Respiratory failure & ventilation
Efficacy and safety of ilaprazole for stress ulcer - associated upper gastrointestinal bleeding prophylaxis in critically ill patients: a randomized, double-blind, non-inferiority phase 3 trial
Primary resultResult — go to the resultAbsolute Risk Difference −0.47 95% CI −4.02 to 3.03Authors' conclusion
Ilaprazole demonstrated non-inferiority to esomeprazole in preventing UGI bleeding in critically ill patients at high risk of stress ulcer.
Study context
- Population
- Critically ill patients at high risk for stress ulcer bleeding requiring invasive mechanical ventilation, 70 hospitals in China
- Participants
- 441 patients
- Comparison
- Ilaprazole vs esomeprazole
- Ilaprazolen = 220
- Esomeprazolen = 221reference
Methodological detailsdouble-blind, non-inferiority, phase 3, multicentre, 70 hospitals across China, July 16, 2021, to April 28, 2022
- Double-blind
- Non-inferiority
- Phase 3
- Multicentre
- 70 hospitals across China, July 16, 2021, to April 28, 2022
Primary result
As reported in the abstract
Absolute Risk Difference
−0.47
95% CI −4.02 to 3.03
P = 0.772
Events by treatment group
Ilaprazole vs esomeprazole
Absolute Risk Difference −0.47 (95% CI −4.02 to 3.03); P = 0.772
Secondary outcomes
Clinically insignificant UGI bleeding, any GI bleeding, 28-day mortality, ICU mortality, pneumonitis
- Comparable incidences between groups
Safety
Hepatobiliary disorders · significantly lower with Ilaprazole
P = 0.012
Adverse events
- Similar between groups
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Efficacy and safety of ilaprazole for stress ulcer - associated upper gastrointestinal bleeding prophylaxis in critically ill patients: a randomized, double-blind, non-inferiority phase 3 trial. Ann Intensive Care. Published 9 March 2026. doi:10.
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