Among intensive care unit patients on mechanical ventilation, pantoprazole was associated with a lower incidence of clinically important upper gastrointestinal bleeding compared to placebo.
An international, randomized clinical trial, published in The New England Journal of Medicine, evaluated the efficacy and safety of intravenous pantoprazole for stress ulcer prophylaxis in 4,821 critically ill patients undergoing invasive mechanical ventilation from 68 intensive care units (ICUs).
Patients were randomly assigned to receive intravenous pantoprazole (40 mg daily) or placebo. The primary efficacy outcome was the incidence of clinically important upper gastrointestinal (GI) bleeding within 90 days, and the primary safety outcome was all-cause mortality at 90 days. Secondary outcomes included ventilator-associated pneumonia, Clostridioides difficile infection, and patient-important bleeding.
Among the 4,821 patients, clinically important upper GI bleeding occurred in 25 of 2,385 patients (1.0%) receiving pantoprazole compared with 84 of 2,377 patients (3.5%) receiving placebo (hazard ratio [HR], 0.30; 95% CI, 0.19-0.47; P < 0.001).
In the pantoprazole group mortality at 90 days was reported in 696 of 2,390 patients (29.1%) and in the placebo group 734 of 2,379 patients (30.9%) (HR, 0.94; 95% CI, 0.85-1.04; P = 0.25). Patient-important bleeding was also reduced with pantoprazole, while other secondary outcomes did not differ significantly between the groups.
Full disclosures can be found in the original study.