Intravenous pantoprazole reduced the risk of clinically significant upper gastrointestinal bleeding in intensive care unit patients by 70% compared to placebo, according to a recent study. The absolute risk reduction was 2.5 percentage points (95% confidence interval [CI], 1.6–3.3), highlighting its clinical relevance.

The REVISE trial, a multicenter, randomized, double-blind study, evaluated the efficacy and safety of intravenous pantoprazole (40 mg daily) for stress ulcer prophylaxis in 4,821 critically ill adults undergoing invasive mechanical ventilation. Conducted across 68 intensive care units (ICUs) in eight countries, the trial reported a significant reduction in upper gastrointestinal (GI) bleeding, which occurred in 1.0% (25 of 2,385) of pantoprazole recipients versus 3.5% (84 of 2,377) in the placebo group (hazard ratio [HR], 0.30; 95% CI, 0.19–0.47; P<0.001; Table 3).

Mortality rates were similar between groups at 90 days (29.1% vs. 30.9%; HR, 0.94; 95% CI, 0.85–1.04; P=0.25). Secondary outcomes showed no significant differences in ventilator-associated pneumonia (23.2% vs. 23.8%) or Clostridioides difficile infection (1.2% vs. 0.7%; P=0.50). Patient-important bleeding, defined as bleeding requiring transfusion, prolonged hospitalization, or resulting in disability, was less frequent in the pantoprazole group (1.5% vs. 4.2%; HR, 0.36; 95% CI, 0.25–0.53; P<0.001).

Subgroup analyses found no evidence of effect modification based on prehospital acid suppression, illness severity, or ICU admission type. The study also notes operational adjustments during the COVID-19 pandemic, ensuring continuity of enrollment while maintaining blinding and protocol fidelity.

Researchers concluded in the New England Journal of Medicine that pantoprazole significantly reduces upper GI bleeding risk in critically ill patients without increasing mortality or risks of ventilator-associated pneumonia or C. difficile infection. However, prior findings of higher mortality in severely ill patients warrant further research in this subgroup. The trial was funded by the Canadian Institutes of Health Research and other national grant organizations.

Full disclosures and additional data, including adjustments for sensitivity analyses, are available in the published study.