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 - 10/03/26
, Dechang Chen a, ⁎
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Abstract |
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.
Le texte complet de cet article est disponible en PDF.Keywords : Upper gastrointestinal bleeding, Stress ulcer, Ilaprazole, Efficacy, Safety
Plan
Vol 16
Article 100044- 2026 Retour au numéro
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