In a large, placebo-controlled trial, researchers found that Protonix was not linked with any adverse event — other than a possible association with enteric infections — for at least 3 years, according to data published in Gastroenterology.
Paul Moayyedi, MB ChB, PhD, of the Population Health Research Institute at McMaster University and Hamilton Health Sciences in Canada hopes that the findings will help quell some fears about long-term use of proton pump inhibitors.
“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,” he said in a press release. “To our knowledge, this is the first prospective randomized trial to evaluate the many long-term safety concerns related to PPI therapy. It is reassuring that there was no evidence for harm for most of these events.”
Researchers performed a 3x2 partial factorial, double-blind trial comprising 17,598 individuals with stable cardiovascular disease and peripheral artery disease. They randomly assigned patients to receive either 40 mg of Protonix (pantoprazole, Pfizer) daily or placebo. They also randomly assigned patients to groups that received either Xarelto (rivaroxaban, Janssen; 2.5 mg twice daily) with aspirin (100 mg daily), rivaroxaban alone (5 mg twice daily) or aspirin alone (100 mg daily).
Investigators collected patient data on the development of pneumonia, Clostridioides difficile infection, other enteric infections, fractures, gastric atrophy, chronic kidney disease, diabetes, chronic obstructive lung disease, dementia, cardiovascular disease, cancer, hospitalizations, and all-cause mortality every 6 months during median 3.01 years, comprising more than 53,000 patient-years of follow-up.
In their analysis, Moayyedi and colleagues did not find any significant difference between the pantoprazole group and placebo group for any safety event other than enteric infections, where rates were higher in the pantoprazole group (1.4%) compared with placebo (1%; OR = 1.33; 95% CI, 1.01–1.75).
The proportions were similar in all other safety outcomes with the exception of CDI, where it was twice as common in the pantoprazole group. However, researchers said the difference was not significant because there were only 13 recorded events.
Moayyedi and colleagues wrote that, like all drugs, PPIs should be used when the benefits outweigh the risks, but their findings show that limiting prescription of PPIs because of fear of long-term risks is not appropriate. – by Alex Young
Disclosures: Moayyedi reports receiving research funding from Allergan and Takeda. Please see the full study for all other authors’ relevant financial disclosures.