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Efficacy and safety of ilaprazole for stress ulcer - associated upper gastrointestinal bleeding prophylaxis in
Jiao Liu1, Xiaojun Pan1, Sisi Huang1
1Department of Critical Care Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No.197 Ruijin 2nd Road, Shanghai 200025, China.
Objectives:
To evaluate the efficacy and safety of Ilaprazole in preventing stress ulcer-associated upper gastrointestinal bleeding in critically ill patients.
Design:
A Randomized, Double-Blind, non-inferiority Phase 3 Trial.
Setting:
70 hospitals across China from July 16, 2021, to April 28, 2022.
Patients:
441 Patients (mean age 59 years; 150 female) at high risk for stress ulcer bleeding requiring invasive mechanical ventilation were enrolled.
Interventions:
Patients were randomly assigned to receive either Ilaprazole (10 mg once daily, first dose doubled; 220 patients) or esomeprazole (40 mg twice daily; 221 patients).
Measurements And Main Results:
441 patients (mean age 59 years; 150 female) were enrolled: 220 received Ilaprazole and 221 received esomeprazole. In FAS set, the primary endpoint occurred in 213 (96.80%) patients in the Ilaprazole and 215 (97.30%) in esomeprazole arms (Absolute Risk Difference: -0.47, 95% CI: -4.02, 3.03, p = 0.772). Secondary outcomes showed comparable incidences of clinically insignificant UGI bleeding, any gastrointestinal bleeding, 28-day mortality, ICU mortality, and pneumonitis. Adverse events were similar between groups, but Ilaprazole had a significantly lower incidence of hepatobiliary disorders (0.9% vs. 5%, p = 0.012).
Conclusions:
Ilaprazole demonstrated non-inferiority to esomeprazole in preventing UGI bleeding in critically ill patients at high risk of stress ulcer.
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