Open, randomized, comparative study of efficacy and safety between Haemopressin and Glypressin in treating acute esophageal varices hemorrhage

Abstract

Background/aims: Hemorrhage from esophageal varices is a major consequence of liver cirrhosis. Pharmacological treatment can be started immediately by an internist to arrest acute esophageal variceal hemorrhage (EVH). Terlipressin is easy to administer and effective in treating acute EVH, with or without adjuvant endoscopic sclerotherapy, and in reducing mortality in these patients. Due to these potentials, a phase IV bioequivalence study was conducted to compare a new brand of terlipressin (Haemopressin: contains 1 mg tri-glycyl-lysin-vasopressin acetate) with one that is currently available in the market (Glypressin).

Methodology: All cirrhotic patients with acute EVH were randomized to receive Haemopressin (n = 19) or Glypressin (n = 22) 2mg i.v. immediately followed by 1 mg. i.v. q4h for 5 days.

Results: The demographics were similar between H-group and G-group. Successful control of acute bleeding within 24 hours was no different between the 2 groups (18/19 vs. 19/22). Failure to control bleeding within 5 days of drug administration was also no different between the 2 groups (4/19 vs. 6/22). Rebleeding events, the requirement for blood transfusions and rescued treatment were also comparative between the 2 groups. Half of the patients in either group had mild, temporary and self-limited side effects.

Conclusions: The study confirms that administration of terlipressin, by either Haemopressin or Glypressin, is generally safe and indeed highly effective in the treatment of acute EVH.