Lack of difference among terlipressin, somatostatin, and octreotide in the control of acute gastroesophageal variceal hemorrhage

Yeon Seok Seo, Soo Young Park, Moon Young Kim, Ju Hyun Kim, Jun Yong Park, Hyung Joon Yim, Byoung Kuk Jang, Hong Soo Kim, Taeho Hahn, Byung Ik Kim, Jeong Heo, Hyonggin An, Won Young Tak, Soon Koo Baik, Kwang Hyub Han, Jae Seok Hwang, Sang Hoon Park, Mong Cho, Soon-Ho Um

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Abstract

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.

Original languageEnglish
Pages (from-to)954-963
Number of pages10
JournalHepatology
Volume60
Issue number3
DOIs
Publication statusPublished - 2014 Jan 1

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Octreotide
Somatostatin
Hemorrhage
Endoscopy
Therapeutics
terlipressin
Mortality
Hemostatics
Liver Cirrhosis
Pharmaceutical Preparations
Confidence Intervals
Safety

ASJC Scopus subject areas

  • Hepatology

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Lack of difference among terlipressin, somatostatin, and octreotide in the control of acute gastroesophageal variceal hemorrhage. / 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.

In: Hepatology, Vol. 60, No. 3, 01.01.2014, p. 954-963.

Research output: Contribution to journalArticle

Seo, YS, Park, SY, Kim, MY, Kim, JH, Park, JY, Yim, HJ, Jang, BK, Kim, HS, Hahn, T, Kim, BI, Heo, J, An, H, Tak, WY, Baik, SK, Han, KH, Hwang, JS, Park, SH, Cho, M & Um, S-H 2014, 'Lack of difference among terlipressin, somatostatin, and octreotide in the control of acute gastroesophageal variceal hemorrhage', Hepatology, vol. 60, no. 3, pp. 954-963. https://doi.org/10.1002/hep.27006
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. / Lack of difference among terlipressin, somatostatin, and octreotide in the control of acute gastroesophageal variceal hemorrhage. In: Hepatology. 2014 ; Vol. 60, No. 3. pp. 954-963.
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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 - 2014/1/1

Y1 - 2014/1/1

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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