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

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

Shawn J Pelletier  1 , Satish N Nadig, David D Lee, John B Ammori, Michael J Englesbe, Randall S Sung, John C Magee, Robert J Fontana, Jeffrey D Punch
Affiliations
Randomized Controlled Trial

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

Shawn J Pelletier et al. HPB (Oxford). 2013 Apr.

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.

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Figures

Figure 1
Figure 1
Flow diagram illustrating study enrolment and disposition of participants
Figure 2
Figure 2
Graft survival in liver transplant recipients randomized to either standard immunosuppression (steroids) or complete avoidance of steroids (no steroids). P = 0.09 with 9-year follow-up
Figure 3
Figure 3
Patient survival in liver transplant recipients randomized to either standard immunosuppression (steroids) or complete avoidance of steroids (no steroids). P = 0.11 with 9-year follow-up
See this image and copyright information in PMC

References

    1. Starzl TE, Marchioro TL, Vonkaulla KN, Hermann G, Brittain RS, Waddell WR. Homotransplantation of the liver in humans. Surg Gynecol Obstet. 1963;117:659–676. - PMC - PubMed
    1. Lerut JP. Avoiding steroids in solid organ transplantation. Transpl Int. 2003;16:213–224. - PubMed
    1. Lake JR. The role of immunosuppression in recurrence of hepatitis C. Liver Transpl. 2003;9(Suppl):63–66. - PubMed
    1. Sheiner PA, Schwartz ME, Mor E, Schluger LK, Theise N, Kishikawa K, et al. Severe or multiple rejection episodes are associated with early recurrence of hepatitis C after orthotopic liver transplantation. Hepatology (Baltimore, MD) 1995;21:30–34. - PubMed
    1. Charlton M, Seaberg E. Impact of immunosuppression and acute rejection on recurrence of hepatitis C: results of the National Institute of Diabetes and Digestive and Kidney Diseases Liver Transplantation Database. Liver Transpl Surg. 1999;5(4 Suppl. 1):107–114. - PubMed

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