EoE Module 10 References-Maoyyedi et al Gastroenterology 2019 Safety of PPIs based on a large multiyear randomized trial of patients receiving rivaroxaban or aspirin

Maoyyedi et al Gastroenterology 2019 Safety of PPIs based on a large multiyear randomized trial of patients receiving rivaroxaban or aspirin

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A large, multi-year randomized trial investigated the safety of proton pump inhibitors (PPIs), specifically pantoprazole, in patients with stable cardiovascular disease receiving rivaroxaban or aspirin. The trial included 17,598 participants, with half receiving pantoprazole and the other half receiving a placebo, over a median follow-up of 3.01 years. Researchers aimed to confirm whether the long-term use of PPIs is associated with adverse events, as suggested by previous observational studies.<br /><br />The study found no statistically significant differences in most safety outcomes between the pantoprazole and placebo groups, including rates of pneumonia, fractures, gastric atrophy, chronic kidney disease, diabetes, chronic obstructive lung disease, dementia, cardiovascular disease, cancer, hospitalizations, and all-cause mortality. However, there was a slightly increased incidence of enteric infections in the pantoprazole group (1.4% compared to 1.0% in the placebo group) and a non-significant increase in Clostridium difficile infections.<br /><br />The trial concluded that pantoprazole, and by extension, PPIs, do not pose any significant long-term adverse risks when used appropriately, except for a potential increase in enteric infections. Despite concerns from previous observational studies, the benefits of PPIs are likely to outweigh the risks for patients with clinically appropriate indications.<br /><br />Overall, this study suggests that PPIs are safe for up to three years, challenging previous reports that associated long-term PPI use with various adverse outcomes like pneumonia, fractures, chronic kidney disease, and dementia. The findings underscore the importance of using PPIs based on clinical need rather than restricting use over unsubstantiated long-term harm concerns. The study was comprehensive and well-supported, with multiple centers and a strong participant base, enhancing the reliability of the results.

Keywords

proton pump inhibitors

pantoprazole

cardiovascular disease

rivaroxaban

aspirin

safety outcomes

enteric infections

long-term use

randomized trial

clinical need