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The following is a summary of “A Noninferiority Trial Comparing 2 Days vs 5 Days of Terlipressin and in Terms of 5-Day Rebleeding for Patients With Acute Gastroesophageal Variceal Hemorrhage,” published in the September 2024 issue of Gastroenterology by Lo et al.
Acute gastroesophageal variceal hemorrhage is a serious complication in patients with liver disease.
Researchers conducted a prospective study to evaluate whether a 2-day regimen of terlipressin and ceftriaxone is noninferior to a 5-day regimen in preventing early rebleeding.
They randomized patients, after successful endoscopic hemostasis, to receive terlipressin (1 mg per 6 hours) and ceftriaxone (1 g daily) for 5 days (group A) or 2 days (group B). Primary endpoints were 5-day rebleeding, and secondary endpoints included 48-hour hemostasis, 42-day rebleeding, and hospitalization days.
The results showed that 48-hour hemostasis was achieved in 95.8% of group A patients and 100% of group B patients (P= 0.13). Very early rebleeding between days 3 and 5 occurred in 1 patient (2.1%) in group A and 2 patients (3.8%) in group B (P= 0.60), demonstrating noninferiority (difference of 1.8%, 95% CI −1.31% to 2.08%), 42 day rebleeding occurred in 10.4% of group A and 7.7% of group B patients (P= 0.63). Median hospitalization was 8.5 ± 3.8 days in group A and 5.6 ± 2.6 days in group B (P< 0.001).
The study concluded that the 2-day regimen of terlipressin and ceftriaxone was noninferior to the 5-day regimen in preventing early rebleeding, with a shorter hospital stay.
Source: journals.lww.com/ajg/fulltext/2024/09000/a_noninferiority_trial_comparing_2_days_vs_5_days.20.aspx
