A study published in Gastroenterology found no evidence to support claims that proton-pump inhibitors cause pneumonia, chronic kidney disease, diabetes and dementia.
Researchers performed a partial factorial double-blind trial of 17,598 participants with stable cardiovascular disease and peripheral artery disease. Patients were randomly assigned into groups where they received either pantoprazole (8,791 patients) or a placebo (8,807 patients). Patients also randomly received rivaroxaban with aspirin, rivaroxaban, or aspirin alone.
Researchers collected data on an array of different diseases, hospitalizations and all-cause mortality every six months for a median follow-up time of 3.01 years and a combined 53,152 patient years of follow-up.
Researchers found no significant difference between the pantoprazole and placebo groups in safety events, except concerning enteric infections, which affected 1.4 percent of the pantoprazole group and 1 percent in the placebo group.
All other safety outcomes had similar proportions, except concerning Clostridium difficile infection. The pantoprazole group had 13 cases of C. diff, twice as many as the placebo group. However, researchers said that number was not statistically significant.
Researchers concluded, "In a large placebo-controlled randomized trial, we found that pantoprazole is not associated with any adverse event when used for three years, with the possible exception of an increased risk of enteric infections."
The study is welcome news to the gastroenterology community, as PPIs are among the most widely used drugs for treating gastroesophageal reflux disease patients. Lead study author Paul Moayyedi, PhD, said, "It is reassuring that there was no evidence for harm for most of these events."