NDT Advance Access published online on September 30, 2009
Nephrology Dialysis Transplantation, doi:10.1093/ndt/gfp506
Improved growth and cardiovascular risk after late steroid withdrawal: 2-year results of a prospective, randomised trial in paediatric renal transplantation
1 Department of Pediatrics I, University Children's Hospital Heidelberg, INF 430, 69120 Heidelberg 2 Dr. V. Haunersches Children's Hospital, Ludwig-Maximilian's-University, Lindwurmstraße 4, 80337 Munich 3 Department of Pediatric Nephrology, Hepatology and Metabolic Diseases, Hanover Medical School, Carl-Neuberg-Straße 1, 30625 Hanover 4 University Children's Hospital, Kochstraße 2, 03641 Jena 5 Children's Hospital Memmingen, Bismarckstraße 23, 87700 Memmingen 6 University Children's Hospital, Mathildenstraße 1, 79106 Freiburg 7 University Children's Hospital, Charité Campus Virchow, Augustenburger Platz 1, 13353 Berlin 8 University Children's Hospital, Albert-Schweitzer-Str. 33, 48149 Münster 9 University Children's Hospital, Baldingerstraße, 35033 Marburg/Lahn, Germany
Correspondence and offprint requests to: Burkhard Tönshoff; E-mail: Burkhard.Toenshoff{at}med.uni-heidelberg.de
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Abstract |
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Background. Long-term corticosteroid treatment impairs growth and increases cardiovascular risk factors. Hence, steroid withdrawal constitutes a major topic in paediatric renal transplantation and maintenance immunosuppression.
Methods. The lack of data from randomised controlled trials caused us to conduct the first prospective, randomised, multicentre study on late steroid withdrawal among paediatric kidney allograft recipients treated with standard-dose cyclosporine microemulsion (CsA) and mycophenolate mofetil (MMF) for 2 years. Forty-two low- or regular-immunologic risk patients were randomly assigned, 
1 year post-transplant, to continue taking or to withdraw steroids over 3 months.
Results. Two years after steroid withdrawal, they showed a longitudinal growth superior to controls [mean height standard deviation score (SDS) gain, 0.6 ± 0.1 SDS versus –0.2 ± 0.1 SDS (P < 0.001)]. The prevalence of the metabolic syndrome declined significantly (P < 0.05), 2 years after steroid withdrawal, from 39% (9/23) to 6% (1/16). Steroid-free patients had less frequent arterial hypertension (50% versus 93% (P < 0.05)) and required fewer antihypertensive drugs [0.6 ± 0.2 versus 1.5 ± 0.3 (P < 0.05 versus control)]. Additionally, they had a significantly improved carbohydrate and lipid metabolism with fewer hypercholesterolaemia and hypertriglyceridaemia (P < 0.05 versus control). Patient and graft survival amounted to 100%. Allograft function remained stable 2 years after steroid withdrawal. The incidence of acute rejections was similar in the steroid-withdrawal group (1/23, 4%) and controls (2/19, 11%).
Conclusion. Late steroid withdrawal in selected CsA- and MMF-treated paediatric kidney transplant recipients improves growth, mitigates cardiovascular risk factors and reduces the prevalence of the metabolic syndrome, at no increased risk of acute rejection or unstable graft function.
Keywords: cardiovascular; metabolic syndrome; mycophenolate mofetil; paediatric renal transplantation; steroid withdrawal
Received for publication: 7. 7.09
Accepted in revised form: 31. 8.09