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Three Part Question

In [adults with known varices] is [terlipressin] effective at [reducing acute bleeding]?

Clinical Scenario

A 55 year old male presents with massive haematemesis. He has known oesophageal varices. He is tachycardic, peripherally shut down and continues to actively vomit fresh blood. You wonder if pharmacolgical treatment with terlipressin will be effective in reducing the bleeding.

Search Strategy

Medline 1966 to 11/02 using OVID interface.
[{exp Gastro-intestinal haemorrhage-all sub-headings] or [exp esophageal varices-all sub-headings}] and [exp lypressin or exp Vasopressin] and [exp Clinical trials-all sub-headings].

Search Outcome

23 papers were identified of which 3 were relevant to the above clinical question.

Relevant Paper(s)

Author, date and country	Patient group	Study type (level of evidence)	Outcomes	Key results	Study Weaknesses
Walker S et al, 1986, Germany	34 patients with 50 endoscopically proven oesophageal variceal bleeds	Double blinded randomised placebo controlled trial	Hospital mortality	3/25 (12%) in terlipressin group and 8/25 (32%) in control group	The use of balloon tamponade was added in a "non-controlled" fashion
			Cessation of bleeding for a continuous 24 hour period within 36 hours of randomisation (p<0.05)	25/25 (100%) bleeding episodes were terminated in the terlipressin group with 20/25 (80%) terminated in the placebo group
Freeman JG et al, 1989, UK	29 patients with active variceal bleed proven on endoscopy	Double blind placebo controlled clinical trial	Cessation of active blood loss on clinical grounds	9/15 (60%) of terlipressin treated patients ceased bleeding compared with 6/16 (37%) of placebo treated patients ceased bleeding. Statistical significance not reached	Small numbers ensuring possible type 2 error
Soderlund C et al, 1990, Sweden	60 patients with endoscopically proven acutely bleeding oesophageal varices	Double blinded randomised placebo controlled trial	Need for balloon tamponade or rescue endoscopy within 24 hours of randomisation	No need for active intervention (balloon tamponade or rescue endoscopy) in 28/31 (90%) of the terlipressin group and in 17/29 (59%) of the placebo group (p<0.01)	The criteria for initiating balloon tamponade or endoscopy were not explicit

Comment(s)

Small but reasonable quality studies indicate that terlipressin is significantly better than placebo in reducing blood loss from actively bleeding oesophageal varices.

Clinical Bottom Line

Use of terlipressin as a pharmacological aid to reducing active oesophageal variceal bleeding appears indicated and effective

References

1. Walker S, Stiehl A, Raedsch R, et al. Terlipressin in bleeding esophageal varices: a placebo-controlled, double-blind study. Hepatology 1986;6(1):112-5.
2. Freeman JG, Cobden I and Record CO. Placebo-controlled trial of terlipressin (glypressin) in the management of acute variceal bleeding. J Clin Gastroenterol 1989;11(1):58-60.
3. Soderlund C, Magnusson I, Torngren S, et al. Terlipressin (triglycyl-lysine vasopressin) controls acute bleeding oesophageal varices. A double-blind, randomized, placebo-controlled trial. Scand J Gastroenterol 1990;25(6):622-30.