15).
Further analysis according to the components of upper gastrointestinal bleeding showed that both treatment arms were comparable in terms of overt or occult bleeding events. However, the likelihood of gastroduodenal bleeding was significantly attenuated in patients who were given pantoprazole (HR, 0.52, 0.28–0.94; p=0.03).
In a subsequent posthoc analysis where the definition of bleeding events was broadened, pantoprazole use remained significantly associated with a lower risk of bleeding of gastroduodenal lesions (HR, 0.45, 0.27–0.74). Pantoprazole also exerted a significant protective effect against peptic ulcer (HR, 0.46, 0.25–0.83) and erosions (HR, 0.13–0.84).