Terlipressin or vasopressin plus transdermal nitroglycerin in a treatment strategy for digestive bleeding in cirrhosis

D’Amico, Gennaro; Traina, Mario; Vizzini, Giovanni; Tinè, Fabio; Politi, F.; Montalbano, Luigi; Luca, Angelo; Pasta, Linda; Pagliaro, Luigi; Morabito, Alberto

doi:10.1016/s0168-8278(05)80059-5

Cited by 62 publications

(25 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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“…Because we could not find relevant data for early rebleeding (within 6 weeks) in patients undergoing long-term ␤-blockers and/or sclerotherapy, sample size calculation was based on the incidence of early rebleeding we observed in the whole population included in a previous trial of treatment of active bleeding, 31 regardless of treatment for long-term prevention of rebleeding. In that trial 30% of patients rebled within 15 days.…”

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Octreotide Compared With Placebo in A Treatment Strategy for Early Rebleeding in Cirrhosis. A Double Blind, Randomized Pragmatic Trial

et al. 1998

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␤-Blockers and sclerotherapy prevent long-term upper digestive rebleeding in cirrhosis but they seem ineffective for early rebleeding. We compared octreotide with a placebo for the prevention of early rebleeding in cirrhotic patients. After control of acute upper digestive bleeding, 262 consecutive cirrhotic patients were randomized to octreotide 100 g subcutaneously three times a day for 15 days (n ‫؍‬ 131) or to the placebo (n ‫؍‬ 131), in a double blind pragmatic trial in which ␤-blockers and/or sclerotherapy were allowed together with the experimental treatment. Separate randomization and analysis were performed according to whether patients were eligible for ␤-blockers and/or sclerotherapy (101 placebo, 97 octreotide) or not (30 placebo, 34 octreotide). Rebleeding within 15 days was the primary measure of treatment efficacy; 6-week rebleeding rate was also assessed as a secondary measure. Fifteen-day cumulative proportions of patients rebleeding were 28% in the placebo group and 24% in the octreotide group (P ‫؍‬ .40); corresponding figures among the 198 patients eligible to ␤-blockers and/or sclerotherapy were 26% and 16% (P ‫؍‬ .05) and among the 64 not eligible for these treatments 33% and 49% (P ‫؍‬ .29). Among patients eligible to ␤-blockers and/or sclerotherapy, a significant reduction of rebleeding episodes (35 vs. 18, P ‫؍‬ .03), blood transfusions (75 vs. 50, P ‫؍‬ .04), and days of stay in hospital (1,544 vs. 1,190, P ‫؍‬ .0001) was also found in the octreotide group: this beneficial effect was confirmed 6 weeks after randomization. Following upper digestive bleeding in cirrhosis, almost 50% of patients rebleed and 30% die within 6 weeks.

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“…It remains to be seen whether these data can be reproduced sin was compared to vasopressin in 5 unblinded trials [21,30,[38][39][40][41][42], there was a significantly lower complica-and establish terlipressin as a gold standard [44]. tion rate with glypressin, even when vasopressin was associated with nitroglycerin [30,42].…”

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Pharmacological Treatment of Acute Variceal Bleeding

Burroughs¹

1998

Digestion

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A review of the progress in pharmacological treatment of portal hypertension is best considered in the clinical setting of the acute variceal bleeding episode, the primary prophylaxis of variceal bleeding, and prevention of rebleeding from varices and portal hypertensive gastropathy. The data from randomized trials has been evaluated using meta-analysis when possible, and a conclusion made regarding the optimal drug or other therapy in the particular clinical setting. A recent meta-analytic review has been published [1].

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Terlipressin or vasopressin plus transdermal nitroglycerin in a treatment strategy for digestive bleeding in cirrhosis

Cited by 62 publications

References 20 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

Octreotide Compared With Placebo in A Treatment Strategy for Early Rebleeding in Cirrhosis. A Double Blind, Randomized Pragmatic Trial

Pharmacological Treatment of Acute Variceal Bleeding

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