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

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

Research output: Contribution to journalArticle

9 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)286-293
Number of pages8
JournalHPB
Volume15
Issue number4
DOIs
StatePublished - Apr 2013
Externally publishedYes

Fingerprint

Liver Transplantation
Steroids
Graft Survival
Incidence
Group Psychotherapy
Survival Rate
Hypertension
Morbidity
Survival
Liver
Therapeutics

ASJC Scopus subject areas

  • Gastroenterology
  • Hepatology

Cite this

Pelletier, S. J., Nadig, S. N., Lee, D. D., Ammori, J. B., Englesbe, M. J., Sung, R. S., ... Punch, J. D. (2013). A prospective, randomized trial of complete avoidance of steroids in liver transplantation with follow-up of over 7 years. HPB, 15(4), 286-293. https://doi.org/10.1111/j.1477-2574.2012.00576.x

A prospective, randomized trial of complete avoidance of steroids in liver transplantation with follow-up of over 7 years. / Pelletier, Shawn J.; Nadig, Satish N.; Lee, David D.; Ammori, John B.; Englesbe, Michael J.; Sung, Randall S.; Magee, John C.; Fontana, Robert J.; Punch, Jeffrey D.

In: HPB, Vol. 15, No. 4, 04.2013, p. 286-293.

Research output: Contribution to journalArticle

Pelletier, SJ, Nadig, SN, Lee, DD, Ammori, JB, Englesbe, MJ, Sung, RS, Magee, JC, Fontana, RJ & Punch, JD 2013, 'A prospective, randomized trial of complete avoidance of steroids in liver transplantation with follow-up of over 7 years', HPB, vol. 15, no. 4, pp. 286-293. https://doi.org/10.1111/j.1477-2574.2012.00576.x
Pelletier, Shawn J. ; Nadig, Satish N. ; Lee, David D. ; Ammori, John B. ; Englesbe, Michael J. ; Sung, Randall S. ; Magee, John C. ; Fontana, Robert J. ; Punch, Jeffrey D. / A prospective, randomized trial of complete avoidance of steroids in liver transplantation with follow-up of over 7 years. In: HPB. 2013 ; Vol. 15, No. 4. pp. 286-293.
@article{94900341bbc5482387fb6f529e5f089f,
title = "A prospective, randomized trial of complete avoidance of steroids in liver transplantation with follow-up of over 7 years",
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.",
author = "Pelletier, {Shawn J.} and Nadig, {Satish N.} and Lee, {David D.} and Ammori, {John B.} and Englesbe, {Michael J.} and Sung, {Randall S.} and Magee, {John C.} and Fontana, {Robert J.} and Punch, {Jeffrey D.}",
year = "2013",
month = "4",
doi = "10.1111/j.1477-2574.2012.00576.x",
language = "English (US)",
volume = "15",
pages = "286--293",
journal = "HPB",
issn = "1365-182X",
publisher = "John Wiley and Sons Inc.",
number = "4",

}

TY - JOUR

T1 - A prospective, randomized trial of complete avoidance of steroids in liver transplantation with follow-up of over 7 years

AU - Pelletier, Shawn J.

AU - Nadig, Satish N.

AU - Lee, David D.

AU - Ammori, John B.

AU - Englesbe, Michael J.

AU - Sung, Randall S.

AU - Magee, John C.

AU - Fontana, Robert J.

AU - Punch, Jeffrey D.

PY - 2013/4

Y1 - 2013/4

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84874681475&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84874681475&partnerID=8YFLogxK

U2 - 10.1111/j.1477-2574.2012.00576.x

DO - 10.1111/j.1477-2574.2012.00576.x

M3 - Article

C2 - 23458449

AN - SCOPUS:84874681475

VL - 15

SP - 286

EP - 293

JO - HPB

JF - HPB

SN - 1365-182X

IS - 4

ER -