This study compared outcomes of steroid withdrawal versus continued steroid therapy in kidney and heart transplant recipients. Over 1500 patients were enrolled from 1994-2002 and followed for 5-6 years on average. Results showed that steroid withdrawal led to superior patient and graft survival rates compared to controls continuing steroids. Steroid withdrawal also reduced risks of complications like osteoporosis and cataracts. However, it was associated with a small increased risk of acute rejection episodes. Overall, the study suggests that steroid withdrawal after 6 months is safe and effective for transplant recipients.

1. Journal Club February 24 th 2008 Christos Argyropoulos

2. Opelz et al. Long term prospective study of steroid withdrawal in Kidney and Heart Transplantation. American Journal of Transplantation 5:720-728, 2006

13. Results II

15. Results IV “ Although only patients with matching controls were included in this analysis, graft survival was virtually identical to that obtained with the series as a whole” Pts 81.9 ±1.8% 88.8 ±1.5% 91.8 ±1.3% Cntrls 75.3 ±1.2% 84.3 ±1.0% 87.9 ±1.0% p 0.0001 0.0016 0.0091

16. Results V Cumulative Incidence of Discrete Creatinine Outcome: 37.3 ± 1.9 % (patients) vs 35.1 ± 1.0% (controls), p –value 0.45 ( all patients ) 33.6 ± 2.6% (patients) vs 50.4 ± 3.0% (controls), p-value < 0.0001 (patients who never required steroids after weaning)

17. Results VI Cumulative Incidence of Acure Rejection Outcome : 8.6 ± 1.1 % (patients) vs 10.2 ± 0.7% (controls), p –value 0.21 ( Kidney ) 35.3 ± 2.8% (patients) vs 30.6 ± 2.3% (controls), p-value 0.15 (Heart)

18. Results VII Cumulative Incidence of Steroid Use at 5 years: 41.4 ± 1.5 % (K) and 55.7 ± 2.5% (H) Statin Use at 5 years: 51.3 (patients) and 59.6 (controls)

22. Vincenti et al. A Randomized, Multicenter Study of Steroid Avoidance, Early Steroid Withdrawal or Standard Steroid Therapy in Kidney Transplant Recipients. American Journal of Transplantation 8:307-316, 2008

33. Results I Delayed Graft Function: 26 (SF), 26 (SW), 23 (CS)

34. Results II

36. Results IV Non – inferiority could not be demonstrated in the ITT analysis In the observed case analysis, the primary non-inferiority point was met for the SF and SW arms

37. Results V

40. Results VIII