TY - JOUR
T1 - Lack of difference among terlipressin, somatostatin, and octreotide in the control of acute gastroesophageal variceal hemorrhage
AU - Seo, Yeon Seok
AU - Park, Soo Young
AU - Kim, Moon Young
AU - Kim, Ju Hyun
AU - Park, Jun Yong
AU - Yim, Hyung Joon
AU - Jang, Byoung Kuk
AU - Kim, Hong Soo
AU - Hahn, Taeho
AU - Kim, Byung Ik
AU - Heo, Jeong
AU - An, Hyonggin
AU - Tak, Won Young
AU - Baik, Soon Koo
AU - Han, Kwang Hyub
AU - Hwang, Jae Seok
AU - Park, Sang Hoon
AU - Cho, Mong
AU - Um, Soon Ho
PY - 2014/9
Y1 - 2014/9
N2 - 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.
AB - 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.
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U2 - 10.1002/hep.27006
DO - 10.1002/hep.27006
M3 - Article
C2 - 24415445
AN - SCOPUS:84906794904
SN - 0270-9139
VL - 60
SP - 954
EP - 963
JO - Hepatology
JF - Hepatology
IS - 3
ER -