Comparison of 2 days versus 5 days of octreotide infusion along with endoscopic therapy in preventing early rebleed from esophageal varices: a randomized clinical study.

Background: Variceal bleeding is a medical emergency with 20% mortality at 6 weeks. The role of vasoactive agents in achieving hemostasis and preventing rebleeding has been well documented. The optimal duration of these agents has not been well established. There are no previous studies yielding the exact duration of octreotide to be administered to prevent rebleed and mortality from esophageal varices. The aim of this study is to evaluate the effect of combination therapy (octreotide and endoscopy), the exact duration of octreotide infusion, its cost-effectiveness, and the outcome in terms of rebleed and mortality.

Patients And Methods: This was a randomized clinical trial including 124 patients with acute variceal bleeding who underwent endoscopic therapy; they were assigned randomly to 2 days (n=62) and 5 days (n=58) of continuous octreotide infusion (50 μg/kg). Early rebleeding (within 42 days of index bleed according to Baveno IV consensus guidelines), transfusion requirement, and mortality were assessed.

Results: The study had predominantly male patients, average age 47 years. Among the patients in the 2-day group, 3 (4.8%) showed early rebleed versus 5 (8.6%) in the 5-day group, but the difference was not statistically significant (P>0.05). Among the patients in the 2-day group, one patient died after 3 weeks and all the patients in the 5-day group survived till 6 weeks on follow-up, and the survival rates were comparable (P>0.05). The treatment in the 5-day group was 2.5 times costlier than that for the 2-day group as shown by a cost-wise analysis.

Conclusion: Two days of octreotide infusion following endoscopic therapy is sufficient and as efficacious as 5 days of infusion in preventing early rebleed, with reasonably better cost-effectiveness.