A non-inferiority trial comparing 2 days vs. 5 days of terlipressin and ceftriaxone in terms of 5-day rebleeding for patients with acute gastro-esophageal variceal hemorrhage.

INTRODUCTION: This trial was to shorten the duration of both vasoconstrictors and prophylactic antibiotics to only 2 days in the therapy of acute gastroesophageal variceal hemorrhage.

METHODS: After successful endoscopic hemostasis of gastroesophageal variceal hemorrhage, eligible patients were randomized to receive terlipressin infusion 1 mg per 6 hours and ceftriaxone 1 gm daily for 5 days (Group A) or similar regimen for 2 days (Group B). Primary end points were very early rebleeding at 5 days and secondary end points included 48 hours hemostasis, 42-day rebleeding and hospitalization days.

RESULTS: Group A was comprised of 48 patients, and Group B was comprised of 52 patients. Both groups were comparable in the severity of liver disease. 48 hours initial hemostasis was 95.8% in Group A and 100% in Group B (p=0.13). Very early rebleeding between 3-5 days occurred in 1 patient (2.1%) in Group A and 2 patients (3.8%) in Group B (p=0.60). The difference was 1.8% and the 95% confidence interval (CI) was -1.31% to 2.08%, which demonstrated noninferiority. 42-day rebleeding occurred in 5 patients (10.4%) in Group A and 4 patients (7.7%) in Group B (p=0.63). The median hospitalization days were 8.5 ± 3.8 days in Group A versus 5.6 ± 2.6 days in Group B (p<0.001)).

DISCUSSION: After successful endoscopic hemostasis of acute variceal bleeding, combination of 2-day terlipressin infusion and ceftriaxone therapy was not inferior to 5-day regimen in terms of very early rebleeding, with the advantage of shortening hospitalization stay.