OBJECTIVES: Patients in intensive care units (ICUs) are at risk of stress-related gastrointestinal (GI) bleeding and stress ulcer prophylaxis (SUP), including proton pump inhibitors, is widely used in the attempt to prevent this. In this secondary analysis of Stress Ulcer Prophylaxis in Intensive Care Unit (SUP–ICU) trial, we assessed 1-year outcomes in the pantoprazole vs placebo groups.

METHODS: In the SUP–ICU trial, 3298 acutely admitted ICU patients at risk of GI bleeding were randomly allocated, stratified for site, to pantoprazole or placebo. In this secondary analysis, we assessed clinically important GI bleedings in ICU and 1-year mortality, health care resource use (e.g. readmission with GI bleeding, use of home care and general practitioner), health care costs, and employment status for the Danish participants using registry data.

RESULTS: Among the 2,099 Danish participants, 2,092 had data in the registries; 1,045 allocated to pantoprazole and 1,047 to placebo. The number of clinically important GI bleedings in ICU was 1.9 percentage points [95% CI: 0.3-3.5] lower in the pantoprazole group vs. the placebo group, but none of the 1-year outcomes differed statistically significantly between groups, including total health care costs (€1954 [-2992 - 6899]), readmission with GI bleeding (-0.005 admissions [-0.016 - 0.005]), 1-year mortality (-0.013 percentage points [-0.051 - 0.026]), and employment (-0.178 weeks [-0.390 - 0.034]).