Large Trial Finds Proton Pump Inhibitors Safe for Longer Term Use

Large Trial Finds Proton Pump Inhibitors Safe for Longer Term Use

https://www.uspharmacist.com/article/large-trial-finds-proton-pump-inhibitors-safe-for-longer-term-use-1/

Hamilton, Ontario—Despite past reports of serious health issues with proton pump inhibitors (PPIs), pharmacists can offer some reassurance to patients using the drugs to treat gastroesophageal reflux disease or related diseases.

A new study published in Gastroenterology found no evidence that PPI use increases risk for pneumonia, chronic kidney disease, diabetes, or dementia. Results came from a large, multiyear, randomized trial of patients receiving rivaroxaban or aspirin.

McMaster University–led researchers said there is no reason to limit PPI prescriptions because of concerns about long-term harm, although the medication should be used only when the benefits are expected to outweigh the risks and according to recommended dose and duration of treatment.

“Our research provides welcome news for the countless patients who rely on PPIs to control their symptoms, as well as the physicians who prescribe this medication,” said lead author Paul Moayyedi, MB, ChB, PhD, The Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada. “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.”

Noting that the drugs are effective at treating acid-related disorders, the study team points out that although the drugs have been shown to be well-tolerated in the short term, observational studies have raised questions about long-term treatment. The trial of 17,598 participants with stable cardiovascular disease and peripheral artery disease was designed to answer those concerns.

The study randomly assigned 8,791 patients to 40 mg of pantoprazole daily and 8,807 to placebo. In addition, participants were divided into groups receiving rivaroxaban (2.5 mg twice daily) with aspirin (100 mg once daily); rivaroxaban (5 mg twice daily); or aspirin (100 mg) alone.

Researchers tracked any development of pneumonia, Clostridium 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, with follow-up of a median of 3.01 years.

Results indicate no statistically significant difference between the pantoprazole and placebo groups in safety events except for enteric infections (1.4% vs. 1.0% in the placebo group; odds ratio, 1.33; 95% CI, 1.01-1.75).

Study authors point out that, for all other safety outcomes, proportions were similar between groups except for C difficile infection, which was approximately twice as common in the pantoprazole versus the placebo group; only 13 events occurred, however, so the difference was not considered statistically significant.

“In a large placebo-controlled randomized trial, we found that pantoprazole is not associated with any adverse event when used for 3 years, with the possible exception of an increased risk of enteric infections,” researchers conclude.

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