With the exception of enteric infections, using proton-pump inhibitors (PPIs) for 3 years does not put individuals at increased risk of adverse events, according to new research presented at Digestive Disease Week.
The researchers randomly assigned 17,598 participants with stable cardiovascular disease who were taking aspirin and/or rivaroxaban but not a PPI to either pantoprazole, 40 mg daily (n=8791), or placebo (n=8807). Participants were evaluated for 3.02 years, resulting in 53,152 patient-years of follow-up.
Data on pneumonia, Clostridium difficile infection and other enteric infections, fracture, gastric atrophy, chronic kidney disease, diabetes, chronic obstructive lung disease, dementia, cardiovascular disease, gastrointestinal cancer, and all-cause mortality were collected to assess for the long-term safety of PPI therapy.
There was no significant difference observed between safety events of participants who used pantoprazole compared with those assigned to placebo. The only exception was with enteric infections (odds ratio, 1.33; 95% CI, 1.01-1.75).
After a median 3 years of PPI therapy, the number needed to harm for enteric infections was 301 (95% CI, 152-9190).
Although hospitalization for C difficile was twice as common in the PPI group than in the placebo group, the difference was not statistically significant. Additionally, the researchers did not identify a difference in hospitalization rates for any noncardiovascular cause, with a rate of 21.6% for both groups.
The results of the analysis were similar even after excluding the approximately 20% of participants in either group who had permanently discontinued their PPI therapy or placebo.
Moayyedi P, Eikelboom J, Bosch J, Dyal L, Connolly S, Yusuf S. Adverse events related to proton pump inhibitor therapy. Results of a randomized trial of pantoprazole versus placebo with 53,152 patient years of follow-up. Presented at: Digestive Disease Week; May 18-21; San Diego, CA. https://www.gastrojournal.org/ article/S0016-5085(19)37225-7/fulltext. Accessed May 23, 2019.