Placebo-Controlled Trial of Terlipressin (Glypressin) in the Management of Acute Variceal Bleeding

Freeman, Jan G.; Cobden, I; Record, C. O.

doi:10.1097/00004836-198902000-00014

Cited by 105 publications

(48 citation statements)

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“…5 This has encouraged the search for pharmacologic alternatives overcoming these limitations. Recent large randomized controlled trials (RCTs) showed that terlipressin effectively controls variceal bleeding with a low rate of side-effects [6][7][8][9][10][11][12] even when used for an extended period. 13,14 Terlipressin has optimal applicability, does not require specialized staff or sophisticated equipment, and is the only drug shown to improve survival from variceal bleeding in placebocontrolled trials 9,15 and meta-analyses.…”

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confidence: 99%

“…The sample size calculation was based on the results of 10 published studies for terlipressin and 15 for emergency sclerotherapy (at the time the study was planned). The estimated overall failure rate for terlipressin was 40% (failure to control bleeding 20% ϩ development of early rebleeding 20%), [6][7][8][9][10][11][12][13]15,16 and 30% (10% ϩ 20%, respectively) for sclerotherapy. 3,14,[17][18][19] The sample size needed to detect clinical equivalence (a difference lower than the maximum expected, was established at 10%) in efficacy was calculated as 83 patients on each arm using a 2-sided test with 80% power at a significance level of 5%.…”

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confidence: 99%

“…3,14,[17][18][19] The sample size needed to detect clinical equivalence (a difference lower than the maximum expected, was established at 10%) in efficacy was calculated as 83 patients on each arm using a 2-sided test with 80% power at a significance level of 5%. The expected incidence of severe side effects was 4% for terlipressin [6][7][8][9][10][11][12][13]15,16 and 16% for EIS. 3,14 To detect such differences in the incidence of severe side effects (2-sided test, ␣ ϭ 0.05, ␤ ϭ 0.20), 95 patients were required in each group.…”

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Multicenter Randomized Controlled Trial of Terlipressin Versus Sclerotherapy in the Treatment of Acute Variceal Bleeding: The TEST Study

et al. 2000

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Failure to control bleeding and early rebleeding account for the high mortality associated with variceal hemorrhage in cirrhosis. We compared endoscopic sclerotherapy to terlipressin, a drug that effectively controls acute bleeding while reducing in-hospital mortality. This multicenter randomized controlled trial included 219 cirrhotic patients admitted for endoscopy-proven acute variceal bleeding and randomized to receive repeated injections of terlipressin during 6 days (n ‫؍‬ 105) or emergency sclerotherapy (n ‫؍‬ 114). Success was defined as obtaining control of bleeding (24-hour bleeding-free period during the first 48 hours) and lack of early rebleeding (any further bleeding from initial control to 5 days later) and survival during the study. Both groups were similar at inclusion. Failure rate for terlipressin was 33% and 32% for sclerotherapy (not significant [NS]). Early rebleeding was responsible for 43% and 44% of failures, respectively. This high efficacy was observed in both Child-Pugh class A ؉ B and Child-Pugh class C patients. Both treatments were similar regarding transfusion requirements, in-hospital stay, and 6-week mortality (26 vs. 19 patients). Side effects appeared in 20% of patients receiving terlipressin and in 30% of those on sclerotherapy (P ‫؍‬ .06); being serious in 4% and 7%, respectively (NS). In conclusion, terlipressin and sclerotherapy are equally highly effective therapies achieving the initial control of variceal bleeding and preventing early rebleeding. Both treatments are safe, but terlipressin is better tolerated. Therefore, terlipressin may represent a first-line treatment in acute variceal bleeding until the administration of elective therapy, especially in hospitals where a skilled endoscopist is not available 24 hours a day. (HEPATOLOGY 2000;32:471-476.)Variceal bleeding complicating cirrhosis results in a high mortality (24% to 35%), mainly determined by the impairment in liver function, the failure to control bleeding, and the development of early rebleeding. 1 The high frequency of early rebleeding (30% to 50%) 2 has led to the recommendation that treatments for variceal hemorrhage should be aimed, not only at arresting bleeding, but also at preventing early rebleeding. 3 Emergency endoscopic injection sclerotherapy (EIS) is widely considered as the best treatment for variceal bleeding. 3,4 However, EIS has limitations because of the difficulties in having an experienced endoscopist on a 24-hours-a-day basis and the risk of causing severe side effects, known to be more frequent following emergency than elective procedures. 5 It is doubtful that banding ligation is better than EIS in acute bleeding. 5 This has encouraged the search for pharmacologic alternatives overcoming these limitations. Recent large randomized controlled trials (RCTs) showed that terlipressin effectively controls variceal bleeding with a low rate of side-effects 6-12 even when used for an extended period. 13,14 Terlipressin has optimal applicability, does not require specialized staff or sophistic...

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Multicenter Randomized Controlled Trial of Terlipressin Versus Sclerotherapy in the Treatment of Acute Variceal Bleeding: The TEST Study

et al. 2000

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“…After this time, if the bleeding is controlled, the dosage should be reduced by half. Five days of dosing should not be exceeded (31,32,33).…”

Section: Vasoactive Drugsmentioning

confidence: 99%

Practical Aproach to Variceal Gastrointestinal Bleeding – Association of Polish Surgeons Guidelines

Wallner¹,

Solecki²,

Ćwik³

et al. 2014

Polish Journal of Surgery

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“…Dear Sir, Terlipressin (triglycyl-lysine vasopressin) is a vasopressin analogue that has proven to be effective in the treatment of huge gastrointestinal haemorrhages [1,2]. The therapeutic effect of the drug is due to its binding to the V 1 and V 2 receptors on the vascular smooth muscle cells of the portal vessels followed by a marked splanchnic vasoconstriction which thus hinders bleeding from these vessels.…”

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Toxic Rhabdomyolysis Induced by Terlipressin Infusion in a Uraemic Patient Suffering from AA-Type Amyloidosis

Rolla

Cannella

Ravetti

1999

Nephron

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Placebo-Controlled Trial of Terlipressin (Glypressin) in the Management of Acute Variceal Bleeding

Cited by 105 publications

References 0 publications

Multicenter Randomized Controlled Trial of Terlipressin Versus Sclerotherapy in the Treatment of Acute Variceal Bleeding: The TEST Study

Multicenter Randomized Controlled Trial of Terlipressin Versus Sclerotherapy in the Treatment of Acute Variceal Bleeding: The TEST Study

Practical Aproach to Variceal Gastrointestinal Bleeding – Association of Polish Surgeons Guidelines

Toxic Rhabdomyolysis Induced by Terlipressin Infusion in a Uraemic Patient Suffering from AA-Type Amyloidosis

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