Noradrenalin vs terlipressin in patients with hepatorenal syndrome: a prospective, randomized, unblinded, pilot study

J Hepatol. 2007 Oct;47(4):499-505. doi: 10.1016/j.jhep.2007.04.010. Epub 2007 May 24.

Abstract

Background/aims: Treatment of hepatorenal syndrome (HRS) is based on vasoconstrictors. Terlipressin is the one with the soundest evidence. Noradrenalin has been suggested as an effective alternative. The current study was aimed at assessing the efficacy and safety of noradrenalin vs terlipressin in patients with HRS.

Methods: Twenty-two consecutive cirrhotic patients with HRS (9 with HRS type 1; 13 with HRS type 2) were included. Patients were randomly assigned to be treated with noradrenalin (0.1-0.7 microg/kg/min) and albumin (10 patients) or with terlipressin (1-2 mg/4h) and albumin (12 patients). Treatment was administered until HRS reversal or for a maximum of two weeks. Patients were followed-up until liver transplantation or death.

Results: Reversal of HRS was observed in 7 of the 10 patients (70%) treated with noradrenalin and in 10 of the 12 patients (83%) treated with terlipressin, p=ns. Treatment led in both groups to a significant improvement in renal and circulatory function. No patient developed signs of myocardial ischemia.

Conclusions: Data from this unblinded, pilot study suggest that noradrenalin is as effective and safe as terlipressin in patients with HRS. These results would support the use of noradrenalin, a cheap and widely available drug, in the management of these patients.

Trial registration: ClinicalTrials.gov NCT00370253.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Antihypertensive Agents / adverse effects
  • Antihypertensive Agents / economics
  • Antihypertensive Agents / therapeutic use*
  • Female
  • Health Care Costs
  • Hepatorenal Syndrome / drug therapy*
  • Hepatorenal Syndrome / mortality
  • Humans
  • Lypressin / adverse effects
  • Lypressin / analogs & derivatives*
  • Lypressin / economics
  • Lypressin / therapeutic use
  • Male
  • Middle Aged
  • Norepinephrine / adverse effects
  • Norepinephrine / economics
  • Norepinephrine / therapeutic use*
  • Pilot Projects
  • Prospective Studies
  • Recurrence
  • Survival Analysis
  • Terlipressin
  • Treatment Outcome
  • Vasoconstrictor Agents / therapeutic use*

Substances

  • Antihypertensive Agents
  • Vasoconstrictor Agents
  • Lypressin
  • Terlipressin
  • Norepinephrine

Associated data

  • ClinicalTrials.gov/NCT00370253