A prospective, randomized trial of complete avoidance of steroids in liver transplantation with follow-up of over 7 years

HPB (Oxford). 2013 Apr;15(4):286-93. doi: 10.1111/j.1477-2574.2012.00576.x. Epub 2012 Sep 28.

Abstract

Objectives: Steroids are a mainstay of treatment in orthotopic liver transplantation (OLT) and are associated with significant morbidity. This trial was conducted to assess the efficacy of steroids avoidance.

Methods: Patients undergoing OLT between June 2002 and April 2005 were entered into a prospective, randomized trial of complete steroids avoidance and followed until November 2011. Recipients received either standard therapy (n = 50) or complete steroids avoidance (n = 50). Analyses were performed on an intention-to-treat basis. The mean follow-up of all recipients was 2095 ± 117 days. Sixteen (32%) recipients randomized to the steroids avoidance group ultimately received steroids for clinical indications.

Results: Incidences of diabetes and hypertension prior to or after OLT were similar in both groups, as was the incidence of rejection. Patient and graft survival rates at 1, 3 and 5 years were lower in the steroids avoidance group than in the standard therapy group (patient survival: 1-year, 80% versus 86%; 3-year, 68% versus 76%; 5-year, 60% versus 72%; graft survival: 1-year, 76% versus 76%; 3-year, 64% versus 74%; 5-year, 56% versus 72%), but the differences were not statistically different.

Conclusions: Complete steroids avoidance provides liver transplant recipients with minimal benefit and appears to result in a concerning trend towards decreased graft and recipient survival. The present data support the use of at least a short course of steroids after liver transplantation.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Diabetes Mellitus, Type 1 / complications
  • Female
  • Follow-Up Studies
  • Graft Rejection / prevention & control*
  • Graft Survival*
  • Humans
  • Hypertension / complications
  • Immunosuppressive Agents / therapeutic use*
  • Liver Transplantation / methods*
  • Male
  • Middle Aged
  • Prospective Studies
  • Risk Factors
  • Survival Analysis
  • Treatment Outcome

Substances

  • Immunosuppressive Agents