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Lack of difference among terlipressin, somatostatin, and octreotide in the control of acute gastroesophageal variceal hemorrhage
Author(s) -
Seo Yeon Seok,
Park Soo Young,
Kim Moon Young,
Kim Ju Hyun,
Park Jun Yong,
Yim Hyung Joon,
Jang Byoung Kuk,
Kim Hong Soo,
Hahn Taeho,
Kim Byung Ik,
Heo Jeong,
An Hyonggin,
Tak Won Young,
Baik Soon Koo,
Han Kwang Hyub,
Hwang Jae Seok,
Park Sang Hoon,
Cho Mong,
Um Soon Ho
Publication year - 2014
Publication title -
hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.488
H-Index - 361
eISSN - 1527-3350
pISSN - 0270-9139
DOI - 10.1002/hep.27006
Subject(s) - terlipressin , octreotide , medicine , somatostatin , gastroenterology , endoscopy , cirrhosis , clinical endpoint , varices , upper gastrointestinal bleeding , portal hypertension , randomized controlled trial , hepatorenal syndrome
Vasoactive drugs are recommended to be started as soon as possible in suspected variceal bleeding, even before diagnostic endoscopy. However, it is still unclear whether the therapeutic efficacies of the various vasoactive drugs used are comparable. The aim of this prospective, multicenter, randomized, noninferiority trial was to characterize the effects of terlipressin, somatostatin, and octreotide when they are initiated before endoscopic treatment in patients with acute variceal bleeding. Patients with liver cirrhosis and significant upper gastrointestinal bleeding were randomly assigned to receive early administration of terlipressin, somatostatin, or octreotide, followed by endoscopic treatment. Patients with nonvariceal bleeding were excluded after endoscopy. The primary endpoint was 5‐day treatment success, defined as control of bleeding without rescue treatment, rebleeding, or mortality, with a noninferiority margin of 0.1. In total, 780 patients with variceal bleeding were enrolled: 261 in the terlipressin group; 259 in the somatostatin group; and 260 in the octreotide group. At the time of initial endoscopy, active bleeding was noted in 43.7%, 44.4%, and 43.5% of these patients, respectively ( P = 0.748), and treatment success was achieved by day 5 in 86.2%, 83.4%, and 83.8% ( P = 0.636), with similar rates of control of bleeding without rescue treatment (89.7%, 87.6%, and 88.1%; P = 0.752), rebleeding (3.4%, 4.8%, and 4.4%; P = 0.739), or mortality (8.0%, 8.9%, and 8.8%; P = 0.929). The absolute values of the lower bound of confidence intervals for terlipressin versus somatostatin, terlilpressin versus octreotide, and octreotide versus somatostatin were 0.095, 0.090, and 0.065, respectively. Conclusion : Hemostatic effects and safety did not differ significantly between terlipressin, somatostatin, and octreotide as adjuvants to endoscopic treatment in patients with acute gastroesophageal variceal bleeding. (H epatology 2014;60:954–963)