Gastroenterology
Volume 137, Issue 3 , Pages 1179-1180, September 2009

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  • Arun J. Sanyal

      Affiliations

    • Division of Gastroenterology, Hepatology, and Nutrition, Virginia Commonwealth University, Richmond, Virginia
  • ,
  • Thomas Boyer

      Affiliations

    • New Arizona Liver Institute, University of Arizona, Tucson, Arizona

published online 24 July 2009.

Article Outline

 

We thank Drs Gerbes and his colleagues for their interest in our work and for sharing their experience with terlipressin, which demonstrates the relative safety of this drug when used for the treatment of the hepatorenal syndrome. Although it is difficult to compare data from a retrospective, open-label investigation to a randomized, double-blind, placebo-controlled study (ie, OT-0401), it seems that the rate of serious adverse events related to treatment are identical (9%) between the OT-0401 bolus regimen and the reported continuous infusion regimen. We would like to highlight, however, that the rate of all serious cardiac adverse events reported in OT-0401 was similar between the terlipressin arm (11%) and the placebo control (13%). Two patients (4%) in the terlipressin arm did experience a serious (albeit reversible and nonfatal) ischemic event, compared with none in the placebo group. Because the calculated terlipressin dose intensity in OT-0401 was on average 3.8 mg/d, it is not surprising that the related serious adverse event rate with continuous infusion (with a dose intensity of 4.3 mg/d) seems to be similar to that reported in OT-0401, as opposed to the higher rate and dose intensity in the TAHRS study. It is also possible that the differences in the rates of cardiovascular adverse events between our study and the TAHRS study reflected differences in adverse event reporting related to the open-label nature of the latter trial. In the absence of larger, randomized, double-blind trials, it remains an interesting hypothesis on whether a continuous infusion regimen of terlipressin would further reduce serious adverse events, in particular ischemic events, while maintaining similar efficacy to improve renal function and reverse the hepatorenal syndrome.

 Conflicts of interest The authors disclose no conflicts.

PII: S0016-5085(09)01178-0

doi:10.1053/j.gastro.2009.07.022

Refers to article:

  • Terlipressin for Hepatorenal Syndrome: Continuous Infusion as an Alternative to IV Bolus Administration , 24 July 2009

    Alexander L. Gerbes, Elisabeth Huber, Veit Gülberg
    Gastroenterology September 2009 (Vol. 137, Issue 3, Page 1179)

Gastroenterology
Volume 137, Issue 3 , Pages 1179-1180, September 2009