Safety profile did not differ for pantoprazole versus placebo except greater risk for enteric infections
MONDAY, June 17, 2019 (HealthDay News) — Use of pantoprazole for up to three years to prevent upper gastrointestinal events in patients receiving anticoagulant therapy with aspirin and/or rivaroxaban has a similar safety profile to placebo except for an increased risk for enteric infections, according to a study published online May 29 in Gastroenterology.
Paul Moayyedi, M.B., Ch.B., Ph.D., from McMaster University in Hamilton, Ontario, Canada, and colleagues conducted a three-by-two partial factorial, multicenter, double-blind, randomized placebo-controlled trial evaluating patients with stable atherosclerotic vascular disease. Participants were randomly assigned to receive rivaroxaban (2.5 mg twice daily) with aspirin (100 mg once daily), rivaroxaban (5 mg twice daily) alone, or aspirin (100 mg) alone. In addition, 17,598 participants were randomly assigned to receive either pantoprazole (40 mg daily; 8,791 participants) or placebo (8,807 participants).
The researchers noted no statistically significant difference between the pantoprazole and placebo groups regarding safety events, except for enteric infections (1.4 percent with pantoprazole versus 1.0 percent with placebo; odds ratio, 1.33). Additionally, Clostridium difficile infection was approximately twice as common in the pantoprazole group versus the placebo group. However, with only 13 events, this difference was not statistically significant.
“Our research provides welcomed news for the countless patients who rely on PPIs to control their symptoms, as well as the physicians who prescribe this medication,” Moayyedi said in a statement.
Bayer funded the study. Several authors disclosed financial ties to pharmaceutical companies, including Pfizer, the manufacturer of pantoprazole.
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