Background: Prophylactic proton pump inhibitors (PPIs) are used frequently in an ICU setting for acid suppression, but this is an off-label use and the evidence in support of using PPI prophylactically is limited. In fact, PPIs have been associated with adverse effects in recent literature including Clostridium difficile infection, myocardial ischemia, and pneumonia.
Study design: Multicenter, parallel group, blinded clinical trial that compared PPI with placebo.
Setting: 78 sites in the United States and Canada.
Synopsis: Among 3,298 total participants, 90-day mortality was 31.1% in the pantoprazole group and 30.4% in the placebo group, which is a relative risk of 1.02 (95% confidence interval, 0.91-1.13; P = .76).
The researchers also used a composite outcome comprising clinically important gastrointestinal bleeding, Clostridium difficile infection, new onset pneumonia, and acute myocardial ischemia. Overall, 21.9% in the pantoprazole group and 22.6% participants in the placebo group had the composite outcome – a relative risk of 0.96 (95% CI, 0.83-1.11). Clinically important gastrointestinal bleeding was the only component of the composite outcome that was significantly different between groups, occurring less often in the pantoprazole group – the relative risk was 0.58 (95% CI, 0.40-0.86).
Bottom line: Pantoprazole does not differ significantly, compared with placebo, with regard to 90-day mortality and a composite outcome of clinically significant events.
Citation: Krag M et al. Pantoprazole in patients at risk of gastrointestinal bleeding in the ICU..
is assistant professor of medicine at Northwestern University Feinberg School of Medicine and a hospitalist at Northwestern Memorial Hospital, both in Chicago.